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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 or facilitate muscle performance.

The device of the model FM-B2403A is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg. 4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations.

Here's a breakdown of the acceptance criteria and the study information based on the provided FDA 510(k) summary for the TENS & EMS Device (Model: FM-B2403A):

Please note: This document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device, not a typical clinical trial report for an AI-powered diagnostic/treatment device. Therefore, many of the typical questions regarding AI device performance studies (like test set provenance, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or explicitly stated in this type of submission. The "acceptance criteria" here refer to regulatory standards and comparative technical specifications, not predictive performance metrics.

Acceptance Criteria and Reported Device Performance

Note 1 (on Table 1): The weight, dimensions, and appearance of the proposed device FM-B2403A have small differences from the predicate device K202866, but these differences are insignificant and won't raise any new risk of safety and effectiveness.
Note 1 (on Table 3): Differences in maximum output voltage, maximum output current, pulse duration, and frequency have passed IEC 60601-2-10 test codes and won't raise new risks.
Note 2 (on Table 3): Differences in net charge, maximum phase charge, maximum current density, maximum power density, bursts per second, burst duration, and duty cycle do not exceed safety limits and have passed IEC 60601-2-10 tests. Maximum average power density <0.25Watts/cm². Therefore, these differences won't raise any new safety and effectiveness risk.

Study Information (Based on a 510(k) Submission for a TENS/EMS Device):

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

   • Test set size: Not applicable. This submission relies on non-clinical (bench) testing against recognized standards and technical comparisons to a predicate device, not clinical data from human subjects for performance evaluation.
   • Data provenance: The performance data comes from non-clinical laboratory studies and safety testing, performed in a controlled environment as part of the device manufacturing and regulatory compliance process. The country of origin for the tests conducted is not explicitly stated but would typically be part of the manufacturer's internal quality management system and testing facilities (Shenzhen, China, in this case). The data is by nature prospective with respect to the regulatory submission, meaning the tests were conducted specifically to support this application.

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

   • Not applicable. "Ground truth" in the AI/diagnostic sense is not relevant here. The "ground truth" for this device's performance is established by meeting electrical safety standards (e.g., IEC 60601 series) and comparing technical specifications to a previously cleared device. The compliance is assessed by engineers and technicians trained in these standards.

3. Adjudication method for the test set:

   • Not applicable. There's no human interpretation or adjudication of outputs in the way you might find in an imaging AI study. The "adjudication" is through physical and electrical measurements and subsequent comparison to predefined pass/fail criteria from international safety standards and the predicate device's specifications.

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. This device is a direct-to-consumer TENS & EMS device, not an AI-assisted diagnostic or therapeutic tool with a human-in-the-loop component.

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

   • Not applicable. Similar to point 4, this is not an AI algorithm. The device's performance is evaluated based on its physical, electrical, and functional characteristics as a medical device.

6. The type of ground truth used:

   • The "ground truth" for this submission are the international electrical safety and performance standards (e.g., IEC 60601 series, ISO 10993 for biocompatibility) and the technical specifications of a legally marketed predicate device (K202866). The device is deemed safe and effective if it meets these established standards and is substantially equivalent in technology and intended use.

7. The sample size for the training set:

   • Not applicable. This is not an AI or machine learning device requiring a training set.

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

   • Not applicable. There is no training set.

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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 or facilitate muscle performance.

The device of the model TU3424-F is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg. 4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations. The electrode pads are cleared by FDA, and 510(k) number is K092546 for the electrode pads. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. The electrode pads are composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient (age ≥ 18) multiple application use. Its output waveform is provided 24 programs and 20 adjustable intensity levels. The LCD screen shows the information of program, level, operating time and channel.

This is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) & Powered Muscle Stimulator (EMS) device, indicating that its substantial equivalence to a predicate device was established based on non-clinical performance data and adherence to recognized standards. A clinical study proving acceptance criteria is not applicable for this type of submission, as the FDA has determined that clinical data is not required to demonstrate substantial equivalence for these devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (K202866, Model: FM-B2403) by meeting recognized voluntary standards and confirming that performance differences do not raise new safety or effectiveness concerns.

