(36 days)
The Access® Hybrttech® PSA QC are tri-level controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of total PSA using the Access® Immunoassay Systems.
The Access Hybritech PSA QC are controls intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of Prostate Specific Antigen (PSA) using the Access Immunoassay systems.
The Access Hybritech PSA QC are ready to use tri-level control material consisting of human PSA in a buffered bovine serum albumin (BSA) matrix with preservatives. The controls are targeted to cover the assay range of approximately 0.008 - 150 ng/mL at three levels of approximate PSA concentrations of 1 ng/mL, 15 ng/mL, and 90 ng/mL.
The provided 510(k) summary for the Access® Hybritech® PSA QC describes a quality control material, not a device that directly measures a patient's condition or uses an AI algorithm. Therefore, many of the requested categories in the prompt (e.g., test set, ground truth, experts, MRMC study, standalone algorithm performance, training set) are not applicable to this type of submission.
However, I can extract the relevant information regarding the acceptance criteria and study proving performance as a quality control material.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Precision: Within-run, between-run, and total imprecision of all three levels of the Access Hybritech PSA QC. | Within-run, between-run, and total imprecision of all three levels of the Access Hybritech PSA QC were less than 5% CV. |
Study Details (as applicable to a Quality Control Material):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The term "test set" in the context of an algorithm or diagnostic device is not directly applicable here. For a quality control material, the "sample size" refers to the number of replicates or runs performed to assess precision.
- The summary states "Within-run, between-run, and total imprecision of all three levels...". This implies multiple replicates at each of the three control levels, over multiple runs, to calculate the Coefficient of Variation (CV).
- Specific numbers of replicates or runs are not provided.
- Data provenance (country of origin, retrospective/prospective) is not specified, but typically such studies for IVD QC materials are conducted in-house by the manufacturer.
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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):
- Not applicable. For a quality control material, the "ground truth" (or target value) for precision is established by the inherent analytical performance of the assay and the stability of the control material itself, not by expert consensus on patient data.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for interpretation of complex data (e.g., medical images) where human judgment might vary. For analytical precision, statistical methods are used for calculation.
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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 quality control material, not a device intended for human interpretation or AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a quality control material used to monitor an immunoassay system, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a quality control material, the "ground truth" for evaluating precision is the expected statistical variation (imprecision) of the material when run on the Access Immunoassay System. This is determined through rigorous laboratory testing. The target concentrations (approx. 1 ng/mL, 15 ng/mL, and 90 ng/mL) for the controls would be established by the manufacturer.
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The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.