Search Results

TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the "TENS AND EMS (TENS and Muscle Stimulator)" device (K243856) does not contain the detailed information necessary to answer your request regarding acceptance criteria and performance study data.

This 510(k) letter is a legal document from the FDA stating that the device has been found substantially equivalent to a legally marketed predicate device. It primarily covers administrative details such as:

• The device name and models
• The applicant's information
• Regulation numbers and product codes
• Regulatory classification (Class II)
• The date of clearance
• General controls provisions (registration, listing, GMP, labeling)
• Information about when new 510(k) submissions might be needed for device changes
• Requirements for Quality System (QS) regulation, UDI rule, and adverse event reporting
• Contact information for the FDA

Crucially, it does not include any technical details about the device's performance, clinical study results, acceptance criteria, or the methodology of studies (e.g., sample size, expert qualifications, ground truth establishment, MRMC studies, or standalone performance). This information would typically be found in the manufacturer's 510(k) submission, which is not publicly available in this FDA clearance letter.

Therefore, I cannot populate the table or provide answers to the specific questions you've asked based on the provided text.

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The Muscle Stimulator Device is indicated to be used for:

• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• Strengthening, Toning and Firming of buttocks, thighs and calves.
• Improvement of muscle tone and firmness, for strengthening muscles in arms.

The Muscle Stimulator Device (model PZ-100) is a non-invasive therapeutic device. The device produces electromagnetic field that interacts with the tissues of the human body. The device has four outputs, and two applicators perform simultaneous treatment.

The Muscle Stimulator Device is equipped with a large color touch screen with wide view angle that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen.

The Muscle Stimulator Device is composed of control display panel module, main control module, temperature module, treatment handle module, and fan cooling module.

The proposed device can simultaneously apply multiple treatment handles to patients, and the handles are held in place by bandages.

This document is a 510(k) clearance letter for the Muscle Stimulator Device (PZ-100). It focuses heavily on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of specifications.

Crucially, there is ABSOLUTELY NO MENTION of acceptance criteria related to a study proving performance, sample sizes, expert involvement, ground truth, or MRMC studies.

The document explicitly states:

• "No clinical study is included in this submission." This means there was no study to prove the device met acceptance criteria in a clinical setting with human subjects.
• The clearance is based on "non clinical tests" to verify that the proposed device met design specifications and was substantially equivalent to the predicate device. These typically involve engineering tests, electrical safety, EMC, and biocompatibility, as listed in the "Non-Clinical Test Conclusion" section.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for proving the device meets those criteria because this information is not present in the provided document.

The document describes regulatory compliance and equivalency based on technical specifications and non-clinical testing, not on a clinical performance study with human subjects, which would typically involve the criteria you asked about (sample size, expert ground truth, MRMC, etc.).

In summary, based on the provided text, the device was NOT proven to meet acceptance criteria through a clinical performance study. Its clearance is based on demonstrating substantial equivalence to a predicate device through non-clinical testing.

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TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

I am sorry, but the provided FDA 510(k) clearance letter for the TENS AND EMS (TENS and Muscle Stimulator) devices (K250360) does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a formal clearance letter confirming the substantial equivalence of the device to a legally marketed predicate device. It outlines regulatory information, such as:

• Device name and product codes
• Regulation numbers and regulatory class
• Indications for Use
• Requirements for manufacturing and post-market surveillance (e.g., Quality System regulation, MDR, UDI rule)

It does not include:

• Details on performance studies.
• Specific acceptance criteria used for performance verification.
• Information on study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

To provide the information you've requested, one would typically need access to the summary of safety and effectiveness data (SSED) or the full 510(k) submission, which are often much more detailed than the public clearance letter.

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TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS (Electrical Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)

The provided text is a 510(k) clearance letter from the FDA for a TENS and EMS device (TENS and Muscle Stimulator). This type of letter does not contain the detailed information about the acceptance criteria and study data that would be submitted as part of the 510(k) premarket notification.

A 510(k) clearance signifies that the device is "substantially equivalent" to a legally marketed predicate device. While this process involves demonstrating safety and effectiveness, the FDA approval letter itself does not typically include the specific performance metrics, study designs, sample sizes, or ground truth methodologies that an AI/ML device submission would detail. Those technical details are part of the original submission package, not the clearance letter.

Therefore,Based on the provided FDA 510(k) Clearance Letter for the TENS AND EMS (TENS and Muscle Stimulator) device (K250053), there is no information available regarding the acceptance criteria or the specific study details that would prove the device meets these criteria. The letter is an official notification of clearance, stating that the device is substantially equivalent to a predicate device, and does not contain the detailed technical data typically found in a product's technical file or a clinical study report.

