(228 days)
The QuadroStarPROYELLOW (wavelength: 577nm) is intended for treatment of benign vascular and benign pigmented lesions.
The QuadroStarPROGREEN (wavelength: 532nm) is intended for vaporisation and photocoagulation of benign vascular and benign pigmented lesions in soft tissue.
The QuadroStarPRO Laser system is a laser Class IV, solid state diode laser, which emits laser radiation with a wavelength of either 577 nm or 532 nm. It`s pulse duration can be varied from millisecond pulses up to continuous operation. The laser power up to 8 Watts is transmitted to the tissue through a transfer fiber and a handpiece, optionally a scanner can be operated.
The laser system consists of:
Laser system including control panel (user interface) Foot switch A transfer fiber with handpiece, optional different spacers.
The provided document is a 510(k) Summary for the QuadroStarPRO laser system. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
However, the document does not contain information about a study proving the device meets specific acceptance criteria in terms of performance in a clinical or diagnostic setting. Instead, it focuses on demonstrating compliance with recognized standards for medical device safety and functionality.
Here's a breakdown of the requested information based on the provided text, and where it's not available:
1. A table of acceptance criteria and the reported device performance
The document lists performance testing against several ISO and DIN EN standards:
- ISO 14971:2009 (Risk management for medical devices)
- DIN EN 60601-1:2006 (Medical electrical equipment - General requirements for basic safety and essential performance)
- DIN EN 60601-1-2:2007 (Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests)
- DIN EN 60601-1-6:2007 (Medical electrical equipment - General requirements for basic safety and essential performance - Collateral standard: Usability)
- DIN EN 60601-2-22:1996 (Medical electrical equipment - Particular requirements for the safety of surgical, therapeutic and diagnostic laser equipment)
- DIN EN 60825-1:2007 (Safety of laser products - Part 1: Equipment classification and requirements)
- DIN EN 62304:2006 (Medical device software - Software life cycle processes)
The "reported device performance" in this context is simply the declaration that the device complies with these standards and the European Medical Device Directive 93/42/EEC + Amendment 2007/47/EC. Specific numerical acceptance criteria and detailed performance results from these tests are not provided in this summary. The 510(k) summary only states "The QuadroStarPRO laser system is tested according to following standards" and then concludes with "The QuadroStarPRO is substantially equivalent to the cited legally marked predicate devices. The minor differences between QuadroStarPRO and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices." This indicates that the device met the requirements of these standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is type testing against engineering and safety standards, not clinical performance testing with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. There is no "test set" or "ground truth" related to clinical or diagnostic performance discussed in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. See point 3.
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
This information is not applicable/not provided. This document pertains to a medical laser device, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI assistance is not relevant to the scope of this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. There is no ground truth related to clinical performance mentioned. The "truth" in this context is compliance with engineering and safety standards.
8. The sample size for the training set
This information is not applicable/not provided. This device is a laser system, not an artificial intelligence or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. See point 8.
In summary: The provided document is a 510(k) summary for a laser device seeking market clearance through substantial equivalence. It confirms compliance with various engineering and safety standards but does not detail clinical effectiveness studies, specific acceptance criteria for diagnostic/treatment performance, or "test sets" in the context of clinical data evaluation. The "study" referenced is the testing performed against the listed international and European standards, to which the device was found to comply, establishing its safety and effectiveness relative to predicate devices.
§ 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.