(70 days)
The Laserseope VELA Erbium: YAG Laser System and Accessories are intended for the surgical incision. vaporization and congulation of soft tissue. All soft tissue is included such as skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage menus membranc, lymph vessels and nodes, organs and glands.
DermatologyPlastic Surgery: Indications include, cpidcrmal nevi, teleagiestasia, soider veins, scinic chailitis, keloids, verrucee, skin togs, keratoses, sear revision, debulking banign tumors, decubitis ulcers and skin resurfacing.
General Surgery: The Erbium: YAG lass is intended for the surgical incision, vaportuation and coagulation of soft tissue during any general surgery application where skin incision, tissue of external lumors and lesions, complete or partial resection of internal organs, tissue abletion and/or vessel coagulation may be indicated.
Genitourinary: Indications include lesions of the external genitalia, welcon and anus, penis, scrown and urchire (includes condyloma acuminata, gian perined condyloma und verrucous carcinoma), valvar lesions, polyps and familial polyps of the colon.
Gynecology: Indications include cervical intraepithelial neoplusia (CDV), herpes simplex, endometrial adhesions, cysts and condyloms.
ENT: Indications include car, nose and throat lessions, polyps, cysts, hyperkeratosis; excision of carcinogenic lissue, oral leukoplakia.
Oral/Maxillofacial: Indications include benign oral tunnors, oral and glossel lessions and gingivectory.
Ophthalmology: Indications include soft tissue surrounding the eye and orbit and unterior capsulotomy.
Podiatry: Indications include warts, plantar verrucae, large mossic verrucae and matrixectory .
The Laserscope Erbium:YAG Laser System and Accessories consists of a moveable console containing power supplies, aiming and treatment lasers on a solid optical deck and a cooling mechanism to dissipate the heat generated by the system. A softouch keypad control panel with LCD displays enables the user to control the laser system operating parameters. The aiming beam is coincident with the Erbium:YAG beam and passes through an articulating arm. The aiming beam emerges at the distal end of a handpiece. Focusing handpiece adapters, which attach to the handpiece, are available in spot sizes of 1 - 8 mm.
The Laserscope Erbium:YAG Laser System and Accessories received 510(k) clearance based on substantial equivalence to a predicate device, the Continuum Biomedical CB Erbium/2.94 Er:YAG Laser System. Therefore, specific acceptance criteria and a detailed study proving the device meets those criteria, as you've requested regarding performance metrics like sensitivity, specificity, or improvement with AI, are not typically part of a substantial equivalence determination for this type of device in 1997.
Instead, the "study" demonstrating the device meets the acceptance criteria is the comparison to the predicate device, establishing that the Laserscope Erbium:YAG Laser System and Accessories has comparable risks and benefits and is substantially equivalent in terms of indications for use, materials, method of operation, and physical construction.
Here's a breakdown of the available information based on your numbered questions, with explanations for what is not present in a 510(k) submission focused on substantial equivalence:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Equivalent safety profile to predicate device | Risks and benefits are comparable to the predicate device. Conforms to federal regulations and performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. |
| Equivalent effectiveness profile to predicate device | Indicated for similar clinical applications (cutting, vaporizing, coagulating soft tissue) as the predicate device. Substantially equivalent in method of operation. |
| Similar Indications for Use | Indications for use are identical to or comparable with the predicate device (various soft tissue procedures in different specialties). |
| Similar performance standards compliance | Conforms with federal regulations and performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. |
Explanation: For a 510(k) clearance based on substantial equivalence, the "acceptance criteria" are implicitly met if the device is found to be as safe and effective as a legally marketed predicate device. There are no explicit quantitative performance metrics like sensitivity or specificity typically defined or "reported" in the way you might see for a diagnostic device or an AI algorithm.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) submission does not describe a clinical study with a "test set" in the context of evaluating performance metrics. The clearance is based on comparison to a predicate device.
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 establishment by experts for a test set is described in this submission, as it's not a performance study in the traditional sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there is no "test set" or performance study described.
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 surgical laser system, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (laser system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is mentioned or used for device evaluation in this substantial equivalence submission. The "ground truth" for showing safety and effectiveness is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth establishment.
§ 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.