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The FT610-B 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 lower extremities due to strain from exercise or normal household work activities. It is also indicated for temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with over-the-counter pain medication, it also provides a heat function intended to temporarily relieve 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 selftreatment regime.

TENS device works by passing electrical currents over the skin via a set of gel pads. As a transfer medium, the gel pads are subject to natural wear and tear, and must be replaced when they stop providing sufficient contact or the main unit no longer sticks to the skin completely. Failure to replace the gel pad may lead to skin irritation as a result of heightened current density in particular areas.

This device is only compatible with the 50 mm x 56 mm gel pads which are the OTC medical device cleared by FDA under K132588, and come with the device.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device. It does not contain information about acceptance criteria and studies in the context of AI/ML device performance or clinical trials with human readers. Instead, it describes a substantial equivalence determination for a physical medical device (HIVOX OTC Electrical Stimulator, FT610-B) based on non-clinical testing and comparison to predicate devices.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes, data provenance, or number/qualifications of experts for a test set.
• Adjudication methods for a test set.
• MRMC comparative effectiveness studies or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set or how its ground truth was established.

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."

Instead, I can provide information based on the non-clinical testing for the physical device:

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

The document states that "All the test results demonstrate the subject device, HIVOX OTC Electrical Stimulator (FT610-B), meets the requirements of its pre-defined acceptance criteria and intended use". Specific numerical acceptance criteria are not detailed in the provided text, but the device performance was measured against recognized consensus standards and guidance documents.

Regarding the other points, the document explicitly states or implies they are not applicable:

• 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 for this type of non-clinical device testing for substantial equivalence.
• 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 context of expert consensus for AI/ML performance is not relevant here. Non-clinical tests typically involve engineers and technicians evaluating against technical standards.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for 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: Not applicable. The device is a physical Transcutaneous Electrical Nerve Stimulator, not an AI/ML diagnostic or assistive tool.
• 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.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is typically defined by the specifications in the standards themselves (e.g., specific electrical output values, temperature limits, material properties).
• 8. The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.
• 9. How the ground truth for the training set was established: Not applicable.

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HIVOX OTC Electrical Stimulator, EM59-1

TENS: This function is designated 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.

SH: This function is designed to be used for temporary relief of minor aches and pains.

HIVOX OTC Electrical Stimulator, EM59-2

TENS: This function is designated 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.

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

SH: This function is designed to be used for temporary relief of minor aches and pains.

HIVOX OTC Electrical Stimulators, EM59-1 and EM59-2, fall into the electrostimulation device category.

EM59-1 provides two basic functions, TENS and SH; EM59-2 provides three basic functions, TENS, EMS and SH:

(1) Electrical stimulation of nerve tracts (TENS)

(2) Electrical stimulation of muscle tissue (EMS)

(3) Superficial heat (SH)

Both two models feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general wellbeing, pain relief, maintaining physical fitness, relaxation, muscle revitalisation and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.

The size of the self-adhesive electrode gel pad is 45x45 mm supplied by Shaoxing DL Healthcare Co., Ltd. It is an OTC medical device cleared by FDA under K182111. On the other hand, the electrode made by PET, sponge, PCB and protect cases is designed by HIVOX BIOTEK INC.

The provided text describes the 510(k) summary for the HIVOX OTC Electrical Stimulator (EM59-1, EM59-2). This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It does not contain information about acceptance criteria and studies demonstrating device performance for an AI/ML powered device, as the device described is an electrical stimulator, not an AI/ML product.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types) because it is not present in the provided document.

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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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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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