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The Nova HD+ is intended for use by adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.

The Nova HD+ system is a noninvasive physical medicine device that uses electrically generated magnetic fields to stimulate muscles in order to improve and facilitate muscle performance.

The Nova HD+ is noninvasive, fully reusable (no disposable components such as electrodes) and have configurations allowing both home care and clinical professional use.

In addition to the main control unit, the Nova HD+ includes a large loop coil applicator (coils) which allow the operator to administer optimal treatment to the desired anatomical part of the body.

The device contains firmware that controls the user interface, the operator controls the magnetic pulse generator intensity and duration of the treatment.

This document is a 510(k) premarket notification for the Nova HD+ device, a powered muscle stimulator. The FDA has determined the device is substantially equivalent to a predicate device (Bemer Classic Set and Bemer Pro-Set K210174).

Here's an analysis of the acceptance criteria and the study that proves the device meets the criteria, based on the provided text:

No specific acceptance criteria or clinical study to prove the device meets those criteria were provided in the document. This submission primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device rather than presenting a novel clinical study with specific performance metrics and acceptance criteria.

The document explicitly states: "Clinical Testing: Not applicable." This means no dedicated clinical study was performed for this 510(k) submission to demonstrate the Nova HD+ meets specific clinical performance acceptance criteria.

Instead, the submission relies on non-clinical testing to demonstrate performance equivalence to the predicate device.

Here's a breakdown of the requested information based on what is available:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical study with specific acceptance criteria was performed, this table cannot be fully completed as requested. The "reported device performance" is essentially the results of the non-clinical tests demonstrating output and compliance with standards.

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

• Test Set Sample Size: Not applicable for a clinical test set. For non-clinical testing, the "sample size" would refer to the number of devices or components tested. This information is not provided in the document, but it typically involves a certain number of manufactured units to ensure consistency and compliance.
• Data Provenance: The general context implies that the non-clinical performance testing was conducted by Aura Wellness, LLC or a contracted lab. The document does not specify country of origin or if it's retrospective/prospective, but performance testing is inherently prospective for the device being submitted.

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

Not applicable, as no clinical study with a test set requiring expert ground truth was conducted.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical study with a test set was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a powered muscle stimulator, not an AI diagnostic or assistance tool that would involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

Not applicable for a clinical ground truth. For the non-clinical performance testing, the "ground truth" would be established by validated measurement equipment and established engineering specifications/standards.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. This device is not an AI/ML model that requires a training set.

Summary Conclusion from the Document:

The provided 510(k) summary states that clinical testing was not applicable. The primary evidence for substantial equivalence relies on:

• Comparison of technological characteristics and intended use with a predicate device.
• Non-clinical performance testing demonstrating that the subject treatment applicator performed equivalently to the predicate applicator, involving measurements of signal waveform output (volts) and magnetic flux output (mT).
• Compliance with various electrical, EMC, software, and biocompatibility international standards (IEC 60601-series, IEC 62304, IEC 62366-1, ISO 10993-series).

The FDA's clearance (K220938) indicates that, based on this non-clinical data and comparison to the predicate, the Nova HD+ was deemed substantially equivalent and therefore does not raise new questions of safety and effectiveness.

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