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The FT-615 is designed for symptomatic relief and management of chronic pain, and for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities and to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorthea (menstrual cramps) when used with over-the-counter pain medication, it also provides a heat function intended to temporarily relief of minor aches and pains.

The subject device is a self-adhesive TENS device with 15 adjustable intensity levels for pain relief. Moreover, it also provides a heat function which can be used alone, or in conjunction with the TENS function simultaneously. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective method of pain relief. It can be used for self-treatment. Any symptoms that could be relieved using TENS must be checked by your general practitioner who will also give you instruction on how to carry out a TENS self-treatment regime.

This FDA 510(k) premarket notification is for a medical device (HEATING TENS, Model FT-615), not an AI/ML powered device. Therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML performance metrics (sample size for test/training sets, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth type, how ground truth was established) is not applicable to this document.

The document discusses the device's substantial equivalence to a predicate device (HIVOX OTC Electrical Stimulator, FT610-B) based on non-clinical testing.

Here's a summary of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

2. Sample size used for the test set and the data provenance: Not applicable as this is not an AI/ML study. Performance was evaluated through non-clinical laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as this is not an AI/ML study.

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 as this is not an AI/ML study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML study. This is a physical device (TENS unit). The mentioned "software validation" refers to the intrinsic software of the device itself, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as this is not an AI/ML study. Ground truth was established by conformance to recognized medical device standards and internal requirements for safety and performance (e.g., electrical safety standards, biocompatibility standards, functional specifications).

8. The sample size for the training set: Not applicable as this is not an AI/ML study.

9. How the ground truth for the training set was established: Not applicable as this is not an AI/ML study.

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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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HIVOX OTC Electrical Stimulator, EM49-1 -

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), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

HIVOX OTC Electrical Stimulator, EM49-2 -

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), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

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

HIVOX OTC Electrical Stimulator – EM49-1 and EM49-2, falls into the electro stimulation device category.

EM49-1 provides one basic function, TENS, whereas EM49-2 provides two basic functions, TENS/EMS:

1. Electrical stimulation of nerve tracts (TENS)

2. Electrical stimulation of muscle tissue (EMS)

The two models also feature two independent stimulation channels and four adhesive electrodes which FDA cleared k number is K132588. For TENS, EM49-1 and EM49-2 are designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities; for EMS, EM49-2 is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance. For these purposes, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.

The principle of electro stimulation units is based on the imitation of impulses in our bodies that are transferred to nerve and muscle fibers with electrodes via our skin. The electrodes can be applied to many parts of the body. In certain applications the user will merely notice a slight tingling or vibrating sensation. For EM49-1, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves and nerve centers in the application area: for EM49-2, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves, nerve centers and muscle groups in the application area.

Here's a breakdown of the acceptance criteria and study information for the HIVOX OTC Electrical Stimulator (EM49-1, EM49-2):

This device is cleared through a 510(k) Special submission, meaning it's substantially equivalent to a previously cleared device. Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through non-clinical testing and comparison to the predicate device, rather than a standalone clinical study with specific performance metrics against a defined standard.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission showing substantial equivalence, specific numerical acceptance criteria (e.g., sensitivity, specificity) for clinical performance are not provided in the document. Instead, the acceptance criteria are about meeting various safety and performance standards for electrical stimulators. The device performance is demonstrated by successfully meeting these test requirements.

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

• Sample Size: Not applicable. The "test set" here refers to the actual device being tested against engineering and bench standards, not a dataset of patients or images.
• Data Provenance: Not applicable in the context of clinical data. The testing was non-clinical (bench testing, engineering verification).

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

• Number of Experts: Not applicable. Ground truth for non-clinical engineering tests is established by industry standards, specifications, and established scientific principles, not by human expert opinion.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers interpreting clinical data. This document describes non-clinical testing.

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 MRMC study was done. This device is an electrical stimulator, not an AI-powered diagnostic tool. The submission states, "No clinical test data was used to support the decision of substantial equivalence."

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

• Not applicable. This isn't an algorithm or AI device; it's an electrical stimulator. Its "performance" is measured by its electrical characteristics, safety, and functionality, not by diagnostic accuracy.

