(55 days)
The SYNCHRON® LX Systems Prealbumin Calibrator, used in conjunction with SYNCHRON® Systems Prealbumin reagent, is intended for use on Beckman's SYNCHRON LX Systems for the calibration of prealbumin test systems.
The SYNCHRON Systems Prealbumin Calibrator is a ready-to-use human serum-based liquid calibrator manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of the calibrator.
The provided document is a 510(k) summary for the SYNCHRON® LX Systems Prealbumin Calibrator. It primarily focuses on demonstrating substantial equivalence to a predicate device and includes very limited performance data. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this document.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Stability: The calibrator should remain stable for a specified duration. The predicate device, and by implication, the new device, is expected to meet stability requirements. | Stress Stability Studies: Support a Beckman stability claim of 24 months. |
Note: The document does not explicitly state acceptance criteria in a quantitative or statistical manner for performance metrics like accuracy, precision, or linearity. The primary "performance" discussed is related to stability and equivalence to the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any performance testing other than the mention of "stress stability studies."
- Data Provenance: Not specified. It can be inferred that the studies were conducted by Beckman Coulter, Inc. (USA), but details about the origin of the samples within those studies are not provided.
- Retrospective/Prospective: Not specified.
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)
- Not applicable. This device is a calibrator for laboratory assays, not an imaging or diagnostic device requiring expert interpretation of results to establish ground truth in the way a medical image or clinical diagnosis would. Ground truth for a calibrator would typically be established through highly accurate reference methods or certified reference materials traceable to international standards (e.g., IFCC reference preparation for plasma proteins, lot CRM 470, as mentioned for value assignment methodology).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As the device is a calibrator, there is no "adjudication" in the sense of reconciling differing expert opinions on a diagnostic outcome. The value assignment methodology (traceable to IFCC reference preparation) serves as the "ground truth" establishment.
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 MRMC study was done. This is a calibrator for an in-vitro diagnostic system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical calibrator, not an algorithm or software. Its performance is evaluated by its ability to accurately calibrate the SYNCHRON® LX Systems Prealbumin Reagent.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the calibrator's value assignment is based on traceability to the IFCC reference preparation for plasma proteins, lot CRM 470. This indicates that the calibrator’s concentration values are assigned using a well-established and internationally recognized reference standard.
8. The sample size for the training set
- Not applicable. This document describes a calibrator; there is no mention of a "training set" as it would apply to machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.