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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.

Device Description

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.

AI/ML Overview

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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K Number

K190673

Device Name

Health Expert Electronic Stimulator

Manufacturer

Shenzhen OSTO Technology Company Limited

Date Cleared

2019-12-12

(272 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K133929

Predicate For

K211736

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Elements of Comparison (Implied Acceptance Criteria)	Subject Device Performance	Predicate Device Performance	Remark (Fulfillment of "Acceptance" - SE = Substantially Equivalent)
Intended Use (PMS & TENS)	PMS (Mode 1~~8): Stimulate healthy muscles for performance. TENS (Mode 9~~25): Temporary pain relief for sore/aching muscles due to strain.	PMS (Mode 1~~8): Stimulate healthy muscles for performance. TENS (Mode 9~~25): Temporary pain relief for sore/aching muscles due to strain.	SE
Power Source(s)	Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A	Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A	SE
Method of Line Current Isolation	Type BF Applied Part	Type BF Applied Part	SE
Patient Leakage Current	NC (Not specified numerically, implying compliance)	AC: 54.5μA, DC: 0.5μA	SE (implies within acceptable limits vs predicate)
SFC (Single Fault Condition) Leakage Current	NC (Not specified numerically, implying compliance)	AC: 120.0μA, DC: 0.6μA	SE (implies within acceptable limits vs predicate)
Avg DC current (device on, no pulses)	< 0.01μA	< 0.01μA	SE
Number of Output Channels	2	2	SE
Number of Output Modes	25	25	SE
Output Intensity Level	99 steps	99 steps	SE
Synchronous or Alternating?	Synchronous	Synchronous	SE
Method of Channel Isolation	Voltage Transform Isolation; "Body+" and "Body-" buttons for body channel, "Sole+" and "Sole-" buttons for feet channel	Voltage Transform Isolation; "Body ▼" and "Body▼" buttons for body channel, "Sole ▲" and "Sole ▼ " buttons for feet channel	SE
Regulated Current or Voltage?	Voltage Control	Voltage Control	SE
Software/Firmware/Microprocessor Control?	Yes	Yes	SE
Automatic Overload Trip	No	No	SE
Automatic No-Load Trip	No	No	SE
Automatic Shut Off	Yes	Yes	SE
User Override Control	Yes	Yes	SE
Indicator Display	On/Off Status, Low Battery, Voltage/Current Level	Yes (for Status, Voltage/Current), No (for Low Battery)	SE (minor display difference for low battery, considered not raising new safety/effectiveness)
Timer Range	25min	25min	SE
Weight	1.9Kg (Without accessories)	2Kg (Without accessories)	SE (Note 1: minor difference, no safety/effectiveness issue)
Dimensions	429.1mm x 426.6mm x 153.8mm	428mm x 428.8mm x 185mm	SE (Note 1: minor difference, no safety/effectiveness issue)
Housing Materials and Construction	Main unit: ABS plastic	Main unit: ABS plastic	SE
Waveform	Pulsed, symmetric, biphasic	Pulsed, symmetric, biphasic	SE
Shape	Rectangular, with interphase interval	Rectangular, with interphase interval	SE
Maximum Output Voltage	44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ	44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±20% @ 10KΩ	SE
Maximum Output Current	88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ	88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ	SE
Pulse Duration	120µs	120µs	SE
Pulse Frequency	77.3Hz	77.3Hz	SE
Net Charge (per pulse)	0µC @ 500Ω; Method: Balanced waveform	0µC @ 500Ω; Method: Balanced waveform	SE
Maximum Phase Charge	10.56µC @ 500Ω	12.78µC @ 500Ω	SE
Maximum Average Current	1.63mA @ 500Ω	0.968mA @ 500Ω	SE
Maximum Current Density (r.m.s)	0.0326mA/cm² @ 500Ω	0.235mA/cm² @500Ω	SE
Maximum Average Power Density	0.000651mW/cm² @ 500Ω	1.38mW/cm² @ 500Ω	SE
ON Time	0.6s	0.6s	SE
OFF Time	0.6s	0.6s	SE
Environment for operating	Temperature: 5 ~ 45°C; Humidity: 20 ~ 65% RH	Temperature: 5 ~ 45°C; Humidity: 20 ~ 65% RH	SE
Environment for storage	Temperature: 0 ~ 45°C, Humidity: 10 ~ 90% RH; Electrode Pad: 10~20°C	Temperature: 0 ~ 45°C, Humidity: 10 ~ 90% RH; Electrode Pad: 10~20°C	SE
Biocompatibility	All user directly contacting materials are compliant with ISO10993-5 and ISO10993-10 requirements.	All user directly contacting materials are compliant with ISO10993-5 and ISO10993-10 requirements.	SE
Electrical Safety	Comply with IEC 60601-1 and IEC 60601-2-10	Comply with IEC 60601-1 and IEC 60601-2-10	SE
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	SE

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

This information is not provided in terms of patient data. The "test set" refers to the specific physical devices and components tested for laboratory and engineering compliance (e.g., electrical safety, EMC, biocompatibility).
Data Provenance: The tests are indicated to be "lab bench testing" (P. 4, section 6) based on international standards (IEC, ISO). The country of manufacture is China, and the submitting entity is Shenzhen OSTO Technology Company Limited. There is no mention of patient data or clinical studies in a retrospective or prospective sense.

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

This concept of "experts establishing ground truth" is not applicable in the context of this 510(k) submission, as it relates to AI/ML or diagnostic performance based on patient data.
The device's performance is verified against engineering standards and specifications, likely by trained laboratory personnel.

4. Adjudication method for the test set:

Not applicable, as this refers to a process typically used in clinical studies or for establishing ground truth in AI/ML performance evaluation, 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:

Not applicable. This device is not an AI-assisted diagnostic or therapeutic tool.

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

Not applicable, as this device does not utilize an algorithm in the AI/ML sense to provide standalone diagnostic or therapeutic performance.

7. The type of ground truth used:

For this device, "ground truth" equates to the established engineering specifications and limits for electrical stimulation devices, as well as the requirements of relevant international standards (e.g., IEC 60601 series for electrical safety and EMC, ISO 10993 series for biocompatibility). The tests confirm the device operates within these predefined, acceptable parameters.

8. The sample size for the training set:

Not applicable, as there is no AI/ML training set involved for this device.

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

Not applicable, as there is no AI/ML training set involved for this device.

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