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The Piccolo® Lactate Test System (presently contained on the MetLac 12 Panel Reagent Disc) used with the Piccolo xpress™ Chemistry Analyzer is intended to be used for the in vitro quantitative determination of lactate concentration in heparinized whole blood or heparinized plasma in a clinical laboratory setting or point-of-care location.

Lactate measurements are used in the diagnosis and treatment of lactate acidosis, monitoring tissue hypoxia, and diagnosis of hyperlactatemia.

The Piccolo MetLac 12 Panel Reagent Disc (which contains the Piccolo Lactate Test System) is designed for lithium heparinized whole blood and lithium heparinized plasma. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted sample mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.

Here's a breakdown of the acceptance criteria and study information for the Piccolo® LAC Test System, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria are generally inferred from the "Summary of Safety and Effectiveness" document, which aims to demonstrate substantial equivalence to a predicate device. For each performance characteristic, the "reported device performance" is the result demonstrated by the Piccolo Lactate Test System.

Study Details

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

• Linearity Study: Seven pools (including a saline blank and lowest non-zero calibrator and its dilutions). Each pool assayed 60 times.
• Precision (Control and Plasma Pool Testing): 80 replicates for each Control Level (N=80), 40 replicates for each Plasma Pool (N=40). Data provenance not specified directly but implied to be internal (Abaxis) based on the context.
• Precision (Fresh Whole Blood - Internal): 20 replicates for each of the 6 samples (N=20 for each). Data provenance is internal (Abaxis).
• Precision (Fresh Whole Blood - External): For each of the three external sites, 4 whole blood samples were tested. Each sample was tested by 2 operators (10 replicates each), totaling 20 replicates (N=20 combined) per sample per site. Total samples across 3 sites: 12. Total tests: over 240. Data provenance is implied to be external study sites but the country is not specified.
• Method Comparison with Predicate Device: 126 heparinized whole blood samples from 126 subjects. Data provenance is an external site, country not specified.
• Interference Studies: For endogenous substances, multiple test pools (at least 4) and a control pool were prepared for each of the two lactate levels. For exogenous substances, human plasma pools contained lactate at 0.70 and 2.60 mmol/L. "Two levels of lactate were used in all testing." Data provenance not specified.
• Reference Interval Determination: 130 heparinized whole blood samples from apparently healthy (self-reported) individuals. Data provenance not specified.

All studies appear to be prospective in nature, as they involve testing samples specifically for the purpose of validating the device. The country of origin of the data is not explicitly stated, but the company (Abaxis, Inc.) is based in Union City, CA, USA.

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)

• No "experts" in the traditional sense (e.g., radiologists, pathologists) were used to establish ground truth for the test set in this context. The studies involve analytical performance.
• For the Method Comparison Study, the "ground truth" or reference was the predicate device, the i-STAT Lactate test (Abbott). This device is an already legally marketed and established lactate testing system.
• For other studies (linearity, precision, sensitivity, interference), the "ground truth" is defined by the known concentrations of calibrators, controls, and spiked samples, or by established laboratory reference methods and protocols (e.g., CLSI guidelines).

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

• None of the described studies utilize an adjudication method involving multiple human readers, as these are in vitro diagnostic device performance studies, not image interpretation or clinical decision-making studies. The performance is assessed against quantitative analytical targets or a reference 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

• No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic instrument, not an AI-assisted diagnostic tool that helps human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

• Yes, a standalone performance assessment was done. The entire submission describes the analytical performance of the Piccolo Lactate Test System, which is an automated instrument, functioning as a "standalone" device to measure lactate concentrations. The "human-in-the-loop" component primarily relates to sample collection, loading, and interpreting the final quantitative result.

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

• Known concentrations / Reference Method:
  • Linearity, Sensitivity, Precision, Interference: Ground truth was established by using calibrators, controls, and spiked samples with known concentrations of lactate or interferents, according to industry standards (e.g., CLSI guidelines).
  • Method Comparison: The predicate device, i-STAT Lactate test (Abbott), served as the reference method for comparison.
  • Reference Interval Determination: The interval was determined by testing samples from a population of "apparently healthy" individuals, and the ground truth for their health status was based on "self-reported" information.

