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Over-The-Counter Use: TENS[ (Program 19, Program 15 (Frequency 15Hz)]: XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. NMES[ (Program 1014, Program 15(5Hz≤Frequency≤50Hz)]: XFT-2000 is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. XFT-2000 is also intended to temporarily increase local blood circulation in health muscles of lower extremities. Prescription Use: XFT-2000 is intended for the following use: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion - Adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Nerve and Muscle Stimulator (model: XFT-2000) is based on the principles of neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).The instrument has two independent channels, easy to operate and use. It can relieve muscle spasm, prevent or delay disuse muscle atrophy, promote local blood circulation, promote muscle function recovery, stimulate calf muscle after surgery to prevent venous thrombosis and maintain or increase the range of activity, and assist in the management of post-operative and post-traumatic acute pain problems. Nerve and Muscle Stimulator (model: XFT-2000) is powered by DC adapter or 3 dry AAA batteries, and used together with self-adhesive Electrode. The device is for both prescription and over the counter. It is neither for lifesupporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Nerve and Muscle Stimulator (model: XFT-2000), extracted from the FDA 510(k) summary (K193275).

It's important to note that this document is a 510(k) summary for substantial equivalence, not a detailed clinical study report. Therefore, some information, especially regarding specific clinical study methodologies, may be absent or generalized.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to predicate devices (K082011 and K162517) through compliance with recognized consensus standards and by showing that any differences do not affect safety or effectiveness. The reported device performance is presented as compliance with these standards and a detailed comparison of technical parameters to the predicate devices.

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

• Sample Size for Test Set: The document explicitly states "N/A" for clinical tests (Section 5.8). The evaluation primarily relies on non-clinical tests demonstrating compliance with recognized standards and a comparison of technical specifications to legally marketed predicate devices. Therefore, there isn't a "test set" here in the sense of patient data used for performance claims.
• Data Provenance: Not applicable in the context of a clinical test set. The data provenance relates to the technical specifications of the device itself and the predicate devices. This information is derived from the device's design and engineering specifications, and the publicly available information for the predicate devices (K082011, K162517). The manufacturer is Shenzhen XFT Medical Limited in China.

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

Not applicable. As noted above, no clinical "test set" with ground truth established by experts was conducted for this 510(k) submission. The performance comparison is based on engineering specifications and adherence to international standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was conducted.

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 (Nerve and Muscle Stimulator) is a physical therapy device and not an AI-powered diagnostic or interpretive tool that would involve "human readers" or AI assistance in the way typically seen in imaging or other diagnostic fields. No MRMC study was mentioned or performed.

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

Not applicable. This device is not an algorithm or AI system. Its performance is inherent to its electrical and mechanical design, validated through compliance with engineering standards.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is established through compliance with international consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ISO 10993-5, ISO 10993-10) and through demonstrating that its technical specifications and intended uses are substantially equivalent to legally marketed predicate devices whose safety and effectiveness have already been established. The comparison relies on documented device parameters and publicly available information for the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an algorithm or AI system that learns from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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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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