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AnemoCheck Home is intended for home use for the determination of hemoglobin level in whole blood from a finger stick by people over the age of 18. This device is intended for people with anemia caused by iron deficiency anemia, vitamin B12 deficiency anemia, folate deficiency anemia, or who have chronic anemia due to sickle cell disease or thalassemia. AnemoCheck Home tests are for in vitro diagnostic use only. Prescription Use Only.

AnemoCheck Home is a home use with prescription anemia test that is semiquantitative, color based, single use test for hemoglobin level determination. Simply, a user performs a finger stick, less than one drop of blood (5uL) is collected into a collection tube within the test cap, the test cap is mated with the test body and shaken. After 2 minutes of development time, the resulting color of the test solution correlates to a color on a color card. The color results correlate to total hemoglobin levels. As shown, the colors range from blue to red (blue and green indicating low hemoglobin levels, yellow indicating slightly decreased hemoglobin levels and orange and red indicating high levels of hemoglobin), with 1.0 g/dL color block resolution. Users may assign values in between two color blocks for a resolution of 0.5 g/dL. AnemoCheck Home is rapid (2 minutes), simple to use, disposable, and is a stand-alone system that does not require electrical power, additional equipment, or training. The device is semi-quantitative and designed to use a specific test body, test cap, blood collection tube and chemical reagent solution. The blood collection tube serves as a pipette and measuring instrument. No dilution is required or measuring is required by the lay user. AnemoCheck Home leverages the same chemistry and technology used in AnemoCheck (K163215). When blood is mixed with the pre-filled solution, an oxidation-reduction (redox) 3.3.5.5.5 tetramethylbenzidine (TMB) and hydrogen peroxide, leading to stable oxidized TMB products. The products exhibit different colors based on the amount of total hemoglobin present in the sample. After 2 minutes, the resulting color of the solution then allows for visual interpretation with the naked eye using a color card for determination of hemoglobin (g/dL).

The provided document is a 510(k) summary for the AnemoCheck Home device. It details a semi-quantitative, color-based test for hemoglobin levels from a finger stick, intended for home use by individuals over 18 with certain types of anemia.

Based on the provided text, here's an attempt to extract the requested information, acknowledging that some specific details (like exact sample sizes for training or specific expert qualifications for ground truth) might not be explicitly stated in this high-level summary.

Acceptance Criteria and Device Performance:

The document broadly states that "Analytical testing of AnemoCheck Home versus the predicate device and comparator methods demonstrate substantial equivalence based on accuracy and precision." However, specific numerical acceptance criteria (e.g., a defined range for accuracy or precision) are not detailed in this summary. Similarly, the "reported device performance" in terms of specific quantitative results for accuracy and precision are also not explicitly provided in a table format. The text only offers a general conclusion that the test results are "comparable to other test methods."

Therefore, a table of acceptance criteria and reported device performance cannot be generated from the given text.

Here's the rest of the information based on the provided document:

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated in the summary document. It mentions "analytical testing" and "test results in the hands of the intended user," implying a test set was used, but the size is not given.
• Data Provenance: Not specified in the summary document. There is no mention of country of origin of the data, nor whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the 510(k) summary. The document does not describe the process of establishing ground truth for the test set in detail. It refers to "clinical laboratory and point-of-care settings" as comparator methods, implying these settings generated the reference values, but not how experts specifically established "ground truth" labels for individual samples.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This information is not provided in the 510(k) summary. The document does not describe any specific adjudication method for the test set results or ground truth establishment.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This device is a semi-quantitative, color-based test for hemoglobin levels. It is interpreted visually by the user based on a color card. There is no mention of an AI component or "human readers" in the context of an MRMC study. Therefore, an MRMC comparative effectiveness study with AI assistance would not be applicable here, and no effect size would be reported.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• This is not an algorithm-only device. It is a physical, color-based test that requires user interpretation. Therefore, a "standalone algorithm-only" performance assessment is not applicable. The device's performance is inherently "human-in-the-loop" as the user matches the color to a card. The summary states, "Test results in the hands of the intended user, an untrained lay user, are comparable to other test methods."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth appears to have been established by "other test methods in clinical laboratory and point-of-care settings." This implies reference laboratory methods (e.g., automated hematology analyzers, or other established POCT devices with known accuracy) were used to determine the true hemoglobin levels for comparison. The specific type of "ground truth" (e.g., expert consensus on visual assessment, or a gold-standard lab test) is not explicitly detailed beyond "comparator methods."

8. The sample size for the training set:

• The 510(k) summary for a medical device (especially one without a complex AI model) typically describes validation studies rather than "training sets" in the machine learning sense. This document describes "analytical testing" and "assessment of performance." The concept of a "training set" for the device's development (e.g., for calibrating the color card) is not explicitly detailed in terms of sample size within this summary.

9. How the ground truth for the training set was established:

• As above, the concept of a "training set" as it relates to machine learning is not directly applicable or discussed in detail for this type of device in the provided summary. The process of how the color card was developed and correlated to specific hemoglobin values during the device's development (which could be considered analogous to "training") is not described in detail, but it would presumably involve comparing the device's color output to measured hemoglobin values from reference methods in a laboratory setting.

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The GEM Premier 7000 with iQM3 is a portable critical care system for use by health care professionals to rapidly analyze lithium heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin, and CO-Oximetry (tHb, O2Hb, MetHb, HHb, sO2*) parameters from arterial, venous, or capillary lithium heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.

*s02 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.

• · pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid- base disturbances.
• · Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:
• Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insividus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
• Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment
• of disease conditions characterized by low or high blood potassium levels.
• Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany.
• Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.
• · Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
• · Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism
• disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.
• · Lactate (Lac) measurement is used:
• to evaluate the acid-base status of patients suspected of having lactic acidosis;
• to monitor tissue hypoxia and strenuous physical exertion;
• in the diagnosis of hyperlactatemia.
• · Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.

• CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional and dysfunctional hemoglobin species.

– Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

• COHo: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

• MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.

• HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.

• O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygen status.

• sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.

The GEM Premier 7000 with iQMs system provides health care professionals with quantitative measurements of lithium heparinized whole blood pH, pCO2, pO2, Na*, K*, Ch, Ca**, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO₂*) from arterial, venous or capillary samples at the point of health care delivery in a clinical setting and in a central laboratory.

*sO₂ = Ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.

