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POCKET TENS (EP-300) which is home used device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

This device powered by CR2032 Lithium 3V battery is a self-adhesive TENS with 15 adjustable intensity levels falling into the electro-stimulation device category. It includes pocket storage rack for electrodes and TENS device. It designed for shoulder, back, upper extremities (arm) and lower extremities (leg) pain relief. Users only need to place the electrode gel pads on the sides of pain point and then power on the device, and adjust the pulse intensity to a proper level to start a 20 minute treatment session. For optimum result, rest 30 minutes between sessions.

TENS refers to the electrical stimulation of nerves through the skin which is a non-pharmacological method of pain relief. Any symptoms that could be relieved using TENS must be checked by patient's general practitioner who will also give patient instruction on how to carry out a TENS self-treatment regime.

This device is only compatible with the 75 mm x 48 mm gel pads which are the OTC medical device cleared by FDA under K083302 or K180865, and come with the device.

The provided text describes the acceptance criteria and the study conducted for the POCKET TENS (EP-300) device.

Here's the information extracted from the document:

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

The document states that the POCKET TENS (EP-300) device underwent a series of safety and performance tests. It doesn't explicitly list specific quantitative acceptance criteria values next to the device performance for most parameters, but generally states that "All the test results demonstrate the subject device, POCKET TENS (EP-300), meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate devices."

However, a comparison table (Section 12) between the subject device and two predicate devices provides various specifications. This comparison indirectly implies the acceptance criteria are met if the subject device's specifications are comparable or within acceptable ranges of the predicate devices and comply with relevant standards.

Here's a summary of the stated performance and comparison points, implying acceptance criteria are met by equivalence or compliance:

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 does not explicitly mention a "test set" in the context of clinical data. It states, "No clinical test data was used to support the decision of substantial equivalence."

Instead, the evaluation appears to be based on non-clinical testing, compliance with recognized standards, and comparison with predicate devices. For these non-clinical tests (e.g., biocompatibility, software validation, EMC, electrical safety, performance verification, usability), the sample sizes are not specified, nor is the country of origin or whether they were retrospective or 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 no clinical test data was used and therefore no need for experts to establish ground truth for a clinical test set. The substantial equivalence relies on technical comparison and compliance with standards.

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

Not applicable, as no clinical test data was used and therefore no adjudication was necessary.

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 Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or interpretative tool that would involve human readers.

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

Not applicable. The device is a physical TENS unit, not an algorithm.

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

Not applicable, as no clinical test data was used. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles outlined in the referenced national and international standards (e.g., ISO, IEC, ANSI/AAMI standards, FDA guidance documents).

8. The sample size for the training set

Not applicable, as the device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as the device is not an AI/ML algorithm.

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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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This home used device is designed to be used for adult and 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. In addition, it also provides a heat function intended to temporarily relieve minor aches and pains.

The FT-810R with a remote controller is a self-adhesive TENS device with 15 adjustable intensity level for pain relief. Moreover, it also provides a heat function which can be used in conjunction with the TENS function. TENS, Transcutaneous Electrical Nerve Stimulation, refers to the electrical stimulation of nerves through the skin which is an effective non-pharmacological 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.

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 device 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.

The provided text is a 510(k) summary for the Hivox Biotek Inc. Heating TENS (FT-810R) device. It details the device's characteristics, its comparison to predicate devices, and the non-clinical tests performed to demonstrate substantial equivalence. However, it explicitly states that "No clinical test data was used to support the decision of substantial equivalence."

Therefore, I cannot provide information on acceptance criteria based on human performance, nor can I describe a study that proves the device meets such criteria, because no clinical efficacy or human performance studies were conducted or presented for this 510(k) clearance. The clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices through engineering and safety testing.

The document focuses on non-clinical testing to ensure the device meets predefined acceptance criteria for safety and performance, primarily in comparison to its predicate devices.

Here's an analysis of the provided information, addressing your points where possible, and explicitly stating where information is not available:

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

The document mentions that "All the test results demonstrate the subject device, Heating TENS (FT-810R), meets the requirements of its pre-defined acceptance criteria and intended use, and its substantially equivalent to the predicate device." However, it does not explicitly list the specific quantitative acceptance criteria or the reported performance for each criterion in a consolidated table. Instead, it lists the types of non-clinical tests performed and implies that the device passed them by stating it "meets the requirements."

