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Transcutaneous Electronic Nerve Stimulator is indicated 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. It is intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with osteoarthritis.

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I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria.

The document is an FDA 510(k) clearance letter for Transcutaneous Electronic Nerve Stimulators. It discusses:

• The FDA's review and determination of substantial equivalence for the listed devices.
• Regulatory aspects such as general controls, special controls, quality system regulations, UDI rules, and adverse event reporting.
• Contact information for FDA resources.
• Crucially, it includes the "Indications for Use" for the devices.

There is no mention of:

• Specific performance metrics or acceptance criteria for the TENS device's functionality (e.g., electrical output, consistency, safety).
• Any studies involving test sets, training sets, ground truth establishment, expert readers, or multi-reader multi-case (MRMC) studies. These types of studies are typically associated with AI/ML-enabled devices, diagnostic imaging devices, or devices requiring clinical performance evaluation beyond basic safety and electrical parameters.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for test sets.
3. Number and qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC studies or effect sizes for human reader improvement with AI.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

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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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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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KTR-2240,KTR-2250,KTR-2610,KTR-2640,KTR-2650:(TENS, EMS, FITNESS)

TENS (Mode~20): 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 2140): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 4150): Improvement of abdominal tone, strengthening of the abdominal muscle development of firmer abdomen.

KTR-2241,KTR-2251,KTR-2242,KTR-2252,KTR-2611,KTR-2641,KTR-2612,KTR-2612,KTR-2652: (TENS)

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

The Low-frequency Multi-function physiotherapy instrument is a portable and battery powered multifunctional device. The low-frequency multi-function physiotherapy instrument (models: KTR-2240, KTR-2250, KTR-2610, KTR-2640, KTR-2650) offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulation. It has 50 operation modes, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. And the TENS (Mode 120) is to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, 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 2140) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. FITNESS (Mode 41~50) is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

The low-frequency multi-function physiotherapy instrument (models: KTR-2241, KTR-2242, KTR-2252, KTR-2611, KTR-2641, KTR-2612, KTR-2612, KTR-2652) offering Transcutaneous Electronic Nerve Stimulator (TENS). It has 15 operation mode, and 6 automatic mode, which can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation. The TENS (Mode 1-15) is intended 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.

The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys.

The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode.

The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit.

The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

The medical device in question is a "Low-frequency Multi-function physiotherapy instrument" that functions as a Transcutaneous Electrical Nerve Stimulator (TENS), Electrical Muscle Stimulation (EMS), and/or a FITNESS device depending on the model. This is a Class II device.

The provided document describes a 510(k) submission (K200177) where the manufacturer, Shenzhen Kentro Medical Electronics Co., Ltd, aims to demonstrate substantial equivalence to previously cleared predicate devices. The study conducted to prove the device meets acceptance criteria is primarily based on nonclinical (bench) testing and comparison of technical specifications with predicate devices, rather than a clinical trial with human subjects.

Here's the detailed breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely implied by compliance with recognized electrical safety and biocompatibility standards, and by demonstrating similar technical specifications to predicate devices. The "reported device performance" is essentially the subject device's specifications and its compliance with stated standards.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable in the context of a clinical test set. The submission relies on bench testing results, comparing the new device's technical specifications and compliance with standards against predicate devices and in vitro tests for biocompatibility. There is no mention of a patient-based "test set" for performance evaluation.
• Data Provenance: The data comes from nonclinical (bench) testing performed by the manufacturer, or through documentation provided by suppliers for components (e.g., electrode pads). The report does not specify the country of origin for these specific tests, but the manufacturer is based in China. The data is retrospective in the sense that it's reported after the tests were conducted, but it's not "retrospective clinical data" as no clinical trials are described.

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

• Number of Experts: Not applicable. The ground truth, in this context, is established by international standards (IEC, ISO) for electrical safety, EMC, usability, and biocompatibility, as well as FDA guidance for software. These standards themselves are developed by expert consensus within their respective fields, but individual experts are not explicitly cited as establishing ground truth for a discrete test set in this document.
• Qualifications of Experts: Not applicable in the context of a clinical test set. The underlying expertise is embedded in the standards and regulatory guidance documents.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no clinical test set requiring expert adjudication. The "adjudication" here is the FDA's review of the submitted technical documentation and its determination of substantial equivalence based on a comparison to recognized standards and predicate devices.

