(17 days)
The HCG Calibrator is intended to be used to calibrate the HCG method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.
The Human Chorionic Gonadotropin (HCG) Calibrator for the Dimension® RxL system is a lyophilized horse serum-based product. The Level 1 calibrator contains no detectable hCG. Levels 2 through 5 contain human unne chorionic gonadotropin. The kit consists of ten vials; two at each of five levels.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Human Chorionic Gonadotropin Calibrator:
The provided document is a 510(k) summary for a medical device called "Human Chorionic Gonadotropin Calibrator." It is not a study that proves a device meets acceptance criteria in the sense of a diagnostic algorithm or AI system. Instead, it's a submission for regulatory clearance based on substantial equivalence to a predicate device.
Therefore, many of the requested categories related to algorithm performance, sample sizes for training/test sets, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of regulatory submission. The "acceptance criteria" here refer to demonstrating that the new calibrator is equivalent to an existing, legally marketed calibrator.
Here's the breakdown based on the provided information, noting where sections are not applicable:
1. A table of acceptance criteria and the reported device performance
For a calibrator, "acceptance criteria" revolve around its intended use and composition being comparable to a predicate device. The "performance" is implicitly its suitability for calibrating an assay, which is established by its equivalence.
| Aspect of Equivalence (Acceptance Criteria Proxy) | Reported Device Performance (Comparison) |
|---|---|
| Intended Use | Calibrator |
| Analytes | Human Chorionic Gonadotropin |
| Matrix | Horse serum |
| Form | Lyophilized |
| Volume per vial, reconstituted | 2.0 mL |
| Levels | 5 levels |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This is not a study evaluating diagnostic performance on patient data. It's a comparison of a new calibrator to an existing one.
- Data Provenance: Not applicable.
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)
- Not applicable. There is no "ground truth" established by experts in the context of an algorithm's diagnostic performance for this type of device. The ground truth, in a general sense, is the established performance and suitability of the predicate calibrator.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication process for a test set is described or implied.
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, nor is it a study involving human readers or comparative effectiveness in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of an algorithm's diagnostic performance. The "ground truth" for this submission is the accepted performance and characteristics of the existing predicate device (aca® plus HCG Calibrator), to which the new device is being compared for substantial equivalence.
8. The sample size for the training set
- Not applicable. There is no algorithm training involved.
9. How the ground truth for the training set was established
- Not applicable. There is no algorithm training involved.
Summary of the "Study" (Rationale for Equivalence):
The "study" presented here is based on a comparison to a predicate device rather than a traditional performance study.
- Rationale for Equivalence: The document states that the HCG Calibrator for the Dimension® RxL system is "substantially equivalent to the aca® plus HCG Calibrator based on the comparison summarized above."
- Key points for equivalence:
- Both are horse serum based products.
- Both contain human urine chorionic gonadotropin as the analyte source.
- Both are intended to be used as calibrators for human chorionic gonadotropin assays.
- Differences noted but implicitly deemed non-critical for equivalence:
- The new device has 5 levels compared to the predicate's 3 levels.
- The new device has 2.0 mL per vial (reconstituted) compared to the predicate's 3.0 mL.
In conclusion, this document demonstrates regulatory compliance through a comparison of characteristics to a predicate device to establish substantial equivalence for a calibrator, not through a performance study of a diagnostic or AI-driven system.
§ 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.