(112 days)
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.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (as demonstrated by compliance) |
|---|---|
| Electrical Safety: Compliance with ANSI AAMI ES60601-1 | Electrical safety testing conducted according to ANSI AAMI ES60601-1 |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 | EMC testing conducted according to IEC 60601-1-2 |
| Laser Safety & Essential Performance (Surgical, Cosmetic, Therapeutic, Diagnostic Laser Equipment): Compliance with IEC 60601-2-22 | Testing conducted according to IEC 60601-2-22 |
| Laser Product Classification & Requirements: Compliance with IEC 60825-1 | Testing conducted according to IEC 60825-1 |
| No adverse effect on safety and effectiveness due to increased average power (0.2-6W to 0.2-10W) | Demonstrated equivalence through testing and comparison of technical specifications, asserting no adverse effect. |
| Identical Indications for Use | Indications for use are identical to the predicate device (K203396). |
| Identical Technological Characteristics (except average power) | Laser Wavelength, Energy per Pulse, Pulses per Second, Pulse duration, Aiming Beam wavelength, Power of Aiming beam are identical to the predicate. |
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.
§ 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.