(105 days)
The SmartXide UltraSpeed laser is incision, excision, 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 general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic urgery, and urology for surgical and aesthetic applications.
Also, the SmartXide UltraSpeed laser is indicated for periodontal applications such as, but not limited to:
- · Removal of diseased or Inflamed soft tissue in the periodontal pocket (sulcular debridement)
- · Biopsies
- Frenectomy, Frenum release
- Gingivoplasty
- Papillectomy
- · Vestibuloplasty
- · Hyperplasia
- Operculectomy
- · Drainage (abscess)
- · Flap surgerv
- · Fibroma (nonmalignant tumor, mucosa, tongue)
- Epulis
- · Aphthous ulcers
- · Removal of soft tissue, cysts, and tumors
· Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long iunctional enithelium).
DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser devices whit a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch.
The provided text is a 510(k) summary for a medical device, the DEKA SmartXide UltraSpeed laser. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
It's crucial to understand that a 510(k) submission primarily focuses on substantial equivalence to a predicate device, not necessarily extensive clinical performance studies or AI model validation. Therefore, the information requested in your prompt regarding acceptance criteria, training/test sets, expert ground truth, and AI performance metrics will likely not be present in this type of document because the device in question is a laser surgical instrument, not an AI-driven diagnostic or therapeutic device. No AI or machine learning components are mentioned for this device.
Based on the provided document, here's an attempt to address your points, highlighting where the information is not applicable or not provided:
The DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser device for incision, excision, ablation, vaporization, and coagulation of body soft tissues. The 510(k) submission establishes its substantial equivalence to a predicate device (DEKA Smart US 20D/UltraSpeed and Smart Clinic laser, K081181) based on similar indications for use, principle of operation, and performance characteristics.
Regarding Acceptance Criteria and Device Performance (as requested for an AI/diagnostic device):
Since this is a laser surgical instrument and not an AI/diagnostic device, the concept of "acceptance criteria" in the context of sensitivity, specificity, or similar performance metrics for an AI model is not applicable. The "device performance" instead refers to its physical specifications and its ability to perform its intended surgical functions safely and effectively.
1. A table of acceptance criteria and the reported device performance
For a laser surgical instrument, acceptance criteria are generally related to its technical specifications and compliance with safety standards rather than diagnostic performance metrics.
| Criteria (for a laser surgical instrument) | Reported Device Performance (from the document) |
|---|---|
| Laser Type | CO2 |
| Wavelength (nm) | 10600 |
| Power (Watts) | 40 |
| Spot Sizes (mm) | 0.2; 0.4 |
| Exposure Modes | Continuous, single and repeated pulse |
| Pulse width (ms) | 0.02-70 |
| Repetition rate (Hz) | 5-100 |
| Aiming beam | Diode laser, 4.0 mW |
| Biological Safety | Compliance with ISO 10993-1 |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 |
| Laser Safety & Performance | Compliance with IEC 60601-2-22, IEC 60825-1 |
Study Proving Device Meets Acceptance Criteria:
The document states: "Tests results demonstrated compliance to related standards." This indicates that non-clinical performance tests were conducted according to the listed international standards (ISO 10993-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) to ensure the device operates safely and effectively as designed.
The following points are largely N/A (Not Applicable) or N/P (Not Provided) in this 510(k) summary for a laser surgical instrument, as they pertain to AI/diagnostic model validation:
2. Sample size used for the test set and the data provenance: N/A. No test set of patient data (images, etc.) is mentioned as this is not an AI diagnostic device. The "tests" mentioned are non-clinical engineering and safety compliance tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. No "ground truth" derived from expert review of patient data is relevant for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
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: N/A. This is a surgical laser, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. There is no algorithm mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A. The "ground truth" for this device would be its adherence to established engineering, electrical, and laser safety standards, and its consistent output of specified laser parameters.
8. The sample size for the training set: N/A. No AI model or training set is mentioned.
9. How the ground truth for the training set was established: N/A.
In summary, this 510(k) document is for a medical laser, not an AI or diagnostic device. Therefore, the detailed questions about AI model validation, test/training sets, and expert ground truth are not relevant to the information presented in this regulatory submission. The "study" proving the device meets criteria consists of non-clinical, engineering, and safety compliance tests against recognized international standards.
§ 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.