The "Table 1 – Comparison to Predicate Devices and Reference Device" does show comparisons of various technical specifications (e.g., maximum temperatureetting, output voltage, current, pulse width, frequency, maximum phase charge, maximum current density, maximum power density, etc.). While these are comparative performance metrics, they are not presented as explicit "acceptance criteria" with a target value + achieved value in the way you might see for clinical performance. The acceptance here is that it falls within a similar, safe, and effective range as the predicate devices.

For example, we can infer acceptance based on the comparison table:

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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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These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs and buttocks areas. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

EMS, Electrical Muscle Stimulator, which improves, tones, firms & strengthens muscle and relaxes stiff muscle through the skin. It is recognized as a clinically proven, effective, non-medication method of training muscle from certain causes. It manages muscle strengthen, toning and firming. It is also free from side effects when used properly, and can also be used as a simple means of self-training.

HIVOX Spopad EMS SP series, SP-911 and SP-921 are the proposed devices for the 510(k) submission. These Electrical Muscle Stimulation units are indicated for the improvement of muscle tone and firmness, for strengthening muscles in arms, abdomen, thighs, and buttocks areas. Not intended for use in therapy or for the treatment of any medical conditions or diseases.

SP-911 and SP-921 are 1-channel battery-operated-user-friendly muscle stimulation system specifically designed to exercise the muscles. Each device comprises namely an electronic stimulator module which generates the required stimulation signals. SP-911 comprises 2 electrodes, which connects the signals from the stimulator to the skin. SP-921 comprises 4 electrodes, which connect the signals from the stimulator to the skin. Power is supplied from one battery, CR2032, located in a compartment protected by a removable battery cover. The user cannot access the wiring or connectors.

The provided text is a 510(k) Summary for the HIVOX Spopad EMS SP-911 and SP-921. It details the safety and performance testing conducted to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study for a new, complex algorithm or AI.

The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." (Section 5.9). This means there was no clinical study conducted where the device's performance was measured against established acceptance criteria using human data, adjudicated ground truth, or expert readers.

Instead, the submission relies on non-clinical testing to demonstrate performance and safety, specifically for a "Powered Muscle Stimulator." The acceptance criteria referenced are for electrical and physical performance characteristics of the device itself, rather than diagnostic accuracy or clinical effectiveness in the context of AI.

Therefore, many of the requested details regarding sample size, data provenance, expert qualifications, ground truth, MRMC studies, or standalone algorithm performance are not applicable to this type of device clearance and the information provided.

I can, however, extract the acceptance criteria for the non-clinical tests that were performed, as implied by the statement "All the test result demonstrate HIVOX Spopad EMS SP-911 and SP-921 meet the requirement of its pre-defined acceptance criteria and intended use". The document also implicitly defines acceptance criteria by noting when differences do not adversely impact safety and effectiveness, and by comparing the subject device's performance against the predicate and relevant standards.

Here's a breakdown of the relevant information provided:

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

The document doesn't present a clean "acceptance criteria" table with "reported performance" directly. Instead, it compares the subject device's performance characteristics to those of its predicate device, and implicitly (though not explicitly numerically) against relevant international standards. The determination of "Identical" implies meeting the same performance characteristics as the cleared predicate, which serves as the de facto acceptance benchmark for substantial equivalence in many parameters. For parameters that are "Different but does not adversely impact safety and effectiveness," the standard or a justified value serves as the acceptance criteria.

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

• Sample Size: Not applicable. The testing was non-clinical (shelf-life, performance verification, usability validation) and involves device samples, not patient data or clinical subjects. The document does not specify the number of devices tested for these non-clinical assessments.
• Data Provenance: The testing was conducted by HIVOX Biotek Inc., based in New Taipei City, Taiwan, R.O.C. (as per "Submitter Address" in Section 5.3). The data is from the manufacturer's internal testing as part of their 510(k) submission. It is not retrospective or prospective clinical data.

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

• Not applicable. As this was a non-clinical submission, there was no "ground truth" derived from expert consensus on medical images or clinical outcomes. The "ground truth" for the device's electrical and physical parameters would be defined by engineering specifications and international standards, measured using appropriate test equipment and procedures.

