(278 days)
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.
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (Summary from comparison) |
|---|---|
| Substantial Equivalence: | |
| - Indications for use | DEKA SmartPerio's indications are a subset of the predicate device's indications. |
| - Technological Characteristics (Laser Wavelength, Energy per Pulse, Pulses per Second, Pulse duration, Average Power, Aiming Beam wavelength, Aiming beam power, Delivery system, Power Requirements, Weight, Dimensions) | Most are identical or similar, with differences noted as not affecting safety and effectiveness. |
| Safety Standards Compliance: | |
| - AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012, cl:2009/(R)2012 and a2:2010/(R)2012 (Medical Electrical Equipment) | Compliant |
| - IEC 60601-1-2 Ed. 4 (Electromagnetic disturbance) | Compliant |
| - IEC60601-2-22 Ed 3.1 (Laser equipment safety) | Compliant |
| - IEC 60825-1 Ed. 3.0 (Safety of laser products) | Compliant |
| Biocompatibility: | Subject device relies on biocompatibility of already FDA-cleared accessories. |
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.
§ 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.