8. The sample size for the training set

• The document does not explicitly describe a "training set" in the context of machine learning or AI models. This device is an in vitro diagnostic device based on enzymatic colorimetric assay methodology.
• However, if by "training set" we consider the data used to initially develop and optimize the assay and its performance characteristics (e.g., establishing reagent concentrations, reaction kinetics, calibration algorithms), this information is not detailed in the 510(k) summary. The document focuses on the validation of the final device.

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

• As noted above, a "training set" as understood in AI/ML is not applicable here. The development and optimization of such a diagnostic assay would typically involve extensive laboratory work to establish optimal reagent concentrations, reaction conditions, and calibration curves. The ground truth for this initial development would come from known standard solutions, reference methods, and clinical samples whose lactate concentrations are reliably determined by established laboratory techniques.

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The RAPIDPoint 500 system is intended for in vitro diagnostic use and is designed to provide the determination in whole blood for the following parameters:

• Partial pressure of carbon dioxide .
• Partial pressure of oxygen .
• . pH
• Sodium .
• Potassium .
• lonized calcium .
• Chloride .
• Glucose .
• Total hemoglobin and fractions: fO2Hb, fCOHb, fMetHb, fHHb .
• Neonatal bilirubin .
• . Lactate

This test system is intended for use in point of care or laboratory settings.

Lactate. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

Lactate (Lac) is a new parameter offered on the RAPIDPoint 500 (RP500) blood gas system. The RP500 system is a point-of-care and laboratory testing blood gas analyzer and currently measures a variety of parameters that have been previously cleared. Enabling the lactate measurement is accomplished through software design changes introduced in Software Version 2.0 and requires the use of a RAPIDPoint 500 Measurement Cartridge. No hardware or mechanical changes were needed.

Here's a breakdown of the acceptance criteria and study information for the RAPIDPoint® 500 System for Lactate measurement:

Device: RAPIDPoint® 500 System with Lactate (Lac) Test

Predicate Device: Siemens Healthcare Diagnostics RAPIDLab 1265

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: Over 140 samples.
• Data Provenance:
  • Country of Origin: Not explicitly stated.
  • Retrospective or Prospective: The "external evaluation study included testing at multiple point-of-care sites with intended use whole blood samples," suggesting these were likely prospectively collected samples in a real-world setting.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• Number of Experts: Not applicable. The ground truth was established by comparison to a predicate device, not by expert consensus on diagnoses.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. The ground truth was established by comparison to a predicate device, not by expert review requiring adjudication.

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

• Was an MRMC study done? No. This device is an in vitro diagnostic (IVD) measurement system, not an imaging or diagnostic aid that relies on human interpretation. The study focused on the analytical performance of the device against a predicate, not on how it assists human readers.
• Effect size of how much human readers improve with AI vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes. The "internal evaluation study entailed testing concentrations of lactate in whole blood across the reporting range." This, along with the external evaluation comparing the device to the predicate, represents the standalone performance of the RAPIDPoint® 500 system's lactate measurement. It is an automated system; there is no human-in-the-loop performance component in the measurement process itself.

7. Type of Ground Truth Used

• Type of Ground Truth: Comparison to a predicate device (Siemens Healthcare Diagnostics RAPIDLab 1265). The performance of the new device was evaluated against the established performance of the legally marketed predicate device.

8. Sample Size for Training Set

• The document does not explicitly state a separate "training set" sample size in the context of machine learning or AI. The RAPIDPoint 500 system uses an amperometric method based on enzyme kinetics, not a machine learning algorithm that requires a separate training phase with a labeled dataset in the traditional sense. The lactate measurement is "accomplished through software design changes introduced in Software Version 2.0," which implies traditional software development and verification rather than machine learning model training.
• The "internal evaluation study entailed testing concentrations of lactate in whole blood across the reporting range" would serve as part of the validation and verification of the system's analytical performance, which is analogous to testing, but not "training" in an ML context.

