(229 days)
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, infected, inflamed and necrosed soft tissue within the periodontal pocket Removal of inflamed edematous tissue.
The Odyssey Navigator Diode Laser is a portable device for delivering laser energy to surfaces within the oral cavity. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 3 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 site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 650mm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery option.
The working end of the delivery fiber is a disposable single-use tip which is attached to a metal autoclavable handpiece. This handpiece system is provided with the device. The fiber tip attachment assembly is delivered sterilized in individual mylar blister packages. Sterlization is accomplished by Irradiation.
The activation of the working beam diodes is completed by use of a foot-actuated switch.
The provided text is a 510(k) Summary for the Odyssey Navigator Diode Laser, seeking substantial equivalence to existing predicate devices. It describes the device's technical specifications, intended uses, and compliance with performance standards. However, it does not contain information about a study proving the device meets specific acceptance criteria based on clinical performance data in the way requested by the prompt (i.e., sensitivity, specificity, accuracy, etc., from a clinical trial).
Instead, the document details the technical characteristics of the new device and compares them to legally marketed predicate devices to establish substantial equivalence. This is a common approach for 510(k) clearances for devices like this, where clinical performance is often inferred from the known performance of substantially equivalent predicate devices with similar technological characteristics and intended uses.
Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what is missing based on the prompt's requirements:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, accuracy). Instead, it relies on demonstrating that the new device's technical specifications (performance characteristics) are similar to those of legally marketed predicate devices.
| Characteristic | Acceptance Criteria (from Predicate Devices) | Reported Device Performance (Odyssey Navigator) |
|---|---|---|
| Wavelength | Around 810 nm (Odyssey 2.4G) or 980 nm (SiroLaser) | 810±20 nm |
| Power Output | 0.1 - 5.0 watts (Odyssey 2.4G) or 0.5 - 7.0 watts (SiroLaser) | 0.1 - 3.0 watts |
| Aiming Beam | 630-650 nm, 3mW (Odyssey 2.4G) or 630-680 nm (SiroLaser) | 630-650 nm, 2mW |
| Cooling System | Fan air cooled (both predicates) | Fan air cooled |
| Pulse Control | Digital emission control (both predicates) | Digital emission control |
| Laser Source | Solid-state diode (both predicates) | Solid-state diode |
| Power Req. | 100-240 VAC @ 50-60 Hz, 1.5A (Odyssey 2.4G) | 100-240 VAC @ 50-60 Hz, 0.5A (switchable) |
| Dimensions | 10" x 8" x 4" (Odyssey 2.4G) or 7.5" x 3.5" x 2-1/8" (SiroLaser) | 7" x 4" x 2-3/8" |
| Weight | 6.5 lbs (Odyssey 2.4G) or 1 lb, control unit only (SiroLaser) | 1 lb, control unit only |
| User Interface | LED Display, Membrane Touch Pad (Odyssey 2.4G) or LCD Touch Screen (SiroLaser) | LCD Touch Screen |
| Compliance | 21 CFR 1040.10, 1040.11, IEC 60601-1, IEC 60601-2-22, IEC 60825-1 (Implicit for predicates) | Complies with these standards and deviations |
| Intended Uses | Similar to predicates | Dental, oral, soft tissue surgery, periodontal procedures |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Information not provided. This document does not describe a clinical trial or performance study with a test set of data. The submission relies on technical characteristics for substantial equivalence.
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 / Information not provided. No ground truth establishment is described as there is no performance study where expert assessment would be needed for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Information not provided. No adjudication method is necessary because no clinical test set is 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
- No. This document is for a laser device, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a hardware device (diode laser), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Information not provided for a clinical performance study. The "ground truth" here is effectively the accepted performance and safety of the predicate devices.
8. The sample size for the training set
- Not applicable / Information not provided. This is not a machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable / Information not provided. As there is no training set, this information is not relevant.
Summary of the Study (as presented in the 510(k) Summary):
The "study" presented here is a technical and regulatory comparison rather than a clinical performance study. The manufacturer, Ivoclar Vivadent, Inc., performed a detailed comparison of their new device, the Odyssey Navigator Diode Laser, against two legally marketed predicate devices: the Odyssey 2.4G Diode Laser (also by Ivoclar Vivadent, Inc.) and the SiroLaser (by Sirona Dental Systems, Gmbh).
The purpose of this comparison was to demonstrate substantial equivalence to the predicate devices. This demonstration is achieved by showing that the Odyssey Navigator shares:
- Similar indications for use in the oral environment.
- Similar design features (wavelength, operating controls, laser delivery method).
- Similar methods of control systems, safety features, and performance monitoring.
- Similar performance specifications (power output, energy type).
- Compliance with recognized performance standards (21 CFR 1040.10, 1040.11, IEC 60601-1, IEC 60601-2-22, and IEC 60825-1).
The "study" concludes that "The Odyssey Navigator Diode Laser is substantially equivalent to the listed laser surgical devices without raising any issues of safety or effectiveness. This device shares similar intended uses, and similar functional and performance characteristics. The device is designed to comply with relevant federal and international safety and performance standards."
In essence, the "proof" that the device meets acceptance criteria is its demonstration of substantial equivalence in technical and functional characteristics to devices already cleared for market, along with compliance to relevant safety standards for laser products.
§ 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.