(525 days)
The VMT™ System is designed for the evaluation of visuo-motor performance disturbances.
The VMT™ System is provided as follows:
a. Trade Name VMT™ System
b. Common and Descriptive Name - Ataxiagraph
The provided document for K971549, the VMT™ System - Ataxiagraph, contains limited information regarding the specific acceptance criteria and detailed study outcomes. It primarily serves as a 510(k) summary and FDA clearance letter, rather than a comprehensive clinical study report.
Here is an analysis based on the information provided, with details explicitly stated as "Not provided" where the document does not offer the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (If stated) | Reported Device Performance | Comments |
|---|---|---|
| Not provided | Clinical studies concluded that the device was safe and effective for its intended use. | The 510(k) summary states that clinical studies were performed and reached this conclusion, but specific performance metrics or acceptance thresholds are not detailed. It likely refers to demonstrating substantial equivalence rather than meeting specific quantifiable performance benchmarks. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not provided.
- Data Provenance: Not provided. The document mentions "clinical studies have been performed," but does not specify where the data originated (e.g., country of origin, specific institutions) or if it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- MRMC Study: Not provided. The document does not describe any study comparing human readers with and without AI assistance, as the VMT™ System is presented as a device for "evaluation of visuo-motor performance disturbances," implying a diagnostic or assessment tool rather than an AI-assisted diagnostic aid for human readers.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as no MRMC study is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- The VMT™ System is described as a device for evaluation, implying it provides output that a human clinician would interpret to assess visuo-motor performance. The document does not specify a "standalone" performance study in the context of an AI algorithm, but rather a clinical evaluation of the device's overall safety and effectiveness. The nature of the device (an "Ataxiagraph") suggests it mechanically measures or quantifies performance, and a human then interprets these measurements.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not provided. Given the nature of a device for "visuo-motor performance disturbances," ground truth might refer to a clinical diagnosis of a condition affecting visuo-motor performance (e.g., balance disorders, neurological deficits), or established clinical scales/assessments. However, the document does not specify.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not provided. The document refers to "clinical studies" for evaluation but does not distinguish between training and test sets or provide sample sizes for either.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not provided. Given that specific training sets are not mentioned, neither is the method for establishing their ground truth.
General Summary of the Study Presented in the 510(k) Document:
The provided 510(k) summary, K971549 for the VMT™ System - Ataxiagraph, states that "Clinical studies have been performed and have concluded that the device was safe and effective for its intended use." This statement is the primary evidence presented to demonstrate that the device meets its acceptance criteria (which are implicitly those required for 510(k) clearance, i.e., substantial equivalence to predicate devices and demonstration of safety and effectiveness). The document does not provide details of these clinical studies, such as specific methodologies, sample sizes, performance metrics, ground truth definitions, or expert involvement. The safety and effectiveness conclusion is a high-level summary of the study outcomes without the supporting data or detailed statistical analysis typically found in a full study report. The predicate devices mentioned are the Equitest System (K851744) and The Pro & Smart Balance Master Systems (K946229), both from NeuroCom International, Inc., implying the VMT™ System's performance was compared to or demonstrated to be similar to these established devices in terms of function and intended use.
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