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TENS: To be used for the temporary relief of pain associated with sore or 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: Intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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This document is a 510(k) clearance letter for a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) device, a regulatory document. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given context.

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The Wrap Accessory Electrodes are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The wrap accessory electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as back, neck, shoulder, elbow, wrist, knee and foot.

The wrap accessory electrodes, made up of conductive silicone rubber, can be used for the stimulation on the body areas such as back, neck, shoulder, elbow, wrist, knee and foot.

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Wrap Accessory Electrodes." It primarily addresses the regulatory approval process and includes a description of the device's intended use.

However, the document does NOT contain any information about acceptance criteria, device performance data (e.g., accuracy, sensitivity, specificity), sample sizes for testing or training, expert qualifications for ground truth establishment, adjudication methods, or MRMC studies.

Therefore, I cannot answer your request using the provided text. The information required to describe the acceptance criteria and the study that proves the device meets them is not present in this document.

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The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue. It is also indicated for the temporary relief of minor muscle and pain associated with overexertion, strains, sprains and arthritis.

Pulsed electromagnetic field wrap

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a "Pulsed Electromagnetic Field Wrap" and primarily discusses regulatory aspects, indications for use, and general controls provisions. It does not include details on performance studies, test sets, expert qualifications, or comparative effectiveness.

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Wrap accessory electrodes, available in a glove style, are cutaneous electrodes intended to be used with legally marketed TENS or EMS stimulating devices. The Wrap accessory electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include the hands (gloves) and feet (socks).It is intended for adult patients.

Wrap accessory electrodes, available in a glove style, are cutaneous electrodes intended to be used with legally marketed TENS or EMS stimulating devices. The Wrap accessory electrodes are non-sterile reusable OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact.

The provided text is a 510(k) premarket notification letter from the FDA regarding "Wrap accessory electrodes." This document is a regulatory clearance for a medical device and does not contain information about the acceptance criteria or a study proving the device meets those criteria, nor does it describe an AI/ML-based medical device performance study.

The document states that the device is "substantially equivalent" to legally marketed predicate devices. This determination of substantial equivalence for a Class II medical device like electrodes is primarily based on performance testing and comparison to existing devices, not on the type of clinical performance study (like an MRMC study or standalone AI performance study) typically performed for AI/ML-based diagnostic devices.

Therefore, I cannot fulfill your request using the provided text. The questions you've asked are relevant for AI/ML medical devices where performance metrics like sensitivity, specificity, or AUC are established, and clinical studies are conducted to demonstrate their effectiveness, often involving human readers and ground truth data.

To answer your questions, I would need a document that describes the clinical performance assessment of an AI/ML device, including study design, results, and ground truth establishment.

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TENS:
To be used for the temporary relief of pain associated with sore or 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:
It is intended for muscle conditioning, used for stimulating abdomen muscles in order to improve or facilitate muscle performance.

The Hi-Dow Wireless TENS/EMS System is a battery operated wireless pulse generator that uses radiofrequency signals sent from a wireless remote control unit to wireless receivers attached to the electrodes(s), which are attached to the skin at the area to be treated. The wireless remote controls the intensity and mode functions of the receiver. When used in TENS Modes, the electrical impulses generated by the receivers stimulate the nerves that are causing pain resulting in gentle electrical sensations instead of pain. When used in EMS modes, the electrical impulses generated by the receivers produce muscle contractions, these contractions help to condition and improve the muscles.

The Hi-Dow Wireless TENS/EMS System is a double-channel and 4 modes muscle stimulation system that helps to relieve minor muscular aches and pains.

The output of both channels can be adjusted individually for intensity in 20 levels and the treatment time is 45 minutes.

The device is powered by rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied with the device.

The Device consists of an electronic stimulatory module which generates the required stimulation signals, 3 sets of electrode pads and a plug-in charging unit.

The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydro gel, no securing materials are required to secure the device to the patient's skin. The electrodes snap onto the receiver.

The provided text is a 510(k) summary for the Hi-Dow Wireless TENS/EMS System, Model HD-5N. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and studies in the traditional sense of a clinical trial for novel device approval.

Therefore, the acceptance criteria and study information will be presented as they relate to the substantial equivalence determination for this type of device.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically demonstrating compliance with recognized standards and similarity to predicate devices, and "reported device performance" refers to the results of testing done to show this compliance and similarity.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary. The "test set" here refers to the actual device undergoing engineering and performance testing against standards, not a clinical data set. The document does not specify the number of units tested.
• Data Provenance: The tests for biocompatibility, electrical safety, EMC, and software verification/validation are typically conducted in a laboratory setting. The country of origin of the data is not specified, but the manufacturing entity is "Hi-Dow Electron Technology(Hefei) Inc., Ltd." which suggests China. These are prospective tests conducted on the device itself. No patient data provenance is relevant for this type of submission focused on engineering performance.

