(38 days)
For use as a calibrator of clinical chemistry assays. Biological materials are added as required to obtain desired component levels. This calibrator material is well suited for automated analytical procedures. Levels of constituent analytes are provided in product labeling.
The Calibrator for Automated Systems (C.f.a.s.) consists of lyophilized human serum with biological materials added as required to obtain desired component levels. Values for constituent analytes are provided in product labeling.
The provided text is a 510(k) summary for a medical device called "Calibrator for Automated Systems (C.f.a.s.)". This document is a regulatory submission for a diagnostic calibrator, not an AI device or a device that directly interacts with human readers for diagnostic purposes. Therefore, many of the requested criteria, such as "acceptance criteria and reported device performance" in the context of clinical accuracy for an AI, "sample size for the test set," "number of experts used," "adjudication method," "MRMC study," and "standalone performance," are not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against a specific set of acceptance criteria in the way one might for a new diagnostic test's accuracy.
However, based on the information provided, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
This type of comprehensive table with quantitative acceptance criteria and corresponding reported device performance with metrics like sensitivity, specificity, accuracy, etc., is not provided in this 510(k) summary. The summary focuses on comparing characteristics and intended use to a predicate device to establish substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable and not provided. The device is a calibrator, and its "performance" is assessed through its characteristics and intended use, not clinical test set performance in a diagnostic sense.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth in the context of diagnostic accuracy for a clinical test is not established for a calibrator in this manner. The "truth" for a calibrator refers to the known concentrations of analytes, which are established through analytical methods, not expert consensus.
4. Adjudication method for the test set:
Not applicable.
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 device is a calibrator, not an AI or a device designed to assist human readers in image interpretation or diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used:
For a calibrator, the "ground truth" would be the analyte concentrations established through reference methods and internal quality control procedures during the manufacturing and characterization of the calibrator material. The document states: "Values for constituent analytes are provided in product labeling." This implies that the manufacturer determines these values.
8. The sample size for the training set:
Not applicable. This is a physical calibrator product, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is applicable from the provided text regarding "acceptance criteria" (understood as characteristics deemed acceptable for substantial equivalence):
The "acceptance criteria" here are implicitly tied to the characteristics of the predicate device for demonstrating substantial equivalence. The study implicitly proving these "criteria" are met is the comparison to the predicate device itself.
| Acceptance Criteria (Implied from Predicate) | Reported Device Performance (C.f.a.s.) |
|---|---|
| Intended Use: For use as a calibrator of clinical chemistry assays, generally for automated analytical procedures. | For use as a calibrator of clinical chemistry assays for automated analytical procedures. |
| Format: Lyophilized pooled human serum with constituents added as required to obtain desired component levels. | Lyophilized pooled human sera with constituents added as required to obtain desired component levels. |
| Stability: Stable at 2-8 °C until expiration date. Stable 2 days when reconstituted, stoppered, protected from light and stored at 2-8° C, with exceptions. | Stable at 2-8 °C until expiration date. Stable 2 days when reconstituted, stoppered, protected from light and stored at 2-8° C, with exceptions noted in labeling. |
| Levels: Single Level | Single Level |
| Constituent Analytes: A specific list of analytes (e.g., Acid Phosphatase, Albumin, Glucose, Sodium, Potassium, etc.) | Matches the predicate device's list of analytes, plus additional analytes (Sodium, Potassium, Chloride, Bicarbonate, UIBC, LD1). This is noted as a "difference" but deemed acceptable for substantial equivalence. |
Study Proving Device Meets "Acceptance Criteria" (Substantial Equivalence):
The "study" is the comparison to the predicate device, Roche Serum Calibrator, as outlined in the 510(k) submission. The FDA reviewed this comparison and determined that the C.f.a.s. is substantially equivalent. This means that, based on the characteristics listed, the new device is considered as safe and effective as the predicate device. The detailed analytical methods used to characterize the analyte values and stability of both the predicate and proposed calibrator are not detailed in this summary but would be part of the full submission that the FDA reviewed.
§ 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.