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Everyway Analog OTC TENS, model N601L is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

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The provided text is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This document does not contain information on the acceptance criteria, study details, or performance metrics of the device as it would typically be presented in a clinical or validation study report.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates that the device was cleared based on its substantial equivalence to a predicate device, rather than through a dedicated study demonstrating performance against specific clinical acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need access to the full 510(k) submission, device validation reports, or clinical study data if such studies were conducted and included in the submission.

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Everyway Incontinence Stimulation System 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.

Everyway Incontinence Stimulation System ( Stimulator models EM-2400 and EM-5300 with Vaginal Probe models PR-02A, PR-04A and PR-14A )

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "Everyway Incontinence Stimulation System." The document is a 510(k) clearance letter from the FDA, which primarily states that the device has been found substantially equivalent to predicate devices and outlines regulatory requirements. It does not include details about specific performance metrics or clinical study results.

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Everyway Analog OTC TENS, model N103A/N302 is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

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The provided text is a 510(k) clearance letter from the FDA for a medical device called "Everyway Analog OTC TENS, model N103A/N302." This document primarily focuses on the regulatory clearance process and does not contain information regarding the acceptance criteria, specific performance study details, or ground truth establishment for a medical device's AI or standalone performance.

Therefore, I cannot fulfill your request for the detailed information outlined in points 1-9 based on the provided text. The document confirms that the device is a Transcutaneous Electrical Nerve Stimulator For Pain Relief and is cleared for Over-The-Counter Use for temporary relief of pain associated with sore and aching muscles. However, it does not describe the technical performance evaluation or clinical study results that would typically be associated with AI or standalone device performance testing.

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TENS (For model EM-6000, EM-6100 & EM-6300) : intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS B/N/M/S1/S2 adjustable mode & TENS Modes P to P6 for EM-6300).

EMS (For model EM-6000, EM-6200 & EM-6300): intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS C/S/A adjustable mode & EMS Modes P7 to P12 for EM-6300).

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I am sorry, but the provided text does not contain any information about acceptance criteria for a medical device or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a TENS/EMS device, confirming its substantial equivalence to a predicate device. It discusses regulatory compliance and indications for use but does not detail performance acceptance criteria or specific study results to demonstrate those criteria are met.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.

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TENS: intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (For EV-806: Choose TENS Modes B/N/M/SD1/SD2 adjustable mode).

EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (For EV-806 : Choose EMS Modes C/S/A adjustable mode)

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The provided text is a 510(k) premarket notification letter from the FDA regarding a Transcutaneous Electrical Nerve Stimulator (TENS)/Electrical Muscle Stimulator (EMS) device. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria. The letter focuses on the regulatory clearance process and substantial equivalence, not on the technical performance evaluation of the device in the context of specific performance metrics or clinical study results.

Therefore, I cannot provide details for the following points based on the given input:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (algorithm only without human-in-the-loop performance) study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The letter indicates that the device is intended for "temporary relief of pain associated with sore and aching muscles" (TENS) and "to stimulate healthy muscles in order to improve or facilitate muscle performance" (EMS). While these are the intended uses, there are no performance metrics or study details within this document to evaluate how well the device achieves these indications.

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TENS: intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes B/N/M/SD1/SD2 as adjustable mode and P1 to P12 preset programs only for EV-906A).

EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes C/S/A as adjustable mode and P13 to P24 preset programs only for EV-906A).

Li-Battery powered OTC TENS/EMS Combination Stimulator, models EV-906/EV-906A.

I am sorry, but the provided text is a 510(k) clearance letter for a medical device and does not contain the detailed information about acceptance criteria, study design, or performance metrics that you are requesting. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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TENS: intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes B/N/M/SD1/SD2 as adjustable mode and P1 to P12 preset programs only for EV-906A).

EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes C/S/A as adjustable mode and P13 to P24 preset programs only for EV-906A).

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The provided text is a 510(k) clearance letter from the FDA for a medical device (EV-906 & EV-906A OTC TENS/EMS Combination). This type of document is administrative and confirms that the device is substantially equivalent to a legally marketed predicate device.

