(65 days)
The DSL 5400 Estrone-Sulfate RIA assay is intended for the quantitative determination of Estrone-Sulfate in human serum or EDTA plasma. The measurement of Estrone-Sulfate is used for in vitro diagnostic use in the diagnosis and treatment of numerous disorders, including infertility, amenormea, differentiation of primary and secondary ovarian malfunction, especially estrogen secreting testicular and ovarian tumors and precocious puberty in females.
The RIA format is a competitive binding protein assay. Radio-labeled Estrone-Sulfate competes with un-labeled Estrone-Suffate in the serum or plasma sample for binding sites to the Estrone-Sulfate antiserum provided with the kit. Separation of free from bound Estrone-Sulfate is achieved by the addition of a second antibody containing goat anti-rabbit gamma clobulin serum with polvethviene giveol as a precipitating aid, centrifugation and decantation of the tubes. The resultant is analyzed in a gamma counter for bound counts per minute. The amount of radio-labeled Estrone-Sulfate bound to the antibody is inversely proportional to the concentration of the Estrone-Sulfate present in the sample.
This document is a 510(k) summary for an in-vitro diagnostic (IVD) device, specifically a Radioimmunoassay (RIA) kit. The provided information is insufficient to answer most of the questions about acceptance criteria and study design as those typically apply to AI/ML or imaging devices.
However, based on the provided text, I can infer some aspects relevant to the substantial equivalence claim.
Here's an attempt to answer the questions based only on the provided text, acknowledging that many will be "not applicable" or "not provided":
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Correlation coefficient (r) indicative of substantial equivalence | r = 0.82 |
| Linear regression equation demonstrating relationship between assays | Y = 0.04(X) + 2.89 (where Y is DSL 5400, X is DSL 8700) |
| Samples covering low, intermediate, and high Estrone-Sulfate levels | Samples chosen based on expected Estrone-Sulfate levels |
Note: The document claims substantial equivalence without explicitly stating numerical acceptance criteria for 'r' or the regression equation. However, the reported values are presented as evidence for this claim.
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: n = 43 human patient samples.
- Data provenance: Not specified. It's unclear if these were prospective samples collected specifically for this study or retrospective samples. Country of origin is not mentioned.
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. This study is a method comparison for an in-vitro diagnostic test, not an AI/ML or imaging study requiring expert interpretation for ground truth. The "ground truth" for each sample is its actual Estrone-Sulfate concentration as measured by the comparative method (DSL 8700 Estrone RIA).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This study is a method comparison for an in-vitro diagnostic test. There is no human interpretation or adjudication step involved in establishing the measurement value for each sample.
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 an in-vitro diagnostic device, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in spirit. The DSL 5400 Estrone-Sulfate RIA kit is a standalone in-vitro diagnostic test that provides a quantitative result without human-in-the-loop performance influencing the assay's measurement. The study directly compares its quantitative output to another standalone assay (DSL 8700).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Comparative method result: The DSL 8700 Estrone RIA, the legally marketed predicate device, served as the comparative method. The "ground truth" for the performance evaluation of the DSL 5400 kit was its agreement with the measurements obtained from the predicate device on the same samples.
8. The sample size for the training set
- Not applicable. This is a traditional in-vitro diagnostic kit, not an AI/ML device that requires a training set. The assay relies on biochemical reactions, not machine learning models.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 862.1280 Estrone test system.
(a)
Identification. An estrone test system is a device intended to measure estrone, an estrogenic steroid, in plasma. Estrone measurements are used in the diagnosis and treatment of numerous disorders, including infertility, amenorrhea, differentiation of primary and secondary ovarian malfunction, estrogen secreting testicular and ovarian tumors, and precocious puberty in females.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.