(57 days)
The SYNCHRON® Systems CAL 5 Plus, when used in conjunction with SYNCHRON® Systems and reagents, is intended for use in the calibration of Antistreptolysin-O (ASO-) on the SYNCHRON CX® Systems and for Antistreptolysin-O (ASO-), C-reactive protein (CRP), and Rheumatoid factor (RF) chemistries on the SYNCHRON LX™ Systems.
This SYNCHRON Systems CAL 5 Plus is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems. The SYNCHRON Systems CAL 5 Plus is for use in the calibration of SYNCHRON Systems Antistreptolysin-O (ASO-), C-reactive protein (CRP), and Rheumatoid factor (RF) chemistries. The SYNCHRON Systems CAL 5 Plus is a frozen liquid human serum matrix identical to the Beckman CAL 5 Plus product.
Here's an analysis of the provided 510(k) summary for the SYNCHRON® Systems CAL 5 Plus, focusing on acceptance criteria and study details.
This document describes a calibrator device, which is different from a diagnostic device that processes images or patient data. As such, many of the typical acceptance criteria and study characteristics for AI-powered diagnostic devices (e.g., sample size, expert ground truth, MRMC studies, standalone performance) are not applicable or described in this type of submission. The focus for a calibrator is on its stability and ability to provide accurate reference points.
Acceptance Criteria and Reported Device Performance
For this calibrator, the primary performance characteristic evaluated is its stability. The acceptance criterion is that the device maintains stability for a claimed duration of 24 months.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Stability of CAL 5 Plus for ASO, CRP, and RF | Predicted stability of 32-33 months (exceeding Beckman's 24-month stability claim) |
Study Details (as applicable to a calibrator)
Since this is a calibrator and not a diagnostic device, many of the requested categories are not directly applicable. I will address the relevant sections and note when information is not provided or applicable for this type of submission.
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "test set" in the traditional sense. The stability study involved incubating the calibrator at different stress temperatures (32°C, 37°C, 41°C) for specific durations (40 days, 24 days, 15.5 days, respectively). The number of individual calibrator units or replicates tested is not provided.
- Data Provenance: Not specified other than "Beckman Instruments, Inc." (the manufacturer). There is no indication of country of origin of data or whether it was retrospective or prospective.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For a calibrator, "ground truth" is established by correlating its value assignment process to a "known standard via the anchor method." This is a metrological process, not an expert-driven diagnostic ground truth.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
-
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 device is a calibrator, not an AI-powered diagnostic device, and does not involve human readers interpreting data.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a chemical calibrator for in-vitro diagnostic assays, not an algorithm. Its "standalone" performance relates to its physical and chemical stability. The study described in the summary is a standalone performance evaluation of the calibrator itself.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Metrological Standard: The ground truth for value assignment is described as correlation to a "known standard via the anchor method." This refers to established chemical or biological reference materials and methodologies for calibrating laboratory assays.
-
The sample size for the training set:
- Not applicable. This device does not use machine learning, so there is no concept of a "training set."
-
How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 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.