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PMS (Mode 1~8)

It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

• TENS (Mode 9~25)
  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.

Health Expert Electronic Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.

Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.

The electronic stimulatory module has the operating elements of ON/OFF Switch, remote control ON/OFF key, Display screen, Heating adjust key, Mode Selection key and Intensity Modification keys.

The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.

The Heating adjust key can help user to select a temperature for warming sensation of the foot range 30 to 40 degree C, the superficial heating time is same as the treatment time you selected. The superficial heating and electrical stimulation can apply simultaneously or apply alternatively. The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the main unit; the adapter wire is used to connect the adapter to the device.

The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

The provided text is a 510(k) Summary for the Health Expert Electronic Stimulator (model: AST-300L). It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence.

However, it does not describe:

• Acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a software or AI/ML device.
• A study that proves the device meets such performance acceptance criteria through the analysis of a test set, expert adjudication, or reader studies.
• Information regarding training sets, ground truth establishment methods for AI/ML, or the number of expert readers for an MRMC study.

The "Test Summary" section (Page 6) indicates various bench tests and standards compliance for electrical safety, electromagnetic compatibility, biocompatibility, usability, and software verification/validation. It also mentions a waveform test report. These are engineering and regulatory compliance tests, not a clinical or performance study of an AI/ML algorithm that would involve a test set, ground truth, or expert readers.

The conclusion of the document is based on substantial equivalence to predicate devices through technological characteristics and safety standards adherence, rather than demonstrating clinical performance of an AI/ML system.

Therefore, based solely on the provided text, the requested information on acceptance criteria and a study proving performance for an AI/ML device cannot be extracted. The device in question appears to be a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), which is a hardware device for pain relief and muscle stimulation, not an AI/ML-driven diagnostic or therapeutic software device.

In summary, none of the specific points (1-9) related to AI/ML device acceptance criteria and performance study can be addressed from this document because it is for a physical medical device, not an AI/ML software.

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PMS (Mode 1~8)

It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS (Mode 9~25)

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.

Health Expert Electronic Stimulator is a portable and adapter powered multifunctional device, offering both Transcutaneous Electronic Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities.

Health Expert Electronic Stimulator has 25 operation modes, which can give certain electrical pulse through 4 pcs of electrode pads placed on the skin to help users to enjoy body stimulation and 2 big electrode pads in Electrode Silicon Area for feet placed on the main unit to help users to enjoy sole stimulation.

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

The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application mode.

The device is equipped with accessories of electrode wire, adapter, remote controller. The electrode wire is used to connect the pads to the main unit; the adapter wire is used to connect the adapter to the device.

The electrode pads, which are provided by Shenzhen Context Kang Technology Company Limited complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

The provided text is a 510(k) Pre-Market Notification for a medical device, the "Health Expert Electronic Stimulator." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials.

Therefore, the document does not contain the type of AI-specific acceptance criteria or detailed study information typically found for novel AI/ML medical devices. The device in question is an electronic stimulator, not an AI/ML-driven diagnostic or therapeutic device.

The "Test Summary" and "Comparison to predicate device" sections outline the types of testing and comparisons performed for this device. These are primarily engineering, electrical, and biocompatibility tests, alongside a comparison of technical specifications to a previously cleared device.

Specifically, the document does not provide information on:

• AI-specific Acceptance Criteria: The device is not an AI/ML product.
• Study Proving Device Meets Acceptance Criteria for AI: No AI-specific studies were conducted because the device is not AI.
• Sample size for test set (for AI): Not applicable.
• Data provenance (for AI): Not applicable.
• Number of experts for ground truth (for AI): Not applicable.
• Qualifications of experts (for AI): Not applicable.
• Adjudication method (for AI): Not applicable.
• MRMC comparative effectiveness study for AI: Not applicable.
• Standalone (algorithm-only) performance for AI: Not applicable.
• Type of ground truth used (for AI): Not applicable.
• Sample size for training set (for AI): Not applicable.
• How ground truth for training set was established (for AI): Not applicable.

The "acceptance criteria" for this device are implicitly derived from the general and special controls for Class II medical devices, and the demonstrated substantial equivalence to the predicate device (K133929). This equivalence is shown through comparison of intended use, technical specifications, and compliance with relevant electrical safety, EMC, biocompatibility, usability, and software verification/validation standards.

Here's what the document does describe in terms of performance and testing:

1. Table of Acceptance Criteria (Implied by Equivalence) and Reported Device Performance:

The "Comparison to predicate device and conclusion" section (Pages 5-6) serves as the primary "performance" and "acceptance" comparison. The acceptance is based on demonstrating that the subject device's characteristics and performance are substantially equivalent to the predicate, and that any differences do not raise new safety or effectiveness issues.

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