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The MedRelief SE-50 and SE-100. and the MedRelief SE-200 and SE-300 in subthreshold and interferential modes, are intended for the following indications:

• Relief of chronic intractable pain. .
• Adjunctive treatment of post-surgical or post-traumatic acute pain. .

The MedRelief SE-200 and SE-300 in muscle stimulation mode are intended for the following indications:

• Relaxation of muscle spasms. ●
• Prevention or retardation of disuse atrophy. .
• Muscle re-education. .
• . Increasing local blood circulation.
• Maintaining or increasing range of motion .
• . Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (SE-300 only).

For the SE-200 and SE-300 in muscle stimulation mode, the lowest three intensity settings may not provide effective muscle contractions to achieve the indications for use, especially when applied to large muscles or muscle groups. These settings are provided so that the intensity may be ramped up slowly for improved user comfort.

The MedRelief SE Series™ provides a selection of both high-level and subthreshold electrotherapeutic modes in a compact, lightweight and userfriendly package. "Subthreshold" as used here means electrical stimulation not strong enough to cause nerve depolarization or muscle contraction, but still active at a cellular level, as in microcurrent TENS. Healthonics' proprietary version of subthreshold stimulation has been named Structured Energy™

Devices in the MedRelief SE Series™ provide combinations of these stimulation modes as follows:

| Model
number | Includes: muscle
stimulation | interferential
stimulation | Structured
EnergyTM | Controls |
|-----------------|---------------------------------|-------------------------------|------------------------|----------|
| SE-300 | X | X | X | Rotary |
| SE-200 | X* | X* | X | Rotary |
| SE-100 | -- | -- | X | Rotary |
| SE-50 | -- | -- | X | Recessed |

• • Output provided over reduced intensity range.

Models SE-200™ and SE-300™ provide all three stimulation modes, while Models SE-50™ and SE-100™ are miniaturized, single-mode Structured Eneray™-only versions. All devices are completely powered by 9-volt batteries, without provisions for line power or AC adapters. All devices are single-channel only.

All SE Series ™ devices produce trains of brief electrical pulses which are applied to the body through self-adhesive electrodes placed on the skin. Pulses recur at a nominal 4150 Hz and may be either 30 microseconds or 120 microseconds long. These pulses form a carrier wave which may then be modulated by one of three different envelopes, yielding respectively Structured Energy™, muscle stimulation, or premodulated interferential stimulation. Envelope frequencies range from 0.25 Hz to 130 Hz, depending on the mode being used.

All functions for a particular mode are preset, and accessed through a single rotary switch which also turns the device on and off. In the SE-200™ and SE-300™, a second rotary switch provides intensity control. In the SE-100™, all control functions are integrated into a single rotary switch, while in the SE-50™ this switch is replaced by two recessed, miniature slide switches.

While the MedRelief SE Series™ incorporates some ancillary digital components such as frequency dividers, its primary functioning is analog, with all digital functions hard-wired. Since there is no microprocessor, no software is needed.

The provided text describes a 510(k) summary for the MedRelief SE Series™ (models SE-50, SE-100, SE-200, and SE-300), which are electrotherapeutic devices. The document explicitly focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies of the device itself.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment cannot be fully extracted from this 510(k) summary. The document does not describe a study involving human readers or standalone algorithm performance.

Here's an breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) submission process for these types of devices relies on demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" here are implicitly related to meeting the functional and safety characteristics of the predicate devices.

The document states:

• "Both new and predicate devices employ electronic circuitry to produce electrical output waveforms at closely comparable voltage and current levels and with closely comparable waveforms and timing."
• "The MedRelief SE Series™ is primarily analog, with some hard-wired digital functions but no microprocessor and thus no software."

F. TESTING outlines the types of testing performed to support the 510(k) submission, indicating conformance to standards and guidance documents rather than specific, measurable performance metrics for clinical efficacy.

2. Sample size used for the test set and the data provenance

This information is not applicable/provided. The document describes technical and safety testing of the device itself (hardware characteristics and compliance with standards), not a study involving a test set of data with clinical outcomes or performance against a specified ground truth.

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

This information is not applicable/provided. As above, there is no mention of a test set with ground truth established by experts.

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

This information is not applicable/provided. No adjudication method is mentioned as there is no test set or expert assessment described.

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

This is not applicable. The device (MedRelief SE Series™) is an electrotherapeutic stimulator, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

This is not applicable. The device is an analog electrotherapeutic stimulator and does not contain an algorithm in the sense of AI or image processing. The document explicitly states: "Since there is no microprocessor, no software is needed."

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

This information is not applicable/provided in the context of clinical performance data. The "ground truth" for this submission refers to compliance with established engineering standards and functional specifications of predicate devices.

8. The sample size for the training set

This information is not applicable/provided. No "training set" is mentioned as it's not an AI/machine learning device.

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

This information is not applicable/provided. No training set is mentioned.

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the MedRelief SE Series™ to existing predicate devices based on technological characteristics, intended use, and compliance with general safety and performance standards. It does not contain clinical study data, performance metrics against a defined "acceptance criteria" for accuracy or efficacy, or information on AI/machine learning components, human reader studies, or training/test sets.

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