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HemosIL Chromogenic Factor IX is an automated assay for the photometric, quantitative determination of factor IX activity in 3.2% citrated plasma on the ACL TOP® Family and ACL TOP Family 50 Series in the laboratory setting by a healthcare professional. HemosIL Chromogenic Factor IX is indicated for use on patients when identifying factor IX deficiency or measuring factor IX activity from patients on replacement therapy. For adult population only. For prescription use only.

Factor IX activity in a patient's plasma is determined using a chromogenic method, in which human factor IX is activated by human factor XIa, and, when formed, factor IXa activates human factor X in the presence of human factor VIII, calcium and phospholipid. The amount of factor Xa generated is proportionate to the factor IX activity and is determined from the hydrolysis of a chromogenic factor Xa substrate. Results are determined by comparing a chromogenic signal to a calibration curve.

Here's a breakdown of the acceptance criteria and the studies that demonstrate the device's performance, based on the provided FDA 510(k) summary for the HemosIL Chromogenic Factor IX:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a separate table. However, it presents performance characteristics that implicitly serve as success metrics for the device's substantial equivalence. I've extrapolated these based on the study findings.

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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 ACL TOP Family 70 Series (ACL TOP 370, ACL TOP 570 and ACL TOP 770 / 770s / 770 LAS) are bench top, fully automated, random access analyzers designed specifically for in vitro diagnostic clinical use by health care professionals in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.

The ACL TOP Family 70 Series are fully automated coagulation analyzers that utilize the same intuitive software, the same consumables, reagents, calibrators and controls, and provide the same analytical methodology for routine and specialty assay result reporting as the predicate ACL TOP Family 50 Series.

The ACL TOP Family 70 Series instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate ACL TOP Family 50 Series:

• . Coagulometric (Turbidimetric) Measurements
• Chromogenic (Absorbance) Measurements .
• . Immunological Measurements

The ACL TOP Family 70 Series also offers the same pre-analytical features available on the ACL TOP Family 50 Series. These features alert the instrument operator to a potential HIL (Hemoglobin, Icteric and Lipemia) interference situation specific to the assays requested for a sample, underfilled sample tubes or a detected clog.

Here's a breakdown of the acceptance criteria and study details for the ACL TOP Family 70 Series device, based on the provided document:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the ACL TOP Family 70 Series appears to be demonstrating equivalent analytical performance to its predicate device, the ACL TOP Family 50 Series, across various representative assays. This equivalency is assessed through precision and method comparison studies.

Table of Acceptance Criteria and Reported Device Performance:

• HemosIL D-Dimer HS 500: Low Control Total %CV 4.8, High Control Total %CV 2.1
• HemosIL Factor VIII: Normal Control Total %CV 3.4, Abnormal Control Total %CV 4.8
• HemosIL RecombiPlasTin 2G (PT): Normal Control Total %CV 1.8, High Abn Control %CV 4.0
• HemosIL RecombiPlasTin 2G (Fibrinogen): Normal Control Total %CV 3.9, Low Fibrinogen Control %CV 8.1
• HemosIL Liquid Anti-Xa: UF Low Control Total %CV 1.8, LMW High Control Total %CV 2.2 |
  | Method Comparison | Linear regression analysis (slope, intercept, correlation coefficient 'r') between the subject device and predicate device should demonstrate equivalent performance across the analytical measuring range (AMR), according to established guidelines (CLSI EP09c. 3rd Ed). | Successfully met criteria. All studies showed strong correlation (r ≥ 0.998) and slopes close to 1 with intercepts close to 0, indicating equivalence. Examples:
• HemosIL D-Dimer HS 500: Slope 1.022, Intercept 0.5575, r 0.998
• HemosIL Factor VIII: Slope 1.006, Intercept -0.0587, r 0.998
• HemosIL RecombiPlasTin 2G (PT): Slope 1.012, Intercept -0.0940, r 1.000
• HemosIL RecombiPlasTin 2G (Fibrinogen): Slope 0.9756, Intercept -1.1220, r 0.999
• HemosIL Liquid Anti-Xa: Slope 0.9804, Intercept -0.0145, r 0.999 |
  | Overall Conclusion | Updates introduced do not impact the labeled performance data of the current menu of FDA-cleared assays. Device is safe and effective for its intended purpose and equivalent in performance to the predicate device. | Analytical study results demonstrate that the ACL TOP Family 70 Series, with updated non-analytical features, is safe and effective for its intended purpose and equivalent in performance to the predicate device (K150877). |

