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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 and facilitate muscle performance. The device is designed to temporarily increase local blood circulation in healthy leg muscles.

Not Found

The provided FDA 510(k) Clearance Letter for Shenzhen Yicai Health Technology Co. Ltd's Transcutaneous Electrical Nerve Stimulator (TENS) does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML medical device.

This document is a standard clearance letter for a physical medical device (TENS/EMS) and focuses on regulatory aspects like:

• Substantial equivalence to predicate devices.
• General controls (registration, listing, GMP, labeling, misbranding).
• Quality System (QS) regulation.
• Unique Device Identification (UDI) requirements.
• Indications for Use.

It does not detail performance studies conducted to establish effectiveness or safety beyond establishing substantial equivalence to a predicate. Specifically, it lacks any mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes for human readers.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or ground truth establishment for training.

Therefore,Based on the provided FDA 510(k) clearance letter, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested. The letter is for a physical medical device (Transcutaneous Electrical Nerve Stimulator) and outlines its regulatory clearance, not the details of a performance study, especially not one applicable to an AI/ML device as your detailed questions suggest.

The document does not contain any information related to:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This is a clearance letter for a device whose mechanism of action is electrical stimulation, not an AI/ML algorithm. The information you are seeking would typically be found in the 510(k) summary or the full submission, which are not included in this clearance letter.

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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 (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 and facilitate muscle performance.

Transcutaneous Electrical Nerve Stimulator is a portable and DC 3.7V battery powered multifunction device that adopts modern electronic science and technology to delivers electric pulses generated to the electrodes. It has two functions: Transcutaneous electrical nerve stimulation(TENS) and Electrical muscle stimulation (EMS).

The device has 20 operation programs. It includes operating elements of Power ON/OFF button, intensity decrease button, Menu selection button, and A/B channel selection button.

The display screen can show battery power, program, mode, keylock status, intensity level, treatment time and output channel. The device is equipped with accessories of electrode cables, and one Type-C cable. The electrode cables are used to connect the pads to the device; the Type-C cable is used to connect the charger and the built-in lithium battery.

In additional, according to different simulation-needed bodies, users can choose the three types of electrode pad based on their own situation. The electrode pads are manufactured by ShenZhen Technology Co., Ltd with 510(k) cleared Number K171381.

The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of filing does not contain detailed clinical study data or acceptance criteria in the format typically used for AI/ML device evaluations. Instead, it demonstrates substantial equivalence to predicate devices primarily through non-clinical performance and a comparison of technical specifications.

Therefore, I cannot extract information related to acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not typically included or required in a non-clinical 510(k) submission for a TENS device.

However, I can extract the available information regarding the device's technical specifications and how its performance is compared to predicate devices, focusing on the "Substantial Equivalence Comparison" tables.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" for clinical performance. Instead, it compares the subject device's technical specifications to those of predicate devices to establish substantial equivalence. The "reported device performance" refers to the subject device's specifications and its compliance with relevant international standards.

Here's a table summarizing key technical specifications and their comparison to predicate devices, drawing from the "Substantial Equivalence Comparison" tables. "Acceptance Criteria" here are implicitly defined by the ranges and characteristics observed in the predicate devices and compliance with relevant standards.

Regarding the study that proves the device meets (these implicit) acceptance criteria:

The document relies on non-clinical performance testing to demonstrate that the subject device (K6106) meets the safety and effectiveness requirements, primarily by showing compliance with recognized international standards and substantial equivalence to legally marketed predicate devices.

The studies referenced are:

• Compliance with International Standards for Medical Electrical Equipment:
  • IEC 60601-1:2005+A1:2012+A2:2020 (General Requirements for Safety)
  • IEC 60601-2-10:2012+A1:2016 (Particular requirements for nerve and muscle stimulators)
  • IEC 60601-1-2:2014+A1:2020 (Electromagnetic compatibility)
  • IEC 60601-1-11:2015 (Requirements for medical electrical systems used in the home healthcare environment)
• Software Validation: FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002". (Though no specific study details are provided, compliance with this guidance is stated).
• Guidance for Product-Specific Requirements: "Guidance Document for Powered Muscle Stimulator 510(k)s Document issued on: June 9, 1999."

