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To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back of neck, back, arm, and leg, due to strain from exercise or normal household and work activities.

• Neck Pad is used on back of neck.
• Meridian Pad is used on shoulder, waist, back, arm and leg.

This instrument is a new generation of a household multifunctional device based on physics, modern microelectronics and clinical practices, it uses low-frequency electronic therapy, and circular traction vibration to temporarily alleviate the pain associated with sore and aching muscles in the shoulder, waist, neck, back, arm, and leg. The main unit is used for the back of the neck and the streamlined ring design follows the physiological curvature of the human body. The Meridian Pad is used on the shoulder, waist, back, arm and leg.

The device has 2 operation modes: Stimulation and heating. The stimulation has 2 modes for stimulating, and 50 output Intensity Levels. The heating only has 1 mode for heating and 3 temperature levels. The device can give a certain electrical pulse through 2 pairs of electrode pads that are placed on the skin to help users to enjoy stimulation on the shoulder, waist, back, arm, and leg when using the individual Meridian pads or on the back of the neck when using the Neck Pad.

For Model AST-905A and AST-905H: The remote control of this device is user-friendly controlled because it has the operating elements of the ON/OFF button. left or right button, and increase or decrease button. The device is equipped with accessories of electrode pads and an electrode wire. The LCD display screen can show the selected mode, the stimulation, and the time remaining of an application mode. The device can be successfully opened only when both the switch button of the remote control and the main unit turned on. When the device connected to the remote control, the remote control is the only controller to select the pulse modes, temperature modes, pulse intensity, temperature levels and adjust the treatment time.

For Model AST-905D: The user can control the device effectively by the buttons on the main unit. There are 5 operation buttons: switch button, "M" button, ""C" button and "—" button. The switch button can help user to turn on/off the device, the "M" button intended to select the "C" button intended to select the temperature mode and the "-" button and "--" button intended to increase or decrease the Intensity Levels or temperature levels. The device is equipped with accessories of Meridian pads and an electrode wire.

This document (K210756) is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It demonstrates substantial equivalence to previously cleared devices. Based on the provided text, there is no acceptance criteria or study that proves the device meets specific performance criteria for AI/ML or diagnostic accuracy, as this is a physical medical device (TENS) and not an AI-powered diagnostic tool.

The acceptance criteria and studies described in your request (related to sample size, expert ground truth, MRMC studies, standalone performance, etc.) are typically applicable to diagnostic AI/ML-powered medical devices that provide results requiring human interpretation or that perform a diagnostic function. This document, however, describes a TENS device, which provides electrotherapy for pain relief.

Therefore, many of your requested points are not applicable to the information contained in this 510(k) summary. The "acceptance criteria" for this type of device are primarily compliance with relevant electrical safety, electromagnetic compatibility, usability, software validation, waveform, and biocompatibility standards, rather than diagnostic performance metrics.

Here's a breakdown of what is applicable from your request, and why the rest is not:

Applicable Information from the Document:

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

  • The document presents a comparison table (Section 7) showing the subject device's specifications and how they compare to predicate devices. This implicitly represents the "performance" relevant to this device type and its "acceptance criteria" are that these specifications are substantially equivalent and meet established safety standards.
  • Acceptance Criteria Mentioned (Implicitly or Explicitly):
    • Compliance with IEC 60601-1-11 (General requirements for basic safety and essential performance - Home healthcare environment)
    • Compliance with IEC 60601-2-10 (Particular requirements for the basic safety and essential performance of nerve and muscle stimulators)
    • Compliance with IEC 60601-1-2 (Electromagnetic compatibility)
    • Compliance with IEC 62366 (Usability)
    • Compliance with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (for software verification and validation)
    • Compliance with "Guidance for Transcutaneous Electrical Nerve Stimulator for Pain Relief Intended for Over the Counter Use and Guidance for Powered Muscle Stimulator for Muscle Conditioning" (for waveform test)
    • Biocompatibility per ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization)
    • Electrical characteristics (e.g., Maximum Output Voltage, Maximum Output Current, Pulse Duration, Pulse frequency, Net Charge, Maximum Phase Charge, Max Average Current, Max Current Density, Max Average Power Density) falling within acceptable ranges and being equivalent to predicates.
  • Reported Device Performance (Examples from Table 7. Comparison to predicate device):
    • Electrical Safety: Complies with IEC 60601-1 and IEC 60601-2-10.
    • EMC: Complies with IEC 60601-1-2.
    • Biocompatibility: Complies with ISO 10993-5 and ISO 10993-10. (Stated as identical to cleared components in K172897)
    • Maximum Output Voltage: 44V±10% @ 500Ω; 80V±10% @ 2KΩ; 112V±10% @ 10KΩ
    • Maximum Output Current: 88mA±10% @ 500Ω; 40mA±10% @ 2KΩ; 11.2mA±10% @ 10KΩ
    • Pulse Duration: 120μs
    • Pulse frequency: 77.3Hz
    • Net Charge (per pulse): 0μC @ 500Ω (Balanced waveform)
    • Maximum Phase Charge @ 500Ω: 10.56μC
    • Maximum Average Current @ 500Ω: 1.63 mA
    • Maximum Current Density (r.m.s) @ 500Ω: 0.0326 mA/cm²
    • Maximum Average Power Density @ 500Ω: 0.0000266 mW/cm²

• Sample sized used for the test set and the data provenance: Not applicable. This device's safety and performance are evaluated through bench testing against standards, not through clinical trials or data sets for diagnostic accuracy.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" establishment in the diagnostic sense for a TENS device.

• Adjudication method: Not applicable.

• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not a diagnostic imaging device.

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical TENS device, not an AI algorithm. Its performance is related to its electrical output and physical safety, not algorithmic accuracy.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device type relates to compliance with electrical, mechanical, and biological safety standards, verified through bench testing and adherence to established reference values from regulations and guidance documents.

• The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.

• How the ground truth for the training set was established: Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The document states that the NECK CARE THERAPY, Model: AST-905A, AST-905D, AST-905H device has been evaluated for safety and performance by lab bench testing. This type of evaluation demonstrates compliance with recognized medical device standards and relevant FDA guidance documents for TENS devices.

The specific tests performed include:

• Electrical safety test: According to IEC 60601-1-11 and IEC 60601-2-10 standards.
• Electromagnetic compatibility test: According to IEC 60601-1-2 standard.
• Usability test: According to IEC 62366 standard.
• Software verification and validation test: According to FDA guidance for software in medical devices.
• Waveform test: Conducted to verify output specifications according to FDA guidance for TENS devices.
• Biocompatibility testing: Confirmed that body-contacting components (Electrode Pads and Neck Pad) comply with ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization). This was cross-referenced to components cleared under predicate device K172897.

The conclusion is that the device is Substantially Equivalent to the predicate devices (K172897 and K190783) because its technological characteristics, features, specifications, materials, mode of operation, and intended use are similar, and differences do not raise new safety or effectiveness issues. The "acceptance criteria" for this submission are met when the rigorous bench testing results demonstrate compliance with these established safety and performance standards for TENS devices.

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