Note: The table in the document has inconsistencies for "Number of Output Modes". The "Predicate Device" column lists "TENS:10, EMS:5" next to the new device's "TENS:19, EMS:5" but then also lists the new device's values in its own column under "New device". The interpretation above assumes the "New device" column accurately describes the proposed device and the "Predicate Device" column describes the predicate. The "SE" in the table signifies that despite these differences, the device is considered substantially equivalent.

Conclusion from document: "After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the model TU3424-F is substantially equivalent to the predicate device K202866 (Model: FM-B2403)."

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

Not applicable. This submission is for a TENS/EMS device and relies on non-clinical performance and safety testing against recognized standards to demonstrate substantial equivalence to a predicate device, rather than a clinical study with a test set of patient data.

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

Not applicable, as no clinical test set requiring expert ground truth was performed for this 510(k) submission.

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

Not applicable, as no clinical test set requiring adjudication was performed for this 510(k) 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 a TENS/EMS stimulator, not an AI-powered diagnostic or interpretive device, and therefore no MRMC study was performed.

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

Not applicable. This device is a physical stimulator and does not involve a diagnostic algorithm for standalone performance evaluation. Its performance is assessed through electrical safety and performance testing, and biocompatibility.

7. The type of ground truth used

The "ground truth" for this submission is established through:

• Compliance with recognized voluntary standards: ANSI/AAMI/ES 60601-1, IEC60601-1-2, IEC 60601-2-10, IEC60601-1-11, ISO10993-5, ISO10993-10. These standards define the acceptable safety and performance characteristics for such devices.
• Comparison to a legally marketed predicate device (K202866): The predicate device's established safety and effectiveness serves as a reference point.
• Non-clinical laboratory studies and safety testing data: These tests directly evaluate the device's electrical output parameters, safety features, and material biocompatibility against the requirements of the standards and comparisons to the predicate.

8. The sample size for the training set

Not applicable. This is a hardware device submission for a TENS/EMS stimulator, not an AI/machine learning algorithm, and therefore does not involve a training set.

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

Not applicable, as there is no training set for this device.

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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 or facilitate muscle performance.

The subject device (Model: FM-B2403) is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg. 4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations. The electrode pads are cleared by FDA, and 510(k) number is K092546 for the electrode pads. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin. The electrode pads are composed of a cover, connector lead wire or snap button, conductive carbon film, conductive hydrogel, and an electrode carrier liner. It is non-sterile and intended for single adult patient (age ≥ 18) multiple application use. Its output waveform is provided 24 programs and 20 adjustable intensity levels. The LCD screen shows the information of program, level, operating time and channel.

This document is a 510(k) Premarket Notification for a TENS & EMS Device (Model FM-B2403). It outlines the device's characteristics and demonstrates its substantial equivalence to a predicate device (HIVOX OTC Electrical Stimulator, Model SEM44).

It's important to note that this document does not describe a study involving an algorithm or AI. Instead, it focuses on the physical and electrical specifications of a medical device (a TENS and EMS stimulator) and compares them directly to a legally marketed predicate device to establish substantial equivalence for regulatory clearance. Therefore, many of the requested details about acceptance criteria for an AI/algorithm-based device and its study will not be present in this type of submission.

However, I can extract the information relevant to this specific device's acceptance strategy, which relies on demonstrating substantial equivalence to a predicate device through non-clinical testing of its physical and electrical parameters.

Here's a breakdown of the available information based on your request, adapted to the context of this traditional medical device submission:

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

For this type of device, the "acceptance criteria" are not framed as performance metrics against a clinical ground truth for an algorithm. Instead, they are the technical specifications and safety standards measured against the predicate device's characteristics and recognized industry standards. The "reported device performance" is essentially its measured engineering specifications.

The table in Section 7.1 and 7.2 of the 510(k) Summary serves this purpose. The "SE" column indicates "Substantially Equivalent," implying that the subject device's performance (its measured characteristics) meets the criteria for substantial equivalence to the predicate.

