Search Results

PMS (Mode 18)
It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.
TENS (Mode 925)
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, as well as certain non-electrical rolling massage through one massage roller.
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.

Here's a breakdown of the acceptance criteria and study information for the Health Expert Electronic Stimulator, Model AST-300C and AST-300D, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly define "acceptance criteria" as a pass/fail threshold for specific metrics. Instead, it demonstrates substantial equivalence to predicate devices by showing that the subject device's performance aligns with relevant safety and performance standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, IEC 62366) and FDA guidance documents.

The table below summarizes the device's technical specifications and compares them to the predicate devices, highlighting where the subject device "complies" with the established standards and guidance, which effectively serves as its acceptance criteria. "SE" in the remarks column generally means "Substantially Equivalent," implying the feature meets the necessary criteria for equivalence.

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

The document describes lab bench testing for safety and performance. This implies the test "set" consists of the device prototypes themselves, rather than a dataset of patient information.

• Sample Size: Not applicable in the context of a dataset. The tests were performed on the device models (AST-300C and AST-300D).
• Data Provenance: The testing appears to have been conducted by Shenzhen OSTO Technology Company Limited, likely in China, as indicated by the company's address. The data is prospective in the sense that the tests were performed specifically for this 510(k) submission to demonstrate compliance.

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

This section is not applicable (N/A) as the submission details engineering and electrical safety testing, not a clinical study involving subjective interpretation of patient data by experts. The "ground truth" for these tests is defined by international standards (IEC, ISO) and FDA guidance documents.

4. Adjudication Method for the Test Set

N/A. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) to establish a consensus "ground truth" when a definitive objective truth (like pathology) is unavailable. This document reports on objective engineering and performance tests, not subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study would compare human reader performance with and without AI assistance, which is irrelevant for an electronic stimulator device that is not an AI/imaging diagnostic tool.

6. Standalone Performance Study

Yes, the studies conducted were essentially standalone performance studies of the device based on engineering and safety standards. The document states:

• "Health Expert Electronic Stimulator has been evaluated the safety and performance by lab bench testing..."
• The tests include electrical safety, electromagnetic compatibility, biocompatibility, usability, software verification and validation, and waveform tests.
  These are all tests of the device itself, without human interaction in a clinical diagnostic context as one might find with an AI-driven image analysis tool.

7. Type of Ground Truth Used for the Test Set

The ground truth for the device's acceptable performance is defined by:

• International Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, ISO 10993-5, ISO 10993-10, IEC 62366.
• FDA Guidance Documents: "Guidance for Pre Market Submissions and for Software Contained in Medical Devices," "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use," and "Guidance for Powered Muscle Stimulator for Muscle Conditioning."

Performance metrics (e.g., leakage current, output voltage, pulse frequency) are compared against the limits or requirements specified in these standards and guidance documents.

8. Sample Size for the Training Set

N/A. This device is an electronic stimulator, not an AI or machine learning model that requires a "training set" of data. The device's functionality is based on direct electrical engineering principles and fixed programming, not learned behavior from a dataset.

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

N/A, as there is no training set for this type of device.

Ask a specific question about this device