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

• Not applicable for the reasons stated above.

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 powered muscle stimulator, not an AI-enabled diagnostic or assistive tool. No MRMC study was performed.

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

• Not applicable. This is a hardware device, not a standalone algorithm.

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

• For the non-clinical tests, the "ground truth" implicitly refers to engineering specifications, regulatory requirements (e.g., 21 CFR 898), and international standards (e.g., IEC 60601 series). Performance verification would involve measuring parameters against these defined acceptable ranges. Usability validation typically involves testing by representative users against predefined usability criteria.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning or AI that requires a "training set."

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

• Not applicable for the reasons stated above.

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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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The EM25 - glute toning device is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the purpose of improvement of muscle tone of the buttocks muscles.

The proposed device, EM25 - glute toning device is a self-adhesive EMS device for muscle training. The device can be applied with accuracy thanks to the use of EMS technology. Made from medical-quality silicone rubber, the elegantly designed EMS pad is extremely slim and flexible and adapts perfectly to the area to be treated. The high-tech circuit provides energy-efficient treatments of 20 minutes each.

Electrical muscle stimulation (EMS) is a widespread and generally recognized method and has been used in sports medicine and rehabilitation for years. In sports and fitness, EMS is used to complement conventional muscle training, to increase the performance of muscle groups and to adjust physical proportions to achieve the desired aesthetic results.

EMS devices work by passing electrical currents over the skin. The gel pad is used as a transfer medium and is subject to natural wear and tear. The gel pad must be replaced if it stops providing sufficient contact, as this will prevent the EMS pad from sticking to the skin. If it is not replaced, the partially increased current density could irritate the skin.

The proposed device, EM25 - glute toning device is assembled with the PCBA and electrode, and the LR03 (AAA) battery supplies the safe low-frequency current. The electrode stuck on the human skin purposes to train the deep muscle. There are 0-15 intensity levels for EM25 - glute toning device. The maximum voltage is divided by 15 (levels) and accumulated for each voltage. But the each increased amperage cannot be over 2%. The intensity level will be minimum when turning on. The user can adjust it from 0 to 15 and gradually increase the intensity level. The whole treatment time is 20 minutes, and then the device switches off automatically.

The EM25 - glute toning device is a powered muscle stimulator intended to improve muscle tone of the buttocks muscles in healthy persons through transcutaneous electrical muscle stimulation (EMS).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in terms of clinical performance metrics (e.g., a specific percentage improvement in muscle tone measured by a defined metric). Instead, the acceptance criteria are implicitly defined by compliance with a series of recognized safety and performance standards. The "reported device performance" is essentially that the device met these standards, and is deemed substantially equivalent to a predicate device.

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

No test set related to clinical performance or human efficacy is mentioned. The primary "test set" for this submission refers to the physical device itself and its components undergoing engineering and biocompatibility testing. The data provenance for these tests is implicitly from the manufacturer's testing (Hivox Biotek, Inc., Taiwan). The document confirms that no clinical test data was used to support the decision of safety and effectiveness (Section 5.9).

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

Not applicable. No clinical test set with human data and expert ground truth was established for this submission. The "ground truth" for the non-clinical tests was adherence to the specified international standards.

4. Adjudication Method for the Test Set

Not applicable. No clinical adjudication method was used, as no clinical studies were performed.

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 muscle stimulator, not an AI-assisted diagnostic or imaging device, and does not involve "human readers" or AI assistance in that context.

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

Not applicable. See point 5. This device is a physical therapeutic device, not an algorithm, and does not have a "standalone" algorithmic performance in the typical sense of AI/software as a medical device.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on adherence to recognized international technical standards for safety, biocompatibility, software lifecycle, and electrical safety (e.g., ISO 10993 series, IEC 62304, IEC 60601 series, ISO 14971). The claim of "effectiveness" is supported by substantial equivalence to an existing predicate device, rather than direct clinical evidence for efficacy.

8. The Sample Size for the Training Set

Not applicable. No training set for an algorithm was used, as this is not an AI/software device that requires machine learning.

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

Not applicable. See point 8.

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