2. Sample sized used for the test set and the data provenance

This document describes a medical device, not an AI/ML algorithm. Therefore, there is no "test set" in the context of diagnostic performance evaluation with patient data. The "testing" refers to engineering and electrical performance testing of the device itself.

• Sample Size: Not applicable in the sense of patient data. The testing would typically involve a specific number of manufactured devices, but this is not detailed in the summary as it's part of the manufacturer's internal quality control and verification activities to ensure each device meets specifications.
• Data Provenance: The device is manufactured by Shenzhen Jianfeng Electronic Technology Co., Ltd. in China. The testing data would be generated from their internal labs or third-party testing facilities engaged by the manufacturer, verifying the device's electro-physical properties against the stated specifications and international standards (e.g., IEC 60601 series). This is prospective testing of the manufactured device.

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

Not applicable for this type of medical device submission. Ground truth, in this context, relates to clinical diagnoses or outcomes, which are not evaluated for this device's substantial equivalence. The "ground truth" for this device is its adherence to engineering specifications and safety standards as measured by accredited test methods, performed by qualified engineers and technicians.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical datasets, particularly for image-based diagnostic AI, where human expert consensus is needed to define a true positive/negative. This process is not part of a regulatory submission for a TENS/EMS device.

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 not an AI or imaging diagnostic tool, so no MRMC study or AI assistance evaluation was performed. The device delivers electrical stimulation for pain relief and muscle performance.

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

Not applicable. This is a physical Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) device, not an algorithm. Its performance is evaluated based on its electrical output parameters, safety, and physical characteristics.

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

The "ground truth" for this device's clearance is its compliance with established electrical and safety standards (e.g., IEC 60601 series, ISO 10993 for biocompatibility) and its functional equivalence to a legally marketed predicate device. This is determined through:

• Measured Electrical Output Parameters: Verification that its output voltage, current, pulse duration, frequency, etc., fall within acceptable ranges and are comparable to the predicate device.
• Safety Testing: Demonstrating compliance with electrical safety (e.g., against electric shock hazards, EMC), mechanical safety, and biocompatibility standards.
• Performance Verification: Ensuring the device operates as intended for TENS and EMS functionalities.

This is fundamentally different from a clinical "ground truth" derived from patient outcomes or expert diagnoses.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As above, no training set is involved.

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The Adhesive Electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrode is for OTC (Over-The-Counter) or Prescription use.

Adhesive Electrodes manufactured by GMDASZ are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:

First layer: Insulating backing material: Fabric/foam/tan fabric
Second layer: Conductive film/Carbon film coated with silver/Aluminum foil film
Third layer: Biocompatible self-adhesive conductive hydrogel
Protective liner: PET

The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" recessed female terminal with insulating outer jacket. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly is incompliance with FDA performance standard 21 CFR Part 898.

This document is a 510(k) premarket notification for "Adhesive Electrodes" manufactured by GMDASZ Manufacturing Co., Ltd. The submission seeks to expand the sales of their existing electrodes (previously cleared under K092546) to include Over-The-Counter (OTC) use, and also introduces new electrodes with an Aluminum foil film conductive layer, comparing them to the predicate device K132998 (Wandy self-adhesive electrodes).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria." Instead, it compares the subject device's performance against two predicate devices (K092546 and K132998) across various technical specifications, which implicitly serve as acceptance criteria. The key performance metrics and their comparison are:

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 does not specify the sample size for any conducted tests.
The data provenance is from GMDASZ Manufacturing Co., Ltd., which is based in Guangdong Province, P.R. China. The studies appear to be prospective testing conducted by the manufacturer to demonstrate substantial equivalence.

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 applicable/not provided. The device is an adhesive electrode, and the evaluation relies on technical and performance testing against established standards and predicate devices, not on expert interpretation of medical images or conditions where "ground truth" is typically established by medical professionals.

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

This information is not applicable/not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or image interpretation studies where multiple readers assess cases and discrepancies are resolved. The studies described here are laboratory/performance tests.

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

This information is not applicable/not provided. An MRMC study is for evaluating diagnostic performance, often with AI. The device is a medical accessory (adhesive electrode) and is not an AI diagnostic tool.