The general conclusion is that "The electrical safety, EMC, biocompatibility, software verification, and output specifications information provided is sufficient to demonstrate substantial equivalence to the Transcutaneous Electrical Nerve Stimulator, model: K6106 is nearly identical to the predicate devices, differences in their characteristics do not raise new questions regarding safety and effectiveness with identical indications for use and essentially identical technological characteristics..." (Page 7).

Non-Applicable Sections for this document type:

2. Sample sized used for the test set and the data provenance: Not applicable. This is a non-clinical submission. No clinical test set data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring 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 device is a TENS/EMS device, not an AI/ML diagnostic or image analysis device that would typically involve human readers or AI assistance.
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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a non-clinical TENS/EMS device submission. Ground truth for safety and performance is based on compliance with electrical, mechanical, and biological standards.
8. The sample size for the training set: Not applicable. This device does not use a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established: Not applicable.

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Transcutaneous Electrical Nerve Stimulator (Model:TENS WMPS2-1) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment.

Transcutaneous Electrical Nerve Stimulator sends gentle electrical current to underlying nerves and muscle groups via electrodes applied onto the skin to relieve pain. The device has 16 programs (12 standard programs and 4 editable programs). It is a lithium battery-powered device comprising the electronic stimulatory module, the accessories of lead wires, the electrodes and the adapter. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes are 510(k) cleared devices (K192568). Size 50*50mm.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document describes the acceptance criteria in terms of compliance with various international standards for medical electrical equipment and a comparison to a predicate device. The reported performance is implicitly stated by asserting compliance with these standards and the substantial equivalence to the predicate.

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

• Test Set Sample Size: Not applicable. The tests performed were non-clinical bench tests on the device itself, not tests involving human subjects or data sets.
• Data Provenance: Not applicable, as no external data was used for performance validation in terms of a clinical test set. The provenance relates to the device's design specifications and its manufacturing processes.

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

• Not applicable. As this was a non-clinical bench test study, there were no human experts establishing a "ground truth" for a test set in the way one would for diagnostic imaging studies. The "ground truth" was established based on compliance with internationally recognized electrical safety and performance standards (e.g., IEC 60601 series). The experts involved would be engineers and testing personnel qualified to perform and interpret these specific standards, but their number and specific qualifications are not detailed in this summary.

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

• Not applicable. There was no clinical test set requiring adjudication. The assessment was based on objective measurements and adherence to engineering standards.

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:

• No. This filing is for a Transcutaneous Electrical Nerve Stimulator (TENS device), which directly manages pain through electrical stimulation. It is not an AI-assisted diagnostic imaging device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

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

• Not applicable. This is not an algorithm or AI-based device. The device operates as a standalone pain relief stimulator.

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

• The "ground truth" for this device's acceptance is its compliance with established international safety and performance standards for medical electrical equipment, specifically those applicable to nerve and muscle stimulators (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-11). The predicate device's performance also serves as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set:

• Not applicable. There is no training set for this type of medical device. Product development and testing are based on engineering specifications and compliance with standards.

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

• Not applicable, as there is no training set.

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TENS (Mode 16)
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of the neck, arm, leg, and foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.
EMS (Mode 16)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

1)Stylish appearance, compact size, humanized design for easy portability.
2)TENS and EMS modes with 6 different modes each, catering to various treatment needs and a wider range of users.
3)Dual-channel output, allowing control of intensity for each channel.
4)Unique combination of electric pulses for a different sensory experience.
5)LCD display for clear and easy use.
6)Powered by three AAA batteries (size 7), providing long-lasting usage and convenient for home and travel use.
7) The electrode patches used with the device are previously cleared under K221589 for safety use. The main unit delivers the electrical

The document describes the acceptance criteria and study proving the device meets the criteria.

