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For Prescription Use Model SE-100:

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

For Prescription Use Models ST-150, ST-200 and ST-300:

• Relief of chronic intractable pain. .
• Adjunctive treatment of post-surgical or post-traumatic acute pain. .
• Adjunctive therapy in reducing the level of pain associated with osteoarthritis of the ● knee.
• Adjunctive therapy in reducing the level of pain from rheumatoid arthritis of the hand. .

The MedRelief" ST Series™, consisting of models ST-100, ST-150, ST-200 and ST-300, is designed to provide subthreshold electrical stimulation for acute and chronic pain, including pain, including pain from osteoarthritis and rheumatoid arthritis, in a single compact, lightweight and user-friendly package. "Subthreshold" stimulation does not normally cause sensation or muscle contraction, but acts at a cellular level to relieve pain.

Each device in the ST Series is comprised of the following main components.

• A power section consisting of battery, switch, test and conditioning components; .
• A dosing timer, initialized at power-on and providing a choice of treatment times; .
• A control oscillator, providing pulse-burst timing; .
• A pulse oscillator, providing timing for individual pulses; and .
• An output section, providing filtering, DC blocking and intensity control.

While some components are digital, all functions are hard-wired and there is no microprocessor or software used. Output is by means of lead wires and skin-contact electrodes already commercially available and legally sold by others.

The member devices in the ST Series™ differ only in the complexity of their controls and number of physician or user options which each model offers.

The provided document (K060669) is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device called the MedRelief ST Series. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on detailed clinical study results and acceptance criteria derived from them.

Therefore, the document does not contain the information required to fully answer the request, particularly regarding specific acceptance criteria for device performance, outcomes of a study proving those criteria were met, sample sizes, expert qualifications, or ground truth establishment.

However, based on the comparative tables, we can infer that the general acceptance criteria for the MedRelief ST Series are substantial equivalence in technological characteristics and intended use to the predicate devices. The study proving this, in the context of a 510(k), is the comparison of the proposed device's characteristics to those of the predicate devices.

Here's an attempt to answer the questions based on the available information, noting where information is not present:

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implied to be that the proposed device's characteristics fall within acceptable limits or are the "same as" the predicate devices. The "reported device performance" is essentially the detailed description of the proposed device's characteristics.

The "study" proving these "criteria" are met is essentially the technical comparison presented in the 510(k) submission, where the characteristics of the MedRelief ST series are directly compared against those of the predicate devices (Healthonics MedRelief SE-50 and Bionicare Model BIO-1000). The FDA's issuance of the 510(k) clearance signifies their agreement that the device is substantially equivalent based on this comparison.

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

This information is not provided in the 510(k) summary. 510(k) submissions for TENS devices demonstrating substantial equivalence rarely require clinical studies with human test sets, especially if the new device is technologically similar to previously cleared devices. The "test set" here would implicitly be the technical specifications and performance measurements detailed in the tables, which were likely derived from in-house engineering tests and comparisons.

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)

This information is not provided. As no clinical study is detailed, the concept of establishing ground truth by medical experts in this context is not applicable. The "ground truth" for this submission would be the verifiable specifications and performance of the device and its predicates.

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

This information is not provided. Not applicable in the context of a technical comparison for substantial equivalence.

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

No, a multi-reader multi-case comparative effectiveness study was not done. This is a TENS device, and the submission is a 510(k) for substantial equivalence, not an AI or imaging device requiring MRMC studies.

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

No, a standalone algorithm performance study was not done. The device does not contain a microprocessor or software (except for Version B of one predicate), therefore, it does not rely on algorithms in the way modern AI devices do. Its performance is based on its hardware characteristics.

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

The "ground truth" for this 510(k) submission consists of technical specifications and performance measurements of both the proposed device and its predicate devices (some measured by Healthonics from predicate devices, some from predicate's 510(k) information). For example, electrical output measurements, timing values, pulse characteristics, current/power densities, and material compositions.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of this device and submission type.

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

This information is not applicable/not provided. There is no "training set" for this device.

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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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