(101 days)
The Fotona Dynamis Er: YAG laser is intended for surgical incision/excision, cutting ablation, vaporization and coagulation of soft and hard tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs, and glands.
· Dermatology and Plastic Surgery Indications: Epidermal nevi, actinic cheilitis, verrucae, skin tags, keratoses and soft tissue resurfacing;
· ENT Surgery Indications: ENT lesions, cysts, polyps, hyperkeratosis, oral leukoplakia;
· Oral/Maxillofacial Indications: Oral and glossal lesions;
· Ophtalmology Indications: Soft tissue surrounding the eye ;
· Intra-oral soft tissue incision, excision, ablation, coagulation;
· General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation is necessary;
· Gynecology Indications: Herpes simplex, endometrial adhesion, CIN (Cervical intraepithelial neoplasia), cysts, condiloma;
· Genitourinary Indications:lesions of the external genitalia, urethra and anus, penis, scrotum and urethra, vulvar lesions, polyps and familial polyps of the colon;
· Podiatry Indications: Warts, plantar verrucae, large mosaic verrucae, matrixectomy;
· The Fotona F-22 Handpiece is intended for:
- In fractionated mode:
Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;
- In non-fractionated mode:
General Surgery Indications: Surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of lesions, complete or partial resection of internal organs, lesions, tissue ablation and vessel coagulation is necessary;
· The Fotona FS-01 Handpiece is intended for:
- Dermatological procedures requiring resurfacing of soft tissue with fractionated handpiece;
Dynamis Nd:YAG laser (1064 nm wavelength):
The Fotona Dynamis Nd: YAG laser is intended for incision, ablation, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological and surgical areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.
· Surgical incison, excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands, fibroma removal, frenectomy and frenotomy;
· Treatment of Aphthous Ulcers; · Excision and Vaporization of Herpex Simplex I and II; · Laser assisted uvulopaletoplasty (LAUP); · Laser assisted lipolysis; · Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types. Fitzpatrick I-VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number if hair regrowing when measured at 6, 9 and 12 months after the completion of a treament regime: · Treatment of wrinkles; · Treatment of mild to moderate inflammatory acne vulgaris; · Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins; · Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: o Matrixectomy o Radical nail excision o Periungual and subungual warts o Plantar warts o Neuromas o Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) · Endo Venous Laser Therapy of superficial incompetent tributary veins associated with varicose veins and varicosities.
The Fotona Dynamis Pro Laser System Family is based on Er:YAG (2940 nm) and Nd:YAG (1064 nm) laser technology. The laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The unit combines two flashlamp-pumped laser sources in one housing, with optical cavities containing the Er: YAG and Nd: YAG crystals. A red diode aiming beam (650 nm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an articulated arm to an optical manual or scanner hand piece (in the case of the Er: YAG laser), or through an optical fiber delivery system to an optical manual or scanner handpiece (in the case of the Nd: Y AG laser). Optionally, the Nd: YAG therapeutic and aiming laser beams can be guided through a fiber having a connector on the proximal end and a bare fiber on the distal end. Fotona's power supply Variable Square Pulse (VSP) Technology, integrated into the laser system, allows control of the laser energy and the laser pulse duration. The user activates laser emission by means of a footswitch.
The Fotona Dynamis Pro Family is designed to operate in single wavelength (Nd:Y AG or Er: Y AG) configurations (models) and dual wavelength (Nd: Y AG and Er: Y AG) configurations (models).
The provided document describes the Fotona Dynamis Pro Family laser system, a medical device for surgical procedures. It seeks to establish substantial equivalence to previously cleared predicate devices rather than present a study with specific acceptance criteria and performance data for a new, AI-driven diagnostic or prognostic device.
Therefore, the requested information for acceptance criteria and a study proving device performance (including sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not directly available in this document. This document is a 510(k) premarket notification for a laser surgical instrument, which typically relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, rather than requiring extensive clinical performance studies with acceptance criteria in the way an AI diagnostic tool would.
Here's a breakdown of what can be extracted or inferred based on the document's nature:
1. A table of acceptance criteria and the reported device performance:
This document does not present specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) or a detailed clinical study comparing the device to a gold standard with predefined thresholds. Instead, the "acceptance criteria" are implied by substantial equivalence to predicate devices. The "reported device performance" is largely framed by its technical specifications matching or being similar to those of its predicates for similar intended uses.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Fotona Dynamis Pro Family) |
|---|---|
| Er:YAG (2940 nm) Wavelength: | |
| - Wavelength: 2940 nm | 2940 nm |
| - Laser Media: Flashlamp pumped solid state Er:YAG rod | Flashlamp pumped solid state Er:YAG rod |
| - Aiming Beam: 650 nm | 650 nm |
| - Output Mode: Pulsed | Pulsed |
| - Pulse Energy: 30 - 3000 mJ | 30 - 3000 mJ |
| - Pulsewidth: 100 - 1500 µs | 100 - 1500 µs |
| - Repetition Rate: up to 50 Hz | up to 50 Hz |
| - Power: up to 20 W | up to 20 W |
| - Beam Delivery: Articulated arm | Articulated arm |
| - User Interface: LCD Touchscreen | LCD Touchscreen |
| Nd:YAG (1064 nm) Wavelength: | |
| - Wavelength: 1064 nm | 1064 nm |
| - Laser Media: Flashlamp pumped solid state Nd:YAG rod | Flashlamp pumped solid state Nd:YAG rod |
| - Aiming Beam: 650 nm | 650 nm |
| - Output Mode: Pulsed | Pulsed |
| - Pulse Energy: up to 50 J | up to 50 J |
| - Pulse Duration: 0.1 - 50 ms | 0.1 - 50 ms |
| - Repetition Rate: up to 100 Hz | up to 100 Hz |
| - Power: up to 80 W | up to 80 W |
| - Beam Delivery: Fiber | Fiber |
| - User Interface: LCD Touchscreen | LCD Touchscreen |
| Safety and Performance Standards Compliance: | The device is designed, tested, and will be manufactured in accordance with listed mandatory and voluntary standards (e.g., IEC 60601-1, IEC 60601-2-22, IEC 60825-1, EN ISO 14971, IEC 62304, ISO 17664, IEC 62366, IEC 60601-1-6). |
| Functional Equivalence: | The device is stated to be "substantially equivalent in terms of indications for use and technology based on technical characteristics" to the listed predicate devices. The risk and benefits are also stated to be "identical to the predicate devices when used for similar clinical applications." |
No specific study with acceptance criteria for diagnostic/AI performance is described. The "study" mentioned is laboratory testing to validate and verify that the proposed device meets design specifications and is substantially equivalent to predicate devices. This type of testing focuses on engineering performance and safety, not clinical efficacy in a comparative AI context.
2. Sample size used for the test set and the data provenance:
- Not applicable. This isn't a diagnostic device using a test set of patient data. The "testing" involved laboratory verification and validation against design specifications and relevant standards.
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 applicable. No ground truth for a test set of patient data was established or used as this is a surgical laser device not an AI diagnostic tool.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring expert adjudication was used.
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. This device is a laser surgical instrument, not an AI-assisted diagnostic tool. No human reader performance, with or without AI, is relevant to its substantial equivalence determination.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is hardware (a laser system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For this type of device, the "ground truth" relates to its adherence to technical specifications, safety standards, and functional equivalence to its predicate devices, rather than a clinical ground truth like pathology or outcomes data in the context of an AI diagnostic study.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 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.