(272 days)
The Cutera GenesisPlus Nd.YAG laser is intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic.laproscopic.laproscopic.label specialites of general otorhinolaryngology (ENT), neurosurgery, oculoplastics, pulmonary.hnoracis surgery, podiaty and urology for surgical and aesthetic applications.
Dermatology:
The Cutera GenesisPlus faser is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, rosaceal diffuse redness, poikiloderma of civatte, scar reduction (including hypertropic and keloid scars), and warts.
The Cutera GenesisPlus laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
The GenesisPlus laser is indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Podiatry:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Matrixectomy .
- Periungual and subungual warts .
- . Plantar warts
- . Radical nail excision
- Neuromas
The Cutera GenesisPlus laser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeast Condida Albicans, etc.).
The Cutera GenesisPlus Laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of a handpiece using a fiber optic delivery system with an optical lens at the aperture. The user activates laser emission by means of a footswitch.
The Cutera GenesisPlus Laser is designed to provide laser energy for use in a variety of dermatology and podiatry procedures.
The Cutera GenesisPlus Laser System, under K122493, is not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, ground truth establishment methods, expert qualifications, adjudication methods, and MRMC studies, are not applicable.
This submission describes a medical laser system and focuses on demonstrating substantial equivalence to a previously cleared predicate device (Cutera GenesisPlus under K103626) by comparing technical specifications and intended uses. The clinical study mentioned did not involve AI/ML performance metrics but rather evaluated the safety and effectiveness of updated treatment parameters for the podiatry indication concerning onychomycosis.
Here's the information that is applicable from your request:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for substantial equivalence are based on demonstrating that the revised Cutera GenesisPlus Laser System is as safe and effective as the predicate device (K103626) and shares similar technological characteristics and indications for use. No specific numerical performance metrics or thresholds are provided as "acceptance criteria" in the context of an algorithmic performance study, as this is a laser device modification, not an AI system.
However, the comparison tables demonstrate that the revised device either matches or has slightly modified parameters (e.g., fluence, spot size, pulse duration, repetition rate for the clear nail indication) that were deemed acceptable based on a clinical study for safety and effectiveness.
Comparison of Technical Specifications for Dermatology Indications for Use:
| Features | Cutera GenesisPlus Laser (K103626) | Cutera GenesisPlus Laser (revised) |
|---|---|---|
| Wavelength | 1064nm Nd:YAG | 1064nm Nd:YAG |
| Aiming Beam | 630-680nm (≤ 2.5mW) | 630-680nm (≤ 2.5mW) |
| Energy per Pulse | 20-3500 mJ | 20-3500 mJ |
| Fluence | 25.5J/cm2 (with 1mm spot) | 25.5J/cm2 (with 1mm spot) |
| Power | ≤ 100W | ≤ 100W |
| Spot Size | Up to 13mm | Up to 13mm |
| Pulse Duration | 100-3000μs | 100-3000μs |
| Output mode | Pulsed | Pulsed |
| Repetition Rate | 5-100 Hz | 5-100 Hz |
| Laser Media | Flashlamp pumped solid state rod | Flashlamp pumped solid state rod |
| User Interface | LCD color touchscreen | LCD color touchscreen |
Comparison of Technical Specifications for Temporary Increase of Clear Nail Indication for Use:
| Features | Cutera GenesisPlus Laser (K103626) | Cutera GenesisPlus Laser (revised) |
|---|---|---|
| Wavelength | 1064nm Nd:YAG | 1064nm Nd:YAG |
| Aiming Beam | 630-680nm (≤ 2.5mW) | 630-680nm (≤ 2.5mW) |
| Fluence | 25.5J/cm2 (with 1mm spot) | 15-18 J/cm2 |
| Power | ≤ 100W | ≤ 100W |
| Spot Size | 1.0-1.5mm | 5mm |
| Pulse Duration | 100μs | 0.3ms |
| Output mode | Pulsed | Pulsed |
| Repetition Rate | 20 Hz | 2-3Hz |
| Burst Mode Sequence | ½ second on, ½ second off | Not applicable |
| Laser Media | Flashlamp pumped solid state rod | Flashlamp pumped solid state rod |
| User Interface | LCD color touchscreen | LCD color touchscreen |
| Laser activation | Footswitch | Footswitch |
| Delivery Devices (How Supplied) | Non-sterile, reusable, cleanable | Non-sterile, reusable, cleanable |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "A clinical study was conducted to evidence that the change to the treatment parameters for the podiatry indication is safe and effective." However, it does not specify the sample size, data provenance, or whether the study was retrospective or prospective. This information would typically be detailed in the full clinical study report, which is not provided in this summary.
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, as this is a laser device and not an AI/ML system requiring expert-established ground truth for algorithmic performance. The clinical study would have involved physicians treating patients and evaluating outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a laser device and not an AI/ML system. Adjudication methods refer to how disagreements among independent readers are resolved to establish a definitive ground truth for AI model evaluation.
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, as this is a laser device and not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a laser device and not an AI/ML system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical study mentioned for the temporary increase of clear nail in patients with onychomycosis, the "ground truth" would be related to clinical outcomes data, specifically the assessment of "temporary increase of clear nail." This would be determined by a clinician based on visual inspection and possibly other diagnostic methods (e.g., microscopy, culture) if the study protocol included them, though the summary does not detail the specific assessment methods.
8. The sample size for the training set
Not applicable, as this is a laser device and not an AI/ML system.
9. How the ground truth for the training set was established
Not applicable, as this is a laser device and not an AI/ML system.
§ 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.