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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

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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.

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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.

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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:

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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.

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