Search Results

The Smart CO₂ surgical laser is indicated for the incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.

Smart CO₂ is a CO₂ laser, having a sealed CO₂ gas tube as the lasing medium. It is a laser with a wavelength of 10.6 µm. Laser activation is by foot switch. Overall weight of the laser is 25 Kg, and the size is 180x62x42 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase.

The provided text mentions "Nonclinical Performance Data: none" and "Clinical Performance Data: none". This indicates that no specific studies were submitted to establish acceptance criteria or demonstrate device performance for the Smart CO2 laser. The 510(k) clearance was based on substantial equivalence to predicate devices, not on direct performance studies of the Smart CO2 itself.

Therefore, I cannot provide the information requested in the prompt based on the provided text.

Here's why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are reported for the Smart CO2.
2. Sample sized used for the test set and the data provenance: No test set was used for performance evaluation of the Smart CO2.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set was used.
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 such study was conducted, as this device is a medical laser, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth was established as no performance studies were conducted for the Smart CO2.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device