The following information cannot be extracted from the provided document:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size used for the test set and data provenance: Not present.
3. Number of experts used to establish ground truth and qualifications: Not present.
4. Adjudication method for the test set: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details: Not present.
6. Standalone (algorithm-only) performance: Not applicable, as this is a physical device, not an AI/ML algorithm.
7. Type of ground truth used: Not present.
8. Sample size for the training set: Not applicable (not an AI/ML device, so no training set in the typical sense).
9. How ground truth for the training set was established: Not applicable.

The letter focuses on regulatory compliance, outlining the device's classification, applicable regulations (e.g., Quality System regulation, UDI Rule), and general controls. It refers to the device as a "TENS and Muscle Stimulator," which is a traditional physical medical device, not an AI/ML software device. Therefore, the questions related to AI/ML specific studies (like MRMC, training sets, ground truth establishment methods for algorithms) are not relevant to this type of device and would not be found in its 510(k) clearance.

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The device is intended to provide electrical stimulation and neuromuscular reeducation for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

Levina Pelvic Floor Muscle Stimulator is a non-implantable, home use device for the treatments of stress, urge, and mixed urine incontinence through the intravaginal probe's electrical stimuli to the muscles of the pelvic floor to induce Kegel-like contractions, which help users to achieve pelvic floor muscle strengthening for maintaining urinary continence in women. The subject device includes a remote control, a stimulator pod and a vagina stimulation probe. Both the remote control and the stimulator pod are powered by an off-the-shelf 3.7V lithium-ion polymer battery. The remote control has a 1.77" TFT LCD screen and 4 buttons to control the stimulator pod. The stimulator pod has two output channels and will perform electrical stimulation according to the parameter settings sent by the remote control. The device is supplied with a reusable (single-patient use) vaginal, dual-electrode, stimulation probe.

The provided text is a 510(k) summary for the Levina Pelvic Floor Muscle Stimulator, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria based on clinical outcomes or diagnostic accuracy. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of clinical performance metrics (like sensitivity, specificity, human reader improvement with AI, etc.) is not present.

However, the document does contain information about "Non-Clinical Testing" with "pre-determined acceptance criteria" which were met. I will extract and organize the available information based on your request.

Here's a breakdown of the available information:

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

The document states: "All pre-determined acceptance criteria were met." but does not provide specific numerical targets or the results from the non-clinical tests in a detailed table format. It lists the types of tests performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This document primarily discusses non-clinical engineering and software testing. It does not refer to "test sets" in the context of clinical data (e.g., patient cases) or population-based data. Therefore, this information is not applicable or available in this document.

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

This information is not applicable as the document does not describe a clinical study involving experts establishing ground truth for a test set.

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

This information is not applicable as the document does not describe a clinical study involving adjudication of a test set.

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:

This information is not applicable. The device is a "Pelvic Floor Muscle Stimulator," an electrical therapy device, not an AI-assisted diagnostic tool for human readers.

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

This information is not applicable as the device is a physical stimulator and not an algorithm-only diagnostic or AI solution. The "Software Verification and Validation Testing" refers to the embedded software in the device, not a standalone AI algorithm for interpretation.

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

For the non-clinical tests, the "ground truth" would be defined by the technical specifications and requirements outlined in the referenced international standards (e.g., ISO 10993, IEC 60601 series). For example, electrical safety "ground truth" would be the specified limits for leakage current or dielectric strength. There is no clinical "ground truth" discussed in this document.

8. The sample size for the training set:

This information is not applicable. The document describes a physical medical device and its non-clinical engineering and software testing, not a machine learning model that would require a "training set."

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

This information is not applicable for the same reasons as point 8.

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The MYOTouch Muscle Stimulator is indicated for use as an adjunct in the treatment of high and low anorectic malformations by helping with the identification of striated muscles to be used in anal reconstructions. The MYOTouch device is intended for use by trained personnel who are competent to apply the appropriate stimuli.

