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510(k) Data Aggregation
(134 days)
The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.
The APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic homeostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.
Here's a breakdown of the acceptance criteria and study information for the Vital Scientific APTT device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Vital Scientific APTT Performance |
|---|---|---|
| Correlation with Predicate Device (APTT-LS on MLA 900C) | "acceptable correlation" (implied by K891337) | Correlation coefficient = 0.938, Slope = 0.727, Intercept = 6.96. The document states this indicates "acceptable correlation." |
| Correlation with Predicate Device (APTT-LS on ACL-100) | "acceptable correlation" (implied by K881367) | Correlation coefficient = 0.930, Slope = 0.952, Intercept = 3.76. The document states this indicates "acceptable correlation." |
| Within-run Precision (%CV) | "< 5 %" | Normal: 1.1 % < 5% Low Abnormal: 4.3 % < 5% High Abnormal: 4.3 % < 5% Average Precision: 3.2% < 5% |
| Day to Day Precision (%CV) | "< 5 %" | Normal: 3.6 % < 5% Low Abnormal: 2.5 % < 5% High Abnormal: 4.0 % < 5% |
| Overall Comparison to Predicate | "clinically acceptable performance comparable" to similar devices | Vital Scientific APTT has "similar intended use, a similar technological principle, and clinically acceptable performance comparable to similar devices currently in commercial distribution and is substantially equivalent to the predicate device." Precision results were stated to be "equivalent" to the predicate for day-to-day and within-run. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 107 patient plasmas for each correlation study (30 normal APTT, 77 undergoing heparin therapy).
- Data Provenance: Not explicitly stated, but the studies were performed using patient plasmas, suggesting clinical samples. The ACL-100 study was conducted in a "clinical laboratory of a community hospital," implying prospective collection or retrospective use of patient samples from that setting. There is no mention of country of origin of the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth for the test set. The study compares the performance of the Vital Scientific APTT reagent to a legally marketed predicate device (Fisher Diagnostics APTT-LS) using measured clotting times. The "ground truth" for the correlation studies is effectively the results obtained by the predicate device, which is an accepted method for determining substantial equivalence of an in-vitro diagnostic.
4. Adjudication Method for the Test Set
Not applicable. This was a direct comparison to a predicate device, not a study involving human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic reagent, not an imaging or interpretive AI device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented are standalone performance evaluations of the Vital Scientific APTT reagent when used with an automated coagulometer (MLA 900C and ACL-100). The performance metrics (correlation, precision) describe the behavior of the reagent itself.
7. The Type of Ground Truth Used
The ground truth for the correlation studies was the measured Activated Partial Thromboplastin Time (APTT) values obtained using the predicate device, APTT-LS manufactured by Fisher Diagnostics. For the precision studies, the "ground truth" is inherent within the statistical analysis of repeat measurements (average and %CV).
8. The Sample Size for the Training Set
This information is not provided. The document describes performance studies comparing the new device to a predicate and evaluating its precision. It does not disclose details about any training data that might have been used in the development of the reagent itself (if applicable, as it's a chemical reagent, not a software algorithm).
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set information is provided.
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