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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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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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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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To be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Muscle Trainer is a product that adopts modern electronic science and technology to delivers electric pulses generated to the user's skin through the electrodes.

Muscle Trainer is mainly composed of the host and electrode patches, as well as it is powered by CR2023 battery. Of which, the electrode patch is cleared in K171381.

Muscle Trainer includes KTR-230 series (KTR-230B, KTR-230W, KTR-230P), KTR-231, KTR-232, KTR-233 and KTR-234 model. All models have three operation modes and one channel, which can give certain electrical pulse through electrode patches on the skin. Their technical parameters are slightly different, but they share the basically same characteristics:

• Electric pulse combination, 0~12 levels can be adjusted and chosen according to personal preference.
• CR2032 Button batteries (DC3V) power supply, easy to use and safe.

The main differences among them are the followings but not affect its intended use:

• Appearance
• The number of control button: KTR-230 series, KTR-231 and KTR-232 have two buttons to control: KTR-233 and KTR-234 have three buttons to control.
• The number of electrode patch used: KTR-230 series, KTR-233 and KTR-234 are equipped with one electrode patch; KTR-231 is equipped with six electrode patches as well as KTR-232 is equipped with two electrode patches.
• Applied parts: KTR-230 series, KTR-233 and KTR-234 apply to abdomen, shoulder, arm, thigh and calf; KTR-231 applies to abdomen in the place where between ribs and hip bones; KTR-232 applies to waist, shoulder, arm, thigh and calf.

The provided text does not contain a typical "acceptance criteria" table with reported device performance metrics in the way one might expect for an AI/ML medical device, as this is a 510(k) for a physical medical device (a powered muscle stimulator). The "acceptance criteria" are implied by the compliance with various international standards and the demonstration of substantial equivalence to predicate devices.

Here's an interpretation of the "acceptance criteria" and "device performance" based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the AI/ML-specific questions (2-9), the provided document does NOT discuss an AI/ML component or study of that nature.

The "Muscle Trainer" is a physical medical device (powered muscle stimulator) and the performance data section focuses on electrical safety, EMC, biocompatibility, and output waveform characteristics – typical for hardware-based medical devices seeking 510(k) clearance via substantial equivalence.

Therefore, for questions 2 through 9, the answer is that the provided document does not contain this information as the device is not described as an AI/ML product.

Specifically:

• 2. Sample sized used for the test set and the data provenance: Not applicable. Performance testing is standard engineering/electrical testing, not a clinical study involving a "test set" of patient data for an algorithm.
• 3. Number of experts used to establish the ground truth... and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/ML is not relevant here.
• 4. Adjudication method: 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.
• 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.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

This document clearly outlines studies related to compliance with electrical safety standards, biocompatibility of materials, and validation of the device's electrical output parameters against established guidance and predicate devices, which are typical for traditional medical device clearance. It does not mention any AI or machine learning components.

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