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 physiotherapy instrument (TENS/EMS/FITNESS), not an AI-powered diagnostic imaging device or a device involving "human readers" or AI assistance in interpretation.

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

• Not applicable. This device does not involve an algorithm generating interpretations or diagnoses that would require standalone performance evaluation. Its "performance" is based on its electrical output characteristics and meeting safety standards.

7. The Type of Ground Truth Used

• The "ground truth" used is defined by adherence to international consensus standards for medical device safety and performance (e.g., IEC 60601 series, ISO 10993 series) and technical specifications that fall within the established range of legally marketed predicate devices. For biocompatibility, the ground truth is established by in vitro test results against ISO standards.

8. The Sample Size for the Training Set

• Not applicable. This device does not employ machine learning or AI that requires a "training set" of data.

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

• Not applicable, as no training set is used.

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

Transcutaneous Electronic Nerve Stimulator (Models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2491, KTR-2492, KTR-2493, KTR-2494) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator. They can give certain electrical pulse through electrode pads placed on the skin to help users to enjoy body stimulation.

For models: KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2301, KTR-2302, KTR-2342 have 3 operation modes:

For models: KTR-2491, KTR-2493, KTR-2493, KTR-2494 have 15 operation modes, 9 manual mode, and 6 automatic mode. They can be remotely controlled with an accessory remote control. And there is a LCD displays on remote control, which display mode and treatment time.

The electronic stimulator module has unified the operating elements of ON/OFF button. Intensity adjust button and Mode selection button.

The device is equipped with accessories of electrode pads, batteries and remote control (For KTR-249X series).

The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

The provided text describes a 510(k) premarket notification for a Transcutaneous Electronic Nerve Stimulator (TENS) and does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically understood in the context of diagnostic or prognostic AI/ML medical devices.

Instead, this document is a regulatory submission demonstrating substantial equivalence to previously cleared predicate devices. The "Test Summary" and "Comparison to predicate device" sections outline engineering tests and comparisons of technical specifications, rather than clinical performance studies against specific acceptance criteria for diagnostic accuracy.

Therefore, an output table as requested cannot be fully populated. However, I can extract the relevant information regarding the tests performed to support the "substantial equivalence" claim.

Here's a breakdown of what is available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a TENS device, the "acceptance criteria" are related to industrial standards and engineering specifications rather than diagnostic performance metrics (e.g., sensitivity, specificity, AUC) typically seen with AI/ML devices. The reported "performance" is compliance with these standards and comparison of technical specifications to predicate devices.

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

The document does not describe a clinical "test set" and therefore does not specify a sample size or data provenance in the context of clinical performance evaluation (e.g., diagnostic accuracy). The testing described is primarily engineering bench testing.

3. 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 context of expert consensus for AI/ML performance is not discussed for this device. The evaluations were based on compliance with engineering standards.

4. Adjudication method for the test set

Not applicable. There was no clinical "test set" requiring adjudication.

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 a TENS device, not an AI/ML diagnostic or prognostic tool.

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

Not applicable. This is a TENS device, not an AI/ML algorithm. Its performance is inherent in its electrical output and user interface, which are assessed through engineering and usability tests.

7. The type of ground truth used

For the engineering tests (electrical safety, EMC, biocompatibility, usability, software verification, waveform output), the "ground truth" is defined by the requirements and specifications within the referenced international standards (IEC 60601 series, ISO 10993 series, IEC 62366-1) and FDA guidance documents. Compliance is assessed against these established technical benchmarks.

8. The sample size for the training set

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

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

Not applicable. There is no training set for this type of device.

Summary of the study that proves the device meets the acceptance criteria (based on available information):

The device's safety and performance were evaluated through a series of lab bench tests to demonstrate compliance with recognized international standards and FDA guidance for TENS devices. These tests included:

• Electrical safety tests: Performed according to IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-10 standards.
• Electromagnetic compatibility (EMC) tests: Performed according to IEC 60601-1-2 standard.
• Biocompatibility tests: Performed according to ISO 10993-1, ISO 10993-5, and ISO 10993-10 standards for the electrode pads.
• Usability tests: Performed according to IEC 62366-1 standard.
• Software verification and validation tests: Performed according to FDA "Guidance for Pre-Market Submissions and for Software Contained in Medical Devices."
• Waveform test report: Conducted to verify the output specifications of the device according to relevant FDA guidance documents for TENS and Powered Muscle Stimulators.

