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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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(29 days)
The Coagulation Controls Levels 1, 2, and 3 are in-vitro diagnostic reagents intended for clinical use as a control to monitor the performance of coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APTT). Level 1 yields result in the normal range. Level 2 yields results in the moderately abnormal range. Level 3 is intended to yield results in the extremely abnormal range.
The Coagulation Control Levels 1, 2 and 3 are lyophilized preparations of citrated plasma obtained from healthy donors, which are adjusted to yield prolonged PT and APTT values. Prior to lyophilization buffer and a stabilizer are added. The bulk plasma is tested using an FDA approved method for HBsAG, HIV antibodies and HCV antibodies and is certified for negativity for each batch.
The provided document describes a 510(k) summary for "Coagulation Control Level 1, 2, 3" by Vital Scientific NV. The document focuses on demonstrating substantial equivalence to predicate devices through precision studies rather than establishing acceptance criteria against a predefined performance target for a novel device. The study design is a comparison to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a predefined target that the device must meet for approval. Instead, it demonstrates performance by comparing its precision data to that of existing, legally marketed predicate devices. The implicit acceptance criterion is that the new device's precision (measured by Average and %CV) should be "substantially equivalent" to that of the predicate devices.
| Control Level | Parameter | Vital Controls Performance (Average ± %CV, n=20) | Reference Controls Performance (Average ± %CV, n=20) | Implicit Acceptance Criteria (Substantial Equivalence) |
|---|---|---|---|---|
| Within-run Precision | ||||
| Level 1 (Normal) | PT | 12.0 ± 1.1% | 11.6 ± 0.7% | Vital Control's precision should be comparable to the reference. |
| Level 2 (Low abnormal) | PT | 18.8 ± 1.4% | 18.7 ± 1.2% | Vital Control's precision should be comparable to the reference. |
| Level 3 (High abnormal) | PT | 32.6 ± 3.5% | 32.6 ± 2.7% | Vital Control's precision should be comparable to the reference. |
| Level 1 (Normal) | APTT | 28.5 ± 2.3% | 24.9 ± 2.3% | Vital Control's precision should be comparable to the reference. |
| Level 2 (Low abnormal) | APTT | 47.0 ± 1.7% | 54.8 ± 2.2% | Vital Control's precision should be comparable to the reference. |
| Level 3 (High abnormal) | APTT | 61.2 ± 1.9% | 95.7 ± 2.3% | Vital Control's precision should be comparable to the reference. |
| Between-run Precision | ||||
| Level 1 | PT %CV | 1.5% | 1.2% | Vital Control's %CV should be comparable to the reference. |
| Level 2 | PT %CV | 3.5% | 2.0% | Vital Control's %CV should be comparable to the reference. |
| Level 3 | PT %CV | 4.5% | 3.3% | Vital Control's %CV should be comparable to the reference. |
| Level 1 | APTT %CV | 1.8% | 0.5% | Vital Control's %CV should be comparable to the reference. |
| Level 2 | APTT %CV | 0.7% | 2.0% | Vital Control's %CV should be comparable to the reference. |
| Level 3 | APTT %CV | 3.9% | 2.7% | Vital Control's %CV should be comparable to the reference. |
Note: The document states "substantially equivalent data" were yielded, implying the reported performance met this implicit criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For within-run precision studies, n = 20 for both Vital Controls and Reference Controls for each level (1, 2, 3) and for both PT and APTT. ("Average ± %CV, n = 20"). For between-run precision, the sample size is not explicitly stated as 'n' but implies multiple measurements over several days ("Day to Day Precision Results").
- Data Provenance: Not explicitly stated. The study was conducted for a US 510(k) submission, but the location of the actual testing is not specified. It is a prospective study as it involves specific experiments for the submission. The plasma itself is obtained from healthy donors, but the origin of these donors (country) is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This study is a precision study comparing a control device to predicate control devices, not a diagnostic device where "ground truth" on patient samples would be established by experts. The "truth" here is the performance of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication method described as it's a quantitative measurement of precision rather than a qualitative diagnostic outcome requiring expert consensus.
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 a study involving human readers or AI assistance. It's a laboratory precision and substantial equivalence study for a diagnostic control.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm; it is a physical control plasma. The comparison is between the new control plasma and existing control plasmas run on a coagulometer (MLA-900C Coagulometer). The performance described is "standalone" in the sense that the control itself is being evaluated for its inherent precision characteristics.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established performance characteristics (precision, i.e., average and %CV) of the legally marketed predicate devices. The goal is to show the new device's performance is substantially equivalent to these established benchmarks.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of this device. This is not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned.
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