Key Components:
Instrument: It employs a unique touch-sensitive color screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
PAK (Cartridge): All required components for sample analysis are contained in the GEM PAK, including sensors, optical cell for CO-Oximetry and total bilirubin, sampler, pump tubing, distribution valve, waste container and Process Control Solutions. The GEM PAK is an entirely closed analytical system. The operator cannot introduce changes to the analytical process before or during the GEM PAK's use-life on board the instrument. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency. The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests. The setup of the instrument consists of inserting the GEM PAK into the instrument. The instrument will perform an automated GEM PAK start-up during which the following is performed: warm-up (15 minutes), sensor conditioning (10 minutes), Process Control Solution (PCS) performance (15 minutes), all of which take about 40 minutes. After GEM PAK start-up, Auto PAK Validation (APV) process is automatically completed: two completely independent solutions traceable to NIST standards, CLSI procedures or internal standards, containing two levels of concentration for each analyte (PC Solution D and E), are run by the analyzer to validate the integrity of the PC Solutions and the overall performance of the analytical system. Note: GEM PAKs that include tBili analyte will require the successful performance of CVP 5 tBili. Includes all necessary components for hemolysis detection, such as an acoustofluidic flow cell, an LED light source and an optical detector, for appropriate flagging of potassium measurements in whole blood samples without additional sample volume or sample processing steps.
Intelligent Quality Management (iQM3): iQM3 is used as the quality control and assessment system for the GEM Premier 7000 system. iQM3 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions, replacing the use of traditional external QC. iQM3 introduces hemolysis detection in whole blood samples, enhancing quality assessment in the pre-analytical phase of testing.

Based on the provided text, the device in question is the GEM Premier 7000 with iQM3, which is a portable critical care system for analyzing blood samples. The document describes its comparison to a predicate device, the GEM Premier 5000, and discusses its performance studies.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not provide a direct table of specific numerical acceptance criteria for each analyte's performance (e.g., pH, pCO2, Na+, etc.) nor does it list the reported device performance in those exact terms. Instead, it states that "All verification activities were performed in accordance to established plans and protocols and design control procedures. Testing verified that all acceptance criteria were met."

The "Performance Summary" section lists the types of studies conducted to demonstrate that the modifications (specifically the new iQM quality check/Hemolysis detection module) do not impact the performance data represented in the Operators Manual, aligning with recognized guidelines. This implies the acceptance criteria are tied to maintaining performance comparable to the predicate device and being within acceptable ranges as defined by the mentioned CLSI guidelines.

Therefore, a table of explicit numerical acceptance criteria and reported performance values for each analyte is NOT AVAILABLE in the provided text. The document broadly states that the device met its acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions several types of performance studies:

• Verification (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Interference on Potassium, Hemolysis Verification)
• Shelf-life and Use-life studies

However, the specific sample sizes used for these test sets are NOT provided in the text. There is also no information about the data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is NOT available in the provided text. The device is an in-vitro diagnostic (IVD) instrument that provides quantitative measurements of various blood parameters. The "ground truth" for such devices typically comes from reference methods, calibrated standards, or comparative analyses with established, highly accurate laboratory instruments, rather than human expert consensus on interpretations like with imaging.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Given that this is an IVD device for quantitative measurements of blood parameters, the concept of "adjudication" by multiple human readers (like in imaging studies) does not directly apply. Performance is assessed through analytical accuracy, precision, and interference studies against known standards or reference methods. Therefore, no adjudication method in the sense of expert consensus on interpretations is described or implied.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. This type of study is relevant for AI-assisted diagnostic tools where human interpretation is part of the workflow. The GEM Premier 7000 with iQM3 is described as an analytical instrument providing direct quantitative measurements, not an AI system assisting human readers with interpretation. The "iQM3" refers to Intelligent Quality Management, which is an automated quality control system for the instrument itself, not an AI for human diagnostic assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone analytical instrument. The performance studies described (Internal Method Comparison, Internal Whole Blood Precision, Hemolysis Verification, etc.) essentially represent "standalone" performance, as they evaluate the accuracy and precision of the instrument's measurements directly. The iQM3 system is an internal quality control mechanism for the device's measurements. Therefore, yes, a standalone performance evaluation of the device's analytical capabilities was implicitly done.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a device that provides quantitative measurements of blood parameters, the "ground truth" for the test set would typically be established using:

• Reference methods: Highly accurate and precise laboratory methods for measuring each analyte.
• Calibrated standards: Solutions with precisely known concentrations of the target analytes.
• Comparison to predicate device: As this is a 510(k) submission, a primary method of establishing "ground truth" performance for the new device is by comparing its measurements against those of a legally marketed predicate device (GEM Premier 5000), which itself would have been validated against reference methods and standards.

The text mentions "two completely independent solutions traceable to NIST standards, CLSI procedures or internal standards" for "Auto PAK Validation (APV)". This strongly suggests that traceable standards and potentially CLSI-defined reference methods were used to establish the ground truth for performance evaluation.

8. The sample size for the training set

The document describes the GEM Premier 7000 with iQM3 as a medical device for quantitative measurements, not explicitly as a machine learning/AI model that requires a "training set" in the conventional sense (i.e., for supervised learning). The iQM3 is an "active quality process control program" with "Pattern Recognition (PR) software." While pattern recognition might involve some form of "training" or calibration, the document does not specify a separate "training set" in terms of data volume for such a process. It focuses on the validation of the device's analytical performance. Therefore, the concept of a "training set" sample size as applicable to AI/ML devices is not explicitly discussed or provided.

9. How the ground truth for the training set was established

As noted above, the primary function of GEM Premier 7000 with iQM3 is quantitative measurement. If the "iQM3" component involved training for its "Pattern Recognition (PR) software," the document does not detail how a specific ground truth for such training was established. It primarily discusses the use of "Process Control Solutions (PCS)" and "Calibration Valuation Product (CVP 5)" for system checks and validation ("Auto PAK Validation (APV) process"). These solutions, traceable to NIST or CLSI standards, function as internal reference points for the device's operational checks and quality control, which could be considered an ongoing form of "ground truth" to maintain analytical performance, rather than a one-time "training set" for model development.

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The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, pO2, sodium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MHb, sO2*) parameters from arterial, venous or capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity.

*sO2 = ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.

· pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.

· Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:

· Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

· Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

· Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

· Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.

· Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

· Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

• · Lactate (Lac) measurement is used:
• · to evaluate the acid-base status of patients suspected of having lactic acidosis;
• · to monitor tissue hypoxia and strenuous physical exertion;
• in the diagnosis of hyperlactatemia.

· Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirubinemia in neonates.

· CO-Oximetry (tHb, COHb, MetHb, O2Hb. HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional hemoglobin species.

• Total Hemoglobin (tHb): Total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.

· COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.

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· MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.

· HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.

· O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygen status.

• sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.

The GEM Premier 5000 system provides fast, accurate, quantitative measurements of heparinized whole blood pH, pCO2, pO2, Na+, K+, Cl-, Ca++, glucose, lactate, Hct, total bilirubin and CO-Oximetry (tHb, O2Hb, COHb, MetHb, HHb, sO2) from arterial, venous or capillary samples.

