(111 days)
The SOPRANO XL™ Multi-Application Platform includes a Diode Laser Module and an optional NIR Module.
The Diode Laser Module:
The HR Mode is intended for hair removal, permanent hair reduction.
The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions.
The NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The SOPRANO XL™ Multi-Application Platform is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
The Soprano XL Multi-Application Platform features an additional indication for the treatment of benign vascular and pigmented lesions introduced to its Diode Module compared to the existing Alma Lasers, Ltd. (former MSq., Ltd.) Soprano Diode Laser System, previously cleared under K052874 for hair removal and long-term hair reduction. The Soprano XL system is indicated for use on all skin types (Fitzpatrick Skin Types I-VI), including tanned skin.
The Soprano XL Multi-Application Platform is a multi-application, multi-technology platform that supports the following technologies:
· Diode laser technology
· Near-infrared light technology (NIR)
Both the Soprano and Soprano XL systems consist of a console, a diode module and a footswitch. The module is pressed against the patient skin and a laser pulse is delivered when the module trigger and the footswitch are activated. The module tip is cooled by the cooling system.
Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen.
The provided document is a 510(k) summary for the Alma Lasers Soprano XL Multi-Application Platform. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through novel studies.
Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving device performance against those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies for new data.
The core argument for clearance is based on the device having "the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices."
Below is a breakdown of why each specific point you requested cannot be found in this document:
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A table of acceptance criteria and the reported device performance: This document does not present specific quantitative acceptance criteria or results from a performance study designed to meet them. It relies on the equivalence to previously cleared devices.
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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): No test set data is described. The clearance is based on comparison to predicate devices, not on new clinical performance data from a test set.
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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): No ground truth establishment for a test set is discussed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or corresponding adjudication method is mentioned.
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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: This device is a laser platform, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and
AI assistance metrics are not applicable and are not present. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This device is a physical laser system, not an algorithm. Standalone algorithm performance is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As no new performance study is detailed, no ground truth methodology for such a study is provided.
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The sample size for the training set: No training set is mentioned as this is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable, as there's no training set.
In summary, this 510(k) submission is a "me-too" application, seeking clearance based on substantial equivalence to existing, legally marketed devices. It does not present new performance data against a defined set of acceptance criteria, nor does it involve AI or algorithmic performance evaluation.
§ 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.