Note: The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. As such, the "acceptance criteria" discussed are primarily related to general device safety and performance according to established standards and the "study" is a non-clinical testing report to demonstrate substantial equivalence to predicate devices, rather than a clinical efficacy trial. The information available in a 510(k) summary for a TENS device typically does not include the detailed breakdown of acceptance criteria and multi-reader studies as might be found for more complex AI/ML-driven diagnostic devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

For this specific device (Transcutaneous Electrical Nerve Stimulator), "acceptance criteria" are predominantly demonstrated through compliance with recognized electrical safety and performance standards, and comparison to predicate devices. There aren't explicit numerical targets for accuracy, sensitivity, or specificity as might be found for a diagnostic AI model.

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

The document does not describe a "test set" in the context of a dataset for an AI model. For this TENS device, the "testing" refers to non-clinical verification and validation activities conducted on the physical device itself.

• Sample Size: Not applicable in the context of an AI/ML test dataset. The testing was performed on the device prototypes/production samples.
• Data Provenance: Not applicable. The "data" are results from engineering and electrical tests on the device, not patient data. The electrode patches relied on previous FDA clearance (K221589), implying their safety and biocompatibility data would originate from the studies for that specific clearance.

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

Not applicable. This is not an AI/ML diagnostic device that requires expert-established ground truth from medical images/data. The ground truth for this device's performance is compliance with engineering standards and direct measurement of its electrical outputs.

4. Adjudication Method for the Test Set

Not applicable. There is no expert review or adjudication process described for the device's functional performance testing.

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

No. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This device is a TENS unit, not an AI diagnostic tool.

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

Yes, in the sense that the device's electrical outputs and safety features were evaluated independently for compliance with standards. This is not an AI algorithm, so the term "standalone" performance isn't directly analogous, but the device's intrinsic characteristics were tested.

7. The Type of Ground Truth Used

The ground truth used for this device is based on:

• Engineering Specifications and Industry Standards: The device's output parameters (e.g., current, frequency, waveform) are measured and compared against design specifications and the requirements of standards like IEC 60601-2-10.
• Safety Standards Compliance: The device's electrical safety and electromagnetic compatibility are tested against established performance criteria outlined in IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11.
• Biocompatibility Data: For the electrode patches, the "ground truth" for safety (e.g., non-cytotoxicity, non-irritation) was established through previous testing for clearance K221589, likely following ISO 10993 standards.

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI/ML algorithm that requires a training set.

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

Not applicable. As there is no AI/ML component or training set, this question is not relevant.

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TENS:

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.

For temporary relief of pain associated with dysmenorrhea (menstrual cramps) when used with overthe-counter pain medications.

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

Not Found

This document is an FDA clearance letter for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about a sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information.

FDA clearance of this type (510(k)) is based on demonstrating substantial equivalence to a predicate device, not necessarily on a de novo study proving new performance against specific acceptance criteria. While the manufacturer would have performed testing to ensure safety and effectiveness for their 510(k) submission, the detailed study information you're asking for is not typically included in the public-facing clearance letter.

To obtain the information you're looking for, you would typically need to review the actual 510(k) submission and its supporting documentation, which is generally not publicly available in this level of detail unless specifically requested through a Freedom of Information Act (FOIA) request.

Therefore, I cannot populate the table or answer the specific questions based on the provided text.

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1. When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended:

• for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
• to temporarily increase local blood circulation in healthy leg muscles
• to stimulate healthy muscles in order to improve and facilitate muscle performance
• to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities(legs) due to strain from exercise or normal household duties
• to relax muscle spasm
• to increase blood flow circulation
• for prevention of retardation of disuse atrophy
• for muscle re-education
• for maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Provide quadricep strengthening
• Improve knee stability secondary to quadricep strengthening

2. When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:

• symptomatic relief and management of chronic, intractable pain
• relief of pain associated with arthritis
• temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties

Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes. The proposed models KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 provide a combination of transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). It has the following basic characteristics: 1) 10 modes to satisfy different demands, mode 1-9 is for foot stimulation and mode body is for body stimulation; 2) wonderful electric pulse combination, 0~20 levels can be adjusted and chosen according to personal preference; 3) wireless remote control allows easy control of the device 5) use while seated or reclining; 6) LCD display makes the operation simple and easy. Transcutaneous Electrical Nerve Stimulator is mainly composed of the main unit, remote control and electrode pads.