9. How Ground Truth for Training Set Was Established

• Not applicable in the context of a machine learning training set, as the device's measurement is based on a defined electrochemical method, not a trained AI model. The accuracy of the "ground truth" for calibrating and verifying the system during development (if any specific calibration data is considered) would be based on reference methods or traceable standards for lactate concentration. The document mentions "software development life cycle including software requirements specifications, risk management report, and overall verification and validation results," indicating traditional software engineering practices rather than AI specific training.

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The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals for multiple patient use in a professional healthcare setting for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis. It is not for use on capillary blood specimens. It Is intended to provide plasma equivalent results to laboratory methods.

The Nova StatStrip Lactate Hospital Meter System has the same fundamental scientific technology and intended use as the currently marketed Nova StatStrip Lactate Hospital Meter System (K100602). Both the Nova StatStrip Lactate Hospital Meter System and the proposed Nova StatStrip Lactate Hospital Meter System are hand held devices with similar intended use to quantitatively measure the lactate levels in whole blood. The principle of operation is the same for the proposed and predicate device. Each utilizes a test strip that is inserted into a meter for results within 13 seconds.

The provided document describes the Nova StatStrip Lactate Hospital Meter System. Here's an analysis of its acceptance criteria and the study that proves whether the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the provided document. Instead, the primary acceptance criterion is substantial equivalence to the predicate device (K100602 - Nova StatStrip Lactate Hospital Meter System) in terms of intended use, technological characteristics, and performance.

Specific Performance Characteristics Compared to Predicate (K100602):

• Measuring Range: Proposed: 0.3 - 20.0 mmol/L (Predicate: 0.7 - 20.0 mmol/L). The proposed device has a wider lower detection limit, implying an improvement rather than just equivalence. This suggests the proposed device meets or exceeds the predicate's range.
• Operating Principle: Electromechanical Biosensor, Lactate oxidase (LOD) - "Same"
• Intended Use: "Same"
• Sample Type: Whole Blood - "Same"
• Sample Size: 0.6 uL - "Same"
• Sample Application: Capillary Draw - "Same"
• Handheld Meter? Yes - "Same"
• Meter Calibration: Automatic - "Same"
• Data Storage: 1000 Patient Tests, 200 QC Tests, 4000 Operators - "Same"
• Test Time: 13 Seconds - "Same"
• Weight: 360 grams - "Same"

Overall: The performance studies confirmed that the blood lactate results from the proposed system were "substantially equivalent to the current methods for blood lactate measurements" and to the predicate device. |

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

• Sample Size: The document does not explicitly state the specific sample size (i.e., number of patient samples or data points) used for the definitive performance testing. It generally refers to "laboratory and clinical testing."
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It just mentions "Laboratory testing was performed" and "clinical testing."

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

This information is not provided in the given text. For a lactate monitor, the ground truth would typically be established by a reference laboratory method, not necessarily by "experts" in the sense of human readers interpreting images or data.

4. Adjudication Method for the Test Set

This information is not applicable as the device is an in vitro diagnostic test determining lactate levels, not an AI system interpreting complex data that requires expert adjudication. The "ground truth" would be the result from a reference laboratory method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging or interpretation tasks, not for continuous measurement devices like a lactate meter.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, effectively. The performance studies described are inherently "standalone" in the context of an automated measuring device. The device itself performs the measurement, and its results are compared against reference methods. While a human operates the device, the core performance being evaluated is the device's accuracy in measuring lactate independent of human interpretation bias. The statement "The laboratory studies demonstrated that the blood lactate results from the Nova StatStrip Lactate Hospital Meter System were substantially equivalent to the current methods for blood lactate measurements" supports this.

7. The Type of Ground Truth Used

The ground truth used for evaluating the Nova StatStrip Lactate Hospital Meter System was based on "current methods for blood lactate measurements," implying reference laboratory methods. The intended use explicitly states, "It Is intended to provide plasma equivalent results to laboratory methods."

8. The Sample Size for the Training Set

This information is not provided in the document. For an in vitro diagnostic device like this, there isn't typically a "training set" in the machine learning sense. The device's calibration and analytical performance are established through development and validation, not through learning from a specific training data set by the end-user.

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

Since a "training set" in the machine learning context is not applicable, the concept of establishing ground truth for it is also not relevant here. Device development and calibration would involve comparing the device's measurements against established reference methods, but this is part of the engineering and verification process for the device itself, not a separate "training set" of data.