It does not contain information about:

1. Acceptance criteria and reported device performance related to a study. The letter states that the 510(k) submission was not re-reviewed for the administrative correction, and the original letter from Dec 19, 2019, simply states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent." This determination is based on a comparison to a predicate device, not on clinical performance acceptance criteria or a study proving performance against such criteria.
2. Sample size, data provenance, expert numbers, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth methods. These are details typically found in a clinical study report or a summary of safety and effectiveness, which are not part of a 510(k) clearance letter.

Therefore, I cannot fulfill your request using the provided input. The document confirms the regulatory clearance of a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) device as substantially equivalent to a predicate, but it does not detail the specific performance studies, acceptance criteria, or methodology that your questions pertain to.

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A6 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

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It appears the provided text is a 510(k) clearance letter from the FDA for a device called "A6 OTC Pain Relief TENS." This document grants market clearance based on substantial equivalence to a predicate device and outlines general controls and regulations.

However, the provided text does not contain any information regarding specific acceptance criteria, study methodologies, performance data, or details about clinical trials for the A6 OTC Pain Relief TENS device.

The questions you've asked (about acceptance criteria, sample sizes, expert qualifications, ground truth, MRMC studies, etc.) are typically found in a different type of FDA submission document, such as a De Novo request or a PMA application, or in a separate clinical study report. A 510(k) primarily focuses on demonstrating substantial equivalence, often through comparisons to an existing predicate device rather than extensive de novo clinical performance studies for a well-understood technology like TENS.

Therefore, I cannot provide answers to your specific questions based on the provided text. The document confirms the device's classification and indications for use, but not the detailed performance study information you're requesting.

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V2 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "V2 OTC Pain Relief TENS" device (K182767) does not contain the detailed information necessary to answer your request.

The letter is a standard FDA clearance document. It confirms that the device is substantially equivalent to a predicate device and outlines general regulatory provisions. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, or types of studies conducted (e.g., test set, training set).
• Information on expert establishment of ground truth, adjudication methods, or MRMC studies.
• Specifics on standalone algorithm performance or the type of ground truth used.

For a medical device like a TENS unit, the primary "study" proving it meets acceptance criteria for substantial equivalence typically involves demonstrating that its technological characteristics (e.g., electrical stimulation parameters, waveform, output intensity) are substantially equivalent to a legally marketed predicate device, and that it performs as intended for its indicated use (temporary pain relief). This is usually supported by:

• Bench testing: To confirm electrical output specifications.
• Performance testing: To ensure it functions as described.
• Biocompatibility testing: If applicable, for patient contact materials.
• Electrical safety and EMC testing: To comply with relevant standards.

The letter itself does not detail these specific tests or their results, nor does it refer to studies involving AI, image analysis, or complex algorithms that would require the kind of detailed information about ground truth, expert consensus, MRMC studies, or training/test sets that you are asking for. Your questions are highly relevant for AI/ML-based medical devices, but this document pertains to a traditional electrical stimulation device for pain relief.

Therefore, I cannot populate the table or answer the specific questions about the study design using the provided text.

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TENS: intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that the EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. The EMS may therefore be considered a technique of muscle training.

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The provided text is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) device (Model EM-5200). This type of device is an electrical stimulator, not an AI/ML-driven diagnostic or prognostic tool.

Therefore, the concepts of acceptance criteria, study data, ground truth, experts, and training/test sets as they relate to AI/ML device performance evaluation do not apply to this document.

The FDA clearance for TENS/EMS devices like this one is typically based on:

• Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics (e.g., waveform, intensity, frequency, output modes) and performance data (e.g., electrical safety, electromagnetic compatibility, biocompatibility).
• Performance Testing: Benchtop testing to ensure the device meets its specifications and applicable IEC standards.
• Clinical Data (if necessary): In some cases, if the device has novel technology or a new indication, limited clinical data might be required, but it would focus on safety and effectiveness for pain relief (TENS) or muscle performance (EMS), not diagnostic accuracy or AI algorithm performance.

In summary, the information requested in your prompt (AI/ML-specific acceptance criteria, ground truth, expert review, training/test sets) is not present in this document because the device in question is a conventional electrical stimulator, not an AI/ML medical device.

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