(514 days)
The Transcend is indicated for temporary reduction in circumference of the abdomen.
The Syneron Transcend is an optical energy in the Infra Red range and a radio frequency of 1 MHz powered system. The device consists of a console and two applicators that deliver electromagnetic energy (IR light and Radio Frequency) and vacuum to treated tissue for the temporary reduction in circumference of the abdomen. The Transcend console includes a control panel, power supply modules, vacuum pump, main Digital Signal Processor, umbilical cable and an adaptor- for connecting the two available applicators, two applicators and two LCD touch-screens.
The Syneron Transcend System is indicated for the temporary reduction in circumference of the abdomen.
Here's an analysis of the provided information regarding its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Temporary reduction in circumference of the abdomen | Satisfied: Clinical study data "demonstrated significant reduction in waist circumference." |
| Safety Profile | Satisfied: "No serious adverse events related to the treatment were reported." Also, lab tests for electromagnetic compatibility, electrical safety, and biocompatibility indicated performance "according to specifications and functions as intended." |
| Efficacy | Satisfied: The clinical study "demonstrated significant reduction in waist circumference." This efficacy was evaluated at 1 week, 1 month, and 3 months post-treatment. |
| Compliance with specifications | Satisfied: Lab tests indicated the device "performs according to specifications and functions as intended." The device also "fulfills the requirements for safety and efficacy." |
| Substantial Equivalence | Satisfied: The device was deemed substantially equivalent to predicate devices (Syneron VelaShape system (K071872) and Alma Lasers Accent UniForm Massager Handpiece (K082622)) based on similar indications, technological characteristics, and principles of operation. Performance data showed differences did not adversely impact performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "over 100 subjects"
- Data Provenance: The study was a "prospective, multicenter" study. While the specific countries are not mentioned for the primary study described, it's clear it was a clinical study. The document also states "Additional data from clinical experience outside the United States further supports the performance of the Transcend for the intended use," suggesting international data might have been considered supplementary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications for establishing ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method. The efficacy was evaluated based on "change in abdomen circumference from baseline to post treatment," which is an objective measurement rather than a subjective assessment requiring expert adjudication.
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
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an aesthetic/medical treatment device (laser/RF system for circumference reduction), not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. The "device" in this context is a physical medical system (hardware and associated technology) that requires human operation for treatment. The performance evaluated was of the device's effect on human subjects, not an algorithm's diagnostic accuracy.
7. The Type of Ground Truth Used
The ground truth used was objective physical measurement: "change in abdomen circumference from baseline to post treatment." This is a quantifiable outcome measure.
8. The Sample Size for the Training Set
The document does not mention a training set in the context of clinical studies for efficacy. The terminology "training set" typically applies to machine learning algorithms. The clinical studies described are for evaluating the performance of the medical device itself.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of clinical efficacy evaluation, the method for establishing its ground truth is not applicable.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.