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The Lactate Acid Test is indicated for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, (3) diagnosis of hyperlactatemia.

The Lactate Test, as part of the i-STAT System, is intended for the in vitro measurement of lactate in arterial, venous, or capillary whole blood.

Not Found

The provided text is a 510(k) summary for the i-STAT Lactate Test. It does not contain the detailed study information typically requested for acceptance criteria, device performance, and ground truth establishment in the context of medical device evaluations. The summary focuses on the administrative aspects of the 510(k) submission, the device's indications for use, and a proposed labeling change.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. A table of acceptance criteria and the reported device performance: This information is not provided in the given text. The 510(k) process for this device is based on "substantial equivalence" to a predicate device (i-STAT Lactate Test part of the CG4+ Cartridge (K982071)), implying that its performance is expected to be similar or equivalent. However, specific acceptance criteria and performance data from a new study are not detailed.

2. Sample size used for the test set and the data provenance: This information is not provided in the given text.

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 given text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not provided in the given text.

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 is a diagnostic test (in vitro measurement of lactate), not an AI-assisted interpretation of images/cases by human readers. Therefore, an MRMC study in this context is not applicable and this information is not provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The i-STAT Lactate Test is a device for in vitro measurement. Its performance is inherent to the device itself. The concept of "standalone performance" without human-in-the-loop, in the context of AI diagnostic tools, is not directly applicable here. The device itself is the "standalone" entity that performs the measurement. The text does not provide specific performance data from a standalone study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided in the given text. For an in vitro diagnostic, ground truth would typically be established by a reference method or laboratory standard.

8. The sample size for the training set: This information is not provided in the given text.

9. How the ground truth for the training set was established: This information is not provided in the given text.

The closest the document comes to discussing "proof" or justification is in the "Justification of the Labeling Change" section, which states: "The clinical value of an elevated blood lactate level in patients with sepsis as well as patients with hypoperfusion as the result of trauma or following cardiac surgery has been well established. A comprehensive review of the literature supporting the change to the 'Clinical Significance' section has been provided." This refers to external clinical literature supporting the interpretation of lactate levels (what hyperlactatemia means clinically), not performance data of the i-STAT Lactate Test device itself.

In summary, the provided 510(k) summary focuses on the administrative aspects of obtaining regulatory clearance by demonstrating substantial equivalence to a predicate device and justifying a labeling change based on existing literature, rather than detailing a specific performance study with acceptance criteria and ground truth methodologies.

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The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by health care professionals for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens. It is not for use on capillary blood specimens. It is intended to provide plasma equivalent results to laboratory methods. The Nova StatStrip Lactate Hospital Meter System is indicated for use in a clinical setting by healthcare professionals as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis.

Nova StatStrip Lactate Test Strips are intended for use only with Nova StatStrip Lactate Hospital Meter for quantitative determination of lactate in fresh venous and arterial whole blood specimens. It is not for use on capillary blood specimens. The performance characteristics of the device for lactate measurements on capillary specimens have not been established. Nova StatStrip Lactate Test Strips are for testing outside the body (in vitro diagnostic use only).

Nova StatStrip Lactate Control Solutions are intended for use with the Nova StatStrip Family of Meters and Nova StatStrip Lactate Test Strips as a quality control check to verify the accuracy of blood lactate test results. There are 2 levels of controls. (Level 1 and Level 2).

Nova StatStrip Lactate Linearity Kit solutions are used to check the linearity of the Nova StatStrip Family of Meters. There are 4 levels of lactate linearity solutions: Level 1, Level 2, Level 3, and Level 4.

The Nova StatStrip Lactate Hospital Meter System consists of:

1. Nova StatStrip Lactate Hospital Meter
2. Nova StatStrip Lactate Test Strips
3. Nova StatStrip Lactate Control Solutions (Levels 1 and 2)
4. Nova StatStrip Lactate Linearity Solutions (Levels 1,2,3 and 4)
5. Meter Docking Station

The provided text does not contain specific acceptance criteria or detailed performance data from a study that would allow for a direct numerical comparison in a table. The document is a 510(k) summary and approval letter, stating that performance studies were conducted and the device was found substantially equivalent to predicate devices. However, it does not provide the raw performance data, acceptance thresholds, or detailed methodology of these studies.

