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Dri-STAT® Reagent ACP is intended for use in the in vitro diagnostic determination of total acid phosphatase and non-prostatic acid phosphatase in human serum as a User Defined Reagent (UDR) application on SYNCHRON® Systems.

The Dri-STAT® Reagent ACP may be used on the family of Synchron Systems. The reagent kit contains 20 reagent bottles that needs to be manually transferred into a Beckman Coulter User-Define Cartridge. Also with 1 bottle of Acetate Buffer. The reagent kit contains a bottle of Acetate Buffer along with a sample treatment.

Here's a breakdown of the acceptance criteria and study information for the Dri-STAT® ACP Reagent, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in the typical sense of threshold values (e.g., "r-value > 0.95"). Instead, it presents performance data for method comparison and imprecision. The implicit acceptance criterion is that the performance of the candidate device (Dri-STAT® ACP Reagent on Synchron Systems) is substantially equivalent to the predicate device (Dri-STAT® ACP Reagent on Cobas Fara). Substantial equivalence is demonstrated through the presented performance data.

Study Details

The provided document describes a study that aims to demonstrate substantial equivalence between the Dri-STAT® ACP Reagent on Synchron Systems (candidate device) and the Dri-STAT® ACP Reagent on Cobas Fara (predicate device).

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

   • Method Comparison Test Set:
     • TACP (Total Acid Phosphatase): 94 serum samples.
     • NPAP (Non-Prostatic Acid Phosphatase): 47 serum samples.
   • Imprecision Test Set: 80 measurements for each control level and human pool for both TACP and NPAP.
   • Data Provenance: Not explicitly stated, but clinical laboratory samples are typically collected in the country where the studies are performed (presumably USA given the manufacturer's location and FDA submission). The studies are retrospective or concurrent analyses of specimens, as it involves method comparison and imprecision testing on collected samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For in vitro diagnostic (IVD) assays like this, the "ground truth" is typically established by the reference method (the predicate device in this case) or known assayed values of controls, rather than human expert consensus.

3. Adjudication method for the test set: Not applicable. As this is an IVD assay evaluation, there is no human adjudication process involved in establishing ground truth for the samples. The predicate device's results serve as the comparison point.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is an evaluation of an in vitro diagnostic reagent, not a medical imaging or interpretation device that would involve multiple human readers.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the entire evaluation is for the standalone performance of the Dri-STAT® ACP Reagent on Synchron Systems as an automated assay. There is no human-in-the-loop component described for its operation or result generation.

6. The type of ground truth used:

   • Method Comparison: The "ground truth" or reference values are the results obtained from the predicate device (Dri-STAT® ACP Reagent on Cobas Fara).
   • Imprecision: "Ground truth" for controls are their known assayed values, and for human pools, the mean determined value from multiple measurements.

7. The sample size for the training set: Not applicable. For IVD reagents, there isn't a "training set" in the machine learning sense. The device's performance characteristics are established through analytical validation studies (method comparison, linearity, imprecision), not by training an algorithm on a dataset. The reagent formulation and instrument settings are designed and optimized by the manufacturer, rather than "trained."

8. How the ground truth for the training set was established: Not applicable, as there is no training set in this context.

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The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to measure total and non-prostatic acid phosphatase concentrations in human serum.
The Bayer ADVIA 1650 Acid Phosphatase assay is an in vitro diagnostic device intended to quantitatively measure total and non-prostatic acid phosphatase concentration in human serum.

The ADVIA 1650 acid phosphatase method measures total and non-prostatic acid phosphatase in serum by a colorimetric procedure published by Hillmann. Tartrate inhibits prostatic acid phosphatase, allowing for measurement of non-prostatic acid phosphatase. The prostatic acid phosphatase concentration can be manually calculated by determining the difference between total acid phosphatase and non-prostatic acid phosphatase.

Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA® 1650™ Acid Phosphatase assay, based on the provided text:

Acceptance Criteria and Device Performance

Note regarding Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for most of these parameters. However, in the context of a 510(k) submission, the "acceptance criteria" are implicitly met if the reported performance is demonstrated to be "substantially equivalent" to predicate devices and acceptable for the intended use in a clinical laboratory setting. The FDA's issuance of the 510(k) implies that the provided data was deemed acceptable.

