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

WIEMSPRO 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.

WIEMSPRO 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, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances.

WIEMSPRO is a device with electronic muscle stimulation based on EMS technology. Reqarding 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 rehabilitationpurposes.

This document is an FDA 510(k) summary for a powered muscle stimulator called "WIEMSPRO." It's a regulatory submission, not a study report. Therefore, it does not contain the information requested about acceptance criteria, device performance results from a study, sample sizes, expert ground truth establishment, or clinical study details.

The document explicitly states:

• "No clinical studies provided."
• "We did not use any new technology in this system, so those differences between our new system and its predicate do not affect the safety and effectiveness (SE):"
  • "0. General information of both devices is the same"
  • "1. Intended use and indications/principle of operations of both devices are the same."
  • "2. There are no differences in the technological characteristic/performance data of the proposed device and those of the predicate device. Thus, the SE is not affected."
• The comparison table (pages 4-5) lists technical specifications and notes "Same" for almost all characteristics between the original WIEMSPRO (K181955) and the "Modified Device" WIEMSPRO (K211298), except for the software version which is "Similar."

This 510(k) submission relies on demonstrating substantial equivalence to a previously cleared predicate device (K181955) by showing that the new device has the same intended use, indications for use, and similar technological characteristics, and that any minor differences do not raise new questions of safety or effectiveness. It does not present new performance data from a specific study designed to meet acceptance criteria through statistical testing.

Therefore, it's not possible to fill out the requested table or answer the questions based on the provided text, as this type of information is typically found in a clinical study report or a different section of a more comprehensive 510(k) submission if new performance data were required.

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WIEMSPRO is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The WIEMSPRO is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of WIEMSPRO training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

WIEMSPRO is a machine with electronic muscle stimulation based on EMS technology. Regarding 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.

WIEMSPRO 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, duration, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The device described in this submission is an electro-medical device intended for stimulating healthy muscles in order to improve or facilitate muscle performance. It is designed for personal training performances.

WIEMSero is a device 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 device must be used over user's cotton undergarments and is therefore not patient-contacting

WIEMSPRO system cannot be used while the user is in motion or lifting weights.

The provided document is an FDA 510(k) premarket notification for the WIEMSPRO device, a powered muscle stimulator. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a specific performance metric against acceptance criteria through a clinical study for an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for clinical validation of AI/ML devices, is not present in this document.

The document discusses bench testing to determine conformance to performance specifications and requirements, particularly for electrical safety, electromagnetic compatibility, and FCC radio frequency testing. It states that "No clinical studies are submitted."

Given the document's content, here's an attempt to answer the questions based on what is provided and to highlight what information is missing:

Acceptance Criteria and Device Performance (Based on Technical Specifications and Bench Testing)

Since this is a 510(k) for a powered muscle stimulator, the "acceptance criteria" discussed are primarily related to meeting established electrical and safety standards for this class of device, and demonstrating equivalence to predicate devices based on technical characteristics. There isn't an explicit table of "AI performance metrics" and their acceptance thresholds as would be common for AI/ML device submissions.

The device performance is reported implicitly by stating compliance with various IEC and FCC standards, and noting the technical specifications in comparison to predicate devices.

Table of "Acceptance Criteria" (Implied by Compliance and Equivalence) and Reported Performance:

• "Electrical safety (including particular requirements for the basic safety and essential performance of nerve and muscle stimulator and for medical electrical equipment)" was performed and showed correct operation.
• Complies with IEC 60601-1-2:2007, IEC 60601-2-10:2012, IEC 60601-1-6 Edition 3.1 2013-10, ANSI/AAMI ES60601-1:2005 / A2:2010. |
  | Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (requirements for electromagnetic compatibility of medical electrical equipment) and FCC Part 15 (unintentional radiators). | - "Electromagnetic compatibility" testing was performed and showed correct operation.
• Complies with IEC 60601-1-2:2007 and FCC 47 CFR Part 15 §15.107 and §15.109. |
  | Software Life Cycle Processes | Compliance with IEC 62304 (medical device software – software life cycle processes). | - Complies with IEC 62304:2006. |
  | Risk Management | Compliance with ISO 14971 (application of risk management to medical devices). | - Complies with ISO 14971:2007. |
  | Technical Equivalence to Predicates| WIEMSPRO's technological characteristics (e.g., classification, product code, regulation number, panel, class, intended use, power source, output modes, current/voltage, waveform, safety features) should be substantially equivalent to the predicate devices (E-Fit EF-1280 and Compex WirelessUSA) or any differences should not affect safety and effectiveness. | - Comparison table provided, indicating "Same" or "Similar" for most characteristics.
• Notable differences (e.g., higher max output current, but lower current density compared to one predicate; absence of TENS function present in one predicate) are argued not to affect safety and effectiveness. "Maximum output current value is higher... however maximum output current density... is much lower than that of Compex Wireless USA... none of the differences spotted impact the equivalence..." |

Study Details (Information Not Applicable or Not Provided for this Device Type/Submission)

The following points are primarily relevant for AI/ML device submissions involving clinical performance evaluation, which is not the nature of this 510(k) submission.

1. Sample sizes used for the test set and the data provenance:
   • Not Applicable / Not Provided. This document describes "bench testing" for electrical safety and EMC, and a comparison to predicate devices, not a clinical study with a test set of patient data for AI performance.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   • Not Applicable. No clinical test set requiring expert-established ground truth is detailed.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   • Not Applicable. No clinical test set requiring adjudication is detailed.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   • Not Applicable / No. This device is a muscle stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed or described.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • Not Applicable. This is a physical medical device, not an AI algorithm. Its performance is evaluated through engineering and safety standards, not standalone algorithmic performance.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
   • Not Applicable. For the bench testing, the "ground truth" would be established engineering standards and test procedures for electrical and electromagnetic performance.
7. The sample size for the training set:
   • Not Applicable. This is not an AI/ML device that undergoes training on a data set.
8. How the ground truth for the training set was established:
   • Not Applicable. No training set exists for this device.

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