Therefore, many of the requested fields cannot be filled with specific information from the provided document.

Here's an attempt to answer based on the available information, with clear indications where information is not provided:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not provided. The document mentions "Laboratory and clinical testing was performed" but does not specify the number of samples or patients included in these studies.
• Data Provenance: Not provided specific details. The studies were described as "Laboratory and clinical testing," implying data collected for the purpose of this submission. The country of origin is not specified, but the submitter is a U.S. company. It's likely prospective data collected for the purpose of the 510(k) submission, given the nature of performance studies for new devices, but this is an inference.

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

• Not provided. The document states "substantially equivalent to the current methods for blood lactate measurements" and "plasma equivalent results to laboratory methods," implying comparison to established methods or gold standards, but the process of establishing ground truth for the specific test set is not detailed.

4. Adjudication method for the test set

• Not provided. Given that the ground truth establishment method is not described, the adjudication method is also not mentioned.

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 a medical device for quantitative determination of lactate in whole blood, not an imaging or diagnostic AI device that involves human reader interpretation. Therefore, an MRMC study is not relevant to this type of device.

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

• The device itself is a standalone system (meter and test strips) that provides a quantitative lactate reading. The performance studies described would inherently be standalone, assessing the device's ability to measure lactate accurately. There isn't a separate "algorithm only" component beyond the device's inherent operation.

7. The type of ground truth used

• The ground truth would implicitly be reference laboratory methods for lactate measurement, as the device aims to provide "plasma equivalent results to laboratory methods" and demonstrate "substantial equivalence to the current methods for blood lactate measurements."

8. The sample size for the training set

• Not applicable/Not provided. This device is a measurement system (meter and test strips), not a machine learning or AI-based diagnostic tool that typically involves a distinct "training set" for model development in the same way. Its performance is based on its electrochemical detection principle and manufacturing precision, not on being "trained" on a dataset. The performance studies mentioned are for validation or verification, not training.

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

• Not applicable/Not provided, as there isn't a "training set" in the context of this type of device.

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The Lactate test, as part of the epoc Blood Analysis System, is intended for use by trained medical professionals as an in vitro diagnostic device for the quantitative testing of samples of heparinized or un-anticoagulated arterial, venous or capillary whole blood in the laboratory or at the point of care in hospitals, nursing homes or other clinical care institutions.

Lactate measurements from the epoc Blood Analysis System are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

The epoc Lactate Test is being added as an additional sensor to the existing single use test card that is used with the epoc Blood Analysis System. This test card is inserted into the epoc Reader and all analytical steps are performed automatically. Patient and user information may be entered into the mobile computing device (epoc Host) during the automated analysis cycle.

The epoc Blood Analysis System is an in vitro analytical system comprising a network of one or more epoc Readers designed to be used at the point of care (POC). The readers accept an epoc single use test card containing a group of sensors that perform diagnostic testing on whole blood. The blood test results are transmitted wirelessly to an epoc Host, which displays and stores the test results.

Here's a summary of the acceptance criteria and study information for the epoc Lactate Test, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (Lactate only)

2. Sample Size and Data Provenance

• Test Set for Method Comparison:
  • Sample Size: 373 patient samples for overall method comparison; broken down into 126 venous, 73 arterial, 174 capillary samples for matrix effects.
  • Data Provenance: Field trials at several hospitals on "patient samples of whole blood at various locations." This indicates prospective, real-world data from multiple sites (likely within North America given the FDA submission).
• Test Set for Blood Precision:
  • Sample Size: 15 samples per user at Site 1, and unspecified number at Site 2 (likely similar).
  • Data Provenance: Field trials at two (2) hospitals on "volunteer samples of whole blood by potential end users." This indicates prospective, real-world data from multiple sites.
• Test Set for Aqueous Precision:
  • Sample Size: 15 samples per user per QC level at Site 1, and unspecified number at Site 2 (likely similar).
  • Data Provenance: Field trials at two (2) hospitals on commercially available control fluids by potential end users.
• Test Set for Anticoagulant Effect:
  • Sample Size: 60 samples (43 from hospital POC sites, 17 from in-house studies).
  • Data Provenance: Patient samples from hospital POC sites and in-house studies.

