(146 days)
YOULASER CO2 laser when used in traditional, non fractionated mode is indicated for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery.
YOULASER CO2 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing.
The YOULASER CO2 Laser System includes a single model named YOULASER CO2 emitting a maximum power of 30 Watt at 10.6 µm.
The YOULASER CO2 Laser is composed externally of a metallic shell with a frontal polyurethane panel containing the touch screen display. On this panel the key switch, emergency red push button and the operation led are inserted too. On the rear panel the footswitch connector, the remote interlock, the power switch are located.
The laser system is composed of power supply, CO2 laser source with air cooling system, optical bench, articulated arm with CO2 scanner, the control electronics.
The electronic, based on a microcontroller, manages the voltage power supply and the CO2 laser source.
This submission describes a medical device, the YOULASER CO2 laser system, seeking 510(k) clearance. The device is a Class II laser surgical instrument for use in general and plastic surgery and dermatology. It operates in both traditional (non-fractionated) and fractionated modes.
Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific quantifiable acceptance criteria for performance metrics. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The performance evaluation is described qualitatively as "safety and effectiveness" and "ablation, coagulation depth and the healing evolution of the skin at the typical settings of use of Youlaser CO2."
Therefore, a table of acceptance criteria and reported device performance cannot be generated with specific numerical values from this document. The overall acceptance criterion is "substantial equivalence" to the predicate devices. The reported device performance is that it was found to be "as safe as effective as the predicated devices" based on the described non-clinical testing.
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Sample Size Used for the Test Set and Data Provenance:
The document mentions a "specific non clinical testing was conducted on the proposed YOULASER CO2 device." However, it does not provide details about the sample size used for this test set.
Regarding data provenance, the testing was conducted on the "proposed YOULASER CO2 device," implying this was a prospective study using the actual device. The country of origin of the data is not explicitly stated, but the applicant/manufacturer is Quanta System SPA, based in Italy.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish ground truth for the non-clinical testing. The assessment of "ablation, coagulation depth and the healing evolution of the skin" would likely be through objective measurements and potentially histological analysis rather than expert consensus on subjective outcomes.
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Adjudication Method for the Test Set:
Since no experts are mentioned for establishing ground truth, there is no adjudication method described. The non-clinical testing appears to be based on objective measurements related to the laser's effects on tissue.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The device in question is a surgical laser, not an imaging diagnostic tool that would typically involve multiple readers interpreting cases. The testing described is non-clinical and assesses direct tissue interaction.
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Standalone (Algorithm Only) Performance Study:
No, a standalone (algorithm only) performance study was not done. This device is a physical surgical laser, not an AI algorithm. Therefore, "algorithm only" performance is not applicable.
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Type of Ground Truth Used:
The "ground truth" for the non-clinical testing appears to be based on objective measurements of tissue response to the laser parameters. This includes "ablation, coagulation depth and the healing evolution of the skin." This would involve direct physical or biological measurements/observations, likely including histological analysis, rather than expert consensus on a subjective interpretation, pathology of a disease state, or patient outcomes data in an extensive clinical trial setting.
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Sample Size for the Training Set:
Since this is a physical medical device and the testing focuses on its physical effects rather than an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable or mentioned.
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How the Ground Truth for the Training Set Was Established:
As the concept of a "training set" for an AI algorithm is not applicable, there is no information on how ground truth for a training set was established.
§ 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.