(42 days)
The proposed Stratus® Myoglobin Fluorometric Enzyme Immunoassay is substantially equivalent in intended use and technological characteristics to the current Stratus® Myoglobin Fluorometric Enzyme Immunoassay, manufactured by Dade International Inc., Miami, FL, previously cleared under Document Control No., K922125/A. The proposed device is being modified to include heparinized plasma as a sample type.
Stratus® Myoglobin Fluorometric Enzyme Immunoassay
The provided K965213 document is a 510(k) Summary for a laboratory assay (Stratus® Myoglobin Fluorometric Enzyme Immunoassay), not a medical device in the typical sense of AI-powered diagnostic tools or imaging devices. Therefore, many of the requested categories in your prompt relating to AI performance, human readers, ground truth establishment for AI, and training/test sets as commonly understood for AI/ML devices, are not directly applicable.
However, I can extract the relevant information pertaining to the acceptance criteria and the study that proves the assay meets those criteria based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation Coefficient (r) | 0.98 (between serum and heparinized plasma samples) |
| Regression Equation (y=Plasma, x=Serum) | y = 0.94x + 7.09 |
| Acceptance Thresholds | Not explicitly stated in the document, but the correlation coefficient and regression equation were "found to be acceptable." This implies the manufacturer had internal thresholds (e.g., r ≥ 0.95 or a certain range for slope/intercept) which these results met. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 101 patient samples.
- Data Provenance: The document states "in-house comparative performance study." This suggests the data was collected by the manufacturer. The country of origin is not specified but is implicitly the same as the manufacturer (USA, Miami, FL). The study was prospective in the sense that these samples were run specifically for this comparison study, rather than re-analyzing existing archived data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This is a laboratory assay where "ground truth" for the comparison is typically the measurement performed on a reference sample type (serum in this case, for comparison with heparinized plasma). The performance is assessed by comparing the results between the two sample types, not against an expert interpretation.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like "2+1" are relevant for expert consensus in imaging or complex diagnostic interpretations, not for quantitative laboratory assay comparisons.
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-powered device or an imaging device involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable in the AI sense. The study describes the performance of the assay itself when used with different sample types. The "algorithm" here is the chemical reaction and measurement process of the immunoassay. Its performance is assessed directly through the correlation study.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the measurement obtained from the serum samples. The study aims to demonstrate that results obtained from heparinized plasma samples are acceptably similar to those obtained from serum samples, which is the established or original sample type for the assay.
- Expert Consensus: Not applicable.
- Pathology: Not applicable.
- Outcomes Data: Not applicable.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a distinct "training set." The study described is a validation study demonstrating the comparability of results using a new sample type.
9. How the Ground Truth for the Training Set was Established
- Not applicable for the reasons stated in point 8.
§ 866.5680 Myoglobin immunological test system.
(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).