(88 days)
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Laser Assisted Uvulopaletoplasty (LAUP) This laser is effective for cutting, ablating, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chroninc palatal snoring. Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Reduction of bacterial level (decontamination) and inflammation Soft tissue crown lengthening 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) Treatment of aphthous ulcers Vestibuloplasty
Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Examples: Removal of beningn lesions from ear, nose and throat. Excision and vaporization of vocal cord nodules and polyps. Incision and excision of carcinoma in-situ. Ablation and vaporization of kyperkeratosis. Excision of carcinoma of the larynx. Laryngeal papillomectomy. Excision and vaporization of herpes simplex I and II.
Arthroscopy: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery. Examples: Menisectomy Synovectomy Chondromalacia
Gastroenterology: Hemostasis, incision, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Examples: Hemostasis of upper and lower GI bleeding Excision and vaporization of colorectal carcinoma Excision of polyps
General Surgery, Dermatology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of Keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcer Hepatobiliary Mastectomy Dermabrasion Vaporization & hemostasis of capillary hemangioma Excision, vaporization & hemostasis of abdominal tumors Excision, vaporization & hemostasis of rectal pathology Pilonidal cystectomy Herniorraphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystecomy Thyroidectomy Resection of organs
GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Examples: Hemorrhoidectomy Excision, vaporization, and hemostasis of rectal pathology Excision, vaporization, and hemostasis of abdominal tumors
Gynecology: Ablation, excision, hemostasis and vaporization of tissue. Examples: Endometrial ablation Excision or vaporization of condylomata acuminata Vaporization of CIN (cervical intraepithelial neoplasia) Cervical conization Menorrhagia
Neurosurgery: Hemostasis of tissue. Example: Hemostasis in conjunction with meningiomas
Ophthalmology: Retinal photocoagulation Diabetic retinopathy
Pulmonary Surgery: Hemostasis, vaporization, and excision of tissue. Examples: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction
Urology: Hemostasis, vaporization and excision of tissues. Examples: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia.
The Twilight™ dental diode laser system may be used to perform several dental applications. Twilight™ uses advanced laser technology to incise, excise and ablate intraoral soft tissues safely and effectively. A Gallium Aluminum Arsenide (GaAIAs) solid state laser diode provides optical energy to oral soft tissues. A flexible fiberoptic handpiece delivers the Twilight™ laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and pulse may be adjusted to specific user requirements.
The provided document is a 510(k) premarket notification for a medical device called "Twilight™," a dental diode laser system. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with specific acceptance criteria and performance data.
Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and detailed ground truth for test and training sets) are not explicitly available in this type of submission.
The core of this 510(k) is to establish that the Twilight™ laser is "substantially equivalent" to predicate devices already on the market. This often means demonstrating similar technological characteristics, intended uses, and safety profiles, rather than conducting new clinical trials to prove efficacy against specific, new acceptance criteria.
However, based on the information provided, here's what can be inferred and stated regarding your request:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or report specific device performance metrics (e.g., success rates, precision, accuracy) from a dedicated study. The "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to predicate devices, meaning it performs similarly and is as safe and effective for its indicated uses.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Implicit from Substantial Equivalence Claim) |
|---|---|
| Safe and effective operation for indications for use. | The device "incise, excise and ablate intraoral soft tissues safely and effectively." |
| "Twilight™ performs through the same mechanism as other diode laser technologies." | |
| Equivalent performance specifications to predicate devices. | Stated as "Equivalent performance specifications." |
| Equivalent intended uses to predicate devices. | Stated as "Equivalent intended uses." |
| Equivalent mechanism of action to predicate devices. | Stated as "performs through the same mechanism as other diode laser technologies." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable/Not provided. This submission does not describe a clinical study with a "test set" in the context of evaluating novel performance. Instead, it relies on the known performance and safety of predicate devices.
- Data Provenance: Not applicable/Not provided. No specific study data is presented. The "evidence of equivalence" is based on comparing the Twilight™ device's specifications and intended uses to those of existing, FDA-cleared predicate devices.
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)
- Number of Experts: Not applicable/Not provided. No clinical study requiring expert-established ground truth is described.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not provided. No clinical study requiring adjudication 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
- MRMC Study: Not applicable. This document pertains to a medical device (laser system) and not an AI/imaging diagnostic device that would typically involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This document is for a physical medical device (laser system), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable/Not provided. No new ground truth was established for this submission. The "ground truth" for demonstrating substantial equivalence rests on the established safety and effectiveness of the predicate devices for their approved indications.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not provided. No training set for an algorithm is relevant to this device submission.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable/Not provided.
§ 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.