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The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (leg) due to strain from exercise or normal household and work activities.

The Electronic Pulse Stimulator is powered by internal battery. It is intended for at home use in delivering electric pulses to tired and sore muscles. These pulses are generated by the device & delivered through electrode pads placed on the skin. The device has 7 stimulation modes: Model-Mode 7. These stimulation modes can be selected by pressing the MODE button on the front of the unit. The device generates small pulses of electrical current. It transmits these pulses to the user's skin through adhesive electrode pads, which activates the nerves below and temporarily relieves pain related to soreness. Its accessories include connecting wires, electrode pads, 2 AAA batteries. The device is for over the counter use. The device does not contain drug or biological products. The device includes Bluetooth functionality, however, in this model of the device, the Bluetooth functionality is not used.

This document is a 510(k) premarket notification for an Electronic Pulse Stimulator (Model MDTS100), seeking clearance for market. The core purpose of this submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical effectiveness through a standalone study with defined acceptance criteria for a novel AI/device performance.

Therefore, the requested information regarding acceptance criteria, performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable in the context of this 510(k) submission.

Explanation:

• Device Type: The device is an Electronic Pulse Stimulator, a transcutaneous electrical nerve stimulator (TENS) for pain relief. TENS devices are well-established medical devices.
• Regulatory Pathway (510(k)): The 510(k) pathway "demonstrates that the device is at least as safe and effective as a legally marketed predicate device that is not subject to premarket approval (PMA)." It primarily relies on demonstrating substantial equivalence in technological characteristics, intended use, and safety/performance without requiring new clinical efficacy trials for established device types unless there are significant differences that raise new questions of safety or effectiveness.
• Stated Testing: The document mentions various engineering and safety tests, such as biocompatibility, electrical safety, EMC, performance bench tests (e.g., output amplitudes, pulse durations), and software verification/validation. These tests ensure the device meets established engineering and safety standards, and its performance parameters are within acceptable ranges for a TENS device.
• Absence of Clinical Testing: The document explicitly states: "The clinical testing was not needed in this submission." This confirms that efficacy was not assessed through a clinical trial with human subjects.
• Focus on Equivalence: The "Comparison list of the technological characteristics" table (pages 5-7) directly compares the proposed device to the predicate device, emphasizing identical or very similar specifications across all key parameters (e.g., waveform, output voltage/current, pulse duration, frequency, number of output modes). The conclusion (page 8) explicitly states, "The proposed device and the predicate device have same performance specification."

Summary of inapplicable information based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not applicable. Performance is established through comparison to a predicate device and engineering benchmarks, not a separate clinical study with predefined acceptance criteria.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No test set involving patient data for clinical performance evaluation is described. System performance (e.g., electrical parameters) is tested on the device itself.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. No "ground truth" for clinical outcomes or diagnoses is established as there is no clinical study.
• 4. Adjudication method: Not applicable. No clinical data requiring adjudication.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study was conducted.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not feature an AI algorithm.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable. No AI model or training set is mentioned for the device's function.
• 9. How the ground truth for the training set was established: Not applicable.

The "study that proves the device meets the acceptance criteria" in this 510(k) context is primarily the bench testing, electrical safety testing, software verification, and the demonstration of substantial equivalence to the predicate device through side-by-side comparison of technical specifications, as detailed in the document. The acceptance criteria for these tests are typically engineering standards and limits rather than clinical performance metrics.

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Mode 1 (PMS): To be used for stimulating healthy muscles in order to improve and facilitate muscle performance.

Mode 2 (TENS): 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

Electronic Pulse Stimulator is a product that adopts modern electronic science and technology to delivers electric pulses generated to the user's skin through the electrodes. It has two modes of different pulse frequencies, mode 1 uses Electrical Muscle Stimulation (EMS) technology for muscle training and mode 2 uses Transcutaneous Electrical Nerve Stimulation (TENS) technology to temporary relieve pain. The device includes operating elements of Power ON/OFF button, intensity increase"+" button, and intensity decrease"-" button and Mode selection button, and could be attached and detached to the electrode pad through the snap-on connector.

In additional, according to different simulation-needed bodies, users can choose the four types of electrode pad based on their own situation. Electronic Pulse Stimulator is suitable for the simulation-needed bodies including hips, arms and legs, abdomen, and feet.

The provided document is a 510(k) Premarket Notification summary for an Electronic Pulse Stimulator (Model S3). It does not contain information about acceptance criteria for a study proving the device meets the acceptance criteria.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data related to existing safety and electrical standards. The "performance data" section primarily discusses compliance with various IEC standards (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-2) and biocompatibility testing (ISO 10993-1). There is no mention of a clinical study with specific acceptance criteria that would involve human subjects, expert readers, or a ground truth process as typically defined for performance evaluation of diagnostic or AI-driven medical devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text does not contain this type of information. It is a regulatory submission for a simple TENS/EMS device for pain relief and muscle stimulation, not a complex diagnostic system that would involve the kind of performance study you are asking about (e.g., MRMC studies, expert ground truth adjudication).

