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TENS: ElectroPulse-Cosmetic is intended to stimulate the face. The device is indicated for cosmetic use.

Infrared Light and Heat: Emits energy in the necr-IR spectrum for temporarily promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where heat is indicted.

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This document is a 510(k) clearance letter from the FDA for the "Electropulse - Cosmetic" device, a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief.

The acceptance criteria and study information typically found in a comprehensive clinical study report or a more detailed 510(k) submission summary are not present in this FDA clearance letter. This document primarily focuses on the FDA's decision regarding substantial equivalence to a predicate device and the regulatory classification.

Therefore, many of the requested details cannot be extracted from the provided text. The letter doesn't describe the studies that were performed to demonstrate the device meets any specific performance criteria, nor does it detail a training or test set, expert involvement, or ground truth establishment.

However, based on the information provided, we can infer some details related to the device classification and intended use, which might be linked to performance expectations for TENS devices in general.

Here's an attempt to answer based only on the provided text, with many fields explicitly marked as "Not provided in the document."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not provided in the document.
• Data Provenance (country of origin, retrospective/prospective): Not provided in the document. The document mainly discusses regulatory classification and substantial equivalence, not clinical study details.

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

• Number of Experts: Not provided in the document.
• Qualifications of Experts: Not provided in the document.

4. Adjudication Method for the Test Set

• Adjudication Method: Not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Done?

• MRMC Study Done?: Not provided in the document. The document is an FDA clearance letter based on substantial equivalence, not a detailed clinical study report that would typically include MRMC study findings.
• Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable, as this device is a TENS/infrared light device and not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Done?

• Standalone Study Done?: Not applicable, as this device is a physical TENS/infrared light device, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: Not provided in the document. For a TENS device, ground truth related to efficacy would typically come from patient-reported pain scales or physiological markers in clinical trials, but these details are not in this document.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not provided in the document.

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

• Ground Truth Establishment for Training Set: Not provided in the document.

Summary from the provided document:

The provided document is an FDA 510(k) clearance letter confirming that the "Electropulse - Cosmetic" device is substantially equivalent to legally marketed predicate devices for its stated indications for use.

• Indications for Use:
  • TENS: Intended to stimulate the face; indicated for cosmetic use.
  • Infrared Light and Heat: Emits energy in the near-IR spectrum for temporarily promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where heat is indicated.
• Regulatory Classification: Class II, Product Codes NFO (Transcutaneous electrical nerve stimulator for pain relief) and ILY (unspecified, but typically related to cosmetic or similar devices).
• Use: Over-The-Counter Use.

The letter focuses on the regulatory decision of substantial equivalence and does not contain details regarding specific clinical trial protocols, acceptance criteria, study methodologies, or performance metrics from any studies that might have been submitted to support the 510(k). These details are typically found in the full 510(k) summary or traditional 510(k) submission, which is not provided here.

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Used for the temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise, or normal household and work activities.
Relaxing muscles and relieving minor aches and pains.
Emits energy at near infrared frequencies to provide topical heating and to provide temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness, promoting relaxing of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

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Here's an analysis of the provided information, focusing on acceptance criteria and study details.

Analysis of the Provided Text:

The provided text is an FDA 510(k) clearance letter for the "ElectroPulse - Pain Relief" device. Unfortunately, this document primarily concerns the regulatory clearance process and does not contain the detailed study information or acceptance criteria that would typically be found in a clinical study report or a premarket submission summary.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a device already on the market. This often relies on demonstrating that the new device has similar technological characteristics and performs comparably to the predicate, rather than providing new, extensive clinical trial data that defines and meets specific acceptance criteria.

Therefore, for many of your requested points, the information is not available in the provided document.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The FDA 510(k) process for "substantial equivalence" does not typically involve defining explicit, quantifiable acceptance criteria (e.g., "device must reduce pain by X% within Y days"). Instead, the primary "acceptance criterion" is demonstrating that the new device is as safe and effective as a predicate device already on the market. The specific performance metrics are often compared to the predicate's known performance or established benchmarks for that device type. The letter states the device is "substantially equivalent," implying these criteria were met.

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

• Sample Size for Test Set: Not specified in the provided document. The 510(k) likely relied on a comparison to predicate device data or possibly non-clinical (e.g., bench) testing, rather than a separate clinical test set for this specific device.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided document.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

Explanation: As this is a 510(k) clearance based on substantial equivalence, a formal "ground truth" establishment by a panel of experts for a new clinical test set is unlikely to have been a requirement or part of the public record in this document. Substantial equivalence relies more on engineering documentation, performance testing against standards, and comparison to predicate devices.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of a 510(k) and the lack of a detailed clinical study report, an adjudication method for a test set is not described.

5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done

• MRMC Study Done?: Not indicated in the provided document.
• Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable. The device (ElectroPulse - Pain Relief) is a physical therapy device (TENS, massager, heat lamp), not an AI diagnostic or interpretive tool. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.

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

• Standalone Study Done?: Not applicable. This is not an algorithmic device.

7. The type of ground truth used

• Type of Ground Truth: Not explicitly stated as "ground truth" in the context of clinical outcomes. For substantial equivalence, the "truth" is typically aligned with the understanding of the predicate device's safety and effectiveness and the device's adherence to relevant performance standards (e.g., electrical safety, TENS waveform characteristics, heat output). If any clinical claims were made, they would need to be supported by evidence, often in comparison to the predicate's known performance or through literature review.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set.

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

• How Ground Truth for Training Set was Established: Not applicable. This is not an AI/machine learning device.

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TENS The symptomatic relief and management of chronic intractable pain, and/or as an adjunctive treatment in the management of post surgical and post traumatic acute pain.

Vibration Relaxing muscles and relieving minor aches and pains.

Heat Lamp Emits energy at infrared frequencies to provide topical heating and to provide temporary relief of minor muscle and joint pain, relieving stiffness, promoting relaxing of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

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This document is a 510(k) premarket notification letter from the FDA regarding the ElectroPulse device. It states that the device is substantially equivalent to legally marketed predicate devices. This type of letter does not typically contain information about comprehensive clinical studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies, which are usually part of a full clinical trial report or a more detailed submission.

Based on the provided text, the specific information requested cannot be extracted. The document confirms the FDA's clearance of the device based on substantial equivalence, implying that the performance of the ElectroPulse is considered comparable to similar devices already on the market, but it does not detail a study conducted by the applicant to prove specific acceptance criteria for the device itself.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or clinical study details as this document is not a clinical study report.

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