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

• For the non-clinical tests (Shelf Life, Biocompatibility, Software Validation, EMC/Electrical Safety, Function test, Usability), the ground truth is established by:
  • Industry standards and regulatory requirements: e.g., electrical safety standards, biocompatibility standards, software development lifecycle standards.
  • Device design specifications: The device is tested to ensure it performs according to its engineered design.
  • Predicate device characteristics: For substantial equivalence, the device's technical characteristics are compared to those of the predicate device.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or AI, so there is no training set.

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

• Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant.

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R-C1 TENS and EMS Stimulator

TENS: This mode 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.

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

R-E1 EMS Stimulator

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

R-T1 TENS Stimulator

This 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.

The RW Series A Electrical Stimulators, which includes models R-C1 TENS and EMS stimulator, R-E1 EMS stimulator and R-T1 TENS stimulator, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.

The device unit of R-C1 was portable device, battery powered (6.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device.

The electrode size is 50*50mm, the manufacturer is Top-Rank Health care Equipment Co., Ltd. The electrode is OTC use and cleared with 510(K), the cleared number is K132588. It has been evaluated and tested according to ISO 10993-1/-5 and -10 standards.

The three models of R-C1, R-E1 and R-T1 have the same appearance, structure, display, electrical principle and CDF, the main differences are software and color. The R-C1 have TENS mode (18 programs), EMS mode (15 programs). The R-E1 only have EMS mode (15 programs) and R-T1 only have TENS mode (18 programs). The R-C1 was combination the function of R-E1 and R-T1.

The provided document is a 510(k) Summary for a medical device (Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator). It describes the device, its intended use, comparison to predicate devices, and non-clinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

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

The document provides a table outlining compliance with recognized consensus standards for safety and performance (page 6). This effectively acts as the acceptance criteria for the non-clinical tests.

The document also provides a detailed comparison table (pages 8-9) with the predicate devices for various technical characteristics. For each characteristic, the comparison indicates "Same," "Different but does not adversely impact safety and effectiveness," or similar justifications, implying that these characteristics meet the acceptance criteria established by the predicate devices or are otherwise deemed safe and effective. Specific numerical values are provided for many parameters, such as maximum output voltage, maximum output current, pulse width range, and frequency.

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

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." (page 6). The evaluation was based solely on non-clinical (laboratory) testing. Therefore, there is no sample size for an effectiveness test set, nor is there data provenance in the context of clinical studies.

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)

Since no clinical studies were performed and the substantial equivalence determination was based on non-clinical, laboratory testing and comparison to predicate devices, this information is not applicable. The "ground truth" for the device's acceptable performance was established by demonstrating compliance with recognized safety and performance standards (e.g., IEC standards) and showing equivalence to legally marketed predicate devices through technical specifications and testing.

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

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

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. The device is an electrical stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

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

Not applicable. The device is an electrical stimulator, not an algorithm. However, the non-clinical tests (e.g., electrical safety, performance, software validation) represent an evaluation of the device's standalone performance against established engineering and safety standards.

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

For this device, the "ground truth" for demonstrating safety and effectiveness was based on:

• Compliance with recognized international consensus standards: Such as IEC 60601 series, ISO 14971, and IEC 62304. These standards define the acceptable performance and safety characteristics for medical electrical equipment.
• Comparison to legally marketed predicate devices: The predicate devices (MT9001, LT3060; K130802) serve as the established "ground truth" for a device of this type being safe and effective for its indicated use. The extensive comparison table (pages 8-9) outlines how the new device's technical specifications either match or differ in ways that do not adversely impact safety and effectiveness compared to these predicates.

8. The sample size for the training set

Not applicable. The device is an electrical stimulator that performs physical functions, not a machine learning model that requires a training set.

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

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

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HIVOX OTC Electrical Stimulator, SEM44 -

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), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

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

HIVOX OTC Electrical Stimulator, SEM44-1 -

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), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

HIVOX OTC Electrical Stimulator - SEM44 and SEM44-1, falls into the electro stimulation device category.

SEM44 provides two basic functions, TENS/EMS; SEM44-1 provides one basic function, TENS:

1. Electrical stimulation of nerve tracts (TENS)

2. Electrical stimulation of muscle tissue (EMS)

The two models also feature two independent stimulation channels and four adhesive electrodes which FDA cleared k number is K132588. For TENS, SEM44 and SEM44-1 are designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities .; For EMS, SEM44 is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance. For these purposes, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.

