(43 days)
The CHEM 3 CAL is an in vitro diagnostic product for the calibration of alcohol (ALC), ammonia (AMON) and carbon dioxide (CO2) methods on the Dimension Vista" System.
CHEM 3 CAL is a multi-analyte, aqueous product containing ethyl alcohol, ammonium bicarbonate and sodium carbonate. The kit consists of six vials, three vials of Calibrator A, and three vials of Calibrator B which are ready for use (no preparation is required). The volume per vial is 2.5 mL.
The provided document is a 510(k) Summary for a calibrator device, not a diagnostic device that performs clinical measurements or predictions. Therefore, many of the typical AI/ML-related acceptance criteria and study descriptions (like MRMC studies, human reader improvement, standalone algorithm performance, or ground truth for a test set) are not applicable to this type of product.
This document describes the validation of a calibrator's stability and its ability to assign accurate values for three analytes on a specific instrument system.
Here's the relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core "performance" for a calibrator relates to its stability and its ability to be accurately assigned values for the analytes it is meant to calibrate.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Shelf-life Stability | Percent change should be less than or equal to 5% when comparing product stored at 4°C with control stored at -20°C over the intended shelf life. | Target shelf life is 12 months. (The document states "Shelf-life stability (expiration) dating assignment at commercialization reflects the real-time data on file at Dade Behring, Inc.," indicating this criterion was met, but does not provide the specific percentage change results in this summary). |
| On-board Stability | Vials punctured by the instrument and stored on-board should be stable for 24 hours. | Stated as "stable for 24 hours." (No specific data presented in the summary, but implies compliance). |
| Open-vial Stability | Open vials (re-capped and stored in a refrigerator) should be stable for 30 days. Tested on days 1, 3, and 32 versus freshly opened vials. | Stated as "stable for 30 days." (No specific data presented in the summary, but implies compliance). |
| Traceability | Analytes must be traceable to established reference materials. | ALC traced to USP Grade Ethyl Alcohol. AMON traced to ACS Grade Ammonium Sulfate. CO2 traced to NIST SRM 351. |
| Bottle Value Assignment | Final bottle values for each level of the commercial lot are assigned using multiple instruments. | Final bottle values assigned using multiple instruments by testing N = 45 replicates per level. (Implies method is robust and accurate, though no specific numerical acceptance range for the assigned values is given in this summary). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The "test set" for a calibrator's performance primarily refers to the samples used to demonstrate its stability and the accuracy of its assigned values.
- Stability Testing: Vials are opened/punctured and tested on days 1, 3, and 32 against freshly opened vials. The number of samples per test point is not explicitly stated in this summary, but would typically involve multiple vials or measurements.
- Bottle Value Assignment: N = 45 replicates per level were tested for final bottle value assignment. There are two levels of calibrator (Calibrator A and Calibrator B).
- Data Provenance: The study was conducted by Dade Behring Inc. (now Siemens Healthineers) for the Dimension Vista™ System. The data is retrospective relative to the submission date and originates from internal testing by the manufacturer. No country of origin for the data is explicitly stated beyond the manufacturer being in the US (Newark, DE).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. This is a calibrator, not a diagnostic device requiring expert interpretation of clinical images or data. "Ground truth" for calibrators is established via metrological traceability to reference materials (USP, ACS, NIST SRM) and gravimetric preparation, followed by instrumental verification.
4. Adjudication Method for the Test Set
Not Applicable. As above, this is not a diagnostic device requiring adjudication of clinical interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, this was not done. This type of study is for comparing human performance with and without AI assistance for tasks like diagnosis or detection from clinical images, which is irrelevant for a chemical calibrator.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable in the traditional AI/ML sense. While the calibrator itself functions "standalone" in its role within the instrument system, there is no "algorithm only" performance study in the context of an AI/ML diagnostic device without human intervention. The calibrator's performance is intrinsically linked to the Dimension Vista™ System's ability to accurately measure analytes based on the calibration curve.
7. The Type of Ground Truth Used
The "ground truth" for this calibrator is established by:
- Gravimetric Preparation: Alcohol, ammonia, and carbon dioxide reference materials are weighed into purified water at specific concentrations.
- Traceability to Reference Standards:
- Alcohol (ALC) is traceable to USP Grade Ethyl Alcohol.
- Ammonia (AMON) is traceable to ACS Grade Ammonium Sulfate.
- Carbon Dioxide (CO2) is traceable to NIST SRM 351.
- Master Pool Verification: Master Pool values are verified by comparing against previously approved Master Pool values.
8. The Sample Size for the Training Set
Not Applicable in the AI/ML sense. There is no "training set" as this is not an AI/ML algorithm that learns from data. The calibrator's formulation and verification are based on established chemical and analytical principles.
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no AI/ML training set, there is no ground truth established for one. The "truth" for the calibrator's assigned values comes from its manufacturing process using traceable reference materials and subsequent instrumental verification.
§ 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.