3. Number of Experts and their Qualifications (for Test Set Ground Truth)

• The document describes the predicate device as the "gold standard" for comparison. The ground truth for the method comparison studies was established by the predicate device (i-Stat™ Lactate Test using i-Stat™ Model 300 Portable Clinical Analyzer).
• No specific number of human experts or their qualifications for establishing ground truth are mentioned, as the comparison is against another established device. However, the predicate device itself would have undergone its own validation with expert input.

4. Adjudication Method

• Given that the ground truth is established by a predicate analytical device, there is no human adjudication method (like 2+1 or 3+1) described or applicable in this context. The comparison is quantitative against readings from the predicate device.

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

• A formal MRMC comparative effectiveness study, as typically performed for diagnostic imaging devices involving human readers, was not conducted or described.
• The studies involved different "users" (phlebotomists, RNs, Anesthesia Techs, Resp Therapists) performing tests, which is a form of multi-reader study, but it's focused on device precision/reproducibility across different operators rather than assessing AI assistance for human diagnostic performance. Therefore, there is no effect size reported for human readers improving with/without AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire document describes the standalone performance of the epoc Lactate Test (algorithm and device combined) against a predicate device and established analytical standards. The reported device performance metrics in the tables (precision, linearity, method comparison slope, intercept, R², bias) are all measures of the device's standalone performance. There is no human-in-the-loop component for result interpretation.

7. Type of Ground Truth Used

• The primary ground truth for the clinical and non-clinical studies is:
  • Readings from a legally marketed predicate device (i-Stat™ Lactate Test using i-Stat™ Model 300 Portable Clinical Analyzer) for method comparison studies.
  • NIST traceable standards for calibration, quality control, and linearity studies.
  • Pooled human serum and blood samples (spiked with known interferents or aged to increase lactate) for analytical specificity and blood precision studies.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for the training set for the epoc Lactate Test development. This type of submission (510(k) for an IVD) typically focuses on validation data rather than internal development/training data for the algorithm.

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

• As the training set size is not disclosed, the method for establishing its ground truth is also not explicitly described in this document. However, given the nature of the device (a quantitative sensor measurement system), the training/development likely involved:
  • Controlled reference materials with known lactate concentrations.
  • Comparison to reference laboratory methods known to be accurate and traceable to NIST standards.

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The lactate sensor is intended for professional and point of care use with the IRMA " Blood Analysis System for the direct measurement of lactate, in human whole blood. The Lactate Cartridge and the IRMA "Blood Analysis System are for in vitro diagnostic use.

Lactate evaluates the acid-base status and is used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

The IRMA" SL Blood Analysis System Lacrate Cartridge is for use with the IRMA "Blood Analysis System. The Lactate cartridge is a single use, disposable cartridge, for the in vitro measurement of lactate in whole blood.

Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The lactate sensor uses an amperometric electrode along with a reference electrode that measures the lactate oxidase reaction. The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartidge is completed when information determined at the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry.

Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If there are no abnormal conditions, then the sample results (measured and calculated) are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.

Here's a breakdown of the acceptance criteria and study information for the Diametrics Medical IRMA® SL Blood Analysis System Lactate Cartridge, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document states "The data demonstrates that the Lactate Cartridge is as safe, effective and performs as well as the legally marketed predicate device to which equivalence is claimed." This implies that the observed performance meets an unstated acceptance criterion of being comparable to the predicate device.

Study Details

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

   • Accuracy: n = 30 (Range evaluated 1 - 250 mg/dl).
   • Precision: Levels 1, 2, and 3 had n = 59 each. Level 4 had n = 58.
   • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).

2. 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 document. For in vitro diagnostic devices like this, ground truth is typically established by comparative methods using a reference laboratory instrument, not by expert consensus on imaging or clinical interpretation.

3. Adjudication method for the test set:

   • This information is not applicable/provided for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology studies).