The provided text is a 510(k) summary for the GEM Premier 5000 device, detailing an operating system upgrade. This document is a regulatory submission for a device change and does not contain the information requested regarding acceptance criteria, device performance tables, study specifics (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or ground truth establishment.

The submission is a Special 510(k), which indicates a modification to an already cleared device, not a de novo clearance requiring extensive clinical performance studies. The core of this submission is a software update (operating system change from Fedora 17 Linux to WindRiver LTS 18 Linux) with the stated reason to "accommodate long-term support of resolutions for common vulnerability exposures."

The document explicitly states:

• "Performance data is limited to Software Verification as the scope of this Special 510(k) is specific to an operating system upgrade..."
• "The changes in this submission do not introduce: Changes to indications for use or intended use, Changes to the fundamental scientific technology, Changes to operating principle, Changes to labeled performance claims."

Therefore, the requested information, which typically pertains to the establishment of initial clinical performance and effectiveness, is not present in this regulatory document for this specific submission. The focus here is on ensuring the device continues to meet its previously established performance claims after a technical software upgrade, rather than demonstrating new performance capabilities.

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The OPTI® B-Lac cassette is intended to be used for the in vitro measurement of pH, PO2, total hemoglobin (tHb), and % Saturated O2 in sodium heparinized venous blood samples on the OPTI CCA-TS and OPTI CCA-TS2 platform in a clinical laboratory location.
· Measurements of blood gases (pCO2, pO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

• · Total hemoglobin (tHb) measurement is used to determine the hemoglobin content of human blood.
  · Oxygen saturation (SO2) measurement is used to determine the oxygen capacity of the hemoglobin.

The OPTI CCA-TS/TS2 are portable devices, microprocessor-based instrument using optical fluorescence for the measurement blood gases, electrolytes and enzymes. The OPTI CCA-TS/TS2 utilize a color, graphical touch screen user interface. A disposable, single-use cassette contains all of the elements needed for calibration, sample measurement, and waste containment. Specific calibration from the cassette is scanned into the analyzer by holding the cassette package in front of the bar code scanner. The cassette is then placed into the measurement chamber. The analyzer warms the cassette to 37.0±0.1°C and performs a calibration verification. When calibration is verified, the analyzer aspirates the blood sample into the cassette and across the optode sensors. Fluorescence emission is then measured after equilibrating with the blood sample. After a single measurement, the cassette containing the blood sample is removed from the analyzer and discarded. The analyzer contains no reagents, blood, or waste. The B-Lac cassette is a disposable, single use cassette that contains four (4) sensors for in vitro quantitative measurements of PO2, PCO2, pH. There is an additional laser based measurement of total hemoglobin (tHb) and SO2. The B-Lac cassette is sealed in a foil pouch along with a desiccant and is marked with a barcode label that includes a lot identification number, calibration information, and expiration date.

The provided document describes the OPTI® B-Lac Cassette for in vitro measurement of blood gases and related parameters. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the performance of the redesigned B-Lac cassette was determined to meet the performance claims made in the original B-Lac cassette submission (K093280) for all analytes. However, the specific quantitative acceptance criteria from K093280 are not detailed in this document. The reported device performance is indicated by the statement that the device "meets the performance claims" or "was demonstrated to meet the performance claims."

Here's a table based on the information provided, noting where specific numerical criteria are not available in this document:

2. Sample Size Used for the Test Set and Data Provenance

• 20-Day Precision:

  • Sample Size: Paired samples run twice daily over 20 days. Three lots of B-Lac cassettes were used, and three levels of aqueous quality control solution.
  • Data Provenance: In-house (presumably US-based, as the company is in Georgia, USA). Retrospective data analysis of prospective testing.

• Within-Run Precision:

  • Sample Size: Multiple repeats using three lots of B-Lac cassettes, three levels of aqueous quality controls, and whole blood manipulated to 3 different levels.
  • Data Provenance: In-house. Retrospective data analysis of prospective testing.

• Method Comparison (in-house):

  • Sample Size: Whole blood samples tonometered to different levels using different O2/CO2 gas mixtures to generate test levels for pH, PCO2, PO2, and SO2. Samples manipulated for tHb. The exact numerical count of samples or measurements is not specified.
  • Data Provenance: In-house. Retrospective data analysis of prospective testing.

• Method Comparison (Altitude):

  • Sample Size: Whole blood samples were tonometered to obtain samples that span the range for PCO2, PO2, and pH, and spiked or diluted for tHb. Aqueous solutions were measured. Number of samples/measurements not specified, but done at 4 distinct altitude sites (75 ft, 1080 ft, 5560 ft, 10151 ft).
  • Data Provenance: Conducted in the USA (Maine, Georgia, North Carolina, Colorado). Retrospective data analysis of prospective testing.

• Interference Testing:

  • Sample Size: 16 interferents tested for each analyte (PCO2, PO2, pH, tHb, SO2). The number of samples per interferent is not specified.
  • Data Provenance: In-house. Retrospective data analysis of prospective testing.

• Stability Testing:

  • Sample Size: Three lots of B-Lac cassettes were tested. One lot was subjected to two cycles of elevated and frozen temperatures.
  • Data Provenance: In-house. Retrospective data analysis of prospective testing for the initial 6 months, with real-time testing ongoing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document describes a medical device for in vitro diagnostic measurements. The "ground truth" for the test set is established by:

• Reference Methods/Predicate Devices:

  • Gravimetric target for PCO2 and PO2 (based on gas concentration).
  • Predicate device ABL90 Flex for pH, PCO2, PO2, and tHb.
  • E series cassettes on the OPTI CCA-TS/TS2 for SO2.

• No human "experts" (e.g., radiologists) were involved in establishing the ground truth in the way
  this question implies for imaging or subjective interpretation devices. The ground truth is
  based on established analytical methods and reference instruments.

4. Adjudication Method for the Test Set

Not applicable. This device provides quantitative measurements, and ground truth is established by reference methods/instruments, not through expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This document does not mention any MRMC comparative effectiveness study where human readers improve with or without AI assistance. This device is an in vitro diagnostic instrument, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the studies described are of standalone performance of the device (OPTI® B-Lac Cassette on OPTI CCA-TS/TS2 platforms). The measurements are performed automatically by the instrument and its embedded algorithms. There is no human-in-the-loop performance described or implied for the measurement process itself, although clinical interpretation of the results by healthcare professionals would follow.