Study Details:

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

   • Precision Studies:
     • For each material/control for the selected representative assays, samples were run for 20 days at two runs per day, 2 replicates per run, resulting in a total of n=80 data points per material.
     • Provenance: Not explicitly stated, but based on the context of an FDA submission for an in vitro diagnostic device, these would typically be laboratory-generated samples or commercial control materials. The studies were performed internally by the manufacturer ("Instrumentation Laboratory Company").
   • Method Comparison Studies:
     • Sample sizes varied per assay:
       • HemosIL D-Dimer HS 500: N = 116 clinical samples
       • HemosIL Factor VIII: N = 104 clinical samples
       • HemosIL RecombiPlasTin 2G (PT): N = 116 clinical samples
       • HemosIL RecombiPlasTin 2G (Fibrinogen): N = 114 clinical samples
       • HemosIL Liquid Anti-Xa: N = 207 clinical samples
     • Provenance: The studies included "clinical samples spanning each assay's analytical measuring range (AMR)." The country of origin of these clinical samples is not specified, but they are prospectively collected or selected for the study based on their span across the AMR.

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

   • This being an in vitro diagnostic (IVD) device for laboratory analysis, the "ground truth" for the test set is established by the measurement itself on a recognized, cleared, and well-characterized comparator device (the predicate ACL TOP Family 50 Series), or by the known concentrations/activity of control materials. It's not a subjective interpretation task that requires human adjudication or expert consensus in the same way as, for example, image-based diagnostic AI. Therefore, no human experts are explicitly mentioned as establishing a subjective ground truth for these analytical performance studies. The "ground truth" for method comparison is the performance of the predicate device.

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

   • None. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective human interpretation (e.g., radiology reads) where discrepancies need to be resolved. For analytical performance studies of a medical device measuring quantitative analytes, the ground truth is objective (the measured value from the predicate device or a known concentration in a control).

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:

   • No. An MRMC study is not applicable here as this is an in vitro diagnostic instrument, not an AI-assisted diagnostic tool that involves human readers interpreting cases. The device automatically performs coagulation and/or fibrinolysis testing.

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

   • Yes, effectively. The entire study evaluates the analytical performance of the device itself (the ACL TOP Family 70 Series) in a standalone manner. While trained lab personnel operate the instrument, the performance metrics (precision, method comparison) are about the instrument's ability to produce accurate and precise results, independent of human interpretive intervention for the results themselves. The device's "algorithm" (its internal measurement and calculation processes) is being evaluated.

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

   • For precision studies, the ground truth is the known concentration/activity of control and plasma pool materials.
   • For method comparison studies, the ground truth is the measured values obtained from the predicate device (ACL TOP Family 50 Series) for the same clinical samples. The principle is to see if the new device produces equivalent results when compared to an already accepted diagnostic method.

7. The sample size for the training set:

   • The document does not mention a training set in the context of machine learning or AI model development. This device is an IVD instrument that utilizes established analytical methodologies (coagulometric, chromogenic, immunological measurements) and software, rather than a machine learning model that requires a discrete training phase with labeled data. The studies performed are verification and validation studies to demonstrate performance and equivalency to a predicate.

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

   • As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable. The device's operation is based on pre-defined analytical principles, not on learning from a training dataset to establish a ground truth.

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