Search Results

The DEKA SmartPerio system is intended to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device is intended to be used in dentistry. The following are the oropharyngeal indications for use: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)

The DEKA SmartPerio is a Nd:YAG laser device for soft-tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip. The modification to the device consists in the increasing of the average output power from 6W to 10W.

The provided text describes a 510(k) premarket notification for a medical device called DEKA SmartPerio. This notification focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a study to prove acceptance criteria for a new, independent device performance claim. The key modification is an increase in average output power.

Therefore, the document does not contain the information requested for a detailed analysis of acceptance criteria, device performance studies (like MRMC or standalone performance), sample sizes, ground truth establishment, or expert involvement as would be typical for a new AI/algorithm-based device clearance or a device making novel performance claims.

Instead, the document focuses on demonstrating that the modified device, despite the power increase, remains equally safe and effective as its predicate by adhering to established electrical safety and laser equipment standards.

However, I can extract the information that is present and indicate where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a modification to an existing device, the "acceptance criteria" are primarily related to safety and effectiveness compared to the predicate, as demonstrated by compliance with relevant standards. There are no specific performance metrics like sensitivity, specificity, or AUC provided in this document that would be typical for an AI/algorithm-driven diagnostic device.

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

Not applicable. This is not a study involving a test set of data (e.g., medical images or patient records) to evaluate an algorithm's performance. The "testing" refers to non-clinical bench testing for electrical, EMC, and laser safety standards.

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

Not applicable, as there is no test set with ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable, as there is no test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This document does not describe an MRMC comparative effectiveness study. This type of study would be relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the scope of this 510(k) submission.

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

Not applicable. The DEKA SmartPerio is a laser device, not an algorithm.

7. The Type of Ground Truth Used

Not applicable. This document pertains to the safety and performance of a physical medical device (a laser) and its compliance with engineering standards, rather than the accuracy of an algorithm against a defined ground truth.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-driven device that requires a training set.

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

Not applicable.

Ask a specific question about this device

The DEKA SmartPerio system is intended to perform the following types of intraoral procedures: soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device is intended to be used in dentistry. The following are the oropharyngeal indications for use: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility tooth mobility. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)

The DEKA SmartPerio is a Nd:YAG laser device for soft-tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip. The DEKA Smartperio device consists of: An AC/DC power supply unit CPU controller LASER source Cooling system User interface with LCD touch screen Beam delivery system Laser activation is controlled by footswitch.

The provided document is a 510(k) summary for the DEKA SmartPerio laser device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide what is available, noting where information is absent.

1. A table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria typically seen in performance studies for new medical devices, nor does it report specific device performance metrics in detail beyond a comparison of technical specifications with a predicate device.

Instead, the document's primary "acceptance criteria" appear to be meeting electrical safety and electromagnetic compliance standards, as well as demonstrating substantial equivalence to a legally marketed predicate device.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document explicitly states "Clinical Performance Data: None" and "Non-Clinical Performance Data" only refers to compliance with electrical and laser safety standards. This implies there was no "test set" of patient data in the sense of a clinical trial or performance study. The data provenance and sample size for such a test set are therefore not applicable or not provided.

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, as no clinical test set or ground truth adjudication using experts is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set or ground truth adjudication is mentioned.

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 DEKA SmartPerio is a laser surgical instrument, not an AI-powered diagnostic or assistive device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The DEKA SmartPerio is a physical medical device (laser surgical instrument), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable, as no clinical performance study requiring a "ground truth" (e.g., for diagnostic accuracy) was performed or reported.

8. The sample size for the training set

Not applicable, as the DEKA SmartPerio is a physical laser device and not an AI or machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, as the DEKA SmartPerio is a physical laser device and not an AI or machine learning algorithm.

Ask a specific question about this device