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

This information is not applicable/not provided. This device is an electrode, not an algorithm. Therefore, "standalone" algorithm performance is not relevant. The device's performance is inherently tied to its physical and electrical properties.

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

The "ground truth" for the performance tests appears to be established industry standards (e.g., EC12/EC53, ISO10993) and the documented performance characteristics of legally marketed predicate devices. The tests conducted (safety, adhesion, current dispersion, reusability, stability) evaluate whether the device meets these pre-defined technical specifications.

8. The sample size for the training set

This information is not applicable/not provided. This medical device is a physical product (electrode) and does not involve machine learning or AI models that require a "training set."

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

This information is not applicable/not provided, as there is no training set for this type of device.

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It is intended to be used for temporary relief of pain associated with sore and aching muscle in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

The TENS is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain.

The TENS consists of LCD, Control Key, Switch, Battery, Output jack and USB port, its accessories includes electrode, electrode cable, USB wire and Battery charger. Only the electrode pads cleared in submission, K092546, are to be used with this device

The proposed device has six models: SM9066, SM9088, SM9090, SM9098, SM9128 and SM9198. The six models have the same design principle and functional components, including battery, LCD, Control Key, Switch, channel number and USB port and accessories. The difference between the six models specifically expressed in the battery specification, LCD dimension, the position of Control key, Switch, and USB port on the proposed device, PCB(Printed Circuit Board) dimension and the number of Output jack numbers.

This document describes a 510(k) submission for Transcutaneous Electrical Nerve Stimulator (TENS) devices. It focuses on demonstrating substantial equivalence to a predicate device, rather than a standalone study proving a device meets specific acceptance criteria based on clinical outcomes or accuracy metrics for a diagnostic device.

Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies is not directly applicable or available in this type of regulatory submission. This document is a premarket notification (510(k)), which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove efficacy through a clinical trial with acceptance criteria for performance.

However, I can extract information related to the device's technical specifications and the testing done to support its substantial equivalence.

Here's a breakdown of what can be extracted and what cannot:

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

• Acceptance Criteria (implicit from comparison to predicate and standards): The implicit acceptance criteria are that the device's technological characteristics are substantially equivalent to the predicate device and that it complies with relevant electrical safety and EMC standards. Specifically, for electrical output parameters, the proposed device's values should be covered by or deemed substantially equivalent to the predicate's values. For current/frequency, they must also meet IEC 60601-2-10 limits.
• Reported Device Performance:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Test Set Sample Size:
  • Bench Testing: Not specified explicitly for each test. The tests were run on the "proposed device" (TENS Models SM9066, SM9088, SM9090, SM9098, SM9128 and SM9198).
  • Biocompatibility: The electrode pads were cleared under K092546. The sample size for those biocompatibility tests is not detailed in this document.
  • Usability Study: Conducted with "a variety of 'patients'" in America. The specific number of participants is not provided.
• Data Provenance:
  • Bench Testing: Performed by the manufacturer (presumably in Hong Kong/China, given the sponsor location) to verify design specifications and compliance with international standards.
  • Biocompatibility: Refers to results from a prior 510(k) submission (K092546) for the electrode pads.
  • Usability Study: Conducted in "America" for the US market. Presumed to be prospective for the purpose of this submission.

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):

• Not applicable. This submission relies on technical comparisons to a predicate device and compliance with recognized standards. There is no "ground truth" to be established by experts in the sense of diagnostic accuracy or clinical outcomes being assessed by human readers. The "ground truth" here is the established safety and effectiveness of the predicate device and the requirements of the standards.

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

• Not applicable. See point 3.

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 a TENS unit for pain relief, not a diagnostic AI system with human-in-the-loop performance. Therefore, no MRMC study was conducted or is relevant.

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

• Partially applicable, but not for an "algorithm" in the AI sense. The bench tests (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) are "standalone" in that they assess the device's technical performance against engineering specifications and international standards, independently of a human user. However, this is not an 'algorithm-only' performance study as understood in AI/diagnostic device contexts.