The document asserts that these tests, along with a detailed comparison of technological characteristics, features, specifications, materials, mode of operation, and intended use against three legally marketed predicate devices, demonstrate that the subject device is Substantially Equivalent (SE) to the primary predicate device. The differences noted (e.g., in number of output modes, maximum output voltage/current, pulse duration, pulse frequency) were concluded not to raise new issues of safety or effectiveness, as they either fell within acceptable ranges or aligned with existing requirements.

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KTR-2210, KTR-2220, KTR-2230: (TENS, EMS, FITNESS)

TENS (Mode1~20): 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 21~40): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. FITNESS (Mode 41-50): Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen.

KTR-2211, KTR-2221, KTR-2231, KTR-2212, KTR-2222, KTR-2232: (TENS)

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

Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) is a portable and battery powered multifunctional device, offering Transcutaneous Electronic Nerve Stimulator (TENS), Electronic Muscle Stimulator (EMS) and FITNESS qualities.

Low-frequency Multi-function physiotherapy instrument (Models: KTR-2210) has 50 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body massage.

The electronic stimulatory module has the operating elements of ON/OFF Key, Display screen, Mode Selection key and Intensity Modification keys.

The LCD display screen can show selected mode and program, output intensity, stimulate frequency, and time remaining of an application mode.

The device is equipped with accessories of electrode wires, and batteries. The electrode wire is used to connect the patches to the main unit. All the accessories, including electrode pads, electrode wire, and batteries can only be changed by special person.

The electrode pads are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

The provided text describes a 510(k) premarket notification for a Low-frequency Multi-function physiotherapy instrument. This document primarily focuses on establishing substantial equivalence to predicate devices through a comparison of technical specifications and an assessment of safety and performance testing against recognized standards. It does not detail a study involving specific acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity) for an AI/CADe device, as the device itself is a physiotherapy instrument, not a diagnostic imaging AI.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, expert qualifications, HRMC studies, standalone performance, ground truth establishment for training, etc.) are not applicable in this context.

However, I can extract the closest equivalents to acceptance criteria and reported "performance" based on the provided safety and performance tests.

Here's a breakdown of the information that can be extracted:

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

For a physiotherapy instrument, "acceptance criteria" relate to meeting safety and performance standards. The "reported device performance" is that the device complies with these standards.

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

This information is not provided in the document. The testing described is primarily bench testing and compliance with standards, not a clinical trial with a "test set" of patients or data in the typical sense of AI/CADe validation.

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/provided. The device is a physiotherapy instrument, not a diagnostic device requiring expert interpretation for ground truth establishment.

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

This information is not applicable/provided. Adjudication is typically for expert review of cases in diagnostic studies, which is not relevant here.

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/provided. The device is a therapeutic physiotherapy instrument, not an AI-assisted diagnostic tool.

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

This information is not applicable/provided. The device is not an algorithm for standalone performance assessment in the context of diagnostic AI. The "performance" assessment is about meeting electrical, EMC, biocompatibility, and output specifications.

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

The "ground truth" for the device's acceptable performance is defined by compliance with established international and FDA-specific standards and guidances for electrical safety, electromagnetic compatibility, biocompatibility, usability, software, and waveform output specifications. This effectively serves as the "ground truth" for its safety and effectiveness for its intended use.

8. The sample size for the training set

This information is not applicable/provided. The document does not describe a training set for an AI/ML algorithm.

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

This information is not applicable/provided. (See point 8)

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

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.

There are three models of Transcutaneous Electrical Nerve Stimulator which are KTR-206, KTR-208 and KTR-209. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, exquisite and portable; 2) various modes to satisfy different demands, applicable to a wider range of people; 3) wonderful electric pulse combination. 0~16 levels can be adjusted and chosen according to personal preference; 4) LCD display make the operation simple and easy; 5) integrated design of the body is easy for function operation and simple in practical use; 6) battery power display; 7) dual channel output. user can cover more treatment areas. For KTR-208 and KTR-209, the two channels are independently controlled for intensity adjustment which is more convenient to use.