7. Type of Ground Truth Used

The ground truth used for performance evaluation includes:

• Gravimetric targets: For PCO2 and PO2 (based on gas concentration for tonometered samples).
• Predicate device measurements: Measurements from the Radiometer ABL90 Flex for pH, PCO2, PO2, tHb, and from the OPTI CCA TS2 E-Series Cassettes for SO2.
• Aqueous quality control solutions and manipulated whole blood samples: Used for precision and linearity studies, where the expected values are known or derived from previous characterization.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. The device utilizes "new algorithms utilized to calculate concentrations for these sensors" (specifically for PCO2) and has updated software. However, the data sets described are for performance verification and validation, not for training a new algorithm from scratch in the classical AI sense. If there was an internal dataset used for algorithm development or "training" (e.g., to derive calibration curves or correction factors), that information is not provided. The described studies are primarily for demonstrating post-development performance.

9. How the Ground Truth for the Training Set was Established

As no specific "training set" is described for algorithm development, the method of establishing ground truth for such a set is not provided. The document focuses on the verification and validation of the device's performance against established clinical and analytical standards.

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The Stat Profile® Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood.

The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.

As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

The provided text describes the performance validation of the Stat Profile® Prime Plus Analyzer System, specifically focusing on its point-of-care (POC) capabilities and comparability to a predicate device. This is a medical device, not an AI/ML software. Therefore, many of the requested categories related to AI/ML software development (e.g., number of experts for ground truth, adjudication method, MRMC studies, training set details) are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and how its performance was proven.

Here's the breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating "substantial equivalence" to the predicate device and by meeting established criteria for method comparison and imprecision, based on CLSI guidelines. The performance data is presented as method comparison statistics (slope, intercept, r-value) and total imprecision (SD, %CV).

Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria thresholds for each parameter prior to the results. Instead, it presents the quantitative results from the study and concludes that these results "confirmed that the performance of the Stat Profile Prime Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Analyzer System (predicate device)."

Therefore, I will present the reported device performance, and the implicit acceptance can be inferred as meeting industry standards for substantial equivalence in medical devices of this type.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Method Comparison (POC vs. Lab):
    • Hct: 417 samples
    • SO2: 398 samples
    • tHb: 416 samples
    • O2Hb: 422 samples
    • COHb: 425 samples
    • MetHb: 437 samples
    • HHb: 322 samples
  • Total Imprecision Performance: 20 runs performed on 3 analyzers, using 3 levels of quality control/linearity materials.
  • Within-Run Whole Blood Precision: Minimum of 2 operators per site across 3 POC sites (total 9 operators). Each precision run consisted of 10 replicate measurements using 7 different whole blood samples (5 native, 2 altered).
• Data Provenance: The study was conducted in the United States, across three Point-of-Care (POC) sites: a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED), and a Respiratory Therapy Lab (RT). The data utilized a mix of quality control materials and discarded blood gas specimens. This suggests prospective collection of real-world samples within a clinical setting.

3. Number of Experts and Qualifications for Ground Truth

• This device is a medical diagnostic instrument, not an AI/ML algorithm. Ground truth for the method comparison study was established by laboratory measurements (presumably using the established predicate device or a gold standard lab method) which the new device's results were compared against.
• The study involved "trained Healthcare Professionals" and "POC personnel". These personnel performed the tests on the new device. Their qualifications are described as "trained, qualified staff found in typical POC sites where blood gas analyzers are utilized," including Respiratory Care, Nursing, and Exercise Physiology personnel. No "experts" in the sense of adjudicating image interpretations are mentioned, as this is not an imaging AI.

4. Adjudication Method for the Test Set

• Not applicable. This is a quantitative measurement device, not an interpretive one requiring expert adjudication. The comparison was quantitative against a reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This is a quantitative measurement device, not an AI-assisted diagnostic tool that would be evaluated for human reader improvement. The study compares the new device's performance to a predicate device and laboratory methods.

6. Standalone Performance

• Yes, effectively. The "Stat Profile® Prime Plus Analyzer System" provides quantitative measurements. The performance data presented (Method Comparison, Total Imprecision, Within-Run Whole Blood Precision) represents the standalone performance of the device in generating these measurements, compared against established laboratory methods or statistical precision targets. There is no "human-in-the-loop" performance as the human simply operates the device to obtain the measurement.

7. Type of Ground Truth Used

• Comparative ("Reference") Method: For the method comparison study, the ground truth was the results obtained from analyses performed by "Lab" (laboratory reference methods, presumably the predicate device or another validated laboratory analyzer). This is a comparative ground truth against an established standard.
• Statistical Targets: For precision studies, the ground truth is implicitly defined by the acceptable statistical variance and bias from the mean of repeated measurements, often against known control material values.

8. Sample Size for the Training Set

• Not applicable. This is a physical, chemical, and optical measurement device, not a machine learning model that requires a "training set" in the computational sense. The device's measurement algorithms are fixed based on spectrophotometric and impedance principles.

9. How the Ground Truth for the Training Set was Established

• Not applicable, as there is no "training set" for an AI/ML model for this device. The principles of measurement are based on established scientific methods (e.g., spectrophotometry and impedance) and not trained on data in the AI/ML sense.

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The Stat Profile Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin, in heparinized arterial and venous whole blood.

The Stat Profile Prime Plus Analyzer System is designed to be a low cost, low maintenance analyzer for the hospital laboratory setting. It consists of the analyzer, sensor cartridges, calibrator packs, auto-cartridge quality control packs (internal controls), ampuled quality control materials (external controls) and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).

The system architecture and user interface for this proposed device is based on the previously cleared Stat Profile Prime CCS Analyzer System (K131703). The predicate for this proposed device is the Stat Profile pHOx Ultra Analyzer System (K110648).

The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed. The reporting of CO-Oximeter parameters (or not reporting them) will also be determined by the selection of the Sensor Cards.

Similar to the predicate device, the Stat Profile Prime Plus Analyzer is a blood gas/cooximetry/electrolyte/chemistry and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control will be used, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures the analyzer is working properly at all times.

The Stat Profile Prime Plus Analyzer accepts samples from syringes, and small cups. The minimum sample size for analysis is 135 µL.

Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.

The provided text describes the Nova Stat Profile Prime Plus Analyzer System, an in vitro diagnostic device. This document is a 510(k) summary submitted to the FDA, detailing the device's substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The general acceptance criteria for "Method Comparison Studies" is that "The blood comparison data for Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin for the Stat Profile Prime Plus analyzers meet the acceptance criteria." Specific numerical acceptance criteria are not explicitly detailed in the provided text, but the study concluded that the device did meet them.

Similarly, for "Precision/Reproducibility," the text states: "The precision data for all parameters meet the within run imprecision specifications for the Stat Profile Prime Plus analyzers." and "The precision data for all parameters meet the between analyzer run to run imprecision specifications for the Stat Profile Prime Plus analyzers." No specific numerical targets for imprecision are given.