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. This 510(k) submission is for an electrical stimulation device (TENS/EMS) and relies on objective measurements against engineering standards and comparison to predicate devices, not on expert consensus for "ground truth" derived from clinical data (e.g., image interpretation). Experts involved would be those certifying compliance with the listed standards (e.g., electrical engineers, biocompatibility specialists), but their number and specific qualifications are not detailed in this summary.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical endpoint adjudication by multiple experts, which is not part of this device's substantial equivalence pathway. The "adjudication" here is the assessment of compliance with predefined engineering standards.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices often involving AI, which is not the case for this TENS/EMS device.

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

• Not applicable. This device is an electrical stimulator, not an algorithm, and its use inherently involves human interaction (application of electrodes, control of intensity and mode). "Standalone" performance as typically understood for AI algorithms is not relevant here. The device's "standalone" performance refers to its ability to meet the specified electrical and safety parameters independently.

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

• The "ground truth" for this submission are the recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series, FCC Part 15) for electrical safety, EMC, biocompatibility, and software validation, as well as the technical specifications and performance characteristics of the legally marketed predicate devices. The device's performance is compared against these objective engineering and regulatory benchmarks, not clinical "ground truth" like pathology or outcomes data.

8. The sample size for the training set

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

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

The JQ-5C is a portable; battery powered (3.7VDC) multi function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device.

Double channels that effectively transfers your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 6 modes of operation.

This document is a 510(k) summary for the Hi-Dow JQ-5C, a powered muscle stimulator and TENS device. It focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria and ground truth evaluations typically seen for novel diagnostic or AI-driven devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by substantial equivalence to predicate devices, particularly T1040, 5000Z, and Compex. The performance is reported in terms of electrical stimulation parameters. There are no explicit "acceptance criteria" or "pass/fail" thresholds stated in this document beyond meeting the general characteristics of the predicate devices.

Note: The "acceptance criteria" here are that the JQ-5C's values fall within a range considered "substantially equivalent" to existing cleared devices. The document explicitly states: "The JQ-5C has modes that offer substantially equivalent technical specifications, features and effective results as the predicate listed." The differences are deemed "insignificant in the terms of safety or effectiveness."

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

This document does not describe a clinical test set with a sample size for evaluating device performance in terms of its intended use (pain relief, muscle stimulation). The "test set" in this context refers to the electrical characteristics of the device being compared against predicate devices. No human subject data or specific "test set" in the sense of clinical cases is mentioned for performance evaluation.

The provenance of the data is from non-clinical tests measuring the electrical outputs of the device and comparing them to those of predicate devices. There is no mention of country of origin for such comparative electrical data, nor is it described as retrospective or prospective in a clinical sense.

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

Not applicable. This type of submission (510(k) for a TENS/PMS device) relies on engineering specifications and comparison to predicate devices, not on expert consensus for clinical ground truth or AI model validation.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication in the context of this submission. The comparison is based purely on technical specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No. This document does not mention any MRMC comparative effectiveness study. This type of study is more common for diagnostic imaging AI devices, not for a powered muscle stimulator/TENS device seeking substantial equivalence based on technical specifications.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The Hi-Dow JQ-5C is a physical medical device, not an algorithm, and the submission is focused on its electrical characteristics and safety, not an AI or software algorithm's standalone performance.

7. The Type of Ground Truth Used

The "ground truth" implicitly used is the technical specifications and cleared status of the predicate devices. The Hi-Dow JQ-5C is deemed safe and effective because its electrical stimulation parameters and intended uses fall within the established and cleared parameters of similar devices already on the market.

Additionally, the document cites:

• "No adverse events have been reported since 2007 with over 300,000 units sold without a prescription in Europe and Asia." This serves as real-world evidence of safety.
• "A number of articles in peer-reviewed publications, which demonstrate that electrical stimulation does improve muscle performance as well as temporary pain reduction." This refers to general scientific literature, not specific to the Hi-Dow JQ-5C, to support the effectiveness of the technology (electrical stimulation) for the stated indications.

8. The Sample Size for the Training Set

Not applicable. This 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 this is not an AI/ML algorithm, there is no training set or ground truth establishment for such a set.

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