(51 days)
VALIDATE® CM2 Calibration Verification / Linearity Test Set solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range in automated, semi automated, and manual chemistry systems. Each VALIDATE® CM2 Calibration Verification / Linearity Test Set consists of two sets of bottles. Set 1 contains BNP, hs-CRP, Troponin-1, and MPO. Set 2 contains NT-proBNP, hs-CRP, Troponin-T and MPO.
Quality control material (assayed and unassayed). VALIDATE® CM2 Calibration / Linearity Test Sets are human based calibration verification materials containing multiple levels used to establish the relationship between theoretical operation and actual performance of the included analytes. There exists a linear relationship among each set of solutions.
The provided text describes a 510(k) submission for a medical device called "VALIDATE® CM2 Calibration Verification / Linearity Test Set." This device is a quality control material used to verify calibration and linearity of chemistry analyzers, rather than an AI-powered diagnostic device or an imaging device.
Therefore, many of the requested categories in the prompt (e.g., sample size for the test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, how ground truth for training set was established) are not applicable to this type of device and the information available in the provided 510(k) summary.
However, I can extract the relevant information regarding acceptance criteria and device performance based on the provided text.
Here's a summary tailored to the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the VALIDATE® CM2 are implicitly tied to demonstrating "substantial equivalence" to its predicate device, the VALIDATE® CM1, in terms of performance for establishing linearity and verifying calibration. The key performance comparison is based on the ability of the CM2 set to function as intended on various chemistry analyzers for the specified analytes, showing a linear relationship across the different levels.
| Acceptance Criteria (Implicit from Substantial Equivalence Goal) | Reported Device Performance |
|---|---|
| Functional Equivalence: Ability to quantitatively verify calibration, validate reportable ranges, and determine linearity in automated, semi-automated, and manual chemistry analyzers. | The performance of VALIDATE® CM2 Calibration Verification / Linearity Test Set solutions on the Beckman Access II (TnI, BNP), the Beckman Immage 800 (hsCRP), the Beckman Synchron DxC with Diazyme reagent (MPO), the Roche e411 (TNT, NTproBNP), and the Roche Integra 400+ (hsCRP) has been shown to be substantially equivalent using pre-production lots of VALIDATE® CM2 Calibration Verification / Linearity Test Sets to the VALIDATE® CM1 Calibration Test Set. |
| Analytical Scope: Cover specific analytes. | VALIDATE® CM2 covers TnI, TnT, BNP, NT-proBNP, hsCRP, MPO. (This is an expansion from CM1 which covered CK-MB, MYO). |
| Matrix: Human serum. | Human Serum (Matches predicate). |
| Number of Levels: Sufficient to establish linearity. | 2 sets of 6 including base matrix (Expanded from CM1's 5 levels, suggesting enhanced linearity assessment). |
| Preparation & Packaging: Liquid, ready to use; specific volume. | Liquid, ready to use; 12 x 2.0 mL (Different packaging volume from CM1, but still liquid, ready to use). |
| Stability & Storage: Until expiration, -10 to -20°C. | Until expiration, -10 to -20°C (Matches predicate). |
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated as a "sample size" in the conventional sense for patient data. The study used "pre-production lots" of the VALIDATE® CM2 Test Sets. The number of individual test sets or runs conducted is not specified.
- Data provenance: Not directly described, but the study involved testing on various commercial chemistry analyzers: Beckman Access II, Beckman Immage 800, Beckman Synchron DxC with Diazyme reagent, Roche e411, and Roche Integra 400+. This implies the testing was conducted in a laboratory setting, likely in the US, given the submission to the FDA. The study is prospective in the sense that the new device (CM2 pre-production lots) was developed and then tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a calibration verification material. Its "ground truth" is its known concentration levels and its ability to demonstrate linearity on analytical instruments, rather than diagnostic interpretations from experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no expert adjudication for this type of device. Performance is objectively measured by the analytical instruments.
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
Not applicable. This is not an AI or imaging device with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. The "performance" is the material's function in an in vitro diagnostic context on automated analyzers, which inherently involves the "human-in-the-loop" in setting up the test and interpreting results from the analyzer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device would be the assigned, analytically-derived target values for each level within the VALIDATE® CM2 test sets and the theoretical linear relationship between these levels. These values are established through rigorous analytical methods (e.g., reference methods, gravimetric dilutions, primary calibrator traceability) during the manufacturing and characterization of the quality control material. The study then verifies that the instrument measures these levels linearly and accurately.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this type of device.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.