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The KaVo KEY Laser Models 1243+ and 1242 are intended for the incision, excision, 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 Frenectomy, incision on frenulum of the cheek Excision of fibromas and flap fibromas Gingivectorny 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) Tooth preparation to obtain access to the root canal Pulpotomy Pulp Extirpation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning. The KaVo KEY Laser Models 1243+ and 1242 are intended for ablation and vaporization of hard tissue in dentistry. The uses include: Removal of carious tissue Enamel Etching Cavity preparation Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curretage.

The KaVo KEY Laser 1243+ is an erbium laser which emits its energy at 2.94 microns. The laser consists of a cabinet, foot switch, fiber optic and hand pieces, and a software controlled user/laser interface.

The provided documentation describes the KaVo KEY Laser 1243+ and KaVo KEY Laser 1242, which are erbium lasers intended for various dental procedures, including the removal of subgingival calculus. The acceptance criteria and supporting study are specifically detailed for this indication.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the sample size for the clinical study. It refers to it as a "well-controlled clinical study."
• Data Provenance: Not explicitly stated (e.g., country of origin, specific clinics). The study was a "well-controlled clinical investigation" with a "2-year follow-up." It can be inferred to be prospective due to the follow-up period and objective criteria measurement at specific intervals.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The study measured "objective criteria" at various time points, suggesting quantitative evaluation rather than subjective expert consensus for the primary outcome.

4. Adjudication Method for the Test Set

• Not specified. The mention of "objective criteria were measured and recorded" suggests quantitative measurement rather than an adjudication process typically used for subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No. This study is for a medical laser device, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, in a sense. The device (KaVo KEY Laser 1242) itself performs the treatment (removal of subgingival calculus), and its performance was evaluated against a control group (mechanical removal). While a clinician operates the device, the study assesses the device's effectiveness in achieving the therapeutic outcome.

7. The Type of Ground Truth Used

• The ground truth for the clinical study was established through objective criteria measured over a 2-year follow-up period. These criteria were used to compare the laser's performance to mechanical removal for subgingival calculus.
• Additionally, SEM examination provided ground truth for surface damage, and laboratory cell adhesion tests provided ground truth for biocompatibility.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This is a medical device study, not an AI model requiring a distinct "training set." The in vitro, in vivo, and clinical studies serve to validate the device's performance.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

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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:

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.

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