(84 days)
For the quantitative calibration of WIENER LAB's clinical chemistry procedures. Calibrador A plus 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.
Calibrador A plus consists of Ivophilized human serum containing the compounds usually determined in clinical chemistry laboratories in the appropriate concentrations to ensure optimum calibration of clinical chemistry procedures. Such concentrations are lot-specific and are provided in product insert.
The provided text describes a 510(k) submission for a medical device called "Wiener lab. Calibrador A Plus". This is a multi-analyte calibrator and the submission focuses on demonstrating substantial equivalence to a predicate device, the ROCHE Calibrator for Automated systems (C.f.a.s.).
Here's an analysis of the requested information, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" or provide performance metrics in the format of a table as typically seen for diagnostic device performance (e.g., sensitivity, specificity, accuracy, precision). Instead, the submission relies on demonstrating substantial equivalence to a predicate device.
The "performance" is implicitly demonstrated through the similarities between the Wiener lab. Calibrador A Plus and the ROCHE C.f.a.s. in terms of:
- Intended Use: Both are for the calibration of clinical chemistry procedures.
- Format: Both are lyophilized pooled human sera with added constituents.
- Constituent Analytes: Both calibrate for the same set of 16 specific analytes (Albumin, Direct bilirubin, Total bilirubin, Calcium, Cholesterol, Creatinine, HDL Cholesterol, Glucose, Iron, Magnesium, Phosphorus, Total proteins, Triglycerides, Uric acid, Urea). The ROCHE device additionally calibrates for broader categories of "Enzymes" and "Electrolytes", which are not explicitly listed for the Wiener lab. calibrator.
- Stability: The ROCHE device's stability is described (stable in refrigerator until expiration, reconstituted for 8 hours at room temp, 2 days refrigerated or 1 month frozen), but the Wiener lab. calibrator's stability information is not provided in the comparison table.
- Levels: ROCHE C.f.a.s. is a "Single Level" calibrator, and this detail is not provided for the Wiener lab. calibrator in the comparison table.
The "acceptance criterion" in this context is that the device is "substantially equivalent" to the predicate device in its intended use, form, and composition for the listed analytes. The "reported device performance" is the statement that "Above mentioned data show substantial equivalency to the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe any specific "test set" of samples or data used for an independent performance evaluation. This submission is focused on demonstrating substantial equivalence through a comparison of product characteristics and intended use, rather than presenting results from a clinical or analytical performance study with a test set. Therefore, information on sample size, data provenance, retrospective/prospective nature, and country of origin is not applicable or not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since there is no described "test set" for performance evaluation, there is no mention of experts or their qualifications used to establish ground truth for such a set. Establishing ground truth typically applies to diagnostic device performance studies, which are not detailed here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no "test set" with a performance evaluation is described, adjudication methods are not applicable and not mentioned in this document.
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
No MRMC study was done. This device is a calibrator, not a diagnostic imaging device with human readers or AI assistance. Therefore, this section is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is a multi-analyte calibrator, not an algorithm. Therefore, this section is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Since no performance study with a test set is described, no specific "ground truth" establishment method (expert consensus, pathology, outcomes data, etc.) is mentioned. The "ground truth" in this context is the established performance and characteristics of the predicate device, to which the new device is being compared for substantial equivalence.
8. The sample size for the training set
The document does not describe a "training set" as this is a calibrator and not a machine learning or AI-based device that would require training data.
9. How the ground truth for the training set was established
As there is no described "training set," the method for establishing its ground truth is not applicable and not mentioned.
§ 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.