(45 days)
The Bayer Lipoprotein Calibrator is intended for in vitro diagnostic use to calibrate Apolipoprotein A1, Apolipoprotein B assays and Direct HDL on the ADVIA IMS Chemistry systems.
The Lipoprotein Calibrator is a human serum based solution containing various non human and human constituents.
The provided document describes a 510(k) premarket notification for a Lipoprotein Calibrator. This document primarily focuses on establishing substantial equivalence to a predicate device and does not detail a study with specific acceptance criteria and performance metrics in the way one might expect for a diagnostic or AI-driven device.
However, based on the information provided, here's an interpretation of the "acceptance criteria" and "study" as they pertain to this calibrator, framed to match the requested format:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Calibrates Apolipoprotein A1, Apolipoprotein B, and Direct HDL assays on ADVIA IMS Chemistry systems. | The device's intended use includes calibrating Direct HDL cholesterol assays, which was the focus of this submission. It is deemed to perform similarly to other products for similar use. |
| Format: Lyophilized mixture of human and bovine serum base with appropriate constituents. | "Same" as predicate device. |
| Constituent Analytes: Apolipoprotein A1, Apolipoprotein B, HDL Cholesterol. | "Same" as predicate device; the difference is assigning values for Direct HDL. |
| Stability: Stable at 2-8°C until expiration; stable 3 days when reconstituted at 2-8°C. | "Same" as predicate device. Stability validated according to Bayer procedures. |
| Levels: Six levels for Apolipoprotein A1 and Apolipoprotein B; a single level for Direct HDL Cholesterol method. | Achieved: "a single level for the Direct HDL Cholesterol method" was added to the existing six levels for other analytes. |
| Equivalent Performance: Performance similar to other products in commercial distribution intended for similar use. | "The performance of the calibrator is similar to other products in commercial distribution intended for similar use." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of typical device validation. The "study" focused on stability validation and demonstrating substantial equivalence. The document mentions "three separate lots of calibrator material" were used for stability validation.
- Data Provenance: Not specified, but given the context of Bayer HealthCare LLC in Tarrytown, NY, and Medical Analysis Systems, Inc. (MAS) in Camarillo, CA, it is likely retrospective testing performed internally by the manufacturer, or under their direction, within the USA.
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 a calibrator, "ground truth" would typically refer to the accurately assigned values of the analytes within the calibrator material, which are established through rigorous metrological traceability, reference methods, and internal quality control, rather than expert consensus on a test set.
4. Adjudication method for the test set
- Not applicable / Not specified. The document does not describe an "adjudication method" as would be used for subjective assessments or interpretations. The evaluation of a calibrator involves objective analytical measurements.
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
- No. This document describes a medical device calibrator, not an AI-driven or interpretation-based diagnostic device. Therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a calibrator, a reagent used to standardize assays, not an algorithm or standalone diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a calibrator's values is established by analytical methods, reference materials, and metrological traceability, ensuring that the assigned values for Apolipoprotein A1, Apolipoprotein B, and Direct HDL cholesterol are accurate and consistent. This is an intrinsic property of the calibrator material itself, based on its chemical composition and precise measurement, rather than expert consensus on a clinical outcome.
8. The sample size for the training set
- Not applicable. This submission focuses on a calibrator, not a machine learning model, so there is no "training set" in the AI sense. The "training" in manufacturing involves process controls and validation using material lots. The document states validation based on "three separate lots of calibrator material."
9. How the ground truth for the training set was established
- Not applicable. As there is no "training set" for an AI model, this question is not relevant. The "truth" for the calibrator lots used in performance validation (stability) would be established by the manufacturer's internal analytical methods and quality control processes to assign specific, traceable values to the analytes within the calibrator.
§ 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.