Search Results

The Sharplan Lasers, Inc. Silktouch XJ Scanner Accessory is a CO2 accessory for a Sharplan Laser (models 60, 80, and 150 x)). It is indicated for soft tissue incision, excision, coagulation, vaporization, and ablation for the following indications: General/Thoracic Surgery, Neurosurgery, Otolaryngology, Dental Surgery (soft tissue only), Gynecology, Podiatry, Plastic Surgery/Dermatology, and Genito-Urinary Surgery.

The Sharplan Lasers, Inc. Silktouch XJ Scanner CO2 Laser Accessory is a motorized, laser beam deflection system that is attached to a Sharplan CO2 laser articulating arm. The device redirects a focused laser beam from moving mirrors, within a specified pattern scan area. Similar to the common surgeon's technique of manually scanning a focused beam over a treatment area, the constantly moving beam of the Silktouch XJ Scanner limits the time of laser exposure on tissue while providing sufficient power density for tissue vaporization at low average power levels. This device features a CO2 handpiece and LCD control panel interface which allows the operator to select or change the various patterns and treatment parameters. This accessory does not defeat or over-ride the safety or control mechanisms which are integral to CO2 laser system.

This document is a 510(k) Summary of Safety and Effectiveness for the Sharplan Lasers, Inc. Silktouch XJ Scanner CO2 Laser Accessory. It's a premarket notification to the FDA, asserting substantial equivalence to predicate devices, rather than a study demonstrating performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a detailed study design is not present in this document.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

No explicit acceptance criteria or quantitative performance metrics are provided in this regulatory submission. The submission focuses on demonstrating substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

No test set or clinical study data is mentioned. The document explicitly states: "No new indications were sought in this premarker notification and no clinical data was presented."

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Not applicable, as no clinical data or ground truth establishment process is described.

4. Adjudication Method:

Not applicable, as no clinical data or ground truth establishment process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was done, nor is it discussed.

6. Standalone Performance Study:

No standalone (algorithm-only) performance study was done or is discussed. The device is a hardware accessory (a laser beam deflection system).

7. Type of Ground Truth Used:

Not applicable, as no clinical data or ground truth establishment process is described.

8. Sample Size for the Training Set:

Not applicable, as this is a hardware device submission, not a machine learning model.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as this is a hardware device submission, not a machine learning model.

What the document does state regarding "proof" and "acceptance":

The "proof" in this context is the argument for substantial equivalence to existing predicate devices.

• Acceptance Criteria (Implicit - Substantial Equivalence): The implicit "acceptance criterion" for this 510(k) submission is that the device is as safe and effective as legally marketed predicate devices and does not raise new questions of safety or effectiveness.
• Study Proving Acceptance (Substantial Equivalence Argument):
  • The document states: "The safety and effectiveness of the Sharplan Lasers, Inc. Silktouch XJ Scanner is based on a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which include the Coherent Computerized Pattern Generator and the Sharplan SwiftLase (aka SilkTouch) CO2 Flashscanner."
  • It further asserts: "From a clinical performance perspective, the aforementioned devices produce a similar therapeutic output in terms of laser spot size and patterns. Regarding the technological characteristics, while are not identical, physical testing of the device has demonstrated that it is similar both in function and performance to its predivate devices. Sharplan Lasers, Inc. believes that none of the modifications made to the device raise any issues pertaining to its safety or efficacy."

This is a regulatory justification, not a rigorous scientific study demonstrating performance against specific, quantifiable acceptance criteria in the way one might evaluate a diagnostic algorithm or a drug. The "physical testing" mentioned is general and not detailed with specific metrics or results in this summary.

Ask a specific question about this device