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 comparative effectiveness study was not done. This is an in vitro diagnostic device (IVD) for direct measurement, not an AI-assisted diagnostic tool that would involve human readers.

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

   • Yes, implicitly. The performance data (accuracy, precision, linearity) presented are the standalone performance of the IRMA® SL Blood Analysis System Lactate Cartridge itself, as an automated in vitro diagnostic device without human interpretation as part of the core measurement process. Human interaction is limited to sample collection, cartridge insertion, and reading the displayed results.

6. The type of ground truth used:

   • For accuracy, the ground truth would have been established by comparing the device's results against a reference method or a legally marketed predicate device (YSI Model 2300 Stat Plus, which is mentioned as the predicate). The "Slope," "Intercept," and "r" values indicate a regression analysis comparing the new device to a reference.
   • For precision, the ground truth is statistical, derived from repeated measurements of the same sample, indicating reproducibility.

7. The sample size for the training set:

   • Not applicable/provided. This device is a sensor-based system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "factory derived calibration parameters" mentioned in the device description contribute to its operational accuracy, but this is a manufacturing/calibration process, not an AI training process.

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

   • Not applicable/provided for the reason stated in point 7. The calibration of the cartridge uses "information determined at the factory for each lot of cartridges" and "measurements taken during the calibration process." This involves pre-determined factory parameters and on-site calibration measurements, not a ground truth established for a "training set" in an AI context.

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The Lactate Pro™ System is intended for the determination of Lactate in whole blood. The system is designed for the determination of blood Lactate by individuals with biochemical indicator of Lactic Acidosis. And evaluate physical performance or to establish a proper intensity of exercise for athletes. The system can be used in the clinical setting.

The Lactate Pro™ System consists of Lactate Pro™ Blood Lactate Test Meter, Lactate ProTM Test Strip.

The provided text does not contain a study that proves the device meets specific acceptance criteria. Instead, it is a 510(k) premarket notification letter from the FDA, granting clearance for the Lactate Pro™ System based on substantial equivalence to predicate devices. It discusses the device's indications for use and classification but does not include detailed performance data or acceptance criteria that a clinical study would typically provide.

Therefore, for items 1-9, the answer will largely be "Not applicable" or "Information not provided in the document."

Here's a breakdown based on the provided text:

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

The document is a marketing clearance letter, not a performance study report. It does not detail specific acceptance criteria for accuracy, precision, or other performance metrics, nor does it present the results of such testing for the Lactate Pro™ System. The FDA's clearance is based on a determination of substantial equivalence to predicate devices.

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

Information not provided in the document.

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)

Information not provided in the document.

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

Information not provided in the document.

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 device is a blood lactate test system, not an AI-powered diagnostic imaging device that would involve human readers.

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

Information not provided in the document. As a blood lactate test system, its standalone performance would typically refer to its accuracy and precision against a reference method, not an algorithm's performance. The document does not contain this data.

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

Information not provided in the document. For a blood lactate meter, ground truth would typically be established by a laboratory reference method (e.g., a laboratory analyzer). The document does not specify this.

8. The sample size for the training set

Not applicable. This device is a measurement system, not a machine learning algorithm that requires a training set in the conventional sense. Any internal calibration data or development data are not discussed.

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

Not applicable. See reasoning for point 8.

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The i-STAT lactate test is useful for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood actifbase status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.

