(147 days)
The FriendlyLight® Nd: YAG lasers are intended to be used in the medical specialties of general and plastic surgery, dermatology, endoscopic general surgery, gastroentermology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculaplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
Dermatology:
The FriendlyLight® Nd: YAG Laser systems are intended for the coagulation and hemostasis of henign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutancous lesions, such as warts, scars, striae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lessons that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The FriendlyLight® Nd: YAG lasers are also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The FriendlyLight® Nd: YAG lasers are also indicated for the removal of unwanted hair, for stable long term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB).
The FriendlyLight® Nd:YAG lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The FriendlyLight® Nd: YAG lasers are indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.
Surgical Application:
The lasers are indicated for the incision/excision and cutting, ablation, coagulation/hemostatis of soft tissue in the performance of surgical applications in endoscopy/laproscopy gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT) neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/ thoracic surgery, gynecology (e.g. menorrhagia) and urology.
The FriendlyLight® Nd:YAG Laser consists of a power supply unit, an air-cooling system, a foot Switch, and the hard prove are, the hand piece is held against the treatment area and the light an unfollow cord. In bather the foot switch and/or hand switch is depressed. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit.
The provided document is a 510(k) summary for the FriendlyLight® Nd:YAG Lasers, a premarket notification to the FDA to demonstrate substantial equivalence to previously marketed devices. It does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria through detailed metrics.
Instead, the document focuses on demonstrating substantial equivalence by stating that the device:
- Has the same intended use and general/specific indications as predicate devices.
- Has similar principles of operation and technological characteristics.
- Does not raise any new questions of safety and effectiveness.
- "has been thoroughly tested according to international standards equivalent to the standard IEC 601. Results from the testing indicate that the device is as safe and effective as the predicate devices." (This is a general statement, not a detailed report of specific performance criteria and metrics).
Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. The other requested information (sample size, experts, ground truth, MRMC, standalone study, training set details) are also not available because the document does not describe a performance study with such details.
Here's what I can extract from the provided text, but it falls short of the detailed request due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific acceptance criteria (e.g., specific quantitative metrics for laser power, beam quality, treatment efficacy, or safety margins) or corresponding reported device performance values. It relies on a general statement of compliance with safety and effectiveness through equivalence to predicate devices and testing to a standard.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in the provided text. The document refers to "thoroughly tested according to international standards equivalent to the standard IEC 601" but does not specify details of any test set, sample sizes, or data provenance for performance.
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)
Not available in the provided text. This type of detail is not typically included in a 510(k) summary focused on substantial equivalence based on technical standards and predicate devices, rather than a clinical performance study with expert adjudication.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not available in the provided text.
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. The device is a laser system, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not available in the provided text. For a laser device, "ground truth" might refer to measured physical properties, successful treatment outcomes, or safety profiles, but no specifics are given.
8. The sample size for the training set
Not applicable/available. The document is for a medical device (laser system), not an AI algorithm that typically has a "training set."
9. How the ground truth for the training set was established
Not applicable/available. (See point 8).
§ 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.