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As a TENS device, FD TENS 2090 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

As a EMS device. FD TENS 2090 is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes on the affected body area. It is intended for:

• Prevention or retardation of muscle disuse atrophy.
• · Relaxation of muscle spasm.
• · Muscle re-education.
• · Maintaining or increasing range of motion.
• · Increasing local blood circulation.
• · Immediate post-surgical of calf muscle to prevent venous thrombosis.

FD TENS 2095 is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

FD TENS 2090 can provide both TENS treatments and EMS treatments. During TENS treatments, the FD TENS 2090 generates electrical pulses and transmit it to the electrodes which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

During EMS treatments, FD TENS 2090 generates electrical pulses and transmit it to the electrodes attached to the patient skin, causing the muscle to expand and contract. It is used to relax muscle spasms. prevent or retard atrophy, maintain or increase range of motion, increase local blood circulation, reeducate muscle and provide immediate post-surgical stimulation of calf muscle to prevent venous thrombosis.

FD TENS 2095 can provide TENS treatment, During treatment, the FD TENS 2095 generates electrical pulses and transmit it to the electrodes, which are attached to the patient's skin. Consequently, the electrical pulses would then pass through the skin to the underlying peripheral nerves to aid in the blocking of pain signals traveling to the brain.

This document is a 510(k) Premarket Notification from the FDA for medical devices named FD TENS 2090 and FD TENS 2095. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (FD TENS 2030 and FD EMS), rather than presenting a study to prove a device meets specific acceptance criteria for a novel AI or diagnostic function.

Therefore, many of the requested elements for an AI-focused study are not present in this document. However, I can extract the information relevant to the device's performance characteristics and how its equivalence was established.

No study proving the device meets specific acceptance criteria in the context of an AI or diagnostic function is described in this document. The document describes a "substantial equivalence" determination based on comparison to predicate devices, focusing on technical characteristics and intended use.

Here's a breakdown of the requested information based on the provided document. Many fields will indicate "Not applicable" or "Not provided" because the document is a 510(k) summary for a non-AI device.

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

Since this is a substantial equivalence submission for TENS/EMS devices and not an AI or diagnostic device, there are no "acceptance criteria" in the traditional sense of diagnostic metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance is based on demonstrating that the new device's technical specifications and intended use are substantially equivalent to the predicate devices.

The "device performance" in this context is its electrical parameters compared to the predicate devices.

Note: The subject device's electrical characteristics are sometimes numerically different from the predicate device but are deemed "substantially equivalent" for this type of device, implying they operate within acceptable and safe ranges for their intended therapeutic effect. The FDA clearance confirms this. For EMS's On/Off Time, the subject device has fixed times while the predicate has adjustable, which is a design difference but likely deemed acceptable for substantial equivalence.

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

• Sample size for test set: Not applicable. This is not a study assessing diagnostic performance on a dataset but a technical comparison of device specifications to predicate devices.
• Data provenance: Not applicable for a diagnostic test set. The data presented are engineering specifications of the devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of experts: Not applicable. Ground truth for a diagnostic test set is not relevant for this type of submission.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable. No test set for diagnostic performance.

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

• MRMC study: No. This is not an AI-assisted diagnostic device.
• Effect size: Not applicable.

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

• Standalone performance: No. This is not an AI algorithm.

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

• Type of ground truth: Not applicable. The "ground truth" for this submission are the established technical specifications and performance characteristics of the legally marketed predicate devices, against which the new device's specifications are compared. The safety and effectiveness are established by meeting these engineering and performance standards, and through compliance with recognized electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2).

8. The sample size for the training set

• Sample size for training set: Not applicable. This is not an AI device that requires a training set.

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

• Ground truth for training set: Not applicable.

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