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Intrelief PFE is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

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I apologize, but this document does not contain the information you requested regarding acceptance criteria and the comprehensive study details.

The document is an FDA 510(k) clearance letter for a "Pelvic Floor Stimulator (Intrelief PFE)." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Results of a standalone (algorithm-only) performance study.
• The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• How ground truth for any training set was established.

This letter focuses on the regulatory clearance process rather than providing a detailed technical or clinical study report.

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Intrelief provides transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS) device for the respective indications listed below.

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 to stimulate healthy muscles in order to improve and facilitate muscle performance.

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The provided text is an FDA 510(k) clearance letter for the Intrelief device, indicating its substantial equivalence to predicate devices for use as a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) for pain relief and muscle performance, respectively.

This document does not contain any information regarding:

• Acceptance criteria for device performance.
• Study details (sample size, data provenance, expert qualifications, ground truth establishment, adjudication methods, MRMC studies, standalone performance) that would prove the device meets specific performance criteria.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text. The FDA 510(k) clearance process primarily evaluates substantial equivalence to existing legally marketed devices, not necessarily a new clinical performance study against specific acceptance criteria for a novel technology.

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EasyStim TN28 OTC is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.

EasyStim TN28 OTC is a portable, battery powered T.E.N.S. device for pain relief intended for over-the-counter use.
There are totally eight (8) modes that are intended for application to the following areas: Shoulder/ Arm, Lower Back and Leg/Foot.
The accessories include electrode cable and electrodes pads which are placed on the specific body part. Generally, the electrodes are connected to the device through electrode cable. The device produces either a fixed or modulated electrical signal through electrodes normally placed on a patient's skin over the area of pain.
Since the device is battery powered, there is no connection to AC mains supply.

The provided document is a 510(k) Summary for the EasyStim TN28 OTC device, a Transcutaneous Electrical Nerve Stimulator (T.E.N.S.). It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of diagnostic or treatment performance.

Here's an analysis based on the information provided, addressing the questions as best as possible within the scope of the document:

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

The document does not explicitly state acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or treatment effectiveness, as would be common for AI/ML-based medical devices or novel therapies. Instead, the substantial equivalence hinges on meeting electrical safety, electromagnetic compatibility, usability, risk management standards, and having similar technical characteristics and indications for use as predicate devices.

The "device performance" reported is primarily a comparison of its technical specifications to those of legally marketed predicate devices.

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 mentions a "usability study" but does not provide any details on the sample size for the test set, data provenance (country, retrospective/prospective), or methodology beyond stating that it "showed that users were able to use the device correctly and safety."

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)

This information is not provided in the document. For a T.E.N.S. device, "ground truth" might relate to observed pain relief or proper device operation, but the document does not elaborate on how these were established or by whom. The "experts" for the usability study are not specified.

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

This information is not provided. The usability study details are minimal.

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 performed or is mentioned. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI-assisted diagnostic or interpretation system that would typically involve human "readers." The focus is on the device's electrical characteristics and safety, not on improving human interpretation.

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

This question is not applicable in the context of this device. The EasyStim TN28 OTC is a physical medical device (T.E.N.S. unit) that operates to deliver electrical stimulation, not a standalone algorithm. Its performance is inherent in its electrical output and user interface, with human interaction being fundamental to its application.

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

The document does not specify a type of "ground truth" in the context of clinical effectiveness or diagnostic accuracy. The usability study would likely rely on direct observation of user interaction and safety, which is a form of observational data. The "performance tests" relate to compliance with electrical and safety standards, not clinical outcomes.

8. The sample size for the training set

This information is not applicable / not provided. This device is not an AI/ML system that undergoes a "training set" for model development.

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

This information is not applicable / not provided for the same reason as point 8.

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