(43 days)
The device is intended to be used with Wako vanadate bilirubin methods to establish calibration points for the determination of Total and Direct bilirubin values in human serum specimens.
The Wako Bilirubin Calibrator is designed to be used with Wako's total and direct bilirubin methodology for the determination of total and direct bilirubin in serum.
The provided text describes a Wako Bilirubin Calibrator, an in vitro diagnostic device, and not an AI/ML-driven device. Therefore, many of the typical acceptance criteria and study details relevant to AI devices (such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or explicitly mentioned in the provided document.
Instead, this document focuses on demonstrating substantial equivalence to an existing predicate device based on performance characteristics relevant to calibrators.
Here's an attempt to extract relevant information per your requested format, acknowledging the limitations for an IVD device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit / Explicit) | Reported Device Performance (Wako Bilirubin Calibrator vs. Predicate) | Meets Criteria? |
|---|---|---|---|
| Substantial Equivalence | High correlation with predicate standard. | Total Bilirubin: Correlation Coefficient = 1.000 | Yes |
| Direct Bilirubin: Correlation Coefficient = 0.9999 | Yes | ||
| Regression Equation (Closeness to Ideal y=x) | Linear relationship with predicate standard. | Total Bilirubin: y = 0.99x - 0.0027 | Yes (very close to y=x) |
| Direct Bilirubin: y = 0.97x - 0.0031 | Yes (very close to y=x) | ||
| Intended Use Compatibility | Designed to be used with Wako's total and direct bilirubin methodology. | Confirmed by statement: "The Wako Bilirubin Calibrator is designed to be used with Wako's total and direct Bilirubin methodology..." | Yes |
Description of the Study Proving Acceptance Criteria:
The study described is a comparison study designed to demonstrate substantial equivalence of the Wako Bilirubin Calibrator to the legally marketed Wako Bilirubin Standard (predicate device).
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not explicitly stated. The document refers to "comparison studies" but does not provide the number of samples or measurements performed.
- Data Provenance: Not explicitly stated. It's an in-house comparison against a predicate device, likely performed by Wako Chemicals USA, Inc. The country of origin for the data is implicitly the USA, where the company and the study would have taken place. It is a prospective study in the sense that Wako conducted it to support their 510(k) submission for this specific calibrator.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (N/A) for this type of device. The "ground truth" here is the performance of the predicate device (Wako Bilirubin Standard), which is already established as a legally marketed product. No human experts were involved in establishing ground truth in the way they would for medical image interpretation.
4. Adjudication method for the test set:
- N/A. As the comparison is against an existing standard, there's no "adjudication" in the sense of resolving discrepancies between human readers or algorithm outputs. The comparison is statistical.
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:
- N/A. This is an in vitro diagnostic calibrator, not an AI/ML device, and therefore no MRMC studies are relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical calibrator used in analytical instrumentation, not an algorithm. Its "standalone" performance is assessed by its characteristics and its ability to calibrate the intended assays accurately.
7. The type of ground truth used:
- The "ground truth" refers to the measurements obtained using the Wako Bilirubin Standard (predicate device) against which the new Wako Bilirubin Calibrator was compared. It's a reference standard rather than expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
- N/A. This device does not involve a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established:
- N/A. As there is no training set, this question is not applicable.
§ 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.