The principle of electro stimulation units is based on the imitation of impulses in our bodies that are transferred to nerve and muscle fibers with electrodes via our skin. The electrodes can be applied to many parts of the body. In certain applications the user will merely notice a slight tingling or vibrating sensation. For SEM44, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves, nerve centers and muscle groups in the application area; for SEM44-1, the electrical impulses that are sent into the tissue influence the transmission of stimulation into nerves and nerve centers in the application area.

The provided document is a 510(k) summary for the HIVOX OTC Electrical Stimulator (Models SEM44 and SEM44-1). It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven medical device. Instead, it details a substantial equivalence determination based on non-clinical testing for an electrical stimulator.

Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for an AI/algorithm device is not applicable or cannot be extracted from this document.

However, I can extract the information relevant to the non-clinical testing performed and the comparison with predicate devices.

Here's a breakdown of the available information based on your request, with a note where information is not present:

Acceptance Criteria and Device Performance Study for HIVOX OTC Electrical Stimulator (SEM44, SEM44-1)

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets for each parameter. Instead, it states that "All the test results demonstrate HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices."

The comparison tables (pages 7-10 and 13-16) describe various technical specifications of the subject device and the predicate devices. For each difference, the document states: "Different but does not adversely impact safety and effectiveness of subject device." This implicitly indicates that the subject device's performance, despite differences, falls within an acceptable range for safety and effectiveness as determined by comparison to the predicate.

Non-Clinical Testing & Performance Summary

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

• Sample Size: Not applicable. This document describes non-clinical engineering and performance testing of a physical device, not an AI/algorithm using a test set of data.
• Data Provenance: Not applicable. The tests performed are laboratory-based non-clinical tests on the device itself.

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

• Not applicable. This is not an AI/algorithm study requiring expert-established ground truth.

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

• Not applicable. This is not an AI/algorithm study involving adjudication of results.

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 document is for an electrical stimulator, not an AI-assisted diagnostic or treatment device.

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

• Not applicable. This refers to an AI algorithm. The device here is an electrical stimulator.

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

• Not applicable. For the non-clinical tests, the "ground truth" or reference standards are the specifications and requirements defined by the relevant international and national safety and performance standards (e.g., IEC 60601 series, ISO 10993 series, 21 CFR 898-7).

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm device.

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

• Not applicable. This is not an AI/algorithm device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Non-Clinical)

The study supporting the HIVOX OTC Electrical Stimulator (SEM44, SEM44-1)'s safety and effectiveness for its intended use is a series of non-clinical tests as detailed in section 5.8 of the 510(k) summary. These tests covered:

• Shelf Life: To ensure the device maintains its performance over its intended lifespan.
• Biocompatibility: To confirm that the materials used in the device are safe for contact with the human body.
• Software Validation: To verify that any embedded software functions correctly and safely. (Both the subject device and predicate devices utilize software/firmware/microprocessor control, as noted in the comparison tables).
• Electromagnetic compatibility and electrical safety: To ensure the device operates safely in its electromagnetic environment and meets electrical safety standards. The document explicitly lists compliance with:
  • IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
  • IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests)
  • IEC 60601-2-10 (Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators)
  • ISO 10993-5/10 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, and Part 10: Tests for irritation and skin sensitization)
  • Compliance with 21 CFR 898-7 (Radiation protection regulations for diagnostic X-ray systems) - Note: This standard appears to be an error in context for an electrical stimulator, as 898-7 typically pertains to X-ray systems. It's likely an oversight in the document or a misstatement.
• Function test: To confirm the device operates as intended in terms of its electrical stimulation outputs (TENS and EMS modes), power delivery, and user controls.

The conclusion of these tests (Section 5.8) states: "All the test results demonstrate HIVOX OTC Electrical Stimulator (SEM44, SEM44-1) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices."

The entire submission is based on demonstrating substantial equivalence to legally marketed predicate devices (K130802 and K150386). The tables provided in the document (pages 7-10 and 13-16) meticulously compare the subject device's features and specifications against those of the predicate devices. For any differences, the rationale is provided that these "do not adversely impact safety and effectiveness of subject device," thereby supporting the claim of substantial equivalence.

No clinical test data was used to support the decision of substantial equivalence (Section 5.9).

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The proposed device is intended for use as the disposable, conductive adhesive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators. i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for OTC use.

The proposed TENS Electrodes are non-sterile laminated, flexible structures composed of materials commonly used in this application: The electrodes are designed for single-patient application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The proposed device mainly consists of electrode pad and wire. The electrode pad is available in rectangular shape, round shape, and butterfly shape, etc.

