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E-Fit EP-1280 is a machine with electronic muscle stimulation based on EMS technology. Regarding is use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy museles and clients, not for rehabilitation purposes.

The E-Fit EF-1280 intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The E-Fit EF-1280 is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the E-Fit EF-1280 training programs is designed for injured or alling muscles and its use on such muscles is contraindicated.

The E-Fit EF-1280 electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations). These excitations of motoneurones are transmitted to the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and fotal session duration), different types of muscle work can be imposed on the stimulated muscles.

The various types of muscle work that the E-Fit E-Fit E-1280 can impose on the stimulated muscles are able to improve or facilitate muscle performance. The E-Fit EF-1280 may therefore be considered a technique of muscle training.

E-fit EF-1280 is a machine with electronic muscle stimulation based on EMS technology. Regarding its use, the device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.

The provided document is a 510(k) summary for the E-Fit EF-1280, a powered muscle stimulator. In these types of FDA submissions, acceptance criteria and detailed study results as commonly found in clinical trials for new drugs or high-risk devices are typically not presented in this format. Instead, the submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This means showing that the new device is as safe and effective as a device already on the market, rather than proving its absolute safety and effectiveness through extensive clinical trials.

Therefore, the specific information requested in your prompt regarding acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets is not available in the provided text.

Here's a breakdown of what can be extracted and what is missing, based on the nature of a 510(k) submission:

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for specific performance metrics in a table. The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device, meaning the new device performs at least as well and is as safe as the predicate.
• Reported Device Performance: Instead of performance criteria, the document provides a comparative table of technological characteristics between the E-Fit EF-1280 and its predicate device, Compex Sport (K011880). This comparison serves as the "performance" demonstration in a substantial equivalence context.

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 / Not Provided: The document does not describe a clinical performance test set or data provenance in the way a clinical study would. The submission relies on a comparison of technical specifications and adherence to recognized standards to demonstrate safety and effectiveness.

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 / Not Provided: No expert-established ground truth is mentioned, as there isn't a performance study evaluating diagnostic accuracy or similar metrics.

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

• Not Applicable / Not Provided: No adjudication method is mentioned, as there isn't a performance study involving human interpretation that would require such a process.

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 / Not Provided: This device is a muscle stimulator, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC study is not relevant to this submission.

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

• Not Applicable / Not Provided: This device is a physical muscle stimulator, not an algorithm, so a standalone algorithmic performance study is not relevant.

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

• Not Applicable / Not Provided: Ground truth for training or testing is not applicable due to the nature of the device and the substantial equivalence submission process.

8. The sample size for the training set

• Not Applicable / Not Provided: There is no mention of a training set as this is not an AI/machine learning device.

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

• Not Applicable / Not Provided: See point 8.

Summary of the Study per the Document:

The "study" presented is a 510(k) Premarket Notification, which is a regulatory submission, not a research study in the traditional sense. It aims to demonstrate substantial equivalence to an existing legally marketed device (the predicate device: Compex Sport, K011880).

The demonstration of substantial equivalence is based on:

• Comparison of Intended Use: Both devices are intended to stimulate healthy muscles to improve/facilitate muscle performance.
• Comparison of Technological Characteristics: A detailed table comparing various parameters (output voltage/current, pulse characteristics, programs, safety features, operator requirements, etc.) is provided. The submitter argues that differences do not raise new issues of safety or effectiveness.
• Adherence to Recognized Standards: The E-Fit EF-1280 is designed and manufactured in accordance with several international standards (EN ISO 14971:2012, EN ISO 13485:2003 /AC2009, IEC 60601-1:2005 3rd edition, IEC 60601-1-2:2007, IEC 60601-1-11:2010, IEC 60601-2-10:2012). Software verification was done according to FDA guidance.

The conclusion is that based on the comparison of intended use, design, materials, and performance, the new device is substantially equivalent to the predicate in all aspects impacting safety and effectiveness, and the differences do not raise new issues of safety or effectiveness.

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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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The Globus Premium Sport and the Globus Premium Fitness Muscle Stimulators are intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Globus Premium Sport and Globus Premium Fitness Muscle Stimulators are not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the Globus Premium training programs are designed for injured or ailing muscles and their use on such muscles is contraindicated

The Globus Premium Sport and Fitness Devices are programmable muscle stimulators. Each device in the family comes with a menu to navigate between different stimulation programs. The Stimulation Programs have been subdivided in menus and submenus to facilitate use for various types of uses.

The Globus Premium Stimulators electrical impulses trigger action potentials on motor neurons of motor nerves. These excitations are transmitted via the motor end-plate to the muscle fibers, where they generate mechanical responses that result in muscle work. Depending on the electrical impulse parameters (current intensity, frequency, shape of the impulse, duration of contraction, duration of rest, total session duration) different types of muscle work can be performed. This work is able to improve or facilitate muscle performance, and may therefore be considered a muscle training technique.

The Globus Premium family models include the Globus Premium Sport and the Globus Premium Fitness. The configurations differ in the navigation menus that allow the user to select the pre-stored electrostimulation programs offered, but offer technically-identical electrostimulations. The core of the Globus Premium device is a constant-current generator; a transformer guarantees insulation between outlet current utilized for the battery charger, and the circuits utilized for stimulation current. A micro-processor elaborates the menu selections and drives the constant-current generator that originates the electrical impulses for the electrostimulation. This is accomplished according to the parameters stored for that particular program. The user can regulate the current continuously from 0-120 mA.

This document is a 510(k) summary for the Globus Premium Sport and Fitness Muscle Stimulators. It does not contain information about acceptance criteria or a study proving device performance in the way a clinical trial or performance study for an AI/CADe device would. Instead, this submission focuses on demonstrating substantial equivalence to a legally marketed predicate device.

Therefore, many of the requested fields cannot be populated as they are not relevant to this type of regulatory submission for this device.

Here's an attempt to populate the table and answer the questions based on the provided text, indicating where information is not available or not applicable:

1. Table of acceptance criteria and the reported device performance

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 submission is a 510(k) for a muscle stimulator based on substantial equivalence to a predicate device, not a performance study involving a test set of data. There is no mention of a test set or data provenance in the context of device performance testing.

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. No test set or ground truth establishment by experts is mentioned or required for this type of 510(k) submission.

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

• Not applicable. No test set and therefore no adjudication method is mentioned.

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. This is a hardware device (muscle stimulator), not an AI or CADe device. Therefore, no MRMC comparative effectiveness study was performed or is relevant.

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

• No. This is a hardware device, not an algorithm, so standalone performance is not applicable in this context.

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

• Not applicable. No ground truth for performance evaluation of a medical imagery or diagnostic algorithm is mentioned. The "ground truth" in this context is the performance and safety profile of the predicate device, which the new device is compared against.

8. The sample size for the training set

• Not applicable. There is no mention of a training set as this is not an AI/ML device.

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

• Not applicable. No training set is mentioned.

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