The provided document is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator, not a study report that includes details about acceptance criteria and device performance based on a test set, expert consensus, or specific clinical outcomes for an AI/ML device. Therefore, I cannot extract the requested information.

The document discusses:

• Device Name and Regulation: Transcutaneous Electrical Nerve Stimulator, Class II medical device.
• Indications for Use: Pain relief and muscle stimulation for various conditions.
• Predicate Device: K220998, also a Transcutaneous Electrical Nerve Stimulator.
• Technical Characteristics Comparison: A detailed table comparing the subject device with the predicate device, highlighting similarities and differences in specifications like power supply, output modes, intensity levels, dimensions, materials, and compliance with voluntary standards.
• Non-Clinical Studies: Lists compliance with various IEC and ISO standards related to electrical safety, EMC, home healthcare environment, nerve and muscle stimulators, and biocompatibility (ISO 10993 series). It also mentions software verification and validation and waveform testing.
• Clinical Information: States "Not applicable."

The absence of "clinical information" indicates that the submission relies on non-clinical testing and substantial equivalence to a predicate device rather than a clinical study demonstrating performance against specific clinical acceptance criteria. There is no mention of an AI/ML component, a test set, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

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The Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) 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. In particular, the TENS WMPS6-1 is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post-surgical and post traumatic pain.

Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) 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 device has 18 programs (13 standard programs and 5 editable programs), powered by 6 pieces of 1.5V batteries or AC 100-240V, comprising electronic stimulatory module and accessories of lead wires, electrodes. Six outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), Size: 50*50mm.

The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It details the device's technical specifications and a comparison to a predicate device to establish substantial equivalence for regulatory clearance. This document does not describe an AI-powered medical device or an associated study for complex acceptance criteria like those involving AI performance metrics (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts).

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from the provided text. The device is a physical medical device (TENS) and the "study" referred to in the document is a series of non-clinical bench tests to compare it to a predicate device, and to verify safety and performance standards.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• No AI Component: The device is a Transcutaneous Electrical Nerve Stimulator, a physical product that applies electrical current. There is no mention of any AI or machine learning component.
• No Diagnostic/Interpretive Task: The device is for pain relief, not for image analysis, diagnosis, risk prediction, or any other task that would typically involve acceptance criteria like sensitivity, specificity, or the need for ground truth established by experts.
• No Human-in-the-Loop Study: Since there's no AI component, there's no MRMC (Multi-Reader Multi-Case) study described for human readers improving with AI assistance.
• No Standalone Algorithm Performance: There is no algorithm to assess in a standalone capacity.
• No Training Set/Test Set (in the AI context): The concepts of training and test sets as they apply to machine learning models are not relevant to the clearance of this physical device. The "test set" here refers to the device itself undergoing bench tests.
• No Ground Truth Establishment by Experts: Ground truth for AI models is often established by expert consensus (e.g., radiologists reviewing images). For this TENS device, "ground truth" would refer to its physical and electrical properties meeting specified standards, validated through engineering tests, not human interpretation.

Summary of what the document DOES describe in terms of performance and comparison:

The document describes acceptance criteria in the context of substantial equivalence to an existing predicate device and compliance with voluntary standards for electrical medical equipment.

• Acceptance Criteria (Implicit via Comparison to Predicate and Standards Compliance): The acceptance criteria are primarily demonstrated by showing that the new device's specifications (e.g., power source, output channels, waveform, voltage, current, safety features) are either identical, similar with acceptable differences (justified by safety and effectiveness analyses), or meet the requirements of relevant electrical safety and performance standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10). The reported device performance is presented as compliance with these standards and the specific electrical output values listed in the comparison table.

