(69 days)
The Velure Family of Diode Lasers are intended for use in dermatology, hair removal, oral, periodontal and surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue.
Velure S5 532nm (Green) Diode Laser Applications: Vascular Lesions, Pigmented Lesions
Velure S8/15, Velure S8/30 and Velure S800 808nm Diode Laser Applications: Vascular Lesions, Unwanted Hair Removal
Velure S9/15, Velure S9/30 980mm Diode Laser Applications: Surgical Cut and coagulate General Surgery GYN ENT Neuro Urgology
Velure S9/7D and Velure S9/15D 980nm Diode Laser Applications: Oral and Periodontal Surgery, Bleaching (tooth whitening)
The Velure Family of Diode Lasers emit a beam of coherent light in either continuous wave or pulse mode at the following wavelengths: 523nm - Velure S5, 808nm - Velure S8/15, Velure S8/30 and Velure S800, 980nm - Velure S9/7D, Velure S9/15, Velure S9/15D and Velure S9/30. Each laser consists of a self-contained console, an SMA fiber delivery system with handpiece, a footswitch, safety goggles and warning label set. The main console contains a Diode laser, a 635nm pilot laser, micro-controller, air cooling system and power supply. The console has an on-off key switch and emergency stop push button. The SMA fiber delivery system connects the console to a variety of fiber optic handpieces and scanner (Velure S5 only).
The provided document is a 510(k) summary for a medical device called the "Velure Family of Diode Lasers and Delivery Device Accessories." This type of submission to the FDA is typically used to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a clinical study with detailed statistical outcomes.
Based on the content of the document, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific performance data from a clinical trial that would typically be used to demonstrate the device meets such criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "Performance Data" section explicitly states: "None provided."
2. Sample size used for the test set and the data provenance
No test set sample size is mentioned because no clinical performance study demonstrating acceptance criteria was conducted or provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no ground truth establishment for a test set is described.
4. Adjudication method for the test set
Not applicable, as no test set requiring 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 a laser system, not an AI-assisted diagnostic or imaging device used by readers. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a laser system, not an algorithm.
7. The type of ground truth used
Not applicable, as no ground truth for a clinical study is described. The "ground truth" for this 510(k) summary is based on the performance and safety profiles of the predicate devices.
8. The sample size for the training set
Not applicable, as no training set for an algorithm is described.
9. How the ground truth for the training set was established
Not applicable, as no training set for an algorithm is described.
Summary of the Document's Approach to Acceptance:
The "Velure Family of Diode Lasers and Delivery Device Accessories" received a 510(k) clearance by demonstrating substantial equivalence to existing legally marketed predicate devices, specifically the Adept Ultralite 532 (K042496) and the Intermedic Diode Laser Family (K053540).
The key "proof" of acceptance in this context is the FDA's letter stating: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."
The document explicitly states:
- "Performance Data: None provided" (page 2)
- "Clinical Data: None provided" (page 2)
Therefore, the acceptance of this device for marketing in the US was based on a comparison of its design, materials, intended use, and technological characteristics to existing predicate devices, rather than on new clinical studies showing specific performance metrics against pre-defined acceptance criteria. The assumption is that if it's substantially equivalent to already approved devices, it is equally safe and effective.
§ 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.