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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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