(25 days)
The Access Ultrasensitive hGH Calibrators are intended to calibrate the Access Ultrasensitive hGH Assay for the quantitative determination of hGH levels in human serum and plasma on the Access Immunoassay Systems.
The Access Ultrasensitive hGH calibrators are lyophilized calibrators to be used with the Access Ultrasensitive hGH assay to generate the hGH calibration curve on the Access Immunoassay Systems. The Access Ultrasensitive hGH calibrator kit contains six 2.0 mL vials, one for each calibrator level. The Access Immunoassay Systems utilize a one-step immunoenzymatic ("sandwich") assay for the quantitative measurement of hGH.
The provided text is for a 510(k) premarket notification for a medical device (calibration kit) and does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of AI/ML or diagnostic performance as typically measured by metrics like sensitivity, specificity, or accuracy.
The submission focuses on demonstrating substantial equivalence of a modified calibration product to its predicate device. The modification involves restandardizing the calibrators to a new WHO standard. There is no mention of a "device" in the sense of an AI/ML algorithm or a diagnostic instrument that would require establishing ground truth with experts, test sets, or comparative effectiveness studies with human readers.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a diagnostic device. The acceptance criterion is implicit: demonstrate that the restandardized calibrators perform equivalently to the predicate calibrators and do not alter the intended use, indications for use, or fundamental scientific technology, or affect safety and efficacy.
- Reported Device Performance: The text states, "Performance data generated from validation testing demonstrates that the restandardized Access Ultrasensitive hGH Calibrators on the Access Immunoassay Systems is substantially equivalent to the currently commercialized Access Ultrasensitive hGH calibrators." However, the specific metrics or values from this "validation testing" are not provided.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| No change in intended use or indications For use | Met |
| No alteration to fundamental scientific technology | Met |
| No effect on safety and efficacy | Met |
| Substantial equivalence to predicate calibrators | Demonstrated through validation testing |
2. Sample sized used for the test set and the data provenance: Not applicable. This is a calibration product, not a diagnostic device evaluated with patient samples. The "validation testing" mentioned is likely related to analytical performance (e.g., standard curve generation, precision, accuracy using control materials), not clinical test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for patient diagnosis or imaging interpretation is not relevant for a calibrator product.
4. Adjudication method (e.g., 2+1, 3+1, none) 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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm is being evaluated.
7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. For the calibrators, the "ground truth" for hGH concentration is traceable to WHO 98/574 (the second international standard).
8. The sample size for the training set: Not applicable. No training set for an AI/ML algorithm is mentioned.
9. How the ground truth for the training set was established: 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.