Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device