For "Linearity Testing", the conclusion is: "The linearity comparison data for all parameters for the Stat Profile Prime Plus analyzers shows good correlation and linearity to the reference analyzers across the claimed measurement range for all parameters and met the acceptance criteria."

The table below summarizes the claimed measurement ranges, which serve as a form of acceptance criteria for the operational limits of the device. The reported performance is a general statement that the device meets "the acceptance criteria."

Note on "Reported Device Performance": The document states that the studies "meet the acceptance criteria." It does not provide specific numerical results or performance metrics (e.g., bias, CV%) for the Nova Stat Profile Prime Plus Analyzer System itself, but rather confirms that its performance is equivalent to the predicate and within acceptable ranges.

Study Information:

1. Sample size used for the test set and the data provenance:

   • Method Comparison Studies: The study compared the Stat Profile Prime Plus to the Nova Stat Profile pHOx Ultra analyzer using an unspecified number of "heparinized whole blood" samples. The provenance of this blood data (country, retrospective/prospective) is not specified.
   • Precision/Reproducibility - Within Run and Run to Run Studies:
     • Within Run Precision: "one run of each of the following sample types and levels was performed, 20 replicates per run." Sample types included: Stat Profile Prime Plus Internal Controls (Levels 1-5), Stat Profile Prime Plus Ampuled Controls (Levels 1-5), and "Two whole bloods, sampled from syringes."
     • Run to Run Precision: "triplicate analyses were performed on a single whole blood sample in ten separate runs during a single day."
     • The provenance of these whole blood samples (country, retrospective/prospective) is not specified.
   • Linearity Testing: Used "whole blood" to establish/verify the Analytical Measurement Range (AMR). The number of samples is not specified. Provenance is not specified.
   • Specificity / Interference Testing: "whole blood collected in lithium heparin vacutainers." The number of samples for screening or dose-response is not specified. Provenance is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is an in vitro diagnostic analyzer that measures objective chemical and physiological parameters in blood samples, not image interpretation or diagnosis by experts. The "ground truth" for the performance studies would be established by the reference methods (e.g., the predicate device or other highly accurate laboratory methods) against which the new device's measurements are compared.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in studies involving subjective interpretation (e.g., by experts) to reach a consensus for ground truth. This is a device measuring objective parameters.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device requiring human interpretation; it directly measures parameters.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The studies described (Method Comparison, Precision, Linearity, Interference) assess the standalone performance of the device's measurement capabilities. The device is designed to provide quantitative measurements and does not involve a human-in-the-loop for interpreting its direct output in the way an AI diagnostic tool might.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance studies appears to be:

   • Method Comparison: Measurements from the legally marketed predicate device (Stat Profile pHOx Ultra analyzer) served as the reference.
   • Precision: Internal controls, ampuled controls, and whole blood samples with expected values.
   • Linearity: Comparison against a "reference analyzer and/or the product specifications."
   • Specificity/Interference: Comparison of measurements with and without potential interfering substances.

7. The sample size for the training set: Not applicable. This device does not appear to employ machine learning algorithms that require a separate "training set" in the conventional sense. Its principles of measurement are based on established spectrophotometric and impedance sensor technologies.

8. How the ground truth for the training set was established: Not applicable, as there is no mention of a machine learning training set. The device's underlying principles are based on known physical and chemical measurement techniques.

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The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O2Hb, MetHb, HHb, sO2*) parameters from arterial, venous or capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's acid/base status, electrolyte and metabolite balance and oxygen delivery capacity. *sO2 = ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin.

· pH, pCO2, and pO2 measurements in whole blood are used in the diagnosis and treatment of life-threatening acid-base disturbances.

· Electrolytes in the human body have multiple roles. Nearly all metabolic processes depend on or vary with electrolytes:

· Sodium (Na+) measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.

· Potassium (K+) measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.

• Ionized calcium (Ca++) measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.

• Chloride (Cl-) measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders, such as cystic fibrosis and diabetic acidosis.

· Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells),

· Glucose (Glu) measurement is used in the diagnosis, monitoring and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

· Lactate (Lac) measurement is used:

· to evaluate the acid-base status of patients suspected of having lactic acidosis;

· to monitor tissue hypoxia and strenuous physical exertion:

· in the diagnosis of hyperlactatemia.

· Total Bilirubin (tBili) measurement is used to aid in assessing the risk of kernicterus and hyperbilirulyinemia in neonates.

• CO-Oximetry (tHb, COHb, MetHb, O2Hb, HHb, and sO2) evaluates the ability of the blood to carry oxygen by measuring total hemoglobin and determining the percentage of functional hemoglobin species.

• Total Hemoglobin (tHb): Total hemoglobin measure the hemoglobin content of whole blood for the detection of anemia.

· COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
· MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.
· HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygen status.
· O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with decxyhemoglobin to measure oxygen status.
· sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygen status.

The GEM Premier 5000 system provides health care professionals with fast, accurate, quantitative measurements of pH, pCO2, pO2, sodium, potassium, chloride, ionized calcium, glucose, lactate, hematocrit, total bilirubin and CO-Oximetry (tHb, O₂Hb, MetHb, HHb, sO₂*) parameters from arterial, venous or capillary heparinized whole blood in central laboratory or point-of-care clinical settings.

*sO2 = Ratio between the concentration of oxyhemoglobin plus deoxyhemoglobin plus deoxyhemoglobin.

Here's an analysis of the acceptance criteria and study detailed in the provided document, addressing each of your requested points:

The document describes the GEM Premier 5000 device, an in vitro diagnostic system for analyzing blood gases and other parameters. The purpose of this specific 510(k) submission is to expand capillary heparinized whole blood claims for pCO2, potassium, chloride, hematocrit, and total hemoglobin. Therefore, the acceptance criteria and study focus on establishing the performance of these analytes with capillary samples on the GEM Premier 5000, demonstrating substantial equivalence to the predicate device (GEM Premier 4000).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate table. Instead, it demonstrates performance by showing that "All results met specification" for precision studies and by providing bias and Total Error (TEa) ranges for method comparison, which implicitly serve as acceptance criteria. For the regression analysis, the slope and intercept being close to 1 and 0 respectively, and a high correlation coefficient (r), are the performance indicators.

