(43 days)
The HemoSite® Test System is a device for in vitro diagnostic use only. The GDS® HemoSite® Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® Meter in a point-of-care setting such as a physician's office or hospital.
The HemoSite® Test System is a whole blood hemoglobin measurement device which consists of the Stat-Site® Meter (K911801), HemoSite® Test Card and {lot-specific} HemoSite® Test Module. The test employs dry reagent technology based on the azidemethemoglobin method. The blood sample is applied to one side of the HemoSite® Test Card and the color develops on the opposite side. The color produced is directly proportional to the concentration of hemoglobin in the sample and is read using light reflectance at a specific wavelength; the reflectance reading is performed and reported by the Stat-Site® meter.
The provided text describes the HemoSite® Test System, a whole blood hemoglobin measurement device. Here's an analysis of the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (HemoSite® Test System vs. Reference) |
|---|---|
| Slope | 0.9717 |
| Intercept | 0.0397 |
| Correlation Coefficient (R) | 0.91 |
Note: The document only provides these three statistical parameters from a regression analysis. It does not explicitly state pre-defined thresholds for "acceptance" for each of these metrics. The conclusion states that the results "compare acceptably with the reference methods," implying that these values were within acceptable limits for FDA clearance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 151 whole blood clinical samples.
- Data Provenance: The samples were obtained at 3 independent physician's office sites. This indicates prospective data collection. The country of origin is not explicitly stated, but given the FDA submission, it is highly likely to be the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established using a "certified reference standard." The document does not mention the number of experts, their qualifications, or their role in establishing this reference standard. It is implied that the reference standard itself is considered the expert "ground truth."
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by comparison to a "certified reference standard," not through expert adjudication of results.
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, an MRMC comparative effectiveness study was not done. The HemoSite® Test System is a device for quantitative determination of hemoglobin, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, this was a standalone performance study. The HemoSite® Test System, which includes the Stat-Site® Meter, HemoSite® Test Card, and Test Module, directly provides the hemoglobin measurement. The study evaluated the performance of this system against a reference standard. There is no mention of human-in-the-loop performance being a variable in the study design.
7. The Type of Ground Truth Used
The ground truth used was a "certified reference standard" for whole blood hemoglobin determination.
8. The Sample Size for the Training Set
The document does not mention a training set. The study described is a clinical validation against a reference standard for the purpose of demonstrating substantial equivalence, not the development or training of a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set is mentioned in the document.
§ 864.7500 Whole blood hemoglobin assays.
(a)
Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.(b)
Classification. Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.