(103 days)
The Access® Hybritech® free PSA QC are bi-level controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of free PSA using the Access® Immunoassay Systems.
The Access Hybritech free PSA QC are controls intended for use in monitoring system performance of immunoenzymatic procedures for the quantitative measurement of free PSA using the Access Immunoassay systems.
The Access Hybritech free PSA QC are ready to use bi-level control material consisting of human free PSA in a buffered bovine serum albumin (BSA) matrix with preservatives. The controls are targeted to cover the assay range of approximately 0.005 – 20 ng/ml at two levels of approximate concentrations of 1ng/mL and 13 ng/mL.
The provided text describes a 510(k) premarket notification for a quality control device, not an AI/ML-driven medical device for diagnosis or prognosis. Therefore, many of the requested fields, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable to this type of device.
However, I can extract the acceptance criteria and the summary of the study performed to demonstrate the device's performance regarding those criteria.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Precision: Within-run | Less than 5% CV |
| Precision: Between-run | Less than 5% CV |
| Precision: Total | Less than 5% CV |
Study Details:
- Sample size used for the test set and the data provenance: Not applicable. This device is a quality control material, and the study focuses on its precision, not diagnostic accuracy on patient data. No "test set" in the context of patient data for diagnostic classification is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic purposes is not relevant for a quality control material. The study assesses the reproducibility of the control material itself.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication of diagnostic outcomes is involved.
- 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 device, not an AI/ML diagnostic aid.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a quality control device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a quality control material is its expected concentration and the variability around it. The study evaluates the reproducibility of this material.
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- 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.