Search Results

LED Facial Mask is an over the counter device. The Red light mode is intended for the treatment of periorbital wrinkles. The Red and Infrared light combination mode is intented for the treatment of full-face wrinkles. The blue light is intended for the treatment of mild to moderate inflammatory acne. The device is indicated for adults only.

LED Facial Mask (Model: AST-804, AST-804A, AST-804B, AST-805, AST-805A, AST-805B)

The provided text is an FDA 510(k) clearance letter for an LED Facial Mask. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

The letter only states that the device is "substantially equivalent" to a legally marketed predicate device for the following indications for use:

• Red light mode: Treatment of periorbital wrinkles.
• Red and Infrared light combination mode: Treatment of full-face wrinkles.
• Blue light: Treatment of mild to moderate inflammatory acne.
• Target population: Adults only.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This information would typically be found in the 510(k) submission itself, not in the clearance letter.

Ask a specific question about this device

PMS(1 ~ 2): It is intended to stimulate healthy muscles in order to improve and facilitate muscle performance. TENS(3 ~ 5): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm and leg due to strain from exercise or normal household work activities by applying current to stimulate nerve.

Heating: The Heating Lumbar Therapy Cushion is intended for temporary relief of minor aches and pains.

The Heating Lumbar Therapy Cushion is a portable TENS/PMS device is equipped with a remote control, an adapter, a pair of electrode pads and electrode wire. The electrode wire is used to connect the electrode pads to the main unit.

The device has 5 stimulate modes and one heating mode, through the stainless steel plate to provide users with lower back stimulation and heat generation to warm and comfortable lower back muscles. In addition, it is equipped with a pair of electrode pads, which can be used to stimulate different parts of the body (the shoulder, waist, back, arm and leg).

The principle of operation of the subject device is:

PMS: A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. This device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.

TENS: The electrodes placed on the skin send small-scale, low-voltage electrical pulses to specific nerves. The purpose is to change the way neurons send signals and prevent pain signals from reaching the brain to relieve pain.

All the functions of the device can only be controlled by the remote control, which should connected to the main unit through a wire. The remote controller has the component of ON/OFF Key, Mode Selection key (left and right), Intensity Modification keys (increase and decrease) and an LCD screen. And the LCD screen can show stimulation mode, stimulation intensity, heating intensity and time remaining of an application mode. The device has 5 stimulation modes, each with 50 stimulation intensity and one heating Mode, heating mode has 3 levels, namely level 1 (37°C), level 2 (40°C), and level 3 (43°C).

The stainless steel plate provides users with lower back stimulation and heat to warm and comfort the muscles of the lower back. The stimulation function and heating function can be used separately or simultaneously. When used with a pair of electrode pads, it must be used simultaneously with the main unit stimulation mode, otherwise the electrode pads will be invalid.

The equipment has four models: AST-622, AST-622B, AST-623B, the four models differ only in appearance.

This document is a 510(k) Premarket Notification from the FDA for a medical device called "Heating Lumbar Therapy Cushion." It establishes substantial equivalence to predicate devices, thus allowing the device to be marketed. However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria through clinical trials or performance assessments that generate quantitative results against those criteria.

Instead, the document focuses on demonstrating that the device is "substantially equivalent" to existing, legally marketed predicate devices. This is achieved primarily through a comparison of technical specifications and performance characteristics, along with verification through non-clinical testing against relevant standards.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria are met in the format requested, as that type of information is not present in this document. The document confirms that non-clinical tests were performed to assure conformance with standards, but it does not report specific performance metrics or acceptance criteria for those tests in a table as requested.

The document explicitly states:

• "6.2 Discussion of Clinical Tests Performed: There were no Clinical Tests."

This means there's no clinical study described that would involve sample sizes, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment in the context of clinical outcomes or diagnostic accuracy.

The tables provided (Elements of Comparison) list various technical specifications and note whether they are "SE" (Substantially Equivalent) or provide a value for comparison. However, these are not pre-defined acceptance criteria in the sense of demonstrating a certain level of clinical performance or accuracy against a ground truth. They are comparisons to predicate devices to establish equivalence.

In summary, the provided document does not contain the information required to answer your request regarding acceptance criteria and a study proving the device meets them, because it does not describe such a study.

Ask a specific question about this device

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.

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.

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:

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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