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Transcutaneous Electrical Nerve Stimulation (TENS) for the temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of the neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

Avazzia OTC TENS electronic pulse massage devices are electrically powered device intended for overthe-counter use and used to apply a microcurrent electrical pulses to electrodes on a user's skin to relieve pain. They are easy-to-use, handheld, AA battery-operated portable devices for use in the home or clinic. The candidate devices have pre-set modes. The devices are portable, battery operated microcurrent electrical stimulation device that applies charge and power to the tissue through electrodes where maximum power delivered to the load is controlled and limited, and an automatic shut off is implemented. The user can apply the built-in onboard electrodes or place self-adhesive conductive electrodes where indicated and apply stimulation for a period of time. The user controls the output by selecting the mode and power setting.

This document is a 510(k) premarket notification for the Avazzia OTC TENS Model Best-AV1™ family of devices. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical trial with acceptance criteria for device performance. Therefore, directly answering all your questions about acceptance criteria and a study proving the device meets them, in the typical sense of a diagnostic or therapeutic study, is not applicable to this document.

However, I can extract the information related to safety and performance from the perspective of substantial equivalence.

Here's an analysis based on the provided document:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission for a TENS device, the "acceptance criteria" are primarily established by demonstrating that the new device (candidate) has similar technological characteristics and performance specifications to a predicate device that has already been cleared by the FDA, and that it does not raise new questions of safety or effectiveness. The reported device performance is presented as a comparison to the predicate.

Study Proving Acceptance Criteria:

The document states: "Verification and validation tests as well as certificates and test reports contained in this submission demonstrate that the submitted models are substantially equivalent to the safety and effectiveness as that of the cleared devices."

Specifically, it mentions:

• "The software verification is conducted according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices – Guidance for Industry and FDA Staff – May 11, 2005."
• "The candidates devices and accessories meet general safety requirements IEC 60601-1 and requirements EMC: IEC 60601-1-2."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document does not describe a clinical trial or performance study with a "test set" of human subjects or patient data in the typical sense of evaluating a diagnostic or therapeutic performance. The "test set" here refers to the device itself undergoing engineering and safety testing. The provenance of this engineering test data is not explicitly stated beyond being part of the submission by Avazzia, Inc. in Dallas, Texas, USA. These tests are typically conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study that involved human experts establishing ground truth for a diagnostic or clinical outcome. The "ground truth" for the engineering performance and safety tests would be the established international standards (IEC 60601-1, IEC 60601-1-2) and the technical specifications of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study involving expert adjudication of clinical findings.

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 device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or imaging device used by human "readers."

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

Not applicable. This is a medical device, not a standalone algorithm in the AI sense. The device's performance is inherently "standalone" in that its electrical output is measured without human intervention in the primary performance tests, but it is used by a human.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this 510(k) submission is based on:

• Engineering Standards: Compliance with international safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2).
• Predicate Device Specifications: The technical and performance characteristics of the previously cleared predicate device (Prospera OTC TENS Electronic Pulse Massager, Models PL009, PL009A, and PL029, K122744). The new device is deemed substantially equivalent if its performance is similar or better, and it doesn't introduce new safety concerns.
• Software Verification: Adherence to FDA guidance for software in medical devices.

8. The sample size for the training set

Not applicable. This device does not employ a machine learning algorithm that requires a "training set" of data.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth established for it.

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For symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and posttraumatic acute pain.

Delta Scanner devices are micro-current transcutaneous electro-stimulation devices for symptomatic relief and management of chronic, intractable pain, and as adjunctive treatment in the management of post-traumatic and post surgical pain. They are handheld, easy-to-use battery operated portable devices, for use in the home or clinic. The technological characteristics of these devices, including waveforms, outputs, and impedance sensing functions are the same as the InterX 5000™ and the Avazzia Best ProTM

The provided text is a 510(k) summary for the Med-Lectric Corporation's Delta Scanner devices. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than conducting new clinical trials with acceptance criteria and performance metrics described in the way a de novo or PMA submission would.

Therefore, the document does not contain the information requested regarding acceptance criteria and a specific study proving the device meets them, as it relates to performance benchmarks (e.g., sensitivity, specificity, accuracy).

Here's why the information is not present and what the document does state:

• Acceptance Criteria & Reported Device Performance: This information is not explicitly stated in the context of a performance study for the Delta Scanner devices. The submission claims substantial equivalence based on technological characteristics and intended use matching predicate devices. The document implies that the "acceptance criteria" are met if the new device's characteristics are similar enough to existing cleared devices.
• Study That Proves the Device Meets Acceptance Criteria: There is no specific clinical study described that proves the Delta Scanner devices meet quantitative performance acceptance criteria in terms of efficacy or safety beyond demonstrating substantial equivalence to predicate devices. The submission mentions "verification and validation tests" but provides no details on their methodology, results, or how they relate to specific performance metrics.

Breakdown of what can be extracted or inferred from the provided text, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria (Inferred): Substantial equivalence to predicate devices (InterX5000™, K042912, K053626; Body-Stim™, Biomodulator™, Best-RSI™, Best Pro™, K062641). Specifically, "technological characteristics... including waveforms, outputs, and impedance sensing functions are the same as the InterX 5000™ and the Avazzia Best ProTM." Also, the "intended uses" are the same.
   • Reported Device Performance: Not mentioned in terms of quantitative clinical outcomes or performance metrics (e.g., pain reduction percentage, adverse events rate, etc.) for the Delta Scanner itself, beyond the claim of substantial equivalence to predicate devices which are presumed to be safe and effective.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set or data provenance is detailed for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is detailed.

4. Adjudication method for the test set: Not applicable.

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 device is a TENS device, not an AI-based imaging or diagnostic tool that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a TENS device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to this type of submission. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set: Not applicable. No training set is detailed.

9. How the ground truth for the training set was established: Not applicable.

Conclusion from the document:

The 510(k) summary for the Delta Scanner devices relies on demonstrating "substantial equivalence" to already cleared devices. The "verification and validation tests" mentioned are general statements regarding software compliance and overall device equivalence, rather than detailed clinical performance studies with specific acceptance criteria and results for the new device itself.

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