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

• For the technical and safety aspects, the "ground truth" is adherence to international electrical safety and performance standards (IEC 60601 series) and the demonstrated safety and effectiveness of the legally marketed predicate device (K102598).
• For biocompatibility, the ground truth is established by the results of standardized ISO 10993 cytotoxicity, sensitization, and irritation tests.
• For usability, the "ground truth" is measured by whether "a variety of 'patients'" understood the labeling sufficiently for safe and proper use.

8. The sample size for the training set:

• Not applicable. This device does not employ machine learning or AI algorithms that require a "training set."

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

• Not applicable. See point 8.

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TENS: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS: It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

SM TENS & PMS is a portable and DC 3.7V battery powered multi function device, offering both Transcutancous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device. SM TENS & PMS has 6 operation modes, which can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electronic stimulatory module has the operating elements of ON/OFF Switch, Display screen, Mode Selection key, Intensity Modification keys, Timing key, Pause key, Output socket, and USB port for battery charging. The display screen can show battery power, selected mode, current intensity, time remaining of an application mode, and indication of a pause. The device is equipped with accessories of electrode pads, electrode cables, battery chargers, and USB cables. The electrode cables are used to connect the pads to the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed by special person. The electrodes are interchangeable. The application area of electrode pads must be larger than 4cm². The electrode pads are provided by GMDASZ Manufacturing Co., Ltd. with 510(k) cleared Number K092546.

This submission is for a Traditional 510(k) for a new device, the "SM TENS & PMS" from Hong Qiangxing (Shen Zhen) Electronics Limited. The device is a portable, battery-powered multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) functionalities. The 510(k) submission seeks to demonstrate substantial equivalence to a predicate device, the "Powered Muscle Stimulator, JQ-5C" (K102598).

The acceptance criteria are established through a comparison of the new device's technical characteristics and performance against the predicate device and relevant safety standards. The study proving the device meets the acceptance criteria is a safety testing protocol, which demonstrates compliance with recognized electrical and medical device standards.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria, for the purpose of a 510(k) for substantial equivalence, are primarily that the new device performs equivalently to the predicate device in its intended use and meets relevant safety standards, without raising new questions of safety or effectiveness. The reported device performance is based on the results of the safety testing.

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

• Sample Size: The document does not specify a "test set" in the context of clinical data for the device. The evaluation is based on engineering testing of a single device (or set of devices sufficient for engineering tests) to verify compliance with standards and comparison to the predicate device's specifications. It is a technical submission, not a clinical trial.
• Data Provenance: The data primarily comes from engineering and bench testing conducted by the manufacturer (Hong Qiangxing (Shen Zhen) Electronics Limited), likely performed in China (Shenzhen, Guangdong, China), where the manufacturer is located. This is a retrospective comparison to existing standards and predicate device specifications.

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

This type of information is not applicable to this 510(k) submission. A 510(k) for an electrical stimulator device like this does not typically involve expert review for ground truth in a clinical sense. The "ground truth" here is compliance with established electrical safety and performance standards, as well as functional equivalence to a legally marketed predicate device. This is assessed through objective engineering tests.

4. Adjudication Method for the Test Set

This is not applicable. There is no "test set" requiring adjudication by experts in the context of this 510(k) submission. The evaluation is against objective engineering standards and a comparative analysis of technical specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices or other technologies where human interpretation or clinical effectiveness is a primary endpoint requiring comparison between different readers or technologies. For TENS/PMS devices seeking substantial equivalence, such studies are not usually required in a 510(k) submission; the focus is on safety and functional equivalence to the predicate.

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

This concept is not applicable to the "SM TENS & PMS" device. This is a direct electrical stimulation device; it does not involve algorithms that perform diagnostic or interpretative functions that would require a "standalone" performance evaluation in the way imaging AI algorithms do. Its performance is evaluated by its electrical output characteristics and safety.

7. The Type of Ground Truth Used

The "ground truth" in this context is compliance with recognized electrical safety and performance standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133, FCC 47 CFR Part 18) and technical specifications of the predicate device. There is no "pathology" or "outcomes data" ground truth as this is not a diagnostic or treatment outcome effectiveness study.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI that would require a "training set." The submission describes a hardware device not an AI algorithm.

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 it.

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