(15 days)
The BURANE XL is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in any surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The BURANE XL is indicated for use in skin resurfacing. The BURANE XL is indicated for use in medicine and surgery, in the following medical specialities: Dermatology, Plastic and Aesthetic Surgery, Gastroenterology, ENT, Thoracic Surgery, Oral & Maxillofacial Surgery, Ophtalmology & Podiatry.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
Dermatology/Plastic Surgery
Indications include, epidermal nevi, telangiectasia, spider veins, actinic keratoses, scar revision, debulking benign tumors, decubitis ulcers.
Gastroenterology
General Surgery
The Er:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during general surgery application where skin and subcutaneous tissue is encountered. Indications include excision of external tumors and lesions, complete or partial tissue dissection, excision of external tumors and lesions, tissue ablation and/or vessel coagulation.
Genitourinary
Indications include lesions of the external genitalia, urethra and anus, penis, scrotum and urethra (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon.
Gynecology
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
ENT
Indications include ear, nose and throat lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia.
Oral/Maxillofacial
Indications include benign oral tumors, oral and glossal lesions and gingivectomy.
Ophtalmology
Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Podiatry
Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy.
BURANE XL is a Er:YAG laser system for dermatological interventions and for aesthetic laser applications. The triple mode technology makes BURANE for aesthetic ideal applications. The Coagulation Mode for different AL an export dother the Ablation Mode for classical ablation procedures, and the combination of both techniques. Furthermore, the laser system enables a quick, precise ablation with minimal thermal tissue damage. Thus an optimal wound health process is achieved. -- the risk of scar formation is minimized. This is due to the BURANE XL's wavelength of 2.94 pm, which has an absorption in water and is thermal damage zone is thus minimized. While the parameters wavelength and pulse form are specified by the device, spot size, laser energy, pulse sequence, and coagulation function can be selected by the treating physician for optimal adjustment to individual requirements.
The provided text is a 510(k) summary for the WaveLight Burane XL device, primarily focusing on its substantial equivalence to predicate devices and its intended uses. It does not contain information about specific acceptance criteria or a study proving the device meets said criteria.
Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided document.
Here's what can be stated based on the text:
1. A table of acceptance criteria and the reported device performance
- Information not provided. The document states "Performance Data None presented."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information not provided. The document states "Performance Data None presented."
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)
- Information not provided. The document states "Performance Data None presented."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Information not provided. The document states "Performance Data None presented."
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
- Information not provided. The document states "Performance Data None presented." This device is a laser system, not an AI-assisted diagnostic tool, so an MRMC study is highly unlikely to be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Information not provided. The document states "Performance Data None presented." This device is a laser system, not an algorithm, so a standalone algorithm performance study is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Information not provided. The document states "Performance Data None presented."
8. The sample size for the training set
- Information not provided. The document states "Performance Data None presented."
9. How the ground truth for the training set was established
- Information not provided. The document states "Performance Data None presented."
§ 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.