• Study That "Proves" Compliance: The "study" here is a series of non-clinical bench tests.

  • Sample Size: This is not a study with a "sample size" in the statistical sense of patient data. It refers to testing the physical device itself.
  • Data Provenance: Not applicable as it's not a data-driven AI study. The tests are bench tests performed on the device.
  • Experts and Ground Truth: Not applicable in the way you've defined them for an AI study. Electrical engineers and regulatory compliance experts would be involved in setting and verifying the test standards.
  • Adjudication Method: Not applicable.
  • MRMC Comparative Effectiveness Study: No.
  • Standalone Performance: The "standalone" performance here refers to the device successfully passing all required electrical and safety tests independently (i.e., not reliant on human interpretation for its function).
  • Type of Ground Truth: The "ground truth" is compliance with established engineering and medical device safety standards for TENS devices (e.g., maximum current density limits, electrical isolation, waveform characteristics).
  • Training Set/Ground Truth for Training: Not applicable.

If you have a document describing an AI medical device, please provide that, and I will be able to answer your questions with the level of detail you are seeking.

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

• Neck Pad is used in back of neck.

The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design. It is a body-worn and home-use device. It uses low-frequency electronic therapy and designed to temporary relief of pain associated with sore and aching muscles in the back of neck. It only has one model: ST-304.
The trade name of the subject device is Transcutaneous electrical nerve stimulator.
The Transcutaneous electrical nerve stimulator (model: ST-304) consists of a main unit and Type C-USB charging cable. The main unit consists of shell, lithium battery (only 1pcs), neck electrodes pads (a pair of fixed neck electrodes pads), lower shell connector and control buttons and silicone pads. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is titanium material (Gr.2). There are only 1 pcs lithium battery in-build in main unit. The model of lithium battery is KRL 103040.
The neck electrodes pads (a pair of fixed neck electrodes pads) are a kind of Titanium material, and the detail content as following description and as the classify of ASTM F67 2017 it is under Gr2.
The Transcutaneous electrical nerve stimulator (model: ST-304) power supply is 3.7V DC using built-in lithium battery(1200mAh). The built-in lithium battery can be recharged. But the power adapter (Input: 100-240V~, 50/60Hz,0.7A, Output: 5V== 1000mA) is not the parts of the subject device so it shall be supplied by the user. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is Titanium material (Gr.2).
The Transcutaneous electrical nerve stimulator (model: ST-304) totally has 3 modes. The stimulation has 2 modes for stimulating and 15 output Intensity Levels for each mode, so the device can give certain electrical pulse through the neck electrodes pads on the intact skin of back neck to help users to temporary relief of pain. The heating only has 1 mode for heating and it can also provide a constant temperature of 32℃ to 38℃ to provide a warming sensation. The stimulation function and heating function can be used separately or simultaneously. The neck electrodes pads provide users with back of neck stimulation and heat to warm and comfort the muscles of the back of neck.
The main unit provides access to adjust the intensity up or down and adjust stimulating mode, put ON/OFF the main unit and heating function.
The Intensity level of electrical stimulation and heating function are easily controlled by the end user using manual, push-button controls. The push-button controls are consisted of four button which are Switch on/off button/mode switch button, heating button, Intensity increase button and Intensity decrease button.
The default stimulation time is 10 minutes, and the user cannot adjust but could turn off the device during working condition.
Transcutaneous electrical nerve stimulator (model: ST-304) has 2 types stimulation modes: Mode 1, Mode 2.
Before use the device to wipe the Electro Therapy Conductive Gel on the Neck Electrode Pads. But the Electro Therapy Conductive Gel is not the part of subject device so it shall be supplied by the user.
Principle of operation:
The Transcutaneous electrical nerve stimulator (model: ST-304) sends low-voltage electrical pulses to specific nerves via two fixed neck electrodes pads applied on the intact skin of back of neck and powered by rechargeable lithium battery. The purpose is to temporarily relieve pain. By adjusting the output voltage and frequency to produce the low-voltage electrical pulses and achieve the effect of electrotherapy. Voltage regulation is realized by the Boost Converter circuit, which controls the voltage amplitude by modifying the PWM control circuit. After that, the voltage is released to the electrode through the analog circuit, and the time change of the output voltage is controlled by modifying the PWM frequency to achieve the specific electrotherapy effect.

