Search Results

The PRO MAX system is a Radiofrequency device intended for use in dermatologic procedures with separate indications for each handpiece.

The TC Handpieces (Shaper Max, Mini Shaper Max, iFine Max) are intended for:
• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation

When used up to 65W, the Mini Shaper Max and Small Max handpieces are also intended for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

The FSR Max Handpiece is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Intensif MAX Handpiece is intended for use in dermatologic procedures for electrocoagulation and hemostasis.

The EndyMed Contour MAX Handpiece is intended for the treatment of the following medical conditions; using the Contour MAX applicator for delivery of non-thermal RF combined with massage:
• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• Temporary reduction in the appearance of cellulite

ENDYMED PRO™ MAX is a computerized system that generates pulses of radio frequency (RF) energy that are emitted onto patient skin. The device consists of a console and seven handpieces that emit either ablative or non-ablative radiofrequency.

The provided document is a 510(k) clearance letter for the EndyMed PRO MAX device. It indicates that the device has been cleared by the FDA, but it primarily focuses on establishing "substantial equivalence" to predicate devices rather than directly presenting the results of a clinical study designed to prove the device meets specific acceptance criteria based on performance endpoints.

The document describes performance testing but does not provide a table of acceptance criteria alongside detailed "reported device performance" in the context of a clinical study or specific performance metrics for the indications for use. Instead, it justifies substantial equivalence through comparison of specifications and generic performance testing.

Here's an attempt to extract the requested information based on what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative acceptance criteria for each indication (e.g., a specific percentage reduction in pain, or a defined improvement in wrinkles). Instead, it focuses on demonstrating that the device can achieve and maintain a therapeutic temperature similar to its predicate devices, which is presumed to lead to the intended effects. Therefore, the "Acceptance Criteria" here are inferred from the safety and performance testing described.

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

• Sample Size for Test Set:
  • For Tissue Heating Testing: "3 subjects with 3 anatomical sites each." (Total of 9 test sites across 3 subjects).
  • For other tests (Electrical Safety, EMC, Software, Biocompatibility, etc.): The document does not specify sample sizes in terms of human subjects or data sets. These are typically engineering or lab-based tests on the device itself or materials.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective for the Tissue Heating Testing. Given the context of a 510(k) summary, these tests are typically part of a prospective verification and validation effort by the manufacturer.

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

The document does not mention the use of experts to establish ground truth for the "test set" in the traditional sense of clinical endpoints for the indications. The tissue heating test measures temperature, which is an objective physical parameter.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method like 2+1 or 3+1. This is expected as the described performance testing (tissue heating, electrical safety) involves objective measurements rather than subjective expert assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done according to the provided document. The submission focuses on substantial equivalence based on technical specifications and bench/performance testing, not clinical comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device described is a physical medical device (Radiofrequency system with handpieces). While it contains software, the "performance testing" described (e.g., tissue heating) refers to the device's physical output characteristics, not an AI algorithm's standalone diagnostic or detection performance. Therefore, the concept of "standalone performance" for an AI algorithm is not applicable in the context presented.

7. The Type of Ground Truth Used

For the "Tissue Heating Testing," the "ground truth" is the measured temperature (39-45°C) achieved and maintained on the tissue. This is an objective, physiological measurement, not expert consensus, pathology, or outcomes data in a clinical trial sense for efficacy.

8. The Sample Size for the Training Set

The document does not mention a training set. This is because the device is a physical RF energy delivery system, and the "performance testing" described is for verification of its physical properties and safety, not for training a machine learning or AI algorithm.

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

Since no training set is mentioned, this question is not applicable.

Ask a specific question about this device