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To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities.

• Neck Pad is used in back of neck.

The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design. It is a body-worn and home-use device. It uses low-frequency electronic therapy and designed to temporary relief of pain associated with sore and aching muscles in the back of neck. It only has one model: ST-304.
The trade name of the subject device is Transcutaneous electrical nerve stimulator.
The Transcutaneous electrical nerve stimulator (model: ST-304) consists of a main unit and Type C-USB charging cable. The main unit consists of shell, lithium battery (only 1pcs), neck electrodes pads (a pair of fixed neck electrodes pads), lower shell connector and control buttons and silicone pads. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is titanium material (Gr.2). There are only 1 pcs lithium battery in-build in main unit. The model of lithium battery is KRL 103040.
The neck electrodes pads (a pair of fixed neck electrodes pads) are a kind of Titanium material, and the detail content as following description and as the classify of ASTM F67 2017 it is under Gr2.
The Transcutaneous electrical nerve stimulator (model: ST-304) power supply is 3.7V DC using built-in lithium battery(1200mAh). The built-in lithium battery can be recharged. But the power adapter (Input: 100-240V~, 50/60Hz,0.7A, Output: 5V== 1000mA) is not the parts of the subject device so it shall be supplied by the user. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is Titanium material (Gr.2).
The Transcutaneous electrical nerve stimulator (model: ST-304) totally has 3 modes. The stimulation has 2 modes for stimulating and 15 output Intensity Levels for each mode, so the device can give certain electrical pulse through the neck electrodes pads on the intact skin of back neck to help users to temporary relief of pain. The heating only has 1 mode for heating and it can also provide a constant temperature of 32℃ to 38℃ to provide a warming sensation. The stimulation function and heating function can be used separately or simultaneously. The neck electrodes pads provide users with back of neck stimulation and heat to warm and comfort the muscles of the back of neck.
The main unit provides access to adjust the intensity up or down and adjust stimulating mode, put ON/OFF the main unit and heating function.
The Intensity level of electrical stimulation and heating function are easily controlled by the end user using manual, push-button controls. The push-button controls are consisted of four button which are Switch on/off button/mode switch button, heating button, Intensity increase button and Intensity decrease button.
The default stimulation time is 10 minutes, and the user cannot adjust but could turn off the device during working condition.
Transcutaneous electrical nerve stimulator (model: ST-304) has 2 types stimulation modes: Mode 1, Mode 2.
Before use the device to wipe the Electro Therapy Conductive Gel on the Neck Electrode Pads. But the Electro Therapy Conductive Gel is not the part of subject device so it shall be supplied by the user.
Principle of operation:
The Transcutaneous electrical nerve stimulator (model: ST-304) sends low-voltage electrical pulses to specific nerves via two fixed neck electrodes pads applied on the intact skin of back of neck and powered by rechargeable lithium battery. The purpose is to temporarily relieve pain. By adjusting the output voltage and frequency to produce the low-voltage electrical pulses and achieve the effect of electrotherapy. Voltage regulation is realized by the Boost Converter circuit, which controls the voltage amplitude by modifying the PWM control circuit. After that, the voltage is released to the electrode through the analog circuit, and the time change of the output voltage is controlled by modifying the PWM frequency to achieve the specific electrotherapy effect.

The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding:

• Acceptance criteria in the context of a clinical study or specific performance metrics for the device's intended use.
• A study that proves the device meets acceptance criteria. No clinical performance study is described.
• Sample size for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

Instead, the document details non-clinical testing performed to demonstrate that the device is as safe and effective as its predicate devices, based on compliance with recognized consensus standards.

However, I can extract information related to the device's technical specifications and how they compare to predicate devices, which implicitly serves as the "acceptance criteria" and "device performance" for the substantial equivalence claim.

1. Table of Acceptance Criteria (Implicit for Substantial Equivalence) and Reported Device Performance:

The "acceptance criteria" for this 510(k) submission are implicitly defined by the technical specifications of the predicate devices. The "reported device performance" refers to the subject device's technical specifications. The discussion of differences (D1-D17) explains why these differences do not raise new questions of safety or effectiveness.

Since this is a 510(k) submission, the device's acceptance is based on demonstrating "substantial equivalence" to predicate devices, primarily through non-clinical testing and comparison of technical characteristics, not through clinical trials demonstrating specific performance criteria against a disease outcome.

