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Dental Soft Tissue Indications: Dental, oral and soft tissue surgery including: Sulcular debridement of diseased or fibrous tissue Excision and biopsy Gingivectomy and gingivoplasty Lesion (tumor) removal Fibroma removal Tissue retraction (troughing) Aphthous ulcers Gingival hyperplasia (excision and recontour) Crown Lengthening Operculectomy Frenectomy Photocoagulation Laser Periodontal procedures, including: Laser soft tissue curettage Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.

The Odyssey 2.4G Diode Laser is a device for delivering laser energy to surfaces within the oral cavity. This energy is generated by means of a solid-state diode which provides a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 5 watts of energy output. The laser energy is delivered to the surgical site by means of a proprietary optical fiber system, which allows for the safe transmission of laser energy to the surgical site without creating undue risk to the patient or operatory staff of collateral laser emissions. The device features some general user controls including an aiming beam, adjustable power output for user definable settings, and continuous or pulse delivery options. The working end of the delivery fiber is contained within a metal handpiece with a disposable single-use tip for emission with the device. Activation of the device is completed by use of a foot-activated switch.

The provided text describes the Odyssey 2.4G Diode Laser and seeks to establish its substantial equivalence to other legally marketed predicate devices, not to meet pre-defined acceptance criteria through a specific study. Therefore, a direct table of acceptance criteria and reported device performance, or details about a study explicitly proving it meets such criteria, cannot be extracted directly from this document.

However, based on the information provided, we can infer the basis for equivalence which acts as a form of "acceptance criteria" for regulatory clearance (510(k) pathway), and describe the comparison made.

Here's an attempt to structure the information as requested, interpreting "acceptance criteria" as the characteristics that demonstrate substantial equivalence to predicate devices:

1. Table of "Acceptance Criteria" (Basis for Substantial Equivalence) and Reported Device Performance

• Max. Power: 5 watts
• Delivery: Proprietary optical fiber system
• Controls: Adjustable power output, continuous/pulse delivery | - Wavelength: 810 nm (all predicates)
• Max. Power: 5-10 watts
• Delivery: Fiber delivery system
• Controls: Similar methods of control, operating controls |
  | Similar Operating Controls | Adjustable power output for user-definable settings, timing options for pulse delivery | Similar methods of control, operating controls |
  | Similar Delivery Systems | Proprietary optical fiber system (ensures safe transmission, prevents collateral laser emissions) | Fiber delivery system |
  | Similar Safety Features | Not explicitly detailed beyond safe transmission of laser energy and prevention of collateral emissions. Compliance with safety standards listed. | Not explicitly detailed, but implied by regulatory compliance and predicate device characteristics. |
  | Similar Performance Monitoring | Not explicitly detailed | Not explicitly detailed |
  | Similar Performance Specifications | - Wavelength: 810 ± 20 nm
• Max. Power: 5 watts | - Wavelength: 810 nm
• Max. Power: 5-10 watts |
  | Similar Energy Type | 810nm Diode Laser | 810nm Diode Laser (Solid-state diode) |
  | Compliance with Standards | 21 CFR 1040.10, 1040.11 (with Laser Notice 50), IEC 60601-1:1998+A1, IEC 60601-2-22:1995, IEC 2001, FCC Part 15 | Implied for predicate devices through their market clearance. |

Summary of Comparative Performance Data (from "PERFORMANCE DATA - Comparison Table"):

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

This document does not describe a test set in the traditional sense of a clinical or performance study where a defined sample of patients or cases is used. The "study" here is a premarket notification (510(k)) application for regulatory clearance, which relies on demonstrating substantial equivalence to predicate devices already legally marketed. The "data" used is primarily the technical specifications and indications for use of both the submitted device and the chosen predicate devices.

• No specific sample size for a test set is mentioned.
• "Data provenance" would refer to the characteristics of the predicate devices themselves, which are legally marketed in the US. This is not a study with specific data from patients or a defined cohort.

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 noted above, there is no "test set" and thus no ground truth established by experts in the context of a performance study. The ground truth for the predicate devices' safety and effectiveness was established through their original regulatory clearance process.

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

Not applicable. There is no test set or adjudication process described.

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. This is not a medical imaging AI device, nor is it a multi-reader multi-case comparative effectiveness study. It's a diode laser for dental soft tissue.

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

Not applicable. This is a physical medical device (diode laser), not an algorithm or AI.

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

The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices, as determined by previous FDA clearances. The applicant is asserting that their device is sufficiently similar in technological characteristics and indications for use that it raises no new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device. There is no "training set" as understood in that context. The "training" for the device's design and manufacturing implicitly comes from general engineering principles and medical device development best practices.

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

Not applicable. As above, there is no training set in the context of AI/ML. The "ground truth" for the device's design and manufacturing is based on established scientific principles, engineering standards, and regulatory requirements for medical devices.

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