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The MF SC GEN2 Facial Toning System is intended to stimulate the face. The device is intended for over the counter cosmetic use.

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The provided document is an FDA 510(k) clearance letter for the "MF SC GEN2 Facial Toning System." It confirms the device's substantial equivalence to legally marketed predicate devices for its stated indications for use.

Crucially, the document does NOT contain any information regarding acceptance criteria or a study proving the device meets these criteria.

This type of FDA letter is primarily a regulatory approval and does not detail the clinical or performance study data that the manufacturer submitted to support their 510(k) application. To provide the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.), one would need access to the actual 510(k) submission document itself, which is typically confidential business information and not released publicly by the FDA in detail.

Therefore,Based on the information provided in the FDA 510(k) clearance letter (K252218), it is not possible to describe the acceptance criteria and the study that proves the device meets these criteria.

The clearance letter primarily states that the device, "MF SC GEN2 Facial Toning System," is substantially equivalent to legally marketed predicate devices for its intended use (to stimulate the face, for over-the-counter cosmetic use). It does not contain the detailed performance data, study design, or acceptance criteria that would have been part of the manufacturer's 510(k) submission.

All sections of your request cannot be fulfilled as the necessary information is not present in the provided document.

To provide the requested details, one would need access to the full 510(k) submission document from Micro Current Technology, Inc., which is not publicly available in this correspondence.

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Intended for the symptomatic relief and management of chronic intractable pain, and as an adjunctive treatment for postsurgical and post-trauma acute pain. The device is indicated for over the counter use.

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The provided text is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device, S21 OTC Transcutaneous Electrical Nerve Stimulator.

It focuses on establishing the substantial equivalence of this TENS device to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to.

Crucially, this document DOES NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) clearance process for devices like TENS machines primarily relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This often involves showing that the new device has the same intended use, technological characteristics, and safety and effectiveness profile as the predicate. It does not typically involve detailed performance studies with acceptance criteria in the manner that an AI/ML medical device might undergo for a de novo or PMA submission.

Therefore, I cannot fulfill your request for information about acceptance criteria and the study that proves the device meets them based on the provided text. The document describes a regulatory clearance process, not a clinical performance study with acceptance criteria.

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The MF SC Facial Toning System is intended to stimulate the face. The device is indicated for over the counter cosmetic use.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "MF SC Facial Toning System." The document is an FDA 510(k) clearance letter, which primarily addresses regulatory aspects like substantial equivalence to predicate devices and adherence to general controls provisions. It does not include details about specific performance studies or their results.

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I am sorry, but based on the text provided, I cannot fulfill your request. The document you provided is an FDA medical device clearance letter for a "Ultra OTC Facial Toning System," which is classified as a "Transcutaneous Electrical Nerve Stimulator For Pain Relief."

This document only covers the regulatory clearance of a physical medical device. It does not contain any information about:

1. Acceptance criteria for an AI/software device.
2. A study that proves a device meets acceptance criteria related to AI/software performance.
3. Specifics of test sets, training sets, ground truth establishment, or expert involvement in relation to AI/software performance.

Therefore, I cannot extract the information needed to populate the table or answer the questions about the study design, as this information is not present in the provided text.

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The Ultra Facial Toning System is intended to stimulate the face. The device is intended for cosmetic use.

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This document is a 510(k) clearance letter from the FDA for a device called "Ultra Facial Toning System." It is a regulatory document addressing the substantial equivalence of the device to existing predicate devices. It does not contain any information about acceptance criteria or the study that proves the device meets those criteria.

Specifically, the document:

• Confirms K181062 as the premarket notification number.
• States the Trade/Device Name: Ultra Facial Toning System.
• Identifies the Regulation Number and Name for Transcutaneous Electrical Nerve Stimulator For Pain Relief.
• Classifies the device as Class II with Product Code NFO.
• Declares the device substantially equivalent for its stated indications for use.
• Outlines general controls provisions and other regulatory requirements.
• Provides contact information for various FDA departments.
• Details the "Indications for Use" which states: "The Ultra Facial Toning System is intended to stimulate the face. The device is intended for cosmetic use."
• Notes it is a Prescription Use device.

Therefore, it is not possible to describe acceptance criteria or a study proving the device meets them based on the provided text, as this information is not present in the document.

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The S21 Transcutaneous Electrical Nerve Stimulator (TENS) device is intended to by used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain by sending electrical impulses through the skin to the nerves lying directly beneath the skin surface. These impulses help to block the body's ability to send a pain message to the brain, thereby reducing the pain sensation. The S21 is a dual channel device that produces constant micro ampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 30 volts.

