(51 days)
The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended for use in the medical specialty of dental surgery.
The Curative980 Diode Lasers (and the delivery accessories that are used with them to deliver laser energy) is indicated for use in a variety of applications requiring incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery.
The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended to deliver laser energy for incision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery as follows:
Dental Surgery
Indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue (intraoral and extraoral) including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications:
- Biopsy
- Excisional and incisional biopsies
- Excision of lesions
- Exposure of unerupted/partially erupted teeth
- Fibroma removal
- Frenectomy
- Frenotomy
- Gingival troughing for crown impressions
- Gingival troughing
- Gingivectomy
- Gingivoplasty
- Gingival incision and excision
- Hemostasis and coagulation
- Hemostasis of donor site
- Implant recovery
- Removal of granulation tissue
- Laser assisted flap surgery
- Debridement of diseased epithelial lining
- Treatment of aphthous ulcers
- 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 loss and tooth mobility)
- Laser soft tissue curettage
- Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- Operculectomy
- Incision and drainage of abscess
- Oral papillectomies; papillectomy
- Removal of hyperplastic tissues
- Pulpotomy
- Pulpotomy as an adjunct to root canal therapy
- Reduction of gingival hypertrophy
- Reduction of bacterial level (decontamination) and inflammation
- Soft tissue crown lengthening; crown lengthening
- Tissue retraction for impressions
- Leukoplakia
- Vestibuloplasty
- Light activation of bleaching materials for teeth whitening.
- Laser-assisted bleaching/whitening for teeth
The Curative980 Diode Lasers are comprised of the following main components:
- Main console containing the major electrical components, including:
- Control Touch-Screen Display Panel including touch controls;
- 980 nm treatment laser (aluminum gallium arsenide (AlGaAs) solid state laser diode);
- 650 nm aiming beam diode laser;
- Delivery device fiber-optic connector port;
- Emergency stop switch;
- Remote interlock connector (External door interlock connector);
- Connector ports for the footswitch and power cord;
- Handpiece holder (attaches to the top of the laser system console);
- Fiber Spool (secures and organizes the optical fiber) attaches to the side of the main console;
- Footswitch:
- Medical grade power cord;
- Delivery Devices:
- Optical Fibers - Reusable, cleanable, sterilizable optical fibers;
- Handpieces -Reusable, cleanable, sterilizable handpieces;
- Handpiece Tips - Disposable single-use tips;
- Accessories:
- Safety Glasses
- Tools:
- Optical Fiber Striper;
- Optical Fiber Cleaver.
The provided text is a 510(k) summary for a medical device (OroScience Curative980 Diode Lasers). This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you've described for, say, an AI diagnostic tool.
Therefore, the information you're asking for regarding acceptance criteria, performance tables, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable to this type of regulatory submission.
The core of a 510(k) summary for a device like this laser is to show that it has the same or similar:
- Indications for Use
- Device Operation
- Overall Technical and Functional Specifications
And that any differences do not raise new questions of safety or effectiveness. The "study" here is essentially a comparison to predicate devices, not a clinical trial against specific performance metrics with a ground truth established by experts.
Here's a breakdown of why this information isn't present in the provided text, using the structure of your request:
-
Table of acceptance criteria and the reported device performance:
- N/A. This document doesn't define specific numerical acceptance criteria for performance; rather, it asserts substantial equivalence to existing predicate devices. The "performance" is implicitly deemed equivalent if the device functions similarly and has the same indications for use as the predicates.
-
Sample size used for the test set and the data provenance:
- N/A. There isn't a "test set" in the sense of clinical data evaluating the device's diagnostic or treatment efficacy against a ground truth. The submission relies on engineering and design comparisons.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No ground truth needed to be established by experts for a test set in this kind of submission.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set or expert adjudication was performed as described.
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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:
- N/A. This is a laser surgical instrument, not an AI-assisted diagnostic tool. MRMC studies are irrelevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Again, this is a physical medical device (laser), not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No ground truth in this context. The "truth" being established is that the device is substantially equivalent to legally marketed devices.
-
The sample size for the training set:
- N/A. This device doesn't use machine learning or require a training set.
-
How the ground truth for the training set was established:
- N/A. No training set exists for this type of device.
In summary, the "study" proving the device meets "acceptance criteria" in a 510(k) context is the demonstration of substantial equivalence to existing predicate devices based on design specifications, intended use, and operational principles, not a clinical trial with performance metrics against a defined ground truth.
§ 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.