(21 days)
The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.
The VelaShape treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted radio frequency (RF) energy and the mechanical manipulation is derived from massage and/or vacuum.
The provided document describes a 510(k) summary for the Syneron Medical Ltd's VelaShape System, specifically concerning a modification to its infrared (IR) light source. This is a special 510(k) submission, meaning it's for a modification to a previously cleared device (VelaShape K071872).
Here's an analysis based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., specific reductions in cellulite or circumference, pain relief scores, etc.). This submission is for a hardware modification, not a new device or a new clinical claim.
The performance data provided focuses on the technical aspects of the modification.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance of new light source compatible with previously cleared specifications (Technical) | "Verification testing was performed to evaluate this modification to ensure the performance of the new light source is compatible with the previously cleared specifications." "Performance testing demonstrates that the VelaShape system performs according to specifications and functions as intended." |
| No new issues of safety or effectiveness (Clinical/Safety) | "The modification of the IR light source to LED raises no new issues of safety or effectiveness." |
| Does not affect indications for use | "The change of the IR light source... does not affect the indications for use..." |
| Does not alter fundamental scientific technology background | "...nor does it alter the fundamental scientific technology background of the device..." |
| Does not affect mode of use | "...nor does it affect the mode of use." |
| No labeling changes affecting indications for use | "There are no labeling changes that affect the indications for use of the device." |
| Electromagnetic compatibility or electrical safety not required (Technical) | "Electromagnetic compatibility or electrical safety testing was not required to support this modification." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable or not specified. This submission focuses on engineering verification of a hardware change rather than a clinical trial for a new claim. The "performance data" refers to technical testing, not human subject data.
- Data Provenance: Not applicable for patient data. The modification involves a change in a component for an existing device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of clinical studies, typically refers to expert diagnoses or pathology results. This submission describes engineering verification, not a clinical study requiring ground truth establishment by medical experts.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set subject to expert adjudication is described.
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. This device is not an AI-powered diagnostic or assistive tool. It is a physical medical device for cosmetic and pain relief treatments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device does not involve an algorithm with "standalone performance" in the way an AI diagnostic tool would.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this modification is based on the previously cleared specifications and performance of the device before the change. The "performance testing" was to ensure the new component meets those existing specifications and that the overall system still "functions as intended" based on its original design and claims.
8. The Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device and submission.
Summary of the Study and Device Proof of Acceptance:
The "study" described is a verification testing process to confirm that a minor hardware modification (changing the infrared light source from a tungsten halogen lamp to an LED) in the VelaShape system does not negatively impact its performance, safety, or effectiveness, and that it remains substantially equivalent to the original cleared device.
The proof the device meets "acceptance criteria" (which are implicit and relate to maintaining the original device's cleared performance and safety profile) is through engineering and performance testing. The document states that "Verification testing was performed to evaluate this modification to ensure the performance of the new light source is compatible with the previously cleared specifications" and that "Performance testing demonstrates that the VelaShape system performs according to specifications and functions as intended."
The core assertion is that "The modification of the IR light source to LED raises no new issues of safety or effectiveness," thereby allowing it to continue to meet its established indications for use related to minor muscle aches and pain, muscle spasm, local blood circulation, temporary reduction in cellulite appearance, and temporary reduction of thigh circumferences. No new clinical trials or human subject data were presented because the modification was deemed to not affect the foundational scientific technology or clinical performance.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.