MYOTouch is a hand-held device designed to be used for surgical correction of neonatal anorectal malformations. MYOTouch is intended for prescription use. The device is a 9V battery-powered, one-channel muscle stimulator. The device is supplied with a Sterile Stylus, which connects to the control unit by cable and plug. The MYOTouch muscle stimulator has been specially designed to meet the requirements of pediatric surgeons who need a reliable and easy to use muscle locating stimulator when carrying out the Pena, "Pull-through", or posterior sagittal anorectoplasty (PSARP) anorectal reconstruction technique. A trained professional or pediatric surgeon must use the MYOTouch device. The pediatric surgeon uses manual, push-button controls to control the electrical stimulation level. The unit is intended for prescription use and is designed with simplicity and ease of use. It has two preset modes available.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device called the MYOTouch Muscle Stimulator. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, the document explicitly states in Section VIII, "No clinical tests were submitted to support this 510(k)."

Therefore, based on the information provided, I cannot answer your request regarding the acceptance criteria and the study that proves the device meets those criteria, as no such study is presented in this document. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device through technical comparisons and compliance with recognized standards, rather than direct performance studies against acceptance criteria.

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TENS(Transcutaneous Electric Nerve Stimulation):

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. PMS(Powered Muscle Stimulation):

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Muscle Stimulator is a portable and DC 3.7V battery powered multifunction device, offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS) qualities in one device.

Muscle Stimulator can give certain electrical pulses through electrode adhesive pads to the suggested area of the body where the electrodes are placed. The electrodes to be used with the device have already been cleared under K182111.

The electronic stimulatory module has the operating elements of an On/Off Switch, Intensity buttons, Output channel buttons, T button, Output ports, and USB port for battery charging.

The LCD display screen can show time remaining of an application program, battery power, program icons, output channel and intensity, etc.

The device is equipped with accessories of electrode pads, electrode cables, a battery charger, and one USB cable. The electrode cables are used to connect the device; the USB cable is used to connect the charger and the built-in lithium battery. All accessories, including USB cables, electrode pads, electrode cables, chargers can only be changed or replaced by a qualified person.

This document is a 510(k) Premarket Notification from the FDA regarding a Muscle Stimulator device. It does not contain information about an AI/ML device or a study involving acceptance criteria for such a device against ground truth.

The document primarily focuses on demonstrating substantial equivalence of the new Muscle Stimulator device (YR-U80-PRO-MAX, YR-U80-PRO, YR-U8-PRO, YR-U8) to existing predicate devices (K143268 and K121719). The document details:

• Device Description: A portable, DC 3.7V battery-powered multifunction device offering both Transcutaneous Electrical Nerve Stimulation (TENS) and Powered Muscle Stimulation (PMS).
• Indications for Use: Temporary pain relief (TENS) and stimulating healthy muscles to improve/facilitate performance (PMS).
• Comparison to Predicate Devices: A detailed table comparing various technical parameters (e.g., power source, output modes, waveforms, electrical characteristics) of the new device with the predicate and reference devices.
• Non-Clinical Testing: Conformance to various electrical safety and performance standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 62133-2, IEC 60601-1-11).
• Clinical Testing: Explicitly states, "No clinical testing was performed on the device."

Therefore, based on the provided text, I cannot extract the information required to answer your questions about acceptance criteria for an AI/ML device, ground truth establishment, sample sizes, or expert adjudication, as these topics are not discussed in the context of this device's submission.

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Electronic Muscle Stimulator is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. Strengthening, toning and firming of arms and legs.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter for an Electronic Muscle Stimulator. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific study-related details you've requested.

The document confirms that the device (Electronic Muscle Stimulator, Model: MP01) is substantially equivalent to legally marketed predicate devices for specific indications for use:

• Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
• Strengthening, toning, and firming of arms and legs.

It also notes that the device is intended for Over-The-Counter Use.

To answer your request, I would need a different document, such as a summary of safety and effectiveness data (SSED) or a clinical study report that details the device's performance against specific acceptance criteria.

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Pelvic Floor Muscle Stimulator (Model name: MagBelle AF180) is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of male and female urinary incontinence.

The Pelvic Floor Muscle Stimulator (model: MagBelle AF180) is a non-invasive therapeutic device which produces electromagnetic field that interacts with the tissues in the pelvic region of the human body. The electromagnetic field delivered in the muscular tissue area triggers the muscle stimulation. MagBelle AF180 consists of the main unit and the chair applicator. The MagBelle AF180 is equipped with a color touch screen that facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters can also be set using the touch screen, buttons and knob on the device. During the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The subject device should only be used under the continued supervision or licensed practitioner. The device supports 3 different function modes: Magnetic stimulation function, Kegel biofeedback training function and Triggering magnetic stimulation function of Magnetic stimulation function and Kegel biofeedback training function).