Study Details

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

   • Correlation (NpACP): N = 64 serum samples.
   • Correlation (Total ACP): N = 71 serum samples.
   • Imprecision: Not explicitly stated as a "test set" in the same way as correlation. Imprecision studies typically involve repeated measurements of control materials or pooled patient samples over several days. For MDC, 44 replicates over 11 days (22 runs) were used.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full study report, but is not present in this summary.

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

   • This device is an in vitro diagnostic assay for measuring biomarkers, not an image-based or diagnostic interpretation device requiring expert review for ground truth. The "ground truth" for method comparison and imprecision studies relies on the established reference method (the predicate device for correlation) and the inherent chemical properties of the analytes. Therefore, this question is not directly applicable in the same way as it would be for AI-powered diagnostic tools. There would be no "experts" establishing ground truth in this context.

3. Adjudication method for the test set:

   • Not applicable. As this is a quantitative chemical assay, the "adjudication" (if one could use that term) is based on the result from the predicate device and standard analytical chemistry principles, not expert consensus or review.

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 a standalone in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, this entire submission describes the standalone performance of the ADVIA 1650 Acid Phosphatase assay as a laboratory instrument. The performance metrics (imprecision, correlation, interference, analytical range, MDC) are all measures of the device's inherent analytical capabilities.

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

   • For the correlation study, the "ground truth" was established by the predicate device (Roche Acid Phosphatase method on the Hitachi system). The ADVIA 1650's results were compared against this established method.
   • For imprecision, analytical range, and MDC, the "ground truth" is derived from standard analytical chemistry and metrology principles, using reference materials, control solutions, and repeated measurements.

7. The sample size for the training set:

   • Not applicable. As an in vitro diagnostic assay using established chemical reactions (Hillmann colorimetric procedure), there is no 'training set' in the machine learning sense. The method's parameters are based on scientific principles and validated through the studies presented.

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

   • Not applicable, as there is no "training set" for this type of IVD device.

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The cassette COBAS INTEGRA Acid / Prostatic Phosphatase contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of total and prostatic acid phosphatase in serum.

The cassette Roche COBAS INTEGRA Benzodiazepines contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA for the semi-quantitative detection of benzodiazepines in human urine using the enzyme ß-glucuronidase.

The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8°C. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents.

The provided text describes two in vitro diagnostic reagent systems: COBAS INTEGRA Acid/Prostatic Phosphatase (ACPP) and COBAS INTEGRA Benzodiazepines with β-glucuronidase (BNZGL). The 510(k) summary focuses on demonstrating their substantial equivalence to previously marketed devices rather than establishing novel acceptance criteria or performing a comparative effectiveness study in the typical sense of AI/human reader studies.

Here's an analysis of the provided information against your requested categories, acknowledging that some categories may not be directly applicable to this type of device and submission:

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

The document presents performance characteristics for the new devices and compares them to their predicate devices, implying these are the "acceptance criteria" for demonstrating substantial equivalence. Exact numerical acceptance criteria (e.g., "CV must be < X%") are not explicitly stated, but rather the performance is shown to be comparable.

COBAS INTEGRA Acid/Prostatic Phosphatase (ACPP)

COBAS INTEGRA Benzodiazepines with β-glucuronidase (BNZGL)

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

• ACPP Accuracy Test Set:
  • Total Acid Phosphatase: n = 260 samples.
  • Prostatic Acid Phosphatase: n = 264 samples.
  • Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be retrospective comparisons to predicate devices' performance claims.
• BNZGL Accuracy Test Set:
  • Positive Samples: n = 50 samples for INTEGRABNZGL vs GC/MS comparison.
  • The table indicates accuracy for positive samples where both INTEGRA with and without β-glucuronidase, and GC/MS all show 50 positive samples and 0 negative samples. This implies 50 positive samples were tested, and perhaps an additional number of negative samples that are not detailed in this specific comparison row, but rather in "overall agreement" data that is not fully presented.
  • Data Provenance: Not explicitly stated (e.g., country of origin). Appears to be retrospective.

