FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided document is a 510(k) summary for the Elecsys LH CalSet II, a calibrator. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, this is a calibrator, not a diagnostic device that performs clinical measurements or applies an algorithm to patient data. Therefore, the typical acceptance criteria and study designs outlined in your request (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth types) do not apply in the context of this specific device.

Instead, for a calibrator, the "acceptance criteria" and "study" would relate to its ability to accurately and consistently calibrate assays, its stability, and its equivalence to the predicate calibrator. The provided document focuses on demonstrating substantial equivalence based on intended use, matrix, storage form, levels, standardization, and stability compared to the predicate.

Here's how we can interpret your request in the context of this calibrator:

1. Table of acceptance criteria and the reported device performance:

Since this is a calibrator, the "acceptance criteria" revolve around its functional equivalence and performance characteristics compared to the predicate device.

Acceptance Criteria (Implied for Calibrator Equivalence)	Reported Device Performance (Elecsys LH CalSet II)
Intended Use: For calibrating the quantitative LH assay on Elecsys immunoassay systems.	Intended Use: "The Elecsys LH CalSet II is used for calibrating the quantitative LH assay on the Elecsys immunoassay systems." (Matches predicate's broader intended use, adapting to newer systems implied).
Matrix: Suitable for LH calibration.	Matrix: Human serum matrix (predicate used "Buffer/protein matrix"). While different, this is presented as an acceptable modification for the calibrator.
Storage form: Stable for intended use.	Storage form: Lyophilized (predicate was liquid). This is a different form but acceptable if stability is demonstrated.
Levels: Provides appropriate low and high calibration points (approx. 1 mIU/mL and 45 mIU/mL).	Levels: Same as predicate ("Low: approx. 1 mIU/mL; High: approx 45 mIU/mL").
Standardization: Calibrated against recognized international standard (NIBSC 80/552).	Standardization: Same as predicate ("Calibrated against 2nd International Standard (NIBSC) 80/552").
Stability: Maintains integrity over specified storage conditions and duration.	Stability:

Lyophilized: up to expiration date (at 2-8°C).
Reconstituted: 1 month at -20°C (freeze only once).
Onboard: use only once.
(These are different from the predicate's stability profiles but are the claimed performance for the new form). |

2. Sample size used for the test set and the data provenance:

Not Applicable. For a calibrator, "test set" in the sense of patient data for diagnostic algorithm validation is not relevant. The studies conducted would involve testing the calibrator's performance characteristics (e.g., accuracy, precision, stability) on the Elecsys immunoassay system. The document does not specify the number of calibration runs, batches, or instruments tested.
Data provenance: Not specified in this 510(k) summary. Given it's a Roche product, internal validation data would be expected.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. As this is a calibrator, there is no "ground truth" established by experts in the clinical sense (e.g., diagnosing a condition). The "truth" for a calibrator relates to its assigned values being traceable to an international standard.

4. Adjudication method for the test set:

Not Applicable. No clinical test set requiring expert adjudication is involved for this device.

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 a calibrator, not an AI-powered diagnostic device. MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a calibrator, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Standardization against International Standard. For a calibrator, the "ground truth" for its assigned values is established through traceability to internationally recognized standards. The document states: "Calibrated against 2nd International Standard (NIBSC) 80/552." This ensures consistency across different assays and laboratories.

8. The sample size for the training set:

Not Applicable. Calibrators do not have "training sets" in the context of machine learning.

9. How the ground truth for the training set was established:

Not Applicable. Calibrators do not have "training sets."

Summary

Regulation Number and Section

§ 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.