(46 days)
The SpectraQuattro™ Pulsed Light System is generally indicated to treat dermatological conditions. The SpectraQuattro™ Pulsed Light System is specifically indicated for the treatment of vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris.
SpectraQuattro™ comes with a variety of light spectrum filters. These are indicated below, along with the respective indications for which they are recommended:
| Light Spectrum Filter | Indications |
|---|---|
| 410-1200 | Mild to moderate inflammatory and pustular inflammatory acne |
| vulgaris | |
| 530-1200 | pigmented lesions |
| 560-1200 | lentigenes |
| 585-1200 | Vascular lesions,rosacea, hemangiomas, leg veins |
| 640-1200 | Hair removal |
The SpectraQuattro Pulsed Light System is intended to provide phototherapeutic light to the body. The SpectraQuattro is a compact, self-contained system that delivers a beam of pulsed light at wavelengths of 300nm to 1400nm, which can be optimized at various wavelength ranges and delivered to the treatment site. The system consists of a control console which houses the power supply, cooling system, handpiece that contains the light source, and footswitch.
This document is a 510(k) premarket notification for the SpectraQuattro Pulsed Light System. It asserts substantial equivalence to predicate devices and does not contain detailed acceptance criteria or a study demonstrating device performance against specific metrics. Therefore, it is not possible to fill out the table and answer all questions as requested.
However, based on the provided text, here's what can be gathered regarding the device and its claims:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or report specific performance metrics for the SpectraQuattro Pulsed Light System beyond its general intended use and indications. The basis for clearance is substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance
No test set or clinical data is presented in this 510(k) summary. The submission is based on a comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring ground truth establishment is described.
4. Adjudication method for the test set
Not applicable. No test set 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 pulsed light system, not an AI diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth is established for performance testing within this document.
8. The sample size for the training set
Not applicable. As a pulsed light system, it does not involve a training set as a machine learning model would.
9. How the ground truth for the training set was established
Not applicable.
Summary of Device and Approval Process from the Document:
- Device Name: SpectraQuattro Pulsed Light System
- Intended Use: Generally indicated to treat dermatological conditions. Specifically indicated for: vascular lesions, rosacea, hemangiomas, leg veins, hair removal, pigmented lesions, lentigenes, and mild to moderate inflammatory and pustular inflammatory acne vulgaris.
- Approval Basis: Substantial equivalence to legally marketed predicate devices, including Radiancy, Inc. SkinStation™ Pulsed Light System, Palomar Estelux™ Pulsed Light System, and CoolTouch, Inc. PRIMA Pulsed Light Therapy System.
- Key Argument for Equivalence: The SpectraQuattro has the same intended use, similar indications for use, the same principles of operation, and similar technological characteristics to the predicate devices. Minor differences are stated not to raise new issues in terms of performance, safety, or efficacy.
- Regulatory Classification: Class II, product code GEX (Laser surgical instrument for use in general and plastic surgery and in dermatology).
- Date Prepared: August 17, 2005
- FDA Decision Date: October 1, 2005 (Letter date)
§ 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.