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 document. For in vitro diagnostic devices, ground truth for quantitative measurements (like acid phosphatase levels) typically comes from reference methods or established laboratory procedures, not from human experts adjudicating images or other subjective interpretations. For benzodiazepine detection, GC/MS is treated as the reference ground truth, which is an analytical method.

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

Not Applicable for these types of in vitro diagnostic tests, which rely on quantitative measurements compared to reference methods (e.g., GC/MS) or predicate biochemical assays. There is no human adjudication process described.

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 document describes in vitro diagnostic assays, not AI-powered medical image analysis tools or other devices that involve human readers/interpreters. Therefore, no MRMC study or AI assistance effect size is discussed.

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

This refers to the performance of the device without human intervention. In the context of these IVD devices, the stated performance characteristics (e.g., precision, accuracy, sensitivity, assay range) are the standalone performance of the reagent system on the COBAS INTEGRA Analyzer. There is no human-in-the-loop component for the analytical part of these tests.

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

• COBAS INTEGRA Acid/Prostatic Phosphatase:
  • Ground truth for accuracy was established by comparison to the predicate device, "Roche Reagent for Acid Phosphatase" (K831834). This is a method comparison study where the predicate acts as the reference or "ground truth."
• COBAS INTEGRA Benzodiazepines with β-glucuronidase:
  • Ground truth for accuracy was established by comparison to Gas Chromatography/Mass Spectrometry (GC/MS) (as indicated in the "Accuracy Positive Samples" table for the predicate device, which is then compared for the new device). GC/MS is a widely accepted confirmatory method for drug detection and serves as the gold standard ground truth in this context.

8. The sample size for the training set

The document does not explicitly identify or specify a "training set" in the context of machine learning. For these diagnostic assays, the development and optimization of the reagent formulation and instrument parameters are analogous to "training" in a broader sense, but there's no data given for this phase. The presented performance data are from validation/verification studies, which would be considered test sets.

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

As there is no explicitly defined "training set" in the machine learning sense, this question is not applicable. The ground truth for the performance evaluations (test sets) is described in point 7.

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The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in vitro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in virro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.

The ILab 600 Clinical Chemistry System is an automated, random access clinical chemistry analyzer that quantifies analytes in physiological fluids using photometry and potentiometry. The device was found substantially equivalent to the ILab 900/1800 Clinical Chemistry System (K932467, K943595) and IL Test assays (K943366, K952646, K943367, K952647).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ILab 600 are implicit in its claim of substantial equivalence to the predicate device, the ILab 900. This means the performance of the ILab 600 must be "statistically similar" to that of the ILab 900 across various analytes and sample types (serum, urine, cerebrospinal fluid).

The reported device performance is demonstrated through method comparison studies and precision studies.

Method Comparison Studies (ILab 600 vs. ILab 900):

Precision Studies (ILab 600):

• Serum Samples: Two levels of serum samples (three for Cholesterol) were tested in triplicate twice a day for 10 days (n=60 total). The Total %CV for most analytes was generally low, indicating good precision. For example:
  • Albumin: Level 1 (1.79%), Level 2 (1.08%)
  • ALT/GPT: Level 1 (1.26%), Level 2 (0.99%)
  • Cholesterol: Level 1 (2.11%), Level 2 (1.35%), Level 3 (1.37%)
  • ISE Sodium: Level 1 (0.94%), Level 2 (0.67%)
• Urine Samples: Two levels of urine samples were tested in triplicate twice a day for 10 days (n=60 total). Similar to serum, Total %CV remained low:
  • Amylase: Level 1 (2.56%), Level 2 (2.02%)
  • Creatinine: Level 1 (2.11%), Level 2 (1.73%)
  • ISE Sodium: Level 1 (1.13%), Level 2 (0.65%)
• Cerebrospinal Fluid Samples: Two levels of CSF samples were tested using IL Test Glucose Oxidase in triplicate twice a day for 5 days (n=30 total).
  • Glucose Oxidase: Level 1 (1.49%), Level 2 (0.98%)

The studies conclude that the ILab 600 and ILab 900 are "statistically similar" for the tests evaluated. The precision studies demonstrate acceptable levels of reproducibility based on the reported Coefficient of Variation (%CV) values for within-run, among-run, among-day, and total precision. No specific numerical thresholds for acceptance criteria were explicitly stated, but the robust statistical similarity and low %CV values imply the device meets the necessary performance standards for clinical use.

