(146 days)
The KaVo KEY Laser 1242 is intended for the incision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry. This includes the following:
Surgery (oral and dental) on soft tissue Aphthae (herpes, decubitus) Incision for drainage of abscesses Frenectorny, incision on frenulum of the cheek Excision of fibromas and flap fibromas Gingivectomy in the case of hyperplasias of the gingiva or excision of hyperplasias Preprosthetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasias, epulides, papillomas, fibromatoses, benign growths Removal of diseased or inflamed tissue in the periodontal pocket (sulcular debridement)
The KaVo KEY Laser 1242 is an Er: Y AG laser operating at 2.94 microns with energy output up to 500 mJ.
The provided document is a 510(k) summary for the KaVo KEY Laser 1242, which is a medical device for surgical applications. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically found for AI/ML-based devices or devices requiring detailed clinical validation against a ground truth.
Instead, the document states: "Performance Data: The specifications and intended uses of the KaVo KEY Laser 1242 are the same or very similar to those of the claimed predicate devices. There are no significant differences between the KaVo KEY Laser 1242 and the claimed predicates in design or under conditions of intended use. The notification included an extensive bibliography and discussions of specific articles in support of the claim for equivalence. Because of this, performance data were not required."
This indicates that the device's acceptance was based on substantial equivalence to legally marketed predicate devices, rather than a specific study demonstrating novel performance criteria. Therefore, most of the requested information (sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission.
Here's a breakdown of the applicable information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices: The KaVo KEY Laser 1242 must be substantially equivalent in specifications and intended uses to legally marketed predicate devices. | The KaVo KEY Laser 1242's specifications and intended uses are the same or very similar to those of the claimed predicate devices (SEO TriLase, Laserscope Er:YAG, Premier Centaur). No significant differences in design or intended use conditions were identified. |
2. Sample size used for the test set and the data provenance: Not applicable. Performance data was not required as equivalence was established through comparison to predicate devices, not through a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a test set was not established.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. The device is not an AI/ML-based diagnostic system that would typically undergo an MRMC study. It is a surgical laser.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a surgical laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The device's approval was based on substantial equivalence, not a direct validation against a clinical ground truth in a performance study.
8. The sample size for the training set: Not applicable. The device is a physical surgical laser, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established: 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.