Here's a breakdown of the reported device performance for the analytes relevant to the expanded claims:

Precision Studies (Internal Precision - Capillary Transfer Samples)
(N=120 per analyte per level, 5 levels each)

Precision Studies (Internal Precision - Capillary Finger-stick Samples)
(N=56 per analyte, single GEM Premier 5000, 2 POC operators, 28 donor samples)

Precision Studies (External POC Precision – Capillary Transfer Samples)
(N=minimum 20 residual whole blood samples over 5 days, triplicate runs, 3 POC operators)

Method Comparison (Pooled Point-of-Care Site and CSL Data with Native Capillary Samples)
(Reference: GEM Premier 4000)

Method Comparison (Pooled Point-of-Care Site and CSL Data with Additional Contrived Capillary Results - Regression Analysis)
(Reference: GEM Premier 4000)

Implied Acceptance Criteria:

• Precision: Standard Deviation (SD) and Coefficient of Variation (%CV) values for each analyte at various levels must meet an internal "specification" (not explicitly stated in the table, but indicated as "All results met specification."). The document mentions analysis being separated for "fixed acceptance criteria range (SD)" and "variable acceptance criteria range (%CV)".
• Method Comparison (Bias): The observed biases at the medical decision levels and their 95% Confidence Intervals (CI) should be within the Total Error (TEa) values provided.
• Method Comparison (Regression): Slope close to 1, intercept close to 0, and a high correlation coefficient (r) (typically >0.975 for quantitative assays).

2. Sample Size Used for the Test Set and Data Provenance

The test sets were derived from various sources:

• Internal Precision - Capillary Transfer Samples:
  • Sample Size: 5 different concentrations of whole blood per analyte, each run on 3 analyzers for 5 days, 1 run/day, 8 replicates/run/level. Total N = 120 per analyte per level.
  • Data Provenance: Internal laboratory setting. Samples were "whole blood... transferred from syringe to a capillary device," implying controlled, possibly contrived, whole blood samples.
• Internal Precision - Capillary Finger-stick Samples:
  • Sample Size: 28 donor samples, each collected into 2 capillary tubes and run in singlicate. Total N = 56 for each analyte (28 donors * 2 samples).
  • Data Provenance: "IL Customer Simulation Laboratory (CSL), using finger-stick samples drawn and run by two (2) point-of-care (POC) operators." This indicates a prospective collection of real human samples in a simulated clinical environment.
• External POC Precision - Capillary Transfer Samples:
  • Sample Size: Minimum of 20 residual whole blood samples run over 5 days, each run in triplicate. Total N = 60-66 samples per analyte (e.g., 63 for pCO2 for main range, 3 for high range; 66 for K+ and Cl-; 60 for tHb).
  • Data Provenance: "External point-of-care (POC) site, using heparinized whole blood patient samples transferred from syringe to a capillary device and run by three (3) POC operators." This suggests prospective collection of residual patient samples in a real clinical POC setting.
• Point-of-Care (POC) Method Comparison - Native Capillary Finger-stick Samples:
  • Sample Size: Minimum of 40 native capillary samples from an external POC site + minimum of 80 native samples from IL CSL. Total N = 129-131 samples for each analyte.
  • Data Provenance: "Native capillary finger-stick samples... collected via finger-stick by six (6) POC operators at an external POC site... and three (3) POC operators in the IL internal Customer Simulation Laboratory (CSL)." This is a prospective collection of real human finger-stick samples from both real-world POC and simulated environments.
• Point-of-Care (POC) Method Comparison - Pooled Data (Regression Analysis):
  • Sample Size: The native capillary samples (N=129-131) were pooled with "contrived whole blood samples (

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The AnemoCheck is an in vitro diagnostic semi-quantitative assay for use in point-of-care, clinical and doctor office laboratories for the determination of hemoglobin level and estimation of hematocrit percentage (within normal hemoglobin range) in anticoagulated (K2EDTA, heparin or citrate) whole blood (capillary or venous). AnemoCheck should not be used to evaluate neonatal samples (birth - 1 month).

The AnemoCheck™ is a semi-quantitative colorimetric assay for determination of total hemoglobin (g/dL) and calculated hematocrit (%) in whole blood. Capillary or venous blood may be used. The assay is rapid (development time is 2 minutes) and is a manual test that does not require electrical power or additional equipment.

The Sanguina AnemoCheck device is a semi-quantitative colorimetric assay for determining total hemoglobin (g/dL) and calculated hematocrit (%) in whole blood.

Here's an analysis of its acceptance criteria and supporting study information:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative acceptance criteria in a table format. However, it indicates "substantial equivalence based on accuracy and precision" relative to the predicate device. For a semi-quantitative device measuring hemoglobin, typical acceptance criteria would involve a certain level of agreement or correlation with a reference method, often expressed as a percentage of agreement within a clinically acceptable range or a specific mean difference and standard deviation.

The document states:

• "Bench testing of AnemoCheck versus the predicate device demonstrate substantial equivalence based on accuracy and precision."
• "Test results are comparable to other test methods in clinical laboratory and point-of-care practices."

Without specific numerical targets for accuracy (e.g., within X% of a reference method) or precision (e.g., coefficient of variation below Y%), the exact "acceptance criteria" are not fully detailed. The conclusion of "substantial equivalence" implies that the performance met the FDA's criteria for a device of this type, likely benchmarked against predicate devices like the Hemocue® Hemoglobin Hb 201+ Analyzing System and Siemens® Advia 2120i.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not explicitly state the sample size used for the test set in the "Summary of Non-clinical Testing" or "Assessment of Performance" sections.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

3. Number of Experts and their Qualifications for Ground Truth

• The document does not provide information on the number of experts used to establish the ground truth for the test set or their qualifications. Given that it's an in vitro diagnostic device for hemoglobin measurement, the "ground truth" would typically be established by a laboratory reference method (e.g., a hematology analyzer) rather than expert consensus, though interpretation of results might involve medical professionals.

4. Adjudication Method

• The document does not describe any adjudication method. This is expected given that the ground truth for an IVD device like this would likely be an objective measurement from a reference instrument, not subjective assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed. This type of study is typically relevant for interpretative devices where human readers assess medical images or data. The AnemoCheck is a direct measurement device, not an interpretative one in the context of MRMC studies.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone study was performed. The "Summary of Non-clinical Testing" states: "Bench testing of AnemoCheck versus the predicate device demonstrate substantial equivalence based on accuracy and precision." This implies the device's performance was evaluated inherently, as a semi-quantitative colorimetric assay, without human interpretation as part of the core measurement. The output of the device (color change) is interpreted manually to determine the hemoglobin level, making it a "manual test that does not require electrical power or additional equipment."

7. Type of Ground Truth Used

• The type of ground truth used would be objective laboratory measurements from predicate or reference devices. The text states: "Bench testing of AnemoCheck versus the predicate device..." and "Test results are comparable to other test methods in clinical laboratory and point-of-care practices." This strongly indicates the AnemoCheck's measurements were compared against established, quantitative hemoglobin assays (like the Hemocue Hb 201+ or Siemens Advia 2120i) which serve as the ground truth.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size used for any training set. As a manual, semi-quantitative colorimetric assay, the development process might involve calibration and optimization rather than a "training set" in the machine learning sense. The information provided focuses on the validation of the final device.