The Transcutaneous Electrical Nerve Stimulator is mainly composed of the host and electrode patches. And it uses AAA batteries for power supply. To start therapy, first insert batteries, then paste the electrode patches 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.

The provided text is a 510(k) Summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. This document is a premarket submission to the FDA demonstrating that the new device is substantially equivalent to a legally marketed predicate device.

Here's an analysis of the provided text, addressing your specific questions, keeping in mind that a 510(k) typically focuses on substantial equivalence rather than a full clinical trial to establish new clinical efficacy. Therefore, some information, like detailed acceptance criteria from a clinical study or human reader performance, may not be explicitly present as they aren't usually required for a 510(k) for this type of device.

1. Table of Acceptance Criteria and the Reported Device Performance

For a TENS device, acceptance criteria in a 510(k) submission primarily revolve around safety, electrical performance, and substantial equivalence to a predicate device, rather than clinical efficacy metrics (like pain reduction improvement percentage). The document establishes "substantial equivalence" as the primary acceptance criterion.

The table below summarizes the comparison to the predicate device, which serves as the de-facto performance standard for substantial equivalence. The "Acceptance Criteria" are implied by the predicate values and compliance with recognized standards.

Notes on Differences and Compliance:

• Number of output modes: Targeted device has 5, predicate has 8, reference devices have more. The submission argues this difference doesn't affect safety and effectiveness as the output parameters of each mode were tested and passed relevant IEC standards (Note 1).
• Appearance, weight, dimensions: Differ from predicate but are deemed insignificant and do not affect safety and effectiveness (Note 2).
• Maximum Average Current: Different from predicate but all targeted device values (8.04mA, 6.89mA, 12.39mA) are < 50mA, complying with IEC 60601-2-10 requirements (Note 3), therefore not affecting safety and effectiveness.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is primarily a non-clinical study involving various tests to demonstrate compliance with recognized electrical safety and performance standards, and comparison of technical characteristics to a legally marketed predicate device. The goal is to establish "Substantial Equivalence (SE)" to the predicate, K140168.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary regarding a TENS device. This document describes non-clinical testing of the device itself (electrical parameters, safety, software verification) rather than testing on human subjects for clinical efficacy. There is no "test set" of patient data mentioned for evaluation of diagnostic or therapeutic performance in humans.
• Data Provenance: The data provenance is from non-clinical bench testing of the new Transcutaneous Electrical Nerve Stimulator device and comparison of its specifications to the predicate and reference devices. This is not patient data from a specific country or retrospective/prospective study.

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

• Not applicable. There is no "ground truth" related to patient outcomes or diagnoses in this 510(k) summary. The "ground truth" for the non-clinical tests would be the specifications and requirements outlined in the referenced standards (e.g., IEC 60601-1, IEC 60601-1-2) which are established by expert consensus in regulatory and technical committees.

4. Adjudication method for the test set

• Not applicable. As there is no clinical test set with patient data requiring interpretation or consensus, no adjudication method like 2+1 or 3+1 was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a TENS device, which directly delivers electrical stimulation for pain relief. It is not an AI-powered diagnostic or assistive technology that human "readers" would use. Therefore, an MRMC comparative effectiveness study involving AI assistance is entirely outside the scope of this device and submission.

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

• Not applicable in the sense of an algorithm performance study. The device is a physical TENS unit. Its "standalone" performance is measured by its electrical output characteristics and compliance with safety standards, as detailed in the technical comparison and non-clinical tests.

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

• The "ground truth" in this context is established by international consensus standards for medical electrical equipment, particularly those related to TENS devices (e.g., IEC 60601 series). These standards define safety and performance requirements that the device must meet. Additionally, the technical specifications of the predicate device serve as a benchmark for demonstrating substantial equivalence.

8. The sample size for the training set

• Not applicable. This device is not an algorithm that requires a "training set" of data.

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

• Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.

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

The Low-Frequency Therapy Instrument is a product that adopts modern electronic science and technology to produce low-frequency electrical pulse and transmit that through the skin to the underlying peripheral nerves by electrodes, in order to reach the therapeutic aim.

There are three models of Low-Frequency Therapy Instrument which are KTR-201, KTR-202, KTR-203. Their technical parameters are slightly different, but they share the basically same characteristics: 1) They are small, and exquisite; 2) they have different treatment modes which can satisfy various demands, thus can be used by a wider range of people; 3) LCD display with a big screen makes the operation easy and clear, and the contents displayed on LCD can guide the treatment.