2. Sample Sizes and Data Provenance

• Test Set (Method Comparison):

  • Serum Samples: Sample sizes ranged from a minimum of 64 (Lipase) to a maximum of 137 (Glucose Oxidase).
  • Urine Samples: Sample sizes ranged from 49 (ISE Potassium and Sodium) to 95 (Glucose Hexokinase).
  • Cerebrospinal Fluid Samples: Sample size was 20 (Glucose Oxidase).
  • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

• Test Set (Precision Studies):

  • Serum Samples: n=60 for most analytes (triplicate measurements, twice a day, for 10 days). Cholesterol used n=60 across three levels.
  • Urine Samples: n=60 for all analytes (triplicate measurements, twice a day, for 10 days).
  • Cerebrospinal Fluid Samples: n=30 for Glucose Oxidase (triplicate measurements, twice a day, for 5 days).
  • Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document pertains to the performance characteristics of a clinical chemistry analyzer, which measures quantitative values of analytes. The "ground truth" in this context refers to the actual concentration of the analytes in the samples. Clinical chemistry analyzer performance is typically evaluated by comparing results to a reference method (in this case, the predicate device ILab 900) or by using certified reference materials with known concentrations. Therefore, expert interpretation or consensus, as might be used in image-based diagnostic AI, is not applicable here. No mention of human experts defining "ground truth" is provided or expected.

4. Adjudication Method

Not applicable. As described in point 3, this is a quantitative measurement device, not an interpretation task requiring adjudication of expert opinions.

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

Not applicable. The device is a clinical chemistry analyzer, not an AI system assisting human readers in diagnostic interpretation. The study evaluates the analyzer's performance directly against a predicate device and for precision, not the human reader's effectiveness with or without AI.

6. Standalone Performance Study

Yes, standalone performance was done.

• Method Comparison Studies: The performance of the ILab 600 was compared directly to that of the ILab 900 (predicate device). This is a standalone comparison of the new device against an established one.
• Precision Studies: The precision of the ILab 600 was evaluated independently, measuring its reproducibility across different runs and days. This is also a standalone performance evaluation of the device itself.

7. Type of Ground Truth Used

The ground truth used for these studies is the quantitative analytical result obtained from the predicate device (ILab 900) for method comparison studies, and the inherent, measured concentration within the biological samples for precision studies. This is a form of reference method comparison or analytical accuracy assessment, rather than pathology, expert consensus, or outcomes data, which are typically associated with qualitative or interpretative diagnostics. For precision, the ground truth is implicitly the true, stable concentration in the control/patient samples being repeatedly measured.

8. Sample Size for the Training Set

Not applicable. The ILab 600 is a clinical chemistry analyzer, which operates based on established chemical and photometric/potentiometric principles and internal calibration curves. It is not an AI/ML device that requires a "training set" in the sense of supervised learning. Its analytical methods are pre-programmed and validated, not learned from data in the way a machine learning algorithm would be.

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

Not applicable, as there is no "training set" for this type of device. The device's operational parameters and calibration are established through engineering design and standard laboratory calibration procedures, not through a data-driven training process.

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This method uses anti-human PAP mouse monoclonal antibodies to inhibit PAP activity which results in much higher specificity than is obtained with tartaric acid inhibition method. With this test kit, the PAP is completely eliminated from ACP in calculating the level of PAP. High sensitivity composite substrate 2,6-doichloro-4-acetylphenyl phosphate (DCAP-P) is used, making it simple and fast to use with general purpose automated analyzers.

The provided text is a 510(k) summary for a Prostatic Acid Phosphatase Reagent Test, focusing on its equivalence to existing methods and the scientific background of PAP testing. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the requested questions about a modern AI/ML medical device submission.

Therefore, I cannot provide the requested table and details based on the given input text. The input discusses a traditional in-vitro diagnostic (IVD) assay from 1997, not an AI/ML-based device that would typically involve the types of studies and criteria mentioned in the prompt (e.g., test sets, training sets, human readers, adjudication, MRMC studies).

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