Search Results

Incision, excision, ablation, vaporization of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The DEKA SMARTXIDE TOUCH is a medical device equipped with a 10.600 nm Carbon Dioxide (CO2) laser source having a maximum power of 40W. The laser energy is delivered to the treatment area via an articulated arm and a delivery accessory connected to its distal end. The articulated arm is an optical assembly that delivers free beam laser radiation. It is made up of seven mirrors placed on rotating knuckles: the mechanical accuracy of the articulated arm allows the CO2 laser beam to travel inside it and along its axis regardless of the arm orientation. The DEKA SMARTXIDE TOUCH laser is equipped with a Scanning Unit, HiScan DOT+, that allows to perform skin resurfacing treatments.

This document is an FDA 510(k) premarket notification for the DEKA SMARTXIDE TOUCH laser system. It describes the device and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets said criteria related to clinical performance.

Here's a breakdown of why the requested information cannot be fully provided from this document:

• Clinical Performance Data: The document explicitly states "Clinical Performance Data: None" (page 4). This means no clinical study was presented to demonstrate the device's effectiveness in a clinical setting against specific acceptance criteria.
• Substantial Equivalence: The FDA's 510(k) pathway often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical studies for every device. For devices like lasers that perform well-understood physical actions (ablation, vaporization), non-clinical testing for safety and electrical performance is often sufficient if the device operates similarly to existing ones.

Therefore, most of your specific questions cannot be answered based on the provided text. I will provide what can be gleamed from the document related to "acceptance criteria" through non-clinical testing.

Acceptance Criteria and Study for DEKA SMARTXIDE TOUCH

Based on the provided FDA 510(k) summary, the device's acceptance criteria are primarily related to non-clinical performance data and conformance to established international standards for medical electrical equipment and laser safety. There is no clinical performance data or associated acceptance criteria presented in this document.

1. Table of Acceptance Criteria and Reported Device Performance

• Laser Type: CO2 (matches predicate)
• Wavelength: 10.6μm (matches predicate)
• Max Power: 40W (within range of predicate: 25W, 60W HP)
• Handpieces Spot Sizes: 0.2 mm, 0.4 mm (matches predicate)
• Pulse Duration: 0.02 to 70 ms (comparable to predicate: 0.2 to 80 ms)
• Pulse Rep Rate: 5 to 100 Hz (matches predicate)
• Scanner Spot size: 350μm (matches predicate)
• Scanner Focal length (EFL): 100mm (matches predicate)
  The document states: "The DEKA SMARTXIDE TOUCH has the same indications for use as the abovementioned predicate device, with same principle of operation and essentially the same performances." |

Note: The "reported device performance" for the standards conformance is an interpretation that the device met these standards, as non-conformance would likely prevent 510(k) clearance.

2. Sample size used for the test set and the data provenance

• Test set sample size: Not applicable for a clinical test set as no clinical performance data was provided. For non-clinical (engineering/safety) testing, the "sample size" typically refers to the device itself and its components, which are tested against relevant standards. The provenance for these tests would be internal laboratory testing by the manufacturer or accredited testing bodies.
• Data provenance: Not explicitly stated beyond "The DEKA SMARTXIDE TOUCH was tested for standards conformance...". This likely refers to in-house testing by the manufacturer or third-party labs contracted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable as no clinical study with a "ground truth" established by human experts was conducted or referenced in this 510(k) summary.

4. Adjudication method for the test set

• Not applicable as no clinical study requiring adjudication was conducted or referenced.

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

• Not applicable. This device is a laser surgical instrument, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a laser surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable for clinical performance. For non-clinical testing, the "ground truth" would be the specifications and requirements of the international standards (e.g., specific electrical safety limits, laser output parameters).

8. The sample size for the training set

• Not applicable as no clinical training set was used.

9. How the ground truth for the training set was established

• Not applicable as no clinical training set was used.

In summary, the provided document focuses on demonstrating substantial equivalence to an existing lawfully marketed device through comparison of technical specifications and conformance to recognized safety and electrical standards. It explicitly states there is no clinical performance data. Therefore, the questions related to clinical trials, expert ground truth, and AI performance are not addressed by this FDA submission.

Ask a specific question about this device