The Cathay Manufacturing Corp. TENS Electrodes (K160081) were compared against a primary predicate device (K080276) and a reference device (K132588) to establish substantial equivalence. The study involved bench testing (non-clinical) to assess performance characteristics.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Maximum and minimum values within ±10% of average value. | Met: No significant deviation; max/min values within ±10% of average. |
   | Stability and shelf life | 2 year | 2 year (demonstrated to be equivalent) |

2. Sample Sizes Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample sizes (number of electrodes) used for each individual performance test (e.g., electrical impedance, tensile strength) on the subject device. It mentions "Largest model: CM100180FC (Rectangle shape: 100 x 180 mm); Smallest model: CM2222FC (square shape: 22 x 22 mm); Irregular representative: CM2542YC(crescent )" were used for testing electrode types, shapes, and sizes. This suggests at least one of each representative size and shape were included.

The data provenance is not specified beyond being "bench testing (non-clinical)." There is no information regarding the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:

This section is not applicable as the study described is a non-clinical bench testing study of TENS electrodes, not a study involving human-in-the-loop performance or expert interpretation of diagnostic images/data. Therefore, there was no ground truth requiring expert establishment.

4. Adjudication Method:

This section is not applicable for the same reasons as above. There was no expert review or adjudication of results required for this type of non-clinical bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to TENS electrodes' physical and electrical performance evaluation.

6. Standalone Performance Study:

Yes, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was done, but not for an AI algorithm. The "algorithm" in this context refers to the device itself and its intrinsic performance as measured by various physical and electrical tests. The bench testing evaluated the device's performance directly against the defined acceptance criteria without human interaction influencing the measurement results.

7. Type of Ground Truth Used:

The "ground truth" for this study was based on objective, quantitative measurements and established industry standards (e.g., IEC 60601-1, IEC 60601-2-10:2012, AS07-003 / GB/T4852-2002). The results of the tests (e.g., resistance values, weight held, adhesion percentage) served as the direct evidence of performance against these pre-defined benchmarks.

8. Sample Size for the Training Set:

This section is not applicable. The device in question is a physical medical device (TENS electrodes), not an AI algorithm that requires a training set. The "design" and "validation" mentioned relate to engineering and manufacturing processes, not machine learning model training.

9. How the Ground Truth for the Training Set was Established:

This section is not applicable for the same reason as above. There was no training set for an AI algorithm.

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To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities (Choose Mode A, B, or C)

To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (Arms) due to strain from exercise or normal household work activities (Choose Mode A, B or C)

To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (Legs) due to strain from exercise or normal household work activities (Choose Mode A, B or C)

To be used for symptomatic relief and management of chronic, intractable pain associated with Arthritis (Choose Mode A)

To stimulate healthy muscles in order to improve and facilitate muscle performance (Choose Mode B)

The Pain Therapy System, Model PTS-II is a selectable dual channel TENS and EMS device operated by DC 3.0V (AAA*2 batteries). It is made up of one main unit, two electrode cables, and two pairs of electrode pads.

There are 3 selectable, pre-programmed output waveforms (modes) to choose from. The two channels share one knob to adjust, the intensity are adjustable from 0 to 5. Running time can be selected among 10, 20 or 40min and recycled. There is a dial with on/off on the side that enables the device to be turned on or off, and it can be used to adjust the output intensity level, turn clockwise to increase intensity and turn anticlockwise to decrease the intensity. In the front of the device, there are 2 buttons and 6 indicator lights, in which one button is the mode selection button, and the other is for time selection. There are three modes A. B. C. respectively indicated by three indicator lights, which are on the right of the mode selection button. The device has 3 timing levels, namely 10, 20, 40 min, and indicated by three indicator lights, which are on the right of the timing selection button.

The provided document is a 510(k) premarket notification from the FDA for a device called "Pain Therapy System, Model PTS-II". It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Crucially, this document is for a Transcutaneous Electrical Nerve Stimulator (TENS) device, not an AI/ML medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/ML device (e.g., performance metrics like accuracy, sensitivity, specificity, or reader studies) are not applicable here. The substantial equivalence for this TENS device is established through non-clinical testing against recognized consensus standards and a comparison of technological characteristics with a legally marketed predicate device.

The questions you've asked (about sample sizes, ground truth experts, MRMC studies, standalone performance, training sets, etc.) are highly relevant to the evaluation of AI/ML medical devices. However, they do not apply to the traditional medical device evaluation process exemplified by this 510(k) submission for a TENS device.

