(55 days)
The AvalancheLase Family and its accessories will be marketed for the following indications for use:
Alexandrite laser (755 nm wavelength): Indications in Dermatology and Aesthetics
- Temporary hair reduction.
- Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin.
- Treatment of benign pigmented lesions.
- Treatment of wrinkles
- The photocoagulation of benign dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Nd:YAG laser (1064 nm wavelength):
The Nd:YAG laser module is intended for incision, vaporization coagulation and hemostasis of vascular lesions and soft tissue in various dermatological areas, and for permanent reduction of unwanted hair in Fitzpatrick skin types I - VI.
Indications in Dermatology and Aesthetics:
- 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 thair 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 wrinkles with S11 (LX Runner) scanner.
- 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, and coagulation of soft tissue) including:
- Matrixectomy
- Radical nail excision
- Periungual and subungual warts
- Plantar warts
- Neuromas
- Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophylla rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
NNd:YAG laser (1064 nm wavelength) therapy:
- Temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, temporary increase in local blood circulation and/or promoting relaxation of muscle.
The AvalancheLase Family is based on Nd:YAG (1064 nm) and Alexandrite (755 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 flashlamppumped laser sources in one housing, with optical cavities containing the Nd:YAG and Alexandrite crystals. A green diode aiming beam (520 mm) is combined with both therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical manual handpiece or scanner. The AvalancheLase Family is designed to operate in single wavelength (Nd:YAG or Alexandrite) configurations (models) and dual wavelength (Nd: YAG and Alexandrite) configurations (models).
The provided text is a 510(k) summary for the Fotona AvalancheLase Family device. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and comparison of technical characteristics and indications for use. It does not include a description of acceptance criteria for a device performance study or the study that proves the device meets those criteria in the way typically associated with AI/ML device evaluations.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, AI assistance effect size, standalone performance, training set details) are not applicable as this document describes a traditional laser surgical instrument undergoing a 510(k) clearance, not an AI/ML powered device.
However, I can extract the information that is present concerning performance claims and the basis for substantial equivalence.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in the formal sense for performance metrics like sensitivity, specificity, accuracy, etc., as it's not an AI/ML device. Instead, it relies on demonstrating substantial equivalence to predicate devices through technical specifications and adherence to recognized standards. The "performance" is implicitly considered to be comparable to the predicate devices if the technical characteristics are similar and the device meets safety standards.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (AvalancheLase Family) |
|---|---|
| Wavelength (match predicate) | Alexandrite: 755 nm; Nd:YAG: 1064 nm |
| Laser Media (match predicate) | Alexandrite: Flashlamp solid state Alexandrite rod; Nd:YAG: Flashlamp solid state Nd:YAG rod |
| Aiming Beam (comparable to predicate) | 520 nm |
| Output Mode (match predicate) | Pulsed |
| Fluence (Up to comparable levels of predicate) | Alexandrite: Up to 500 J/cm²; Nd:YAG: Up to 600 J/cm² |
| Spot Size (comparable to predicate) | 2-30 mm |
| Pulse Width (comparable to predicate) | Alexandrite: 0.2 – 200 ms; Nd:YAG: 0.1 - 200 ms |
| Repetition Rate (comparable to predicate) | Alexandrite: Up to 60 Hz; Nd:YAG: Up to 80 Hz |
| Beam Delivery (match predicate) | Fiber |
| System Cooling (match predicate) | Self-contained, water to air heat exchanger |
| User Interface (match predicate) | LCD Touchscreen |
| Safety and Electrical Standards (conformity) | Conforms to multiple IEC/AAMI/ISO standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60825-1, ISO 14971) |
| Software Verification/Validation (according to FDA guidance) | Completed (considered "moderate" level of concern) |
| Biocompatibility (according to ISO 10993-1) | Performed on handpieces and scanner for direct contact components |
| Indications for Use (comparable to predicate without new safety/effectiveness questions) | Alexandrite: Hair reduction, pigmented lesion treatment, wrinkles, vascular lesions. Nd:YAG: Incision, vaporization, coagulation, hemostasis, hair reduction, wrinkles, acne vulgaris, pigmented/vascular lesions, podiatry, onychomycosis, pain relief. |
2. Sample size used for the test set and the data provenance
Not applicable. This device is a laser surgical instrument, and the provided document does not describe a performance study with a test set of data samples (e.g., medical images, patient records). The evaluation is based on non-clinical testing of the device itself (electrical, mechanical safety, software V&V, biocompatibility) and a comparison of its technical specifications and intended use against legally marketed predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as there is no "test set" or "ground truth" establishment in the context of an AI/ML performance study described. The document relies on recognized standards and the established safety and efficacy of predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" requiring adjudication.
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
No. This device is a laser surgical instrument and does not involve AI assistance for human readers or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. Its performance is inherent to its physical and functional design, which is assessed through non-clinical bench testing and comparison.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of an AI/ML performance study. The "ground truth" for this submission is adherence to established industry safety and performance standards (e.g., IEC, ISO) and demonstrating that the device's technical characteristics and indications for use are substantially equivalent to those of legally marketed predicate devices.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device requiring a training set or its associated ground truth.
§ 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.