The S21 is a dual channel device that produces constant micro ampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 30 volts.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, comparative effectiveness studies, standalone performance, or ground truth establishment.

The document is a 510(k) premarket notification letter from the FDA regarding a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms that the device is substantially equivalent to a legally marketed predicate device and can proceed to market. The "Indications For Use" section describes the intended use of the device but does not include any performance metrics or study results.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or the detailed study information.

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The E275 Transcutaneous Electrical Nerve Stimulator (TENS) device is intended to by used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain by sending electrical impulses through the skin to the nerves lying directly beneath the skin surface. These impulses help to block the body's ability to send a pain message to the brain, thereby reducing the pain sensation.

The E275 is a dual channel device that produces constant micro ampere currents with the selected envelopes, waveforms; frequencies, and polarity, with a maximum voltage of 30 volts.

I am sorry, but based on the provided document, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter and an "Indications For Use" statement. It does not contain information about:

1. Acceptance criteria and reported device performance: This document only states the device's indications for use.
2. Sample size and data provenance for the test set: Not mentioned.
3. Number of experts and qualifications for ground truth: Not mentioned.
4. Adjudication method: Not mentioned.
5. MRMC comparative effectiveness study: No information on a comparative effectiveness study, with or without AI assistance, is provided.
6. Standalone performance study: No details about a standalone performance study are present.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not mentioned as there's no mention of a training set or an AI component.
9. How ground truth for the training set was established: Not mentioned.

The document primarily focuses on the FDA's determination of substantial equivalence for the E275 Transcutaneous Electrical Nerve Stimulator (TENS) device to a legally marketed predicate device. It confirms the device's regulatory classification and allows it to be marketed. It does not include the detailed technical study results or acceptance criteria that would typically be found in a design validation report or a clinical study report.

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The MED 4000 Transcutaneous Electrical Nerve Stimulator (TENS) device is intended to by used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain by sending electrical impulses through the skin to the nerves lying directly beneath the skin suarane impulses help to block the body's ability to send a pain message to the brain, thereby reducing the pair. sensation.

The MED 4000 is a dual channel device that produces constant micro ampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 30 volts.

The provided documents are a 510(k) clearance letter and an "Indications For Use" statement for the MED 4000 Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of regulatory document does not typically include detailed studies with acceptance criteria, sample sizes, expert qualifications, or detailed performance metrics as would be found in a later clinical trial or a more recent AI/ML device submission.

The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy and safety through comprehensive studies for novel devices.

Therefore, the specific information requested cannot be extracted directly from these documents. Here's why and what can be inferred:

1. A table of acceptance criteria and the reported device performance: Not provided. The 510(k) essentially states the device is "substantially equivalent" to predicate devices for the given indications. No quantitative performance metrics or specific acceptance criteria are listed in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. A 510(k) submission for a TENS device from 1999 would likely rely on existing data and performance of predicate devices, or potentially very limited non-clinical testing if specified. No details about a specific test set, its size, or provenance are in this letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable or provided. This type of information is relevant for studies involving subjective assessment (e.g., image interpretation), which is not the primary focus of a TENS device submission for chronic pain relief.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided. Similar to point 3, this is for assessments needing expert consensus.
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. The MED 4000 is a TENS device, not an AI/ML diagnostic tool or an AI-assisted device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The MED 4000 is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not explicitly stated in the provided documents. For TENS devices, "ground truth" for chronic pain relief would typically be patient-reported outcomes or pain scales, observed through clinical studies. However, the 510(k) itself does not detail such studies or their ground truth methodologies.
8. The sample size for the training set: Not applicable. This refers to machine learning models, which the MED 4000 is not.
9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided documents:

The documents confirm the MED 4000 TENS device received 510(k) clearance (K993823) from the FDA on November 19, 1999. This clearance signifies that the device was deemed "substantially equivalent" to a predicate device marketed prior to May 28, 1976, or reclassified devices. The stated "Indications For Use" are for the symptomatic relief of chronic intractable pain by sending electrical impulses to block pain messages to the brain.

The 510(k) process in 1999 primarily required demonstrating that the new device was as safe and effective as a legally marketed predicate device, often by showing it had the same technological characteristics and indications for use, or that any new technological characteristics did not raise new questions of safety or effectiveness. It did not require the detailed performance studies, specific acceptance criteria, or AI/ML-related information requested in the prompt.

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