Summary of Missing Information (as per your request, not present in the document):

2. Sample size for the test set and the data provenance: Not applicable, as no clinical test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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 is not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical ground truth is established for efficacy.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical testing for electrical safety, EMC, biocompatibility, and software verification, as listed in Section 7. This testing demonstrates that despite minor technical differences, the device is as safe and effective as the predicate devices for its intended use.

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The Air Compression Therapy Device(model: ST-502) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device (model: ST-502) simulates kneading and stroking of tissues by using an inflatable garment.

Air Compression Therapy Device, model: ST-502 is a powered inflatable tube massager. The Air Compression Therapy Device, model: ST-502 is consists of an air pump, air pressure sensor, leg sleeves and adapter. The air pump, air pressure sensor and control components are protectively housed in a plastic case of the control unit. The control unit is connected to the dedicated leg sleeves via a series of hoses; each leg sleeve has 3 compression chambers. The Air Compression Therapy Device, model: ST-502 utilizes the pneumatically controlled leg sleeves actuated by an electronically controlled air pump unit.

The "Power" button, "Intensity" button, "Mode" button and LED indicators/displays provide for user interface. There is also a port for connecting the AC adapter plug.

The leg sleeves consist of air pipes and three airbags encased inside a soft medical fabric for increased patient comfort and biocompatibility compliance.

In operation, the user simply turns the power on via the "Power" button. And the user presses the "Intensity" button, "Mode" button to adjust the pressure intensity and working mode of the device as the needs of users.

The compression massage direction is from foot room and push up the thighs. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The leg sleeves work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.

During in the working condition, once the leg sleeves pressure of the airbags reach the proper level(240mmHg), the device is turned off, and the leg sleeves deflates to the ambient pressure through a valve inside the plastic case.

The provided text, a 510(k) Premarket Notification from the FDA, describes an "Air Compression Therapy Device, model: ST-502". This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K193354).

It does not contain information related to acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/ML-driven medical device. The device described is a physical medical device (a powered inflatable tube massager) and the evaluation is for substantial equivalence to a predicate, not performance against specific AI/ML metrics.

Therefore, I cannot provide the requested information about acceptance criteria and a study report as it pertains to an AI/ML device per your prompt, because the provided input does not describe such a device or study.

If the prompt was intended to ask about the non-AI/ML device described in the document, here's what can be inferred about its "acceptance criteria" and "proof" based on the provided FDA submission:

Interpretation for the provided Non-AI/ML Device (Air Compression Therapy Device):

For this type of device, "acceptance criteria" would primarily revolve around demonstrating performance and safety characteristics similar to the predicate device, as well as adherence to recognized consensus standards. The "study that proves the device meets the acceptance criteria" would be the collection of non-clinical tests and comparisons performed.

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

The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way an AI/ML study would specify metrics and results. Instead, it demonstrates substantial equivalence by comparing technical characteristics and compliance with standards. The "acceptance" is implied by demonstrating equivalence to a legally marketed device and meeting safety and performance standards.

Here's an inferred table based on the comparisons made:

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

• This is not applicable in the context of an AI/ML test set.
• For this physical device, the "test set" would implicitly refer to the physical units subjected to the non-clinical tests (e.g., electrical safety, EMC, biocompatibility). The document does not specify the number of units tested, which is typical for such submissions where testing is generally done on representative samples.
• Data provenance is not specified, but these are typically lab-based non-clinical tests.

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

• This is not applicable for this device as it's not an AI/ML device requiring expert ground truth for classification/detection.
• The "truth" for this device is based on objective measurements against engineering and safety standards (e.g., measuring pressure output, electrical leakage, electromagnetic emissions, and biological reactions in lab tests).

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

• Not applicable as there is no human-in-the-loop assessment or subjective interpretation being adjudicated. The tests are objective measurements against specified standard limits.

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 a physical therapy device, not an AI/ML diagnostic or assistive tool. No human reader studies were conducted or are relevant.

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

• Not applicable. This is not an algorithm-only device. The core functionality is mechanical (pneumatic compression).

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

• For this device, the "ground truth" for its safety and performance is established through compliance with recognized consensus standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and direct physical/mechanical measurements (e.g., pressure output, timing accuracy, noise level). There is no "pathology" or "outcomes data" ground truth in the sense of a medical diagnostic AI.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that context.

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

• Not applicable. As there's no training set for an AI/ML model.

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