(339 days)
The DSL-9700 Active™ PSA Immunoradiometric Assay (IRMA) Kit provides materials for the quantitative measurement of Total PSA in human serum to aid in the management (monitoring the reoccurrence of prostate cancer) of prostate cancer patients. This assay is intended for in vitro diagnostic use.
The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the coated tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwich" complex. Unbound materials are removed by decanting and washing the tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound PSA is directly proportional to the concentration of the PSA present in the sample.
The provided text describes the DSL 9700 PSA IRMA kit, an immunoradiometric assay for the quantitative measurement of Total PSA in human serum. This device is intended to aid in the management (monitoring the recurrence of prostate cancer) of prostate cancer patients.
Here's an analysis of the acceptance criteria and the study that demonstrates the device meets these criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (DPC IMMULITE PSA assay) must be demonstrated. | Equivalence Demonstrated: Linear regression analysis of 286 human serum samples tested on both the DSL 9700 PSA IRMA and the DPC IMMULITE PSA assay resulted in the equation Y = 1.25(DPC IMMULITE) + 0.33 with a correlation coefficient (r) = 0.97. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: 286 human serum samples.
- Data Provenance: The document does not explicitly state the country of origin. It can be inferred that these were human serum samples collected for this specific validation, but it doesn't specify if they were retrospective or prospective. Given the context of a 510(k) submission, it's likely they were carefully selected for the purpose of demonstrating equivalence retrospectively.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study focuses on comparing the new device against a predicate device, not on establishing a ground truth via expert review of patient cases.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. The study compares two assays directly using quantitative measurements, not through an adjudication process of expert interpretations.
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 section is not applicable. The DSL 9700 PSA IRMA kit is an in-vitro diagnostic device (an assay), not an AI-powered diagnostic imaging or interpretation system that would involve human readers or AI assistance. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant to this device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone study was performed. The DSL 9700 PSA IRMA kit is a laboratory assay that provides a quantitative measurement. The performance (measurement of PSA levels) is determined by the assay kit itself, without human interpretation of images or complex decision-making based on algorithm output. The study described is a direct comparison of the numerical outputs of the DSL 9700 PSA IRMA kit and the DPC IMMULITE PSA assay.
7. The Type of Ground Truth Used
The "ground truth" in this context is the quantitative measurement provided by the predicate device, the DPC IMMULITE PSA assay. The goal was to establish substantial equivalence to this already legally marketed device, meaning its measurements are accepted as the standard for comparison. The samples were chosen across a range of expected PSA levels (low, intermediate, high), implying that the actual PSA level in each sample, as determined by the predicate, was the reference point.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. For this type of in-vitro diagnostic device, the "development" or "calibration" might involve internal runs during product development. The provided sample size (n=286) refers to the set used for demonstrating substantial equivalence to the predicate device, which would typically be considered a validation or test set in the context of a regulatory submission.
9. How the Ground Truth for the Training Set Was Established
Given that this is an In-Vitro Diagnostic (IVD) assay and not an AI or imaging device, the concept of "ground truth for a training set" as it relates to expert annotations for AI is not applicable. The development of such assays involves establishing analytical performance characteristics (e.g., sensitivity, specificity, accuracy, precision) against known standards or reference methods. The "ground truth" for calibrating or developing the DSL 9700 PSA IRMA assay would likely have been established through:
- Reference materials with certified PSA concentrations.
- Cross-validation with established, highly accurate laboratory methods or other well-characterized PSA assays.
The document does not detail these specific developmental steps, as the summary focuses on the comparative study for regulatory clearance.
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.