The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding:

• Acceptance criteria in the context of a clinical study or specific performance metrics for the device's intended use.
• A study that proves the device meets acceptance criteria. No clinical performance study is described.
• Sample size for test sets or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for the training set was established.

Instead, the document details non-clinical testing performed to demonstrate that the device is as safe and effective as its predicate devices, based on compliance with recognized consensus standards.

However, I can extract information related to the device's technical specifications and how they compare to predicate devices, which implicitly serves as the "acceptance criteria" and "device performance" for the substantial equivalence claim.

1. Table of Acceptance Criteria (Implicit for Substantial Equivalence) and Reported Device Performance:

The "acceptance criteria" for this 510(k) submission are implicitly defined by the technical specifications of the predicate devices. The "reported device performance" refers to the subject device's technical specifications. The discussion of differences (D1-D17) explains why these differences do not raise new questions of safety or effectiveness.

Since this is a 510(k) submission, the device's acceptance is based on demonstrating "substantial equivalence" to predicate devices, primarily through non-clinical testing and comparison of technical characteristics, not through clinical trials demonstrating specific performance criteria against a disease outcome.

Summary of Missing Information (as per your request, not present in the document):

2. Sample size for the test set and the data provenance: Not applicable, as no clinical test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical ground truth is established for efficacy.
8. The sample size for the training set: Not applicable.
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 context refers to the non-clinical testing for electrical safety, EMC, biocompatibility, and software verification, as listed in Section 7. This testing demonstrates that despite minor technical differences, the device is as safe and effective as the predicate devices for its intended use.

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1. When using Electrical Muscle Stimulation, Transcutaneous Electrical Nerve Stimulator is intended:

• for users with conditions or disease that are associated with impaired (poor) blood flow in the legs/ ankles/ feet, the device through the foot-pads is intended for use as an adjunctive treatment (as an addition to your existing treatment) to temporarily reduce lower extremity pain, swelling and cramping
• to temporarily increase local blood circulation in healthy leg muscles
• to stimulate healthy muscles in order to improve and facilitate muscle performance
• to temporarily relieve pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities(legs) due to strain from exercise or normal household duties
• to relax muscle spasm
• to increase blood flow circulation
• for prevention of retardation of disuse atrophy
• for muscle re-education
• for maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Provide quadricep strengthening
• Improve knee stability secondary to quadricep strengthening

2. When using Transcutaneous Electrical Nerve Stimulator to deliver Transcutaneous Electrical Nerve Stimulation (TENS), it is intended to provide:

• symptomatic relief and management of chronic, intractable pain
• relief of pain associated with arthritis
• temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties

Transcutaneous Electrical Nerve Stimulator is a product that adopts modern electronic science and technology to deliver electric pulses generated to the user's skin through the electrodes. The proposed model KTR-405 provides a combination of transcutaneous electrical nerve stimulation (TENS) and electrical muscle stimulation (EMS). It has the following basic characteristics: 1) 10 modes to satisfy different demands. Modes 1-8 are for foot and can be switched to another mode for a minute automatically, while mode 9 is for knee and mode 10 for body. Modes for foot, knee and body can be switched manually during a session; 2) wonderful electric pulse combination, 0~150 levels can be adjusted and chosen according to personal preference; 3) rechargeable battery which can work up to 36 hours 4) wireless and rechargeable remote control allows easy control of the device 5) use while seated or reclining with Relax and Recline mode; 6)foot cover helps keep feet warm and cosy; 7) LCD display and power display make the operation simple and easy; 8) carry handle for easy transportation; 9) magnetic power cable for simple and safe connection. Transcutaneous Electrical Nerve Stimulator is mainly composed of the host and electrode patches. And it can be run either from the mains power supply or via its internal rechargeable battery. To start therapy, you need to connect the device to the mains power supply. This will charge the battery, allowing you to use the device wirelessly in subsequent sessions. Then while seated, place both your bare feet onto the footpads of the device or paste the electrode pads onto painful areas and press on/off button to power on. The modes and intensity can be selected according to needs. And the current status is displayed on LCD.

