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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, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The Wireless Pain Relieve Device includes TENS mode. Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. TENS uses tiny electrical impulses sent through the skin to nerves to modify your pain perception. TENS does not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. For Transcutaneous Electrical Nerve Stimulation (TENS) Self-adhesive electrodes are placed on the skin close to the area of pain. The user can choose 23 pre-set TENS programs. In each program, the intensity can be adjusted. The Wireless Pain Relieve Device is controlled by means of an APP on a mobile device (phone or table) or remote control. The communication is done via Bluetooth Low Energy. The APP operates on iOS or Android platforms (iOS 8.0 or greater, Android 5.0 or greater).

This document is a 510(k) summary for the Wireless Pain Relieve Device, Model LT5011C, seeking substantial equivalence to a predicate device (Wireless Pain Relieve Device LT5018C). It does not contain information about a clinical study with acceptance criteria and device performance in the manner typically seen for clinical trials. Instead, it focuses on demonstrating substantial equivalence through comparison of technological characteristics and compliance with electrical safety, EMC, and software standards.

Therefore, many of the requested items (acceptance criteria, device performance from a clinical study, sample sizes, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, and ground truth for training) cannot be extracted because this document describes a premarket notification for a Class II medical device based on substantial equivalence, not a detailed clinical study demonstrating new efficacy or performance.

However, I can extract information related to the technical performance and standards compliance tests performed to demonstrate safety and effectiveness for this type of device.

Here's a summary of the available information:

1. Table of acceptance criteria and the reported device performance (based on technical specifications and safety/EMC standards):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This submission relies on technical testing and comparisons to a predicate device, not a clinical study involving patients or a test set of data in the sense of AI/ML evaluation.

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):
Not applicable. No ground truth establishment by experts for a test set is mentioned. The assessment is based on compliance with established engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method for a test set is mentioned.

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 device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or interpretive system. Therefore, no MRMC study or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI/algorithm-only device. Its performance is assessed through its electrical output characteristics and safety features.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" here is adherence to engineering specifications and international safety standards (IEC 60601 series, ISO 10993).

8. The sample size for the training set:
Not applicable. There is no training set in the context of an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable.

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TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

The Wireless Pain Relieve Device includes TENS, EMS (including MASSAGE Program) mode. Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. EMS works by sending electronic pulses to the muscle needing treatment; this causes the muscle to exercise passively. The Wireless Pain Relieve Device is controlled by means of an APP on a mobile device (phone or table) and remote control. The communication is done via Bluetooth Low Energy. The APP operates on IOS and Android platforms (IOS 8.0 or greater, Android 5.0 or greater).

The provided text describes the 510(k) summary for the Wireless Pain Relieve Device, Model LT5018C, and its comparison to a predicate device (Smart Pain Reliever LT5019). It doesn't detail a study to prove acceptance criteria in the typical sense for assessing diagnostic or prognostic performance (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are related to established safety and performance standards for electrotherapy devices, and the "study" is a series of engineering tests and comparisons to the predicate device.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are compliance with recognized electrical safety, electromagnetic compatibility (EMC), and software standards, as well as maintaining similar output specifications to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

This document describes technical performance testing rather than clinical study. Thus, concepts of "test set" sample size and data provenance (country of origin, retrospective/prospective) are not directly applicable in the way they would be for a diagnostic AI device.

• Test Set: The "test set" consisted of the physical device (Model LT5018C) undergoing various engineering tests (biocompatibility, electrical safety, EMC, software).
• Data Provenance: The tests are standard engineering evaluations of the device's hardware and software against recognized international standards. The provenance is from the manufacturer's testing or test labs conducting these certification tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. Ground truth, in this context, is adherence to technical standards and the specifications of the predicate device, which is determined by testing against predefined objective criteria rather than expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. The "test set" here refers to the device being tested against technical standards, not a set of cases requiring adjudication for ground truth.

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 device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) for pain relief and muscle conditioning. It is not an AI-assisted diagnostic or prognostic device that would involve human readers interpreting cases.

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

This refers to the device's function as a TENS/EMS unit. The device operates independently (albeit controlled by an app or remote control) to deliver electrical stimulation. The performance measured is its adherence to output specifications and safety standards, both of which are "standalone" in the sense that they assess the device's intrinsic characteristics. The regulatory submission primarily focuses on the device's adherence to these standards and its substantial equivalence to a legally marketed predicate via bench testing and comparison of technical specifications.

7. The Type of Ground Truth Used

The "ground truth" for this submission is:

• Compliance with recognized international standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-2, IEC 62304.
• Demonstrated performance within acceptable ranges: As compared to the predicate device (Smart Pain Reliever LT5019), and often also against general FDA guidance for Powered Muscle Stimulators (e.g., maximum average power density

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