(19 days)
The PhotoGenica SPIR is indicated for use in dermatology, specifically cutaneous vascular lesions.
The Cynosure PhotoGenica SPIR laser is indicated for coagulation of dermatological vascular lesions.
The PhotoGenica SPIR is a solid state laser, having the alexandrite crystal as the lasing medium. It is a pulsed laser with an invisible wavelength of 755nm and a non-contact handpiece. Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x 19"x24" (HxWxD). Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase.
The provided 510(k) summary for the Cynosure PhotoGenica SPIR does not contain information regarding acceptance criteria or a study to prove the device meets acceptance criteria.
Instead, the submission relies on the concept of substantial equivalence to a previously cleared predicate device (Cynosure PhotoGenica LPIR and Cynosure Apogee Laser). This means that the manufacturer is asserting the new device is as safe and effective as a legally marketed device, rather than providing new performance data against specific acceptance criteria.
Therefore, most of the requested information cannot be extracted from this document. Here's a breakdown of what can be inferred or explicitly stated:
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Table of Acceptance Criteria and Reported Device Performance: Not applicable. No specific acceptance criteria or performance data for the PhotoGenica SPIR are reported in this document. The submission states "Nonclinical Performance Data: none" and "Clinical Performance Data: none".
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set data is provided for the PhotoGenica SPIR.
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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): Not applicable. No test set data or ground truth establishment is described for the PhotoGenica SPIR.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set data or adjudication method is described for the PhotoGenica SPIR.
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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 laser system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a laser system, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No ground truth data is presented for the PhotoGenica SPIR.
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The sample size for the training set: Not applicable. This device is a laser system, not a machine learning model requiring a training set.
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How the ground truth for the training set was established: Not applicable. This device is a laser system, not a machine learning model.
In summary, the 510(k) process for this device, at this stage, relies on demonstrating substantial equivalence rather than presenting new performance data against pre-defined acceptance criteria.
§ 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.