9. How Ground Truth for the Training Set Was Established

• The document does not provide information on how ground truth was established for any training set. If a training phase existed (e.g., for optimizing the color scale), it would logically also rely on objective laboratory measurements from reference methods for hemoglobin.

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The GEM Premier 5000 is a portable critical care system for use by health care professionals to rapidly analyze heparinized whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory. The instrument provides quantitative measurements of Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O2Hb. COHb. MetHb. HHb. sO2 from venous, arterial and capillary heparinized whole blood. These parameters, along with derived parameters, aid in the diagnosis of a patient's oxygen delivery capacity.

• Hematocrit (Hct) measurements in whole blood of the packed red cell volume of a blood sample are used to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).
• Total Hemoglobin (tHb): Total hemoglobin measure the hemoglobin content of whole blood for the detection of anemia.
• · COHb: Carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
• · MetHb: Methemoglobin measurements are used to determine different conditions of methemoglobinemia.

· HHb: Deoxyhemoglobin, as a fraction of total hemoglobin, is used in combination with oxyhemoglobin to measure oxygenation status.

· O2Hb: Oxyhemoglobin, as a fraction of total hemoglobin, is used in combination with deoxyhemoglobin to measure oxygenation status.

· sO2: Oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus deoxyhemoglobin, is used to measure oxygenation status.

The GEM Premier 5000 system provides health care professionals in central laboratory or point-of-care clinical settings with fast, accurate, quantitative measurements of Hematocrit and Total Hemoglobin from venous and arterial heparinized whole blood, as well as quantitative measurements of O₂Hb, COHb, MetHb, HHb, sO2 from venous, arterial and capillary heparinized whole blood.

Key Components:
Analyzer: Employs a unique color touch screen and a simple set of menus and buttons for user interaction. The analyzer guides operators through the sampling process with simple, clear messages and prompts.
GEM Premier 5000 PAK (disposable, multi-use GEM PAK): Houses all required components necessary to operate the instrument once the cartridge is validated. These components include the sensors, CO-Ox optical cell, Process Control (PC) Solutions, sampler, pump tubing, distribution valve and waste bag. The GEM PAK has flexible menus and test volume options to assist facilities in maximizing efficiency. NOTE: The EEPROM on the GEM PAK includes all solution values and controls the analyte menu and number of tests.
Intelligent Quality Management 2 (iQM2): iQM2 is an active quality process control program designed to provide continuous monitoring of the analytical process before, during and after sample measurement with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions. iQM2 is a statistical process control system that performs 5 types of continuous, quality checks to monitor the performance of the GEM PAK, sensors, CO-Ox, and reagents. These checks include System.

The provided text describes the GEM Premier 5000, a portable critical care system for analyzing heparinized whole blood samples. It focuses on the device's technical specifications and performance studies to demonstrate substantial equivalence to a predicate device (GEM Premier 4000) for Hematocrit and CO-Oximetry measurements.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" for precision or method comparison studies in a single table with target values. Instead, it presents the "Within Analyzer SD/CV" and "Total SD/CV" or "Bias" for various analytes and compares them to specifications which are indirectly implied to be the acceptance criteria. For the purpose of this response, I will interpret "SD/CV Spec" as the acceptance criteria for reproducibility and "Medical Decision Levels" with a calculated "Total Error Observed" compared to an unstated "GEM Premier 5000 Total Error Specifications" as acceptance criteria for accuracy.

Here's a table summarizing the reported device performance based on the precision and method comparison studies:

Table 1: Summary of Device Performance against Implicit Criteria

Note: For the Total Error Observed, the document states these were compared to "GEM Premier 5000 Total Error Specifications," but these specifications are not explicitly provided in the text for all analytes. However, for capillary clinical testing, specific TEa values are given for some analytes, which are used here as proxies for acceptance criteria where available.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Internal Precision Study (Aqueous Controls):
  • Sample Size: 120 per analyte/level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run).
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
• Internal Precision Study (GEM PAK Process Control Solutions):
  • Sample Size: 120 per analyte/level (3 analyzers, 20 days, 2 runs/day, 1 replicate/run).
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
• Internal Precision Study (Whole Blood):
  • Sample Size: 120 per analyte/sample mode (3 analyzers, 5 days, 1 run/day, 8 replicates/run).
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective. Origin of whole blood samples likely internal or procured, not specified by country.
• Reproducibility Study (Aqueous Controls – Point-of-Care (POC) Setting):
  • Sample Size: 90 per analyte/level (3 external POC sites, 3 different GEM Premier 5000 instruments, triplicate measurements, twice a day, total 30 replicates per level, pooled).
  • Data Provenance: External clinical POC settings, prospective. Country of origin not specified, but likely USA based on the FDA submission.
• External Precision (Whole Blood - Central Lab and POC settings):
  • Sample Size: Varies by analyte and site (e.g., Hct Normal Mode POC-All N=126, CSL N=36, Lab1 N=30, Lab2 N=30). The overall study involved multiple whole blood specimens (at least two per day) analyzed in triplicate daily for 5 days.
  • Data Provenance: 2 external central laboratories, 1 internal Customer Simulation Laboratory (CSL), and 3 external POC locations. Prospective, "contrived whole blood specimens were analyzed in addition to native specimens" in the CSL. Country of origin not specified, but likely USA based on the FDA submission.
• Analytical Specificity (Interference Study):
  • Sample Size: Not explicitly stated as a single "test set" size for all substances, but experiments were conducted with various concentrations of interfering substances.
  • Data Provenance: Internal study (Instrumentation Laboratory Co.), prospective.
• Internal Method Comparison (Clinical Samples):
  • Sample Size: Varies by analyte (N=376 for Hct, N=373 for O2Hb, etc.).
  • Data Provenance: Clinical samples (heparinized whole blood) altered as needed to cover medical decision levels. Internal study, retrospective/prospective hybrid (samples altered to cover ranges).
• Clinical Testing (Point-of-Care Setting - Normal Mode):
  • Sample Size: Varies by analyte (e.g., N=490 for Hct, N=485 for COHb).
  • Data Provenance: Three (3) external point-of-care (POC) sites and one (1) internal Customer Simulation Laboratory (CSL) at IL. Heparinized whole blood patient samples from the intended use population. Samples spiked in CSL to cover reportable ranges. Provenance likely USA, prospective.
• Clinical Testing (Capillary Samples):
  • Sample Size: Native capillary samples: N=52 (external POC), N=100 (IL CSL) for a total of 152 native samples for O2Hb, HHb, sO2. Total N becomes 180-182 when pooled with additional internally prepared contrived capillary samples for specific analytes (pages 29-30).
  • Data Provenance: One external POC site and the IL internal Customer Simulation Laboratory (CSL). Native finger-stick samples and contrived capillary samples. Provenance likely USA, prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document relates to an in-vitro diagnostic device measuring blood parameters. Ground truth in this context is typically established by comparative measurements against a recognized reference method or a predicate device, not by expert consensus in the same way an imaging AI would use expert radiologist reads.

