(90 days)
Fractional mode is indicated only for ablative skin resurfacing.
Non-fractional mode is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.
The Fractional CO2 Laser Therapy System has two operational modes: fractional mode and non-fractional mode.
The Fractional CO2 Laser Therapy System has 6 modules: Control Display Panel Module, Main Control program Module, Articulated arm Module, Fan Cooling Module, Laser Module and Foot switch module.
The provided document describes a 510(k) premarket notification for a medical device, the Fractional CO2 Laser Therapy System (EXFU CO2). It focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing.
Crucially, this document explicitly states: "No clinical study is included in this submission." This means that there is no clinical data presented in this FDA submission regarding human performance, specifically in terms of how human readers or users might improve with or without AI assistance, or any other performance metrics that would typically come from a clinical trial in a human population.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable to this specific submission, as it relies solely on non-clinical testing and comparison to an equivalent predicate device's established performance and safety based on its technical specifications and non-clinical standards conformance.
However, based on the information provided, I can address the relevant points:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission based on substantial equivalence using non-clinical testing, the "acceptance criteria" are typically the conformance to recognized performance standards and the demonstration that the technical specifications of the proposed device are equivalent to or better than the predicate device. The "reported device performance" is the result of these non-clinical tests.
| Acceptance Criteria Category | Specific Acceptance Criteria (based on predicate equivalence and standards) | Reported Device Performance (as demonstrated by testing) |
|---|---|---|
| Indications for Use Equivalence | To have the same indications for use as the predicate device. | SAME as predicate device (K172096): Fractional mode for ablative skin resurfacing. Non-fractional mode for incision, ablation, vaporization, and coagulation of body soft tissues (intraoral included) in aesthetic (dermatology/plastic surgery), ENT, gynecology, neurosurgery, dental/oral surgery, and genitourinary surgery. |
| Technical Feature Equivalence | All key technical parameters to be equivalent or demonstrably safe/effective if different. | Laser Type: CO2 (SAME) |
| Laser wavelength: 10.6μm (SAME) | ||
| Maximum Output power: 30W (SAME) | ||
| Pulse Duration: 20μs – 5000μs (SAME) | ||
| Fractional Pulse energy: Max 150mJ (SAME) | ||
| Repetition rate: 1,000Hz (SAME) | ||
| Scan area: 20x20mm (SAME) | ||
| Spot size: 100-200μm (fractional), Max 1.3mm (non-fractional) (SAME) | ||
| Number of microbeams per surface area: Max 289 spot/cm² (SAME) | ||
| Energy per microbeam (fractional): 150mJ (SAME) | ||
| Total power per surfaced area (fractional): Max 30W (SAME) | ||
| Treatment Time: 10-15 min (SAME) | ||
| Pulse rate (nonfractional): 1Hz - 1,000Hz (SAME) | ||
| Pulse width (nonfractional): 20μs – 5000μs (SAME) | ||
| Operational mode: Fractional mode, normal mode (CW, Pulse, Single Pulse) (SAME) | ||
| Cooling: Air cooling (SAME) | ||
| User Interface: LCD touch screen (SAME) | ||
| Optical guide: Articulated arm (SAME) | ||
| Safety and Performance Standards Conformance | Conform to relevant national and international standards for medical electrical equipment and laser products. | ISO 10993-5:2009: Tested for in vitro cytotoxicity |
| ISO 10993-10:2021: Tested for skin sensitization | ||
| ISO 10993-23:2021: Tested for irritation | ||
| IEC 60601-1:2020: Conforms to General requirements for basic safety and essential performance (verified by test report included for electrical requirements analysis) | ||
| IEC 60601-1-2:2020: Conforms to Electromagnetic disturbances | ||
| IEC 60601-2-22:2019: Conforms to Particular requirements for laser equipment | ||
| IEC 60825-1:2014: Conforms to Safety of laser products | ||
| Differences Analysis Safety/Effectiveness | Any differences from the predicate device must not raise new questions of safety or effectiveness. | Aiming beam: Proposed device Max 3mW vs. Predicate Max 4mW. Analyzed as adequate for user feedback, thus not raising new safety/effectiveness concerns. |
| Electrical Requirements: Proposed device 110-240V, 50/60Hz vs. Predicate 100-240VAC, 50-60 Hz. Conforms to IEC 60601-1 performance standard, thus not raising new safety/effectiveness concerns. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as no clinical test set or human data was used. The submission relies entirely on bench testing and comparison of specifications.
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)
This information is not applicable as no clinical test set or human data was used, and thus no expert ground truth or adjudication was required in the context of this 510(k) submission. Ground truth for non-clinical testing refers to established engineering specifications and standard requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no clinical test set or human data was used, and thus no adjudication of human interpretations was performed.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a laser therapy system and is not an AI-powered diagnostic or assistive device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical laser therapy system, not a software algorithm or AI that performs standalone analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is derived from:
- Established engineering specifications and design requirements: The device's technical parameters (e.g., laser power, wavelength, pulse duration) are designed to meet specific values.
- International and national performance standards: Conformance to standards like ISO 10993 (biocompatibility) and IEC 60601 (electrical safety, laser safety) serves as the "ground truth" for safety and essential performance. Test reports demonstrate adherence to these standards.
- Predicate device's specifications and performance: The predicate device (K172096) serves as the benchmark against which the proposed device's specifications are compared for substantial equivalence. The predicate device's clearance implies its specifications are safe and effective for the indicated uses.
8. The sample size for the training set
This information is not applicable as no training set (for machine learning or AI) was used in this submission.
9. How the ground truth for the training set was established
This information is not applicable as 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.