(113 days)
The Trios™ system is indicated for long term stable, or permanent, hair reduction; for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions and for the treatment of mild to moderate inflammatory Acne Vulgaris.
The use of Trios 1 in aesthetic applications is based on the principle of Selective Photothermolysis. According to this principle, pulsed light parameters (wavelength, pulse duration and energy fluence) are chosen to selectively target light sensitive cells while minimizing damage to surrounding tissues. Trios The consists of the following major components: Main Console, Operator Control Panel, Three Hand Pieces. The main console contains the high voltage electronics, the control panel, monitoring modules and the cooling system. The hand pieces house the mechanism which generates the light pulse. The hand piece is connected to the system console by an umbilicus cord containing electrical wiring. Light from a Xenon flash lamp, located in the hand piece, is directed through a long-pass optical filter and focused into a transparent light guide that is placed in contact with the skin.
This 510(k) summary for the Viora Trios™ System does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is available:
What the document does provide:
- Device Name: Trios™ System
- Company: Viora Ltd.
- Indications for Use: Long term stable, or permanent, hair reduction; treatment of benign cutaneous vascular lesions; treatment of benign pigmented lesions; and treatment of mild to moderate inflammatory Acne Vulgaris.
- Predicate Devices: Radiancy Mistral Device (K072331), IFL Professional System (K050165), McCue Energist Ultra VPL Intense Pulse Light System (K060234), and Lumenis Family of IPL Systems (K030527).
- Statement of Substantial Equivalence: The document states that the Trios™ System "has the same intended use and the same performance characteristics as the following predicate devices," and therefore "is substantially equivalent to those devices."
What the document does NOT provide (and is required by your request):
- A table of acceptance criteria and the reported device performance: This document is a summary and asserts substantial equivalence based on predicates. It does not present specific performance metrics or acceptance criteria for the Trios™ system itself in a clinical or performance study.
- Sample size used for the test set and the data provenance: No performance study details are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific performance study is detailed.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable. The device is a direct treatment device, not an AI diagnostic/interpretative tool that would typically involve MRMC studies in this context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI diagnostic algorithm.
- The type of ground truth used: Not specified, as no study is detailed.
- The sample size for the training set: Not applicable; this device is a physical IPL system, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Explanation:
This 510(k) submission establishes substantial equivalence primarily by demonstrating that the Trios™ System has the same intended use and similar performance characteristics to already cleared devices. For many energy-based aesthetic devices, detailed clinical studies with specific performance metrics and acceptance criteria comparable to what you'd expect for an AI diagnostic device are often not included in the 510(k) summary itself. Instead, the submission relies on the established safety and effectiveness of the predicate devices.
To find the kind of information you are looking for (e.g., specific clinical study results, performance metrics, and acceptance criteria), one would typically need to:
- Look for a full 510(k) submission (which is usually much more extensive than the public summary).
- Search for published clinical trials or peer-reviewed literature specifically on the Viora Trios™ System.
- Review the labeling or user manual for performance claims, which would be substantiated by internal studies, though these might not be explicitly detailed in the public 510(k) summary.
In summary, based only on the provided text, the criteria you've asked for cannot be extracted because the document focuses on substantial equivalence to predicate devices rather than detailing the direct performance criteria and results of a specific clinical study for the Trios™ system.
§ 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.