(84 days)
The Laserscope Aura Dye Laser System and Accessories are intended for the surgical Incision/excision, ablation and coagulation of soft 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/Plastic Surgery: Indications include epidermal nevi, telangiectasia, spider veins, verrucae, skin tags, anal tags, keratoses, debulking benign tumors and cysts, superficial skin lesions, and benign pigmented lesions.
General Surgery: Indications include surgical incision, vaporization, ablation and coagulation of soft tissue where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablations and/or vessel coagulation may be indicated.
Genitourinary: Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (Includes condyloma acuminata, giant perineal condyloma and verruccous carcinoma), vulvar lesions, polyps and familial polyps of the colon.
Gynecology: Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts, and condyloma.
Oral/Maxillofacial: Indications include benign oral tumors, oral and glossal lesions.
Otorhinolaryngology/Head and Neck (ENT): Indications include ear, nose and throat lesions, polyps, cysts, excision of carcinogenic tissue and oral leukoplakia.
Ophthalmology: Indications include soft tissue surrounding the eye and orbit.
Podiatry: Indications include wart, plantar verrucae, and large mosiac verrucae.
The Laserscope Aura Dye Laser System and Accessories consists of a moveable consoles containing power supples, aiming and treatment lasers on a solid optical deck, and a cooling mechanism to dissipate the heat generated by the system.
The entire laser unit and controls are contained in two consoles, an Aura KTP/532 laser as a pump source, and a Dye Module to produce treatment light. Consoles 1 and 2 are electrically connected to the facility's power source. Emission of the pumping laser beam from Console 1 is through a flexible fiber optic to Console 2, the Dye Laser Module. Treatment light is delivered from Dye Module through fiber optic handpieces and/or scanner. The user interface consists of an LCD on Console 1 which displays laser parameters, data on connected devices and information on messages and prompts. Located on the front panel of Console 1 are four knobs enabling the user to select laser settings, and a READY/STANDBY button for selecting READY or STANDBY mode. An on/off keyswitch turns the laser system on and off. An emergency shut off button disables the laser and places the laser system in a holding status.
The provided 510(k) summary for the Laserscope Aura Dye Laser System (ADLS) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for a diagnostic or AI-driven medical device.
The document is a traditional 510(k) submission for a surgical laser system, focusing on substantial equivalence to predicate devices based on safety and fundamental functional characteristics (wavelength, pulse duration, frequency), rather than performance metrics like sensitivity, specificity, or image quality, which would be relevant for devices involving image analysis or diagnostic outcomes.
Therefore, many of the requested details, such as sample sizes, ground truth establishment, expert qualifications, and MRMC studies, are not applicable or present in this type of submission.
Here's a breakdown of what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with Federal Regulations | The Laserscope Aura Dye Laser System and accessories complies with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. |
| Substantial Equivalence to Predicate Devices | The Laserscope Aura Dye Laser System is substantially equivalent to Laserscope Aura and Orion Lasers systems, as well as the Coherent Versa Pulse C, Candela ScleroPulse, and Cynosure PhotoGenica LV laser systems based on wavelength, pulse duration and/or pulse frequency. The risks and benefits are comparable to predicate devices when used for similar clinical applications. The device meets requirements for substantial equivalence according to Section 510(k) guidelines regarding indications for use, materials, method of operation, and physical construction. |
| Safety and Effectiveness | Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale. |
Limitations: The document does not specify quantitative performance metrics (e.g., specific power output ranges, energy delivery accuracy, beam spot size consistency) that would typically be associated with "acceptance criteria" for a detailed engineering or performance study. The "acceptance criteria" here are high-level regulatory compliance and substantial equivalence demonstrations.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable/Not Provided. This submission is for a physical laser device, not a diagnostic algorithm that would typically use a "test set" of data. The "testing" referred to is likely engineering verification and validation of the device's physical parameters and safety functions against internal specifications and regulatory standards, not clinical data analysis.
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/Not Provided. Ground truth establishment by experts is relevant for diagnostic performance evaluation, which is not the focus of this submission. The "ground truth" for a laser device would be its physical specifications and functionality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable/Not Provided. Adjudication methods are used in studies involving subjective expert review of cases, which is not relevant for this device.
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/Not Provided. MRMC studies are specific to evaluating diagnostic systems, especially those with AI components that assist human readers. This document is for a surgical laser, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable/Not Provided. This is a hardware device (laser), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable/Not Provided in this context. For a physical device like a laser, "ground truth" would relate to its manufacturing specifications, output parameters (e.g., wavelength stability, power output accuracy, beam profile), and safety features, which are verified through engineering tests and quality control, not clinical data labels like pathology or expert consensus.
8. The sample size for the training set
Not Applicable/Not Provided. Surgical lasers do not have "training sets" in the context of statistical or machine learning models.
9. How the ground truth for the training set was established
Not Applicable/Not Provided. As there is no "training set," this question is not applicable.
§ 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.