(75 days)
The Venus Epileve is intended for all Fitzpatrick skin types, including tanned skin, for use in dermatology, general and plastic surgery applications for:
- · Hair removal:
- Permanent hair reduction (defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen); and
- · Treatment of pseudofolliculitis barbae.
The Venus Epileve device consists of a tabletop console (main unit) and one detachable diode laser applicator. The system console is the main enclosure that holds and contains all external and internal system components: a power supply unit, laser diode driver, controller unit, and touch screen with LCD display. The console incorporates a water cooling system with a pump in order to constantly keep the tip of the applicator, light guide, chilled. The detachable diode laser applicator is connected to the system via a cable passed through the applicator connectors located in the designated compartment on the system's rear side. When not in use, the applicator can be secured within the applicator cradle on the top panel of the console. The applicator delivers the laser energy to a patient's skin through the applicator's tip made of a sapphire light guide framed in aluminum anodized shells. The applicator is supplied with only one spot size light guide. The device also comes with a footswitch, goggles, patient eye protectors, and water filling kit.
The provided text describes the Venus Epileve device, a laser surgical instrument for hair removal and permanent hair reduction. It outlines its technical specifications, intended use, and the performance tests conducted to demonstrate its safety and effectiveness compared to a predicate device.
However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly within the context of an AI/human-in-the-loop system or the detailed methodology of clinical studies for performance metrics like accuracy, sensitivity, or specificity. The "Performance Data" section primarily details engineering and electrical safety tests, and a comparison to a predicate device based on technical specifications.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance (for metrics like accuracy, sensitivity, specificity, etc., common in AI/diagnostic device studies). The document only mentions "performance tests" that demonstrated the device meets system requirements and specifications, without defining quantifiable acceptance criteria for clinical efficacy or outlining the results in a table format.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study details and effect size.
- Standalone algorithm performance details.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Venus Velocity Diode Laser System) based on similar intended use, indications for use, and technological characteristics, supported by engineering performance tests (e.g., electrical safety, software validation, laser safety). It does not describe a clinical study with detailed performance metrics and ground truth establishment, which would be necessary to derive the information you've requested.
The "Performance Data" section summarizes:
- Performance Bench Testing: Evaluated the system's outputs against specifications and compared them to the predicate device. Stated that "differences... do not raise new types of safety or effectiveness concerns."
- Electrical Safety and Electromagnetic Compatibility: Tested per IEC standards (60601-1, 60601-1-2, 60601-1-6, 60825-1, 60601-2-22). All results were "passing."
- Software Testing: Verification and validation showed the system "performed as intended and that the energy outputs... meet specifications."
These are typical pre-market notification (510(k)) submissions for devices demonstrating substantial equivalence to a predicate, rather than novel devices requiring extensive new clinical efficacy studies with the types of performance metrics and ground truth setup you've outlined.
§ 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.