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For use in the measurement of vibratory thresholds, or sensibility, in clinical situations where various neuropathies may exist.

The VSA 3000 - Vibratory Sensory Analyzer is a computerized device for the quantitative assessment of large nerve fiber dysfunction, designed for both clinical and advanced research applications. It measures the sensory threshold for vibration.

The provided text describes a 510(k) premarket notification for the VSA 3000 Vibratory Sensory Analyzer. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results to establish acceptance criteria and performance. Therefore, much of the requested information regarding acceptance criteria, specific study design, and statistical outcomes is not present in the provided document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., sensitivity, specificity, accuracy). The acceptance criteria for a 510(k) submission primarily revolve around demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed predicate device.
• Reported Device Performance: The document describes the functionality and purpose of the device, but does not provide quantitative performance metrics (e.g., specific accuracy, precision, or diagnostic yield values).

What the document does state regarding performance/equivalence:

2. Sample Size Used for the Test Set and Data Provenance:

• Not provided. The 510(k) summary does not contain information about a specific test set or clinical study with a defined sample size for the VSA 3000 itself. The focus of the 510(k) is on comparing the device to existing predicates rather than presenting novel clinical performance data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

• Not provided. This information would typically be part of a clinical study report, which is not included in this 510(k) summary.

4. Adjudication Method for the Test Set:

• Not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant to studies where multiple readers or experts independently assess cases, typically for diagnostic accuracy. This information is not present.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No indication of an MRMC study. The document does not mention any study comparing human readers with and without AI assistance, nor does it quantify an effect size for such a comparison. The VSA 3000 is described as a device for "measurement of vibratory thresholds," which implies a direct measurement tool rather than an AI-assisted diagnostic aid for human readers.

6. Standalone Performance Study (Algorithm Only):

• No indication of a standalone performance study in the context of an algorithm's diagnostic accuracy. While the device itself performs measurements, the document does not present data from a "standalone" study in the sense of an algorithm's diagnostic performance without human-in-the-loop, as would be typical for AI/ML devices. The device is a standalone vibrating sensory analyzer, but its performance is described in terms of its function and equivalence, not as an algorithm's diagnostic output.

7. Type of Ground Truth Used:

• Not provided. For a device that measures vibratory thresholds, the 'ground truth' would implicitly be the actual vibratory sensation perceived by the patient, often correlated with clinical diagnoses of neuropathy. However, the exact methodology for establishing this in a formal study is not detailed.

8. Sample Size for the Training Set:

• Not applicable / Not provided. The VSA 3000 is a measurement device, not an AI/ML system that would typically have a "training set" in the context of machine learning model development.

9. How Ground Truth for the Training Set Was Established:

• Not applicable / Not provided. As above, the concept of a "training set" ground truth as applied to AI/ML is not relevant here.

In summary: The provided document is a 510(k) substantial equivalence letter and summary. It focuses on demonstrating that the VSA 3000 is similar in indications for use, technology, and safety/effectiveness to predicate devices (Bio-thesiometer, Vibraton II, Case IV) that were already legally marketed. It does not contain the detailed clinical study data, acceptance criteria, or performance metrics typically found in documents for devices requiring de novo clearance or a PMA, especially those involving AI/ML. The "study" here is the assertion and argument for substantial equivalence, rather than a clinical trial proving specific performance against predefined statistical targets.

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