For the Internal Method Comparison and Clinical Testing studies, the GEM Premier 5000 was compared to the predicate device, the GEM Premier 4000. The predicate device itself serves as the "reference standard" or "ground truth" for demonstrating substantial equivalence. The document does not specify human experts establishing ground truth for the test set; rather, the predicate device and established analytical methods (e.g., CNMetHb procedure - CLSI H15-A3 for tHb) are used as comparators.

The Linearity study also mentions comparing results to "reference analyzers or standard reference procedures (i.e. CNMetHb procedure - CLSI H15-A3 for tHb)".

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of in-vitro diagnostic device. "Adjudication" typically refers to the process of resolving discrepancies between human readers or between human readers and an AI output, especially in imaging studies where subjective interpretation is involved. For this device, ground truth is established through quantitative comparisons against established reference methods or a predicate device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in-vitro diagnostic device that provides quantitative measurements of blood parameters, not an AI-based imaging or diagnostic aid that assists human readers/clinicians in interpretation. Therefore, no MRMC study or assessment of human reader improvement with/without AI assistance was conducted or would be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies presented evaluate the performance of the device itself in a standalone capacity. The GEM Premier 5000 provides quantitative measurements directly. Operators interact with the device to load samples and retrieve results, but the analytical process and result generation are entirely performed by the instrument's internal "algorithm" (i.e., its measurement and data processing capabilities).

The device description on page 5 highlights its autonomy:

• "The analyzer guides operators through the sampling process with simple, clear messages and prompts."
• "After inserting the GEM PAK, the instrument will perform an automated PAK warm-up..."
• "Auto PAK Validation (APV) process is automatically completed..."
• "iQM2 manages the quality control process, replacing external quality controls."

This indicates that the device operates autonomously for its core measurements, with human intervention for sample loading and result review, but not for interpreting the raw measurement signals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the performance studies was established through:

• Comparison to a Legally Marketed Predicate Device: The GEM Premier 4000 served as the primary comparator for method comparison studies, demonstrating substantial equivalence.
• Standard Reference Procedures/Analyzers: For linearity studies and potentially for other analytical performance aspects, comparison to "reference analyzers or standard reference procedures (i.e. CNMetHb procedure - CLSI H15-A3 for tHb)" was used.
• Certified Control Materials: Aqueous controls and GEM PAK Process Control Solutions that are "traceable to NIST standards, CLSI procedures or internal standards" were used for precision and reproducibility studies. These materials have known, certified values which serve as ground truth for assessing device accuracy and precision.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms as the primary focus is on proving the analytical performance of an in-vitro diagnostic instrument through traditional analytical validation studies (precision, linearity, method comparison, etc.).

However, the device incorporates "Intelligent Quality Management 2 (iQM2)" which is described as "an active quality process control program designed to provide continuous monitoring of the analytical process... with real-time, automatic error detection, automatic correction of the system and automatic documentation of all corrective actions." While iQM2 itself would have been developed and "trained" or calibrated using extensive internal data during the device's R&D phase, the public 510(k) summary does not provide details on a specific training set size for the iQM2 component. The studies presented are for the validation of the final device's performance, not the internal development of iQM2.

The "internal precision study" and "internal method comparison" are validation studies of the final device. The data shown in these tables is for testing the device's performance, not training it.

9. How the ground truth for the training set was established

As noted in point 8, a "training set" in the context of typical AI/ML models is not explicitly described or relevant for the approval justification in this 510(k) summary. The document validates the measurement accuracy and precision of the device against predicate devices and reference methods, not an AI model that learns from data in the field.

If "training set" refers to the data used to initially calibrate the instrument's sensors and algorithms during development, this ground truth would have been established through:

• Primary Reference Methods: Employing highly accurate and precise laboratory methods (e.g., gas chromatography, certified spectrophotometric methods, gravimetric/volumetric methods) to determine the true concentration of analytes in reference materials and clinical samples.
• Reference Materials/Standards: Calibrating the device using NIST-traceable standards and other certified reference materials with known analyte concentrations.
• Extensive Internal Testing and Optimization: Using a large array of characterized samples (e.g., blood samples with varying analyte concentrations, interfering substances) to optimize the device's measurement algorithms and ensure accurate performance across its claimed reportable range.

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The NBM-200 is a portable Hemoglobin and oximetry monitor. It non-invasively spot checks and displays Hemoglobin (Hb), estimated Hematocrit (Hct) values, functional saturation of arterial oxygen hemoglobin (SpO2), and pulse rate (PR). These parameters can be displayed periodically for patient monitoring.

The monitor estimates Hct via a calculation based on the Hb measurement for normal hemoglobin values (11 to 17 g/dl) only and abnormal values will not be displayed. It is intended for use by trained medical personnel, with adult individuals, in non-critical clinical and non-clinical settings (e.g. non-critical settings in hospitals, hospital-type facilities, mobile environments, clinics, physician offices and ambulatory surgery centers). In this context, non-critical means patient examination settings where continuous monitoring is unnecessary. Non-critical environments exclude, for example, intensive care units.

The NBM-200 is a portable Hemoglobin and oximetry monitor, based on occlusion spectroscopy technology, for non-invasive spot checking of hemoglobin (Hb), estimated Hematocrit (Hct), SpO2 and pulse rate.

The NBM-200 includes a reusable ring-shaped sensor probe that fits on the patient's finger, and a portable desktop monitor that calculates and displays the measurement result.

The sensor probe consists of a multi-wavelength optical measuring system and inflatable cuff employing pneumatic tissue manipulation. Blood flow in the finger can be briefly occluded and the resulting changes in its optical behavior are analyzed to provide accurate measurements of Hb.

The provided text is a 510(k) summary for the NBM-200 Pulse Oximeter and Hemoglobin Monitor. It describes the device, its intended use, and its substantial equivalence to a predicate device (NBM 200MP). However, it explicitly states, "Clinical data for the predicate NBM 200-MP were submitted for the K124041 clearance and no clinical data were generated for the modified device."

This means that the document does not contain the acceptance criteria or the study details for the NBM-200 itself. It relies on the clinical data and acceptance criteria established for the predicate device (NBM 200MP) from its K124041 submission.

Therefore, I cannot extract the requested information from the provided text for the NBM-200. The document states that no clinical data was generated specifically for the NBM-200 device.

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