(13 days)
The BURANE is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in all 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 is indicated for use in skin resurfacing. The BURANE is indicated for use in medicine and surgery, in the following medical specialities: Dermatology, Plastic 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 cheilitis, keloids, verrucae, skin tags, anal tags, 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 incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation.
Genitourinary
Indications include lesions of the external genitalia, urethra and anus, penis, condyloma acuminata, giant perineal condyloma (Includes condyloma actinoma), 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 is a Er:YAG laser system for dermatological interventions and for aesthetic laser applications. The BURANE has an Ablation Mode and a Coagulation Mode. Furthermore, the laser system enables a quick, precise ablation with minimal thermal damage. Thus an optimal wound healing process is achieved and thermal tissue admission is minimized. This is due to the BURANE's wavelength of 2.94 µm, which has an absorption maximum in water and is absorbed very well by tissue water. The thermal damage zone is thus minimized. While the parameter wavelength is 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 FDA 510(k) summary for the BURANE laser system does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
The "Performance Data" section explicitly states "None presented." ([3]). This indicates that the submission did not include a study demonstrating specific quantitative performance metrics against pre-defined acceptance criteria.
Therefore, I cannot populate the requested tables and answer most of the questions, as the information is not present in the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. Table of acceptance criteria and the reported device performance:
- Cannot be 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):
- Cannot be provided. No performance study was presented, so there is no test set or related data.
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):
- Cannot be provided. No performance study was presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No performance study was 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:
- Cannot be provided. This device is a laser system, not an AI or imaging device with human readers. No MRMC study would be applicable or expected for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This device is a laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided. No performance study was presented.
8. The sample size for the training set:
- Cannot be provided. No performance study involving a training set (as understood in the context of AI/algorithms) was presented. The device itself (a laser) would have gone through internal development and testing, likely involving various materials and potentially animal/cadaveric models, but this is not typically referred to as a "training set" in this context nor is it detailed in this 510(k) summary.
9. How the ground truth for the training set was established:
- Cannot be provided. No performance study was presented.
Summary of what the document does provide:
- Device Name: BURANE ([1])
- Device Type: Er:YAG laser system for dermatological interventions and aesthetic laser applications, with ablation and coagulation modes. ([1])
- Indications for Use: Detailed for various medical specialties including Aesthetic Surgery, Dermatology/Plastic Surgery, Gastroenterology, General Surgery, Genitourinary, Gynecology, ENT, Oral/Maxillofacial, Ophthalmology, and Podiatry. It is intended for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. ([1], [5], [6])
- Predicate Devices: Several other laser systems are listed for substantial equivalence. ([1])
- Regulatory Status: Cleared via 510(k), classified as a Class II device (Laser surgical instrument for use in general and plastic surgery and in dermatology). ([3])
The absence of performance data in this 510(k) summary suggests that the FDA's substantial equivalence determination was primarily based on the similarity of the BURANE device's technological characteristics, indications for use, and safety profile to already legally marketed predicate devices, rather than a new clinical performance study.
§ 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.