To directly answer your numbered points based on the absence of such information in this document:

1. A table of acceptance criteria and the reported device performance: Not provided. The document outlines technological characteristics and compliance with electrical safety and biocompatibility standards, not performance metrics from a study with defined acceptance criteria.
2. Sample sizes used for the test set and the data provenance: Not applicable. No "test set" in the context of a performance study is described. The "testing" refers to bench testing against industry standards.
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 establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication is described.
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 is not an AI-driven or diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm with standalone performance in the sense of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for a performance study is not established or discussed.
8. The sample size for the training set: Not applicable. This device is not described as involving a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment for it is described.

The document states that "The electronic pulse stimulator is substantially equivalent to the predicate devices based on intended use, design, specifications and performance." The "performance" here refers to meeting established electrical safety and biocompatibility standards, not a clinical performance validation against a pre-defined ground truth in a study with human subjects.

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TENS (Modes 1, 2, 4, 5, 6, 8)

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.

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS (also called EMS, Modes 1, 3, 7)

To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Heating Mode Temporary relief of minor aches and pains.

Electronic Pulse Stimulator delivers electric pulses generated to the user's body areas such as the back neck and foot through the electrodes. The portable and compact device has multiple modes of different pulse frequencies, covering TENS and PMS that is also called Electrical Muscle Stimulation (EMS). It includes operating elements of ON/OFF button, intensity increase button, intensity decrease button, mode selection button, and/or timer selection button, and could be attached to electrodes. In addition, the device may also provide heat/temperature. While used in the heating mode, the device is coupled with electronically controlled electrodes to provide automatic thermal heat to the skin with the maximum temperature of 43 °C.

The device could be easily operated through its buttons to manually realize its functions, such as turning on/off, increasing/decreasing intensity, changing mode/timer, and providing heat/temperature if needed. The optional wireless control via a remote or Bluetooth APP could provide a secondary operation way to the user, who could be able to wirelessly realize the functions mentioned above.

The electrodes cleared include the electrode pads and electrode garments, which could be packaged separately and/or together with the subject device.

This document is a 510(k) summary for an Electronic Pulse Stimulator (device K162517). It describes the device, its intended use, and demonstrates substantial equivalence to predicate devices (K153520 and K070299). Since this is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulation (PMS) device, the acceptance criteria and study information will focus on its electrical and heating parameters rather than clinical performance metrics typically associated with AI/ML devices (like sensitivity, specificity, AUC).

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a predetermined numerical threshold for a clinical outcome (e.g., "sensitivity must be >90%"). Instead, it demonstrates "substantial equivalence" based on various technical specifications and intended use. The "reported device performance" is essentially a comparison of these technical specifications between the subject device and the predicate devices.

The table below summarizes the comparison from Table 1 in the document for the subject device (PL-029K13, as it includes the heating mode) and its primary predicate (PL-029K6, K153520) for electrical stimulation, and the heating predicate (ezFit Digital Heating TENS, K070299) for the heating function. The ranges and specific values are presented as performance data.

For non-clinical tests, the "acceptance criteria" were compliance with specific voluntary standards:

• IEC 60601-1 (medical electrical equipment safety and essential performance)
• IEC 60601-1-2 (electromagnetic compatibility)
• IEC 60601-2-10 (particular requirements for nerve and muscle stimulators)
• FDA Guidance for Premarket Submissions for Software Contained in Medical Devices.

The reported device performance for these non-clinical tests is that the device "conformed" and "met the requirement of safety" for the standards and guidance, respectively.

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

The document explicitly states: "The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical tests were performed on the subject device..."

Therefore, there is no clinical test set, human subject data, or data provenance (country of origin, retrospective/prospective) described in this 510(k) summary for the purpose of demonstrating substantial equivalence. The evaluation relies on technical comparisons to predicate devices and adherence to engineering and safety standards.

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

As no clinical test set was used, there was no ground truth established by experts in a clinical context for this submission. The "ground truth" for the non-clinical tests would be the specifications and requirements of the regulatory standards themselves, which are established by expert committees in their respective fields (e.g., electrical engineering, medical device safety).

4. Adjudication Method for the Test Set

Since no clinical test set with human subject outcomes was used for demonstrating substantial equivalence, no adjudication method (like 2+1 or 3+1 consensus) was applied.

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. This type of study is typically performed to evaluate the impact of an AI/ML device on human reader performance, which is not applicable to an Electronic Pulse Stimulator submission focused on electrical and heating parameters and substantial equivalence to existing devices.

