(58 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. This document does not specify quantitative performance criteria for TENS or infrared light/heat functionality. | Not provided in the document. The document confirms substantial equivalence but does not present specific performance metrics from a study. |
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.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).