I am unable to provide information about the acceptance criteria and study proving device efficacy based on the provided text. The document is an FDA 510(k) clearance letter for a Transcutaneous Electrical Nerve Stimulator (TENS), Model: KTR-405.

Here's why:

• 510(k) Clearance vs. Clinical Efficacy: A 510(k) clearance primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, not necessarily extensive clinical efficacy trials. The manufacturer demonstrates that the new device is as safe and effective as a previously cleared device.
• Lack of Clinical Study Details: The document explicitly states "Clinical information: Not applicable" (page 10). This confirms that no clinical studies were performed or submitted for this particular 510(k) application to prove the device's performance against specific acceptance criteria in patient populations.
• Non-Clinical Studies: The "Non-clinical studies and tests performed" section (page 9-10) focuses on engineering and safety standards (e.g., IEC standards for electrical safety, ISO standards for biocompatibility, software verification). These are crucial for safety but do not provide clinical performance metrics like sensitivity, specificity, or changes in patient outcomes.
• Predicate Device Comparison: The comparison table between the subject device and the predicate device (pages 6-7) mainly highlights similarities in intended use, regulations, and basic technical specifications. It does not include performance data or acceptance criteria that would typically be found in a clinical study report.

Therefore, the provided text does not contain the information needed to answer your questions about acceptance criteria or a study proving device performance as you've requested. The "reported device performance" in the context of this document is adherence to safety and performance standards for TENS devices, rather than clinical effectiveness metrics.

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The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) 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. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin to relieve pain. The device has 16 programs (12 standard programs and 4 editable programs). It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and 4x1.5V AAA alkaline batteries. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K213879), Size 50*50mm.

The provided text describes the 510(k) summary for the Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1). Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly derived from its substantial equivalence to the predicate device (K202893). The "Comparison" column in the table indicates "Same" or "Similar" for most parameters, meaning the new device's performance aligns with the established performance of the predicate. Note 1 explicitly addresses the difference in deviation from amplitude, frequency, and pulse width.

Study to Prove Acceptance Criteria:

The study proving the device meets the acceptance criteria is a non-clinical bench test study.

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

• Sample Size: Not explicitly stated as "sample size" in the traditional sense for an AI/diagnostic study. For bench tests, it typically refers to the number of devices tested. This information is not provided in the document.
• Data Provenance: Not applicable in the context of clinical data for this type of submission, as no clinical data was included. For bench tests, the data would have originated from laboratory testing of the manufactured devices. The manufacturer is Bozhou Rongjian Medical Appliance Co., Ltd. in China.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This information is not applicable/not provided. The assessment of these types of electrical stimulators primarily relies on objective physical and electrical measurements against established standards, not necessarily on expert interpretation of ambiguous data points.

4. Adjudication Method for the Test Set:

• This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpretive tasks (e.g., radiology reads), which is not the nature of the bench tests reported here.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not including in this submission."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

• Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI algorithm. Its performance is evaluated through its physical and electrical characteristics according to safety and performance standards.

7. The Type of Ground Truth Used:

• The ground truth for this device's performance evaluation is established through compliance with recognized voluntary standards and objective physical and electrical measurements as defined by those standards.
  • ANSI AAMI ES60601-1: 2005/(R) 2012 And A1: 2012, C1: 2009/(R) 2012 And A2: 2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1: 2005, MOD)
  • IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment - Part 2-10: Particular Requirements For The Basic Safety And Essential Performance Of Nerve And Muscle Stimulators
  • IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

8. The Sample Size for the Training Set:

• Not applicable. The device is an electrical stimulator, not an AI/machine learning algorithm requiring 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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