The provided text describes a 510(k) premarket notification for a "Pelvic Floor Muscle Stimulator" (MagBelle AF180). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness through a comprehensive clinical study with extensive statistical analysis of acceptance criteria. Therefore, the details requested in the prompt, such as specific acceptance criteria and detailed study outcomes with statistical measures, are not fully elaborated in the provided document in the typical format of a standalone clinical trial report.

However, based on the information provided, here's a summary of the available details regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All pre-determined acceptance criteria were met" for non-clinical testing. For the clinical data, the acceptance criterion was implicitly that the subject device's pelvic floor muscle strength measurements were "comparable" to a reference device. Specific quantitative criteria and detailed performance metrics are not provided in this regulatory summary.

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

• Sample Size for Kegel Biofeedback functionality test: 100 urinary incontinence patients (male and female, age range: 22-70).
• Data Provenance: The study was conducted "in a hospital set-up," implying a prospective study. The country of origin of the data is not explicitly stated but is likely China, given the submitter's location.

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

• Number of Experts: At least one clinician was involved in manually testing pelvic floor muscle strength using the modified Oxford Grading Scale. The document doesn't specify the number of additional clinicians or their specific qualifications (e.g., years of experience, specialty beyond "clinician").

4. Adjudication Method for the Test Set

• The document implies a comparison method where the subject device's measurements were calibrated and compared against manual assessment by a clinician and a reference device. It does not describe a formal expert adjudication method like "2+1" or "3+1." The clinician's manual assessment appears to serve as a form of ground truth or benchmark activity.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not performed or described. This device is a therapeutic device, not an AI diagnostic algorithm that assists human readers.

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

• The device itself is a standalone therapeutic device with a "Kegel Biofeedback functionality." The study assessed the performance of this functionality in measuring pelvic floor muscle strength, comparing its output to manual assessment and a reference device. This qualifies as evaluating a standalone function of the device.

7. The Type of Ground Truth Used

• For the Kegel Biofeedback functionality, the ground truth was established by:
  • Expert Clinical Assessment: Manual testing of pelvic floor muscle strength by a clinician using the modified Oxford Grading Scale.
  • Comparison to a Reference Device: Measurements from the subject device were compared to those from the legally marketed reference device, K201014 (MyOnyx System).

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of the clinical data presented. The 100 patients were used for verification and calibration of the Kegel biofeedback mode, which might imply a form of internal "training" or adjustment during development, but it's not described as a distinct training set for an AI/algorithm in the traditional sense. The focus here is on device function verification.

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

• As a training set is not explicitly mentioned, the method for establishing its ground truth is also not described. However, for the verification of the Kegel biofeedback mode, the calibration and comparison process involved manual assessment by a clinician and comparison with a reference device.

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Powered Muscle Stimulator (Model name:MagGraver F200) is indicated to be used for:

• · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen.
  · Strengthening, Toning and Firming of buttocks.

Powered Muscle Stimulator (Model name:MagGraver F200) is a non-invasive therapeutic device. The device produces electromagnetic field that stimulates the tissues of the human body, the device helps to strengthen, tone, and firm the abdomen and buttocks by stimulating muscle.
The device has two output channels and two applicators, one applicator (Form A) is applicable for abdomen and another (Form B) is applicable for buttocks. The applicator can plug in either output channels. The two outputs of device enable simultaneous treatment by two applicators.
The Form A applicator consists of round coil and cooling system. The Form B applicator consists of figure-of-eight coil and cooling system.
There is a pressure kit is used to monitor abdomen muscle contraction by monitor the pressure between applicator and abdomen, the pressure kit is only used with Form A applicator.
The device is equipped with a color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen. During the therapy the device keeps information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. The screen angle can be adjusted.

I'm sorry, but this document does not contain the information required to fulfill your request. The document is an FDA 510(k) clearance letter and summary for a Powered Muscle Stimulator (MagGraver F200). While it addresses device safety and effectiveness in comparison to a predicate device, it does not describe:

1. Acceptance criteria for an AI/algorithm-based device and reported performance against those criteria. This device is a physical electromedical device, not an AI/algorithm-based diagnostic or therapeutic tool.
2. Sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance. These concepts are relevant to the validation of AI/ML models, which is not the subject of this document.
3. Ground truth establishment or training set details. Again, these relate to AI/ML model development and validation.

The primary performance data presented relates to non-clinical bench testing of the magnetic field intensity and pulse characteristics, and compliance with general medical device standards (e.g., IEC 60601-1 for safety). There is no mention of a performance study proving the device meets acceptance criteria related to AI/ML.

Therefore, I cannot extract the requested information from the provided text.

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