(156 days)
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 95% confidence | 5.0 ng/mL of nordiazepam at > 95% confidence |
| Accuracy: Positive Samples (INTEGRA vs GC/MS) | 50 (INTEGRA +)/50 (GC/MS +) ; 0 (INTEGRA -)/0 (GC/MS -) from table | 50 (INTEGRA +)/50 (GC/MS +) ; 0 (INTEGRA -)/0 (GC/MS -) from table; i.e., 100% agreement when positive |
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.
§ 862.1020 Acid phosphatase (total or prostatic) test system.
(a)
Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.