Here's a breakdown of what is relevant from the document regarding its "acceptance criteria" (which are more accurately "conformance criteria" in this context) and "proof":

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

Instead of acceptance criteria for AI performance, the document lists technological characteristics of the proposed device and compares them to the predicate device. The "acceptance criteria" here are essentially that the proposed device's characteristics are sufficiently similar to the predicate device, or any differences do not raise new questions of safety or effectiveness.

The "reported device performance" is essentially the demonstrated compliance with the listed consensus standards and the presentation of these technological parameters. The conclusion (Page 8) states: "bench testing and safety report documentation demonstrate that the submitted device could maintain the same safety and effectiveness as that of predicate device."

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 isn't a study involving human subjects or data sets in the AI/ML sense. The "testing" refers to bench testing and compliance with electrical safety and performance standards.
• The device is manufactured by "Counter Scientific Development (GZ) Ltd" in Guangzhou, China.

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. Ground truth in the AI/ML context is not relevant for this type of device submission. The "ground truth" here is the adherence to established engineering and safety standards.

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

• Not applicable. No adjudication in the AI/ML context.

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. No MRMC study. This is a physical device, not an AI assistance tool for human readers.

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

• Not applicable. Not an algorithm. The "standalone performance" is the device's ability to meet its operational specifications and safety standards on its own.

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

• Not applicable. The "ground truth" for this device's evaluation is compliance with recognized consensus standards (ANSI/AAMI ES60601-1, IEC 60601-2-10, IEC 60601-1-2) which define safety and essential performance parameters, and the comparison of its technical specifications to a predicate device.

8. The sample size for the training set

• Not applicable. No training set for an AI/ML model.

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

• Not applicable. No training set.

In summary, the provided document details a 510(k) submission for a non-AI medical device (TENS). The evaluation methodology relies on comparison to a predicate device and compliance with established electrical and safety standards, rather than the AI/ML-specific testing and evaluation criteria you've outlined.

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The Tyece OTC TENS Device, Model SEM44 is to be used for temporary relief of pain associated with sore and aching muscles in the lower back, arms, or legs due to strain from exercise or normal household activities.

The Tyece OTC TENS Device, Model SEM44 is a dual channel TENS device operated by DC 4.5V (3 AAA batteries). It is made up of one main unit, two electrode cables, and two pairs of electrode pads. There are 12 selectable, pre-programmed output waveforms (modes) to choose from, blus 3 programmable modes. The two channels can be individually adjusted for intensity from 0 to 50. Running time can be selected from 5 to 100 minutes. All parameters (Menu, Program Number, Impulse intensity for channels, Jow battery, key-lock, frequency, pulse width and timer) are displayed on a full screen display. The only patient contacting components are the Electrode Pads. The patient contacting materials are FDA cleared under K132588.

This is a premarket notification (510(k)) for a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective. In this context, the "acceptance criteria" and "device performance" usually refer to the equivalence demonstrated through engineering and non-clinical testing against recognized standards and comparison to the predicate device. Clinical studies for proving effectiveness in terms of pain relief are typically not required for 510(k) submissions of TENS devices if substantial equivalence can be shown through non-clinical means.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission of a TENS device, the acceptance criteria are generally defined by compliance with recognized consensus standards for electrical safety, electromagnetic compatibility, and performance, as well as demonstrating comparable technical characteristics to the predicate device. The "device performance" reported is its compliance with these standards and its specified output characteristics.

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

The document states: "Savia did not conduct, nor rely upon, clinical tests to determine substantial equivalence of the SEM44 vs. the predicate." Therefore, there is no test set of clinical data from human subjects in the traditional sense. The testing performed was non-clinical bench testing to validate design and ensure conformance with voluntary design standards. This means there is no data provenance related to human subjects (country of origin, retrospective/prospective).

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. As noted above, no clinical test set was used for determining substantial equivalence, hence no experts were involved in establishing ground truth for such a set. The "ground truth" was established by the requirements of the recognized consensus standards and direct comparison of technical specifications to the predicate device.

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

Not applicable, as no clinical test set involving human subjects requiring adjudication was used.

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 TENS unit, not an AI-assisted diagnostic or therapeutic device that would typically involve human readers or MRMC studies.

