(21 days)
MA Calibrator, when used in conjunction with SYNCHRON Systems MA Reagent (P/N 475100), is intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin.
The SYNCHRON CX® Systems Microalbumin Calibrator , when used in conjunction with SYNCHRON Systems Microalbumin Systems Reagent (P/N 475100), is intended for use on the SYNCHRON CX Systems for the calibration of Microalbumin. This product contains a 3.0 mL bottle each of Levels 1 to 6 of Microalbumin Calibrator.
This document is a 510(k) Summary of Safety and Effectiveness for the SYNCHRON CX® Systems Microalbumin Calibrator. It outlines the device's intended use, comparison to a predicate device, and a summary of performance data.
Here's an analysis of the requested information based on the provided text:
1. Table of acceptance criteria and reported device performance
The document does not explicitly state acceptance criteria in a quantitative format, nor does it provide detailed device performance metrics beyond a stability claim. It focuses on demonstrating substantial equivalence to a predicate device.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Stability | 24 months (stress stability studies support this claim) |
2. Sample size used for the test set and the data provenance
The document makes no mention of a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The "Summary of Performance Data" section is very brief and refers to "data in the Premarket Notification" without elaboration.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
There is no mention of experts, ground truth establishment methodologies, or their qualifications. The evaluation appears to be based on laboratory testing for stability and comparison to a predicate device, not on expert interpretations of results.
4. Adjudication method for the test set
No adjudication method is mentioned, as there is no described test set involving human interpretation requiring adjudication.
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 document describes a medical device calibrator, not an AI-based diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This calibrator is a physical product used to set reference points for a diagnostic system. It does not involve an algorithm or standalone performance in the sense of an AI model. Its performance is intrinsic to its chemical properties and stability.
7. The type of ground truth used
The concept of "ground truth" as typically applied to diagnostic accuracy studies (e.g., pathology, clinical outcomes) is not directly applicable here. For a calibrator, the "truth" likely refers to the assigned concentration values of the calibrator levels, which are traceable back to a reference standard. The document states:
- Traceable to the IFCC reference preparation for plasma proteins, lot CRM 470.
This indicates that the "ground truth" for the calibrator's values is established by its traceability to an internationally recognized reference material.
8. The sample size for the training set
This device is not an algorithm or AI model that requires a "training set." Therefore, no training set or sample size is applicable or mentioned.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.