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To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

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I apologize, but the provided text from the FDA 510(k) letter for the "Electronic Pulse Stimulator" does not contain information about acceptance criteria for device performance, nor details of a study proving the device meets such criteria.

The document is a standard FDA clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use. It outlines regulatory requirements and contact information, but it does not delve into the specifics of performance testing or clinical studies with the kind of detail you are requesting (e.g., sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance).

Therefore, I cannot provide the requested table or answer the specific questions about the study and acceptance criteria based on the provided text.

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To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities.

The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to temporarily relieve pain in different body areas. The subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the user's skin through the electrode pads for pain relief. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.

The provided document is an FDA 510(k) Pre-Market Notification for an Electronic Pulse Stimulator. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain a study that proves the device meets acceptance criteria in the way typically expected for an AI/ML medical device submission.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed devices based on technical characteristics and adherence to recognized electrical safety and electromagnetic compatibility standards. There is no mention of a clinical study or performance metrics related to diagnostic accuracy, sensitivity, specificity, etc., which are common for AI/ML device evaluations.

Therefore, many of the requested fields cannot be directly answered from the provided text. I will address the points that can be gleamed from the document.

Acceptance Criteria and Device Performance for Electronic Pulse Stimulator (K141260)

Based on the provided FDA 510(k) summary, the "acceptance criteria" are related to demonstrating substantial equivalence in technical specifications (electrical output parameters, pulse characteristics), intended use, and compliance with recognized safety standards. Performance is reported in terms of these technical specifications compared to predicate devices. There is no explicit acceptance criteria for efficacy beyond demonstrating similar technical function to predicate devices and adherence to general safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable. This submission relies on engineering bench testing and comparison to predicate device specifications, not a clinical test set with patient data.
• Data Provenance: Not applicable in the context of clinical studies. The data related to electrical output parameters are from bench tests of the subject device and specifications of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No "ground truth" in the clinical sense was established by experts for a test set. The validation focused on whether the device's technical specifications met engineering requirements and were comparable to predicate devices.

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

• Not applicable. No clinical test set requiring adjudication was used.

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. This device is an Electronic Pulse Stimulator, not an AI/ML diagnostic or assistive device that would involve human readers or image interpretation.

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

• Not applicable. This is not an AI/ML algorithm. The device's performance is standalone in the sense of its physical output, but there's no "algorithm-only" performance study in the context of AI/ML.

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

• Not applicable. For this type of device, "ground truth" relates to the accurate measurement of electrical output parameters and compliance with recognized safety standards (e.g., IEC 60601 series). The "truth" is whether the device produces the specified electrical pulses safely and reproducibly.

8. The sample size for the training set:

• Not applicable. There is no AI/ML component, thus no training set.

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

• Not applicable. There is no AI/ML component, thus no training set or associated ground truth.

Summary of the Study (Device Evaluation):

The "study" presented is a non-clinical evaluation demonstrating substantial equivalence of the Electronic Pulse Stimulator (K141260) to previously cleared predicate devices (K131921 and K131290).

• Methodology: The evaluation involved comparing the subject device's technical characteristics (e.g., maximum output voltage and current, pulse width, frequency, phase charge, current density, power density) with those of the predicate devices. Deviations in these parameters were assessed for their impact on safety and effectiveness.
• Key Findings: The submission states that "The differences, such the output voltage and current, between the subject device and the predicate devices are insignificant in terms of safety or effectiveness."
• Supporting Tests: The device underwent several non-clinical tests to ensure safety and performance, including:
  • IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
  • IEC 60601-1-2: Electromagnetic Compatibility requirements and tests.
  • IEC 60601-2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
  • Verification of software in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
  • Biocompatibility assessment of the electrode pads.
• Conclusion: Based on these non-clinical tests and the comparison of technical specifications, the submitter concluded that the subject device is substantially equivalent to the predicate devices and is as safe and effective for its intended over-the-counter use for temporary pain relief.

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To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg, due to strain from exercise or normal household and work activities.

The Electronic Pulse Stimulator is a Transcutaneous Electrical Nerve Stimulator (TENS), intended for the over-the-counter use to relieve pain in different body areas (waist, back, neck, shoulders, legs, and arms). The proposed Electronic Pulse Stimulator, which is compact, portable, and microprocessorcontrolled, delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief. According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.

This is a 510(k) premarket notification for a medical device called "Electronic Pulse Stimulator," which is a Transcutaneous Electrical Nerve Stimulator (TENS). The submission argues for substantial equivalence to a predicate device (Prospera OTC TENS Electronic Pulse Massager, K122744).

Here's the analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (TENS), the "acceptance criteria" are primarily related to meeting established electrical and safety standards, and demonstrating substantial equivalence to a legally marketed predicate device. There aren't "performance metrics" in the typical sense (e.g., accuracy, sensitivity, specificity) as one would find for diagnostic AI. Instead, the performance is assessed by meeting established technical specifications that are equivalent to the predicate.

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

This submission does not involve a "test set" or "data provenance" in the context of AI/ML performance evaluation. The device is a TENS unit, and its evaluation for substantial equivalence is based on:

• Comparison of technical characteristics with a predicate device.
• Non-clinical testing against recognized electrical safety and electromagnetic compatibility (EMC) standards.
• Software verification.
• Accessory safety.

There are no patient data sets (retrospective or prospective) used to "test" the device's diagnostic or predictive capabilities, as this is a therapeutic device, not a diagnostic AI.

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

Not applicable. As explained above, there is no "test set" for which ground truth is established by experts in the context of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" and thus no adjudication method for it.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. TENS devices are not typically evaluated using MRMC studies, as they are not diagnostic tools where human reader performance is a primary metric. The effectiveness of TENS devices is evaluated through clinical trials for specific indications (though for this 510(k), compliance with previous predicate device's intended use and safety standards is sufficient).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the "Electronic Pulse Stimulator" because it is not an AI/ML algorithm or a diagnostic device. It is a physical medical device (TENS unit) that delivers electrical pulses. Its performance is inherent to its physical and electrical specifications, not an algorithm's standalone performance.

7. The Type of Ground Truth Used

Not applicable. There is no "ground truth" as would be defined for AI/ML assessment (e.g., pathology, expert consensus, outcomes data) in this 510(k) submission. The "truth" here is compliance with established electrical and safety standards and equivalence to a predicate device's design and specifications.

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI/ML component; therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth establishment for one.

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