(41 days)
The PSA Calibrator is an in vitro diagnostic product intended to be used to calibrate the Prostate Specific Antigen (PSA) method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassy module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.
Prostate Specific Antigen (PSA) Calibrator for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is a frozen product. The Level 1 calibrator is horse serum based with no detectable PSA. Levels 2 through 5 contain human PSA-ACT in a bovine serum albumin base. The kit consists of ten vials; two at each of five levels, containing 1 mL each.
This document is a 510(k) premarket notification for a medical device called "Prostate Specific Antigen (PSA) Calibrator". It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a clinical study for a diagnostic algorithm would.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than proving performance against acceptance criteria for a novel device.
Therefore, many of the requested items cannot be answered from the provided text as they pertain to a type of study that was not conducted or documented here.
Here's a breakdown based on the information provided:
1. A table of acceptance criteria and the reported device performance
This information is not present in the document. The document describes a comparison to a predicate device, not a performance study against predefined acceptance criteria for a novel device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present. No test set or clinical study data is provided.
3. 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)
This information is not present. No test set requiring ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present. No test set requiring adjudication is 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes a calibrator for a clinical chemistry system, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not done in the context of an algorithm. This device is a calibrator, a reagent used to ensure the accuracy of an analytical instrument. Its performance is evaluated through its ability to calibrate the instrument, not as a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present. The concept of "ground truth" for a calibrator is related to the accuracy of the analyte concentration within the calibrator itself, typically established through reference methods or certified reference materials, but this specific detail is not provided.
8. The sample size for the training set
This information is not present. There is no mention of a training set as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
This information is not present. As there is no training set, this question is not applicable.
Summary of what the document does provide:
- Device Name: Prostate Specific Antigen (PSA) Calibrator
- Intended Use: To calibrate the PSA method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
- Predicate Device: aca® plus Prostate Specific Antigen Calibrator
- Comparison to Predicate Device: The document highlights similarities in intended use, analyte (PSA-ACT), matrices (horse serum, BSA), and states that both are manufactured using the same matrices and contain PSA-ACT as the analyte source.
- Conclusion: The PSA Calibrator for the Dimension® RxL system is substantially equivalent to the aca® plus PSA Calibrator.
This document serves as a regulatory submission (510(k)) to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance studies against specific acceptance criteria for a novel technology.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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.