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As an NMES device, indications are for the following conditions:

-Relaxation of muscle spasms

-Retardation or prevention of disuse atrophy

-Increased local blood circulation

-Re-Educating muscles

-Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

-Maintaining or increasing range of motion.

As a TENS device, indications are for the following conditions: -Symptomatic relief and management of chronic intractable pain -Adjunctive treatment for post-surgical and post-traumatic acute pain

TimeWaver Frequency is an electrical stimulation device that supports the treatment of specific medical conditions, using currents in the microampere range with different frequencies. It can be applied to different areas of the body and is a multifunctional electrotherapy device with two stimulation channels and two treatment modes that deliver neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulations (TENS).

The TimeWaver Frequency device is a prescription device intended to be used by healthcare providers in a healthcare setting and is not approved for use in a home environment. The use of the device on a particular patient is solely the decision of the medical professional, who is responsible for having the proper training and exercising his or her informed medical judgement.

The principals of electrotherapy correspond to the process observed during voluntary muscle contraction. NMES pulses stimulate motor points of target muscle contraction. This can help reeducate and strengthen muscles following injury or surgery. TENS blocks the pain signal sent from the affected area on nerve pathways.

The TimeWaver Frequency device provides 6 treatment programs for NEMS and two treatment programs for TENS. The NMES programs are for relaxation of muscle spasms, disuse atrophy, blood circulations, re-educating muscles, stimulation of calf muscles, and range of motion. The TENS programs are for chronic pain and acute pain. In all modes adhesive electrodes are used to deliver the stimulation.

The TimeWaver Frequency is controlled by an application software program. A personal computer or a notebook is necessary to install the application software and is not provided with the TimeWaver Frequency system. The TimeWaver Frequency software must be used as a stand-alone application on its own computer, which is not used for other software applications. The user interface has several sections. The title bar contains the current program version, the lower status bar shows if hardware components are correctly connected, and the menu bar allows selection of the section to work within. The software requires setting up a new client to include relevant patient information. Treatments are conducted by selecting the appropriate treatment from the Programs module.

The TimeWaver Frequency device operates using an external power supply and/or an internal battery. It is supplied with instructions for use, the TimeWaver Frequency device, power supply, USB cable, electrode connector cables, 50mm x 50mm and 50mm x 90 mm adhesive electrodes.

Sorry, but the provided text from the FDA 510(k) submission for the TimeWaver Frequency device ({0} through {14}) describes a substantial equivalence determination based on non-clinical testing and comparison to a predicate device, rather than a study with acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy.

The document states:

• "TimeWaver has completed comprehensive design verification testing, electrical safety and electromagnetic compatibility testing, software verification and validation to ensure that the TimeWaver Frequency device performs as intended." (Page {5})
• "All necessary non-clinical testing was conducted on the TimeWaver Frequency device to confirm that the device performs as intended." (Page {13})
• The enumerated nonclinical tests include electrical safety and electromagnetic compatibility, biocompatibility verification, and software verification and validation. (Page {14})

There is no information within the provided text about:

• Acceptance criteria related to clinical performance (e.g., sensitivity, specificity, accuracy).
• A study specifically measuring device performance against such criteria.
• Sample sizes for a clinical test set or data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• A multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• A standalone algorithm performance study.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for a clinical training set or how its ground truth was established.

The FDA 510(k) clearance process for this type of device (Powered Muscle Stimulator and Transcutaneous Electrical Nerve Stimulator) often relies on demonstrating substantial equivalence to a legally marketed predicate device through engineering and performance bench testing, rather than new clinical trials demonstrating efficacy or safety if the indications for use and technological characteristics are similar and do not raise new questions of safety or effectiveness.

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The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arms and legs due to strain from exercise or normal household work activities and for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The Healy device is a single channel wearable electrotherapy device that is designed to alleviate temporary and chronic muscle and joint pain on multiple body locations. It delivers microcurrent therapy through the simple and convenient use of the dedicated iOS or Android App, or on product controls. Reusable, selfadhesive and contouring electrodes allow for discreet and convenient placement on multiple pain locations on the body. The system contains one unit, which is rechargeable and is attached to the electrode via cables. The electrode can then be applied to intact skin at the desired location for therapy and pain relief. Control of the Healy system is completed through the available App or on product controls.

The provided text is a 510(k) summary for the Healy device, which is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Omron Avail, Model PM601, K172079) rather than providing detailed acceptance criteria and a study proving the device meets those criteria.

However, based on the information provided, we can infer some details related to acceptance criteria and the underlying studies.

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

The document doesn't present a specific table of acceptance criteria with corresponding performance metrics like a typical clinical trial report. Instead, it relies on demonstrating equivalence to a predicate device by comparing various technological characteristics and performance parameters. The "acceptance criteria" can be interpreted as demonstrating that the device's characteristics are either "No Difference", "Similar", or if different, that the differences "do not raise new questions of safety or effectiveness" when compared to the predicate device.

Here's an aggregated summary table based on the "Substantial Equivalence Comparison Table" and "Output Comparison" in the provided text. The "Acceptance Criteria" column reflects the implicit criteria used for substantial equivalence, i.e., that the device characteristics should be comparable to the predicate. The "Reported Device Performance" is the value for the Healy device. The "Outcome/Compliance" indicates whether the Healy device was found to be acceptable in comparison to the predicate.

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

The document does not describe any clinical study with a "test set" in the context of typical AI/software performance validation involving human data. The submission is a 510(k) for a TENS device, and the "performance data" section states, "All necessary non-clinical testing was conducted on the Healy device to confirm that the device performs as intended." This primarily refers to bench testing, electrical safety, EMC, and software validation.

Therefore, there is:

• No reported sample size for a test set.
• No clinical data provenance (country of origin, retrospective/prospective).

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

Not applicable. As no clinical "test set" based on human data or expert review was used for performance evaluation, no experts were needed to establish ground truth. The evaluation focused on engineering and software validation.

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

Not applicable. No expert-adjudicated test set was used.

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 is not an AI/imaging device. The Healy device is a transcutaneous electrical nerve stimulator, and the submission does not mention any AI component or human reader assistance.

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

This question is typically relevant for AI/software devices. The "standalone" performance here relates to the device's physical and electrical functioning. The document states that "non-clinical, bench testing included performance verification to confirm acceptable performance of device features and functions" and "It was functionally tested and found to be in compliance with the specification." This implies standalone testing of the device's electrical and software functions.

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

For the non-clinical testing, the "ground truth" was established by engineering specifications, international standards (IEC, EN), and regulatory guidance. For example:

• Electrical safety tests against IEC 60601 series standards.
• EMC tests against IEC 60601-1-2 and EN 301 489-1 & 17.
• Software validation against EN 62304, EN ISO 13485, EN ISO 14971, EN 62366 and FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices.
• Performance parameters (voltage, current, frequency, etc.) were compared against the predicate device's specifications and relevant safety limits (e.g., current density limit of 2mA/cm2 from IEC60601-2-10).

8. The sample size for the training set

Not applicable. The Healy device is a hardware medical device (TENS) with associated software for control. The provided documentation does not describe an AI/ML component that uses a "training set" in the typical sense for learning or pattern recognition.

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

Not applicable, as no training set for an AI/ML component is mentioned or relevant to this submission.

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