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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

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

Electronic Muscle 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 models AST-300A and AST-300W have 9 buttons which is more than other models. Compared with other models, the "Time+" and "Time-" buttons are used to adjust the treatment time.

The LCD display screen can show selected mode, output intensity of body and/or sole, and time remaining of an application model. The device is equipped with accessories of electrode pads, 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 are complying with the biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization), are interchangeable.

AI/ML Overview

This document is a 510(k) Summary for an Electronic Muscle Stimulator, demonstrating substantial equivalence to a predicate device. It is not a report for an AI-powered medical device and therefore does not contain information typically found in such reports regarding acceptance criteria for AI performance, specific studies with test sets, expert ground truth establishment, MRMC studies, or training set details.

Based on the provided text, here's what can be extracted, and where limitations exist:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, AUC). Instead, it compares the subject device's specifications to those of a predicate device to demonstrate substantial equivalence. The acceptance is implicitly shown by meeting the same or similar specifications as the already cleared predicate device, and demonstrating that any differences do not raise new safety or effectiveness issues.

Here is a table based on the "Elements of Comparison" between the Subject Device and Predicate Device, which serves as the "performance" for this type of device:

Acceptance Criteria (e.g., Predicate Device Performance)	Reported Device Performance (Subject Device)	Remark
Device Name and Model: Health Expert Electronic Stimulator Model: AST-300F, AST-300H, AST-300J	Electronic Muscle Stimulator Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W	--
510(k) Number: K190673	Applying (K211736)	--
Intended Use (PMS): To stimulate healthy muscles to improve and facilitate muscle performance.	Same	SE (Substantially Equivalent)
Intended Use (TENS): Temporary relief of pain associated with sore and aching muscles in shoulder, waist, back, neck, arm, leg, foot due to strain from exercise or normal household work activities by applying current to stimulate nerve.	Same	SE
Power Source(s): Adaptor Input: 100-240Vac, 50-60Hz, 0.1A; Output: 5Vdc, 1A; Unit Input: 5Vdc, 1A	Same	SE
Method of Line Current Isolation: Type BF Applied Part	Same	SE
Patient Leakage Current (NC): AC: 54.5 µA, DC: 0 µA	AC: 54.5 µA, DC: 0.5 µA	SE
Patient Leakage Current (SFC): AC: 120.0 µA, DC: 0 µA	AC: 120.0 µA, DC: 0.6 µA	SE
Average DC current through electrodes (device on but no pulses): < 0.01 µA	Same	SE
Number of Output Channels: 2	Same	SE
Number of Output Modes: 25	Same	SE
Output Intensity Level: 99 steps	Same	SE
Synchronous or Alternating?: Synchronous	Same	SE
Method of Channel Isolation: Voltage Transform Isolation, "Body+" and "Body-" buttons for body channel, "Sole+" and "Sole-" buttons for feet channel	Same	SE
Regulated Current or Regulated Voltage?: Voltage Control	Same	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): Yes	Yes	SE
Indicator Display (Low Battery): No	No	SE
Indicator Display (Voltage/Current Level): Yes	Yes	SE
Timer Range: 25 min (default)	AST-300N, AST-300S, AST-300T, AST-300V: 25 min (default); AST-300A and AST-300W: can adjust the time (5-25min)	SE
Weight: 1.9Kg (Without accessories)	Varies by model (e.g., AST-300A: 1.62kg, AST-300W: 1.99kg)	SE Note (Differences do not raise safety/effectiveness issues)
Dimensions: 429.1mm x 426.6mm x 153.8mm	Varies by model (e.g., AST-300A: 209.7x215.3x52.3mm, AST-300W: 464.7x419.6x181mm)	SE Note (Differences do not raise safety/effectiveness issues)
Housing Materials and Construction: Main unit: ABS plastic	Same	SE
Waveform: Pulsed, symmetric, biphasic	Same	SE
Shape: Rectangular, with interphase interval	Same	SE
Maximum Output Voltage: 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±20% @ 10KΩ	44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ	SE (Note: Subject device's 10KΩ tolerance is ±10% vs predicate's ±20%, meaning it's tighter, which is acceptable)
Maximum Output Current: 88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ	Same	SE
Pulse width: 120µs	Same	SE
Pulse frequency: 77.3Hz	Same	SE
Net Charge (per pulse): 0µC @ 500Ω; Method: Balanced waveform	Same	SE
Maximum Phase Charge: 10.56μC @ 500Ω	Same	SE
Maximum Average Current: 1.63mA @ 500Ω	Same	SE
Maximum Current Density (r.m.s): 0.0326mA/cm² @ 500Ω	Same	SE
Maximum Average Power Density: 0.0000266mW/cm² @ 500Ω	Same	SE
ON Time: 0.6s	Same	SE
OFF Time: 0.6s	Same	SE
Environment for operating: Temperature: 5 ~ 45° C; Humidity: 20 ~ 65% RH	Same	SE
Environment for storage: Temperature: 0 ~ 45°C, Humidity: 10 ~ 90% RH; Electrode Pad: 10~20°C	Same	SE
Biocompatibility: All user directly contacting materials are compliance with ISO10993-5 and ISO10993-10 requirements.	Same	SE
Electrical Safety: Comply with IEC 60601-1 and IEC 60601-2-10	Same	SE
EMC: Comply with IEC 60601-1-2	Same	SE

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

Sample Size: Not applicable. This submission relies on substantial equivalence to an existing device, not a new clinical study.
Data Provenance: Not applicable for a typical "test set" as understood for AI performance. The provenances relate to the standards adherence (e.g., IEC, ISO standards for electrical safety, EMC, biocompatibility) through lab bench testing. The country of origin of the device manufacturer is China.

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

Not applicable. This device is an Electronic Muscle Stimulator, not a device that processes complex data (like medical images) requiring expert interpretation for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. No test set requiring adjudication of findings is described.

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 is not an AI-assisted device.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this type of device, "ground truth" is established by adherence to recognized performance and safety standards (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility). The testing mentioned (Electrical safety, EMC, Biocompatibility, Usability, Software V&V) are based on these established engineering and safety requirements.

8. The sample size for the training set:

Not applicable. This device does not use an AI model that requires a training set.

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

Not applicable.

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