(165 days)
It is indicated for soft tissue incision of recipient sites for laser assisted hair transplantation.
The Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory is a motorized, laser beam deflection system that is attached to a CO2 laser articulating arm. The device redirects a focused laser beam through 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 Flash Scanner limits the time of laser exposure on tissue while providing sufficient power density for tissue vaporization at low average power levels The SilkTouch Flash Scanner has controls for varying the scanned area setting the exposure time. This device is used with a CO2 handpiece. When the unit is turned off, the connected laser operates to its specifications and allows incision or manual scanning for vaporization purposes.
This document is a 510(k) summary for the Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory. It primarily focuses on establishing substantial equivalence to predicate devices and does NOT contain information about acceptance criteria or a dedicated study proving the device meets specific performance criteria as typically expected for contemporary medical device submissions, especially for AI/ML devices.
Therefore, many of the requested sections regarding acceptance criteria, study design, expert involvement, and ground truth establishment cannot be answered from the provided text. The document is from 1996 and reflects the regulatory requirements and practices of that time, which differ significantly from current standards for demonstrating device performance.
Here's a breakdown based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| The device performs the "same function" as predicate devices for the "same indication." | "the aforementioned devices while are not identical, perform the same function for the same indication." |
| Raises "no safety or efficacy concerns" based on "histological information submitted." | "Based upon the histological information submitted, Sharplan Lasers, Inc. believes that the expanded indications for this device raises no safety or efficacy concerns." |
| Substantially equivalent to predicate devices. | "The Sharplan Lasers, Inc. SilkTouch CO2 Flash Scanner Accessory is substantially equivalent to the following devices: the Norcross Scientific SurgiScan CO2 Scanner, the A-Z Surgical Super Punch, and the Robbins Acrotorque Hand Engine." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified. The document mentions "histological information submitted," but does not detail the source, nature, or quantity of this data. It's unclear if this refers to animal studies, human cadaveric tissue, or limited human clinical observations.
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Not specified.
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. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device.
7. The type of ground truth used
- The document mentions "histological information submitted." This suggests that tissue analysis (e.g., biopsies, tissue samples) might have been used to assess the effects of the laser. However, the exact nature of this "ground truth" and how it was used to validate performance is not detailed.
8. The sample size for the training set
- Not applicable/Not specified. This is not an AI/ML device and therefore does not have a "training set" in the modern sense.
9. How the ground truth for the training set was established
- Not applicable/Not specified. This is not an AI/ML device.
Summary of Limitations based on the provided text:
The provided 510(k) summary (from 1996) is focused on demonstrating substantial equivalence to predicate devices rather than providing a detailed study with specific acceptance criteria, performance metrics, and rigorous ground truth establishment that would be expected for a device submission today, especially for one involving complex algorithms or clinical decision support. The evaluation largely relies on the similar function and indication of existing devices, supplemented by unspecified "histological information."
§ 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.