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

Not applicable. The device is a Transcutaneous Electrical Nerve Stimulator; it's a physical device that delivers electrical impulses, not an algorithm in the context of AI or imaging. Performance was evaluated as a standalone product against technical specifications and standards.

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

The "ground truth" for this 510(k) submission is primarily established by:

• Recognized consensus standards: Electrical safety, EMC, performance standards (e.g., IEC 60601 series).
• Technical specifications of the predicate device: The Tyece device's technical characteristics are compared directly to the cleared predicate device to ensure substantial equivalence.
• Design requirements: Internal company design requirements for the device.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the clinical sense, as clinical studies were not performed for this submission.

8. The sample size for the training set

Not applicable. Since no clinical studies were performed and the device is not an AI/machine learning model, there is no concept of a "training set" of data.

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

Not applicable, as no training set was used.

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The Revitive IX (OTC) is intended to be used for electrical stimulation of the muscles of the lower leg for the purposes of supporting muscle function, and improving blood circulation. In addition Revitive IX (OTC) is intended to be used for electrical stimulation of sore and aching muscles to relieve pain. The device is intended for home use for 30 minutes per treatment with a maximum of 3 hours treatment time per day as required.

Revitive IX (OTC) is indicated for:

• To temporarily increase local blood circulation in healthy leg muscles
• To stimulate healthy muscles in order to improve and facilitate muscle performance. ●
• For temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties.

The Revitive IX (OTC) consists of foot pads and/or electrode pads that deliver electrical stimulation to the lower limb muscles, electrode pads may also deliver electrical stimulation to muscles in the shoulder, waist, back and arms; an optional feature that allows for ankle movement during stimulation; a remote control; dust protectors for the electrode pads; and a user interface. Replacement electrode pads are available separately under 510(k) K132588.

Revitive IX (OTC) is a neuromuscular electrical stimulation (NMES) device that applies electrical impulses that are of sufficient intensity to produce an artificial contraction of the muscle tissue. The device delivers electrical stimulation to the lower limb muscles through foot pads and/or through electrode pads which may be positioned on the lower limb, waist, back or arms. The foot pads are made of conductive black nitrile butyl rubber (NBR) containing carbon, while the electrode pads are made from conductive carbon film coated with an adhesive hydrogel on a cloth backing. It has an optional IsoRocker™ feature that allows ankle movement during stimulation. When enabled, the lsoRocker™ allows Revitive IX (OTC) to tilt back and forth as the muscles contract and relax. The main body of the device is constructed from ABS plastic.

The Revitive IX (OTC) is intended for multiple uses in the home environment and is not provided sterile. The software included in the device controls the pulses generated by the device to stimulate the muscle. The software allows the device to generate various different shapes of pulses with different repetition rates, duration and magnitude. The Revitive IX (OTC) utilizes standard household AC/DC power supply with a 5V DC power adaptor.

The provided text describes the Revitive IX (OTC) device and its substantial equivalence to predicate devices, focusing on safety and performance, but it does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria.

The document is a 510(k) summary for an Over-The-Counter (OTC) powered muscle stimulator (Revitive IX), and typically these submissions demonstrate substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria for an AI algorithm.

However, I can extract the information that is present concerning performance testing and usability studies:

1. Table of Acceptance Criteria and Reported Device Performance

As stated, the document does not explicitly list "acceptance criteria" in the typical sense of a target performance metric for an AI system (e.g., sensitivity, specificity, AUC). Instead, it refers to compliance with safety and biocompatibility standards and successful usability testing.

The following information is NOT present in the provided text, as it pertains to AI/algorithm performance studies which are not described for this device.

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 (N/A) as no AI performance study is described.
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): N/A.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A.
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: N/A.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A.
8. The sample size for the training set: N/A.
9. How the ground truth for the training set was established: N/A.

Summary of what is available from the document:

The document describes performance data primarily related to meeting established medical device safety, EMC, and biocompatibility standards (e.g., ISO and EN standards). A usability study was also conducted to demonstrate safe and effective operation by intended users in a home environment for OTC use, following FDA human factors draft guidance. The device is a "Powered Muscle Stimulator" and the "software included in the device controls the pulses generated by the device to stimulate the muscle." However, this software is for device function control, not for an AI-driven diagnostic or treatment recommendation system that would typically have the AI-specific performance metrics requested. The submission is a 510(k) for substantial equivalence, implying that its safety and effectiveness are established by comparison to existing legally marketed predicate devices, supported by compliance with relevant standards and usability testing.

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