The i-STAT lactate test is contained in a single use cartridge. In use, two to three drops of blood are placed in the cartridge as described below. The cartridge is inserted into the thermally controlled i-STAT Model 200 Portable Clinical Analyzer and all analytical steps are performed automatically. Patient and user information may be entered into the analyzer via a keypad during the automated analysis cycle. The i-STAT System is an in vitro analytical system comprising a network of one or more portable clinical analyzers designed to be used at the point of patient care. The analyzers employ single-use test cartridges containing biosensor chips to perform diagnostic tests on whole blood. The system further comprises an infrared communications link from the analyzers to auxiliary information management devices such as printers, personal computers, laboratory information systems and hospital information systems. The i-STAT analyzers, as part of the i-STAT System, are intended for use by health-care professionals for the in vitro analysis of arterial, venous or capillary whole blood at the point of patient care. Tests with the i-STAT System are carried out in test cartridge. It houses the sensor array, aqueous calibrator, fluid channels, and a waste reservoir). Electrochemical sensors on biosensor chips are housed in cartridges in a variety of sensor test configurations appropriate to clinical needs. Test panels are identified by name and color code on the cartridge label. In addition, test panel configurations are encoded into the cartridge in a mechanical feature in the cartridge housing. An array of electrical pins in the analyzer recognizes the mechanical feature and automatically identifies the cartridge test panel type. In use, whole blood is introduced into the sample well of the cartridge at the sample port. After closure, the cartridge is inserted into the cartridge door of the analyzer. Insertion of the cartridge initiates a precisely controlled and monitored sequence of steps performed by the instrument without user intervention. These steps are: - Electrical contact is made between the analyzer electronic input circuits and the . The analyzer identifies the type of cartridge being used and the tests cartridge. contained in the cartridge. - Calibrator is positioned over the sensors. Each lactate test is calibrated with calibrator . fluid that contains a pre-determined amount of lactic acid. - Calibration measurements are made as the sensors generate signals mathematically . related to analytic concentrations. In the i-STAT lactate test the concentration of lactate is directly related to the appearance of hydrogen peroxide (measured by amperometrically) generated by lactic acid oxidase acting on lactic acid in the calibrator fluid or in the blood sample. - . Blood sample washes out the calibrator with the aid of an air bubble between the two. - . Blood sample is positioned over the sensors. - . Calculations of sample concentrations are performed and displayed. The displayed results are also stored in the analyzer memory and can be transmitted by infrared communication link to commercially available computers or printers. The lactate test cartridge is assembled from plastic components that provide the conduits for fluid handling and house the sensor chips. In the cartridge containing the test for lactate, the sensors comprise a patterned metallic layer, supported on a silicon/silicon dioxide substrate, coated with a thin membrane containing lactic acid oxidase.

Here's a breakdown of the acceptance criteria and the study details for the i-STAT Lactate test, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for i-STAT Lactate Test

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a predicate device comparison study rather than explicitly stating acceptance criteria in advance. However, the "conclusions" section confirms that the device meets established standards by being substantially equivalent to the predicate. The performance comparisons provided serve as the basis for this determination.

2. Sample Size and Data Provenance for Test Set

• Sample Size (Test Set):

  • Clinical Comparison - Blood: 46 patient samples
  • Clinical Comparison - Plasma: 47 patient samples

• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "patient samples" and "sites" (Site 1 for blood comparison, Site 2 for plasma comparison), implying clinical data rather than simulated. Without further detail, it's difficult to categorize definitively.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for the clinical comparison. The "ground truth" was established by comparison to existing, cleared analytical devices (the predicate device and a standard laboratory instrument).

4. Adjudication Method for Test Set

No adjudication method is described. The comparison is directly between the i-STAT device and the reference devices.

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

No MRMC comparative effectiveness study was performed. This device is an in vitro diagnostic (IVD) for measuring a analyte; therefore, human reader improvement with AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance was done. The study evaluates the i-STAT Lactate test (the algorithm/device) directly against established methods without human interpretation of results influencing the primary analytical performance.

7. Type of Ground Truth Used

The ground truth for the clinical test set was established by comparison to existing, cleared analytical devices:

• Predicate Device: Stat Profile® Plus Ultra/Lactic acid test (for whole blood comparison).
• Standard Laboratory Instrument: (unspecified, but used for plasma comparison).

8. Sample Size for Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. The i-STAT Lactate test is an IVD device based on biosensor technology. Its performance is characterized through:

• Non-clinical studies: Calibration verification solutions (5 concentrations) and aqueous controls (N=120 for normal range, N=120 for abnormal range) were used to establish linearity and imprecision.
• Clinical studies: Blood and plasma samples from patients were used for comparison.

There is no mention of a "training set" in the sense of data used to train a predictive model.

9. How Ground Truth for Training Set was Established

As there is no explicit mention of a "training set" in the context of AI/ML, this question is not directly applicable. For the non-clinical studies (linearity, imprecision), the ground truth was established by using known concentrations of lactic acid in calibration verification solutions and aqueous controls.

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