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

No, a standalone performance study in the context of an AI/ML algorithm was not done. The "performance" in this submission refers to the technical specifications of the device (e.g., output voltage, current, temperature) and its compliance with safety standards.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

For the technical specifications, the "ground truth" is established by engineering measurements against reference standards (e.g., voltmeters, ammeters, thermometers calibrated to international standards) to verify the device's output. For compliance with voluntary standards (IEC 60601-1, -1-2, -2-10), the "ground truth" is the requirements outlined in those international standards. For software, it's compliance with FDA guidance for software in medical devices.

8. The Sample Size for the Training Set

Since this is not an AI/ML device, there is no training set sample size described. The device's operation is based on fixed electrical circuits and heating elements, not learned models.

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

As there is no training set, this question is not applicable.

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The Electronic Pulse Stimulator MDTS100 is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household and work activities.

The MDTS100 Electronic Pulse Stimulator is an electrically powered device intended for over the counter use and used to apply an electrical current to electrodes on a user's skin to relieve pain. The proposed device is intended for at home use in delivering electric pulses to tired and sore muscles. The proposed device consists of controlling host device, output connecting cable and skin electrodes. The proposed device has many safety measures such as output load detection, timing indication and so on. It is adopted battery as the power supply. The output waveform is adopted "square waveform" as the basic wave. It simulates the various output modes by various frequency combination. The waveform is mainly for single rectangular. The output waveform intensity is continuous adjustable. The working time is controlled automatic. The MDTS100 is adopted the method that inputting the specific low frequency pulse current into the human body through the human skin to treat the pain. The MDTS100 Electronic Pulse Stimulator has seven stimulation modes. These stimulation modes can be selected by pressing the MODE button on the front of the unit. The MDTS100 comes with 2 independent output channels by pressing the CHA button. Channel A&B are selected by default. Pressing the & buttons will decrease & increase the intensity of stimulation. LCD screen display the left remaining stimulation time in the lower left corner. The default time is 20 minutes. The proposed device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization. The device is for over the counter use. The device does not contain drug or biological products. The device is software-driven and software validation is provided in software.

This document is a 510(k) Premarket Notification for the Electronic Pulse Stimulator Model MDTS100, which is a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of this submission is to demonstrate that the device is substantially equivalent to a legally marketed predicate device (Prospera OTC TENSE Electronic Pulse Massager, Model PL029, K122744).

The document details the device's indications for use, its technical characteristics compared to the predicate, and functional and safety testing performed.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense for clinical effectiveness. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device, which inherently means meeting safety and performance characteristics similar to a device already deemed safe and effective by the FDA. The comparison tables (Table 3-1 and Table 3-2) illustrate the technical characteristics of the proposed device against the predicate.

While no quantitative clinical performance metrics (e.g., sensitivity, specificity, accuracy) are reported for this device, a table comparing key technical parameters and their reported values for both the proposed and predicate device is provided.

Table: Comparison of Technical Characteristics and Performance

The document concludes that the differences in output parameters (voltage, current, pulse duration, charge) between the proposed device and the predicate device "do not raise any new questions of safety or effectiveness." This statement effectively serves as the "acceptance criteria" for these differing parameters – that they fall within a range considered safe and effective for TENS devices when evaluated against recognized safety standards.

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 focuses on non-clinical (bench) testing for substantial equivalence, not clinical studies involving human subjects with a "test set" in the context of clinical performance. Therefore, there is no mention of a human "test set" sample size or data provenance in this submission.

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

Not applicable. This is a non-clinical submission. Ground truth, in a clinical context, is not established for this type of submission.

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

Not applicable. This is a non-clinical submission.

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 (TENS), not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or is relevant to this submission.

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

Not applicable. While the device is "software-driven," the performance evaluation is not an "algorithm-only" standalone test in the context of AI or diagnostic algorithms. The device's performance is tested as a complete system (hardware and software) through bench testing against electrical safety and EMC standards.

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

For the non-clinical testing:

• Electrical Safety & EMC: The "ground truth" is defined by the voluntary standards cited: IEC 60601-1:2005, IEC 60601-1-2:2007, IEC 60601-1-11:2010, and IEC 60601-2-10:2012. These standards specify thresholds and testing methodologies for electrical characteristics, electromagnetic compatibility, and specific requirements for nerve and muscle stimulators.
• Biocompatibility: The "ground truth" for the electrode pads is established by their prior FDA clearance (K090198) and compliance with ISO 10993 standards, which cover biological evaluation of medical devices.
• Software Validation: The "ground truth" for software functionality is established against the FDA Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.
• Cleaning: The "ground truth" is simply that the cleaning instructions were tested and found sufficient, as presented in the system test report.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that involves a "training set."

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

Not applicable. This is not an AI/machine learning device.

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TENS (Modes 1, 2, 4, 5, 6)

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

It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS (Modes 1 and 3)

To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

It is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding an "Electronic Pulse Stimulator." It confirms substantial equivalence to predicate devices for specific Indications for Use. However, this document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is primarily a notification of regulatory clearance, not a summary of performance studies.

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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.

Not Found

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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