The Low-Frequency Therapy Instrument is mainly composed of the host and electrode patches and it uses AAA batteries for power supply. To start therapy, first insert batteries, then paste the electrode patches onto treatment areas and press power button to turn the power on. The modes and intensity can be selected according to needs. The current status is displayed on LCD.

This FDA 510(k) submission describes the "Low-Frequency Therapy Instrument" (Models: KTR-201, KTR-202, KTR-203), a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.

Here's an analysis of the acceptance criteria and supporting studies based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, the acceptance is implied by demonstrating substantial equivalence to a predicate device (Shenzhen OSTO Technology Company Limited's Health Expert Electronic Stimulator, Model AST-300C and AST-300D, K133929) and compliance with relevant voluntary standards.

The "Technological characteristics and substantial equivalence" table (pages 5-6) serves as the core comparison for "performance." Key metrics and their comparison to the predicate are:

The primary "acceptance criteria" here are substantial equivalence to the predicate device and compliance with recognized IEC standards. The study aims to demonstrate that its electrical characteristics and safety parameters are comparable or fall within accepted safety limits defined by these standards, despite some differences from the predicate.

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

The document describes non-clinical tests only. There is no mention of a clinical test set involving human subjects for performance or efficacy evaluation. The "data provenance" therefore refers to the origin of engineering and safety test results, rather than clinical data.

• Sample Size: Not applicable as no clinical test set is described. The relevant "samples" would be the units of the device models (KTR-201, KTR-202, KTR-203) used for engineering and electrical testing. The exact number of units tested is not specified but is typically a small number for such compliance testing.
• Data Provenance: The tests are non-clinical (engineering, electrical, software, biocompatibility). These tests were conducted by the manufacturer (Shenzhen Kentro Medical Electronics Co., Ltd) or accredited labs. The nationality is implied to be China, where the manufacturer is located. All tests are inherently prospective as they are conducted specifically to support this 510(k) submission.

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

Not applicable. As no clinical test set is described, there is no "ground truth" established by medical experts for performance or efficacy. The "ground truth" in this context would be the specifications and requirements of the relevant IEC standards (e.g., IEC60601-1, IEC60601-2-10) and FDA guidance, against which the device's electrical outputs were measured. Compliance is determined by whether the measured parameters fall within the limits set by these standards.

4. Adjudication Method for the Test Set

Not applicable. Since there's no clinical data or human assessment of primary endpoints, no expert adjudication method (like 2+1, 3+1) is described or needed.

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

No. An MRMC comparative effectiveness study is a type of clinical study involving multiple readers (e.g., radiologists) evaluating multiple cases (e.g., medical images) to compare the diagnostic performance of different methods or devices. This is not applicable to a TENS device, which provides direct therapeutic electrical stimulation, not diagnostic information. The submission focuses on substantial equivalence based on technical specifications and safety standards, not comparative clinical effectiveness.

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

The device itself is a standalone therapeutic device; it is not an algorithm that requires human input to interpret its output in the same way an AI-powered diagnostic tool would. Its "standalone performance" is implicitly demonstrated through the non-clinical tests (electrical output, safety, software validation) showing it meets its design specifications and relevant standards. The device is intended for over-the-counter (OTC) use by consumers without professional human-in-the-loop operation, reflecting its standalone nature.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is:

• Engineering/Performance Specifications: The device's own design specifications for output parameters (voltage, current, frequency, pulse duration, waveform).
• Voluntary Consensus Standards: The requirements and limits defined by international standards such as IEC 60601-1 (general safety), IEC 60601-1-11 (home healthcare environment), IEC 60601-2-10 (nerve and muscle stimulators), and IEC 60601-1-2 (EMC). For biocompatibility, ISO 10993-5 and ISO 10993-10 for the electrode patches.
• Predicate Device Characteristics: The established safety and effectiveness profile of the legally marketed predicate device (K133929), used as a benchmark for substantial equivalence.

There is no pathology or outcomes data from a clinical trial presented as ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is an electrical stimulation device, not an AI/machine learning algorithm that requires a "training set" of data.

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

Not applicable, as no training set is used for this type of device.

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