(62 days)
The LightScalpel LS-10 CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, or coagulation of soft tissue in specialties such as: general surgery, dermatology, gynecology, oral surgery, otorhinolaryngology, plastic & reconstructive surgery, podiatry, and urology.
The LightScalpel LS-10 laser system is a mobile platform that utilizes a radio frequency (RF) excited carbon dioxide (CO₂) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 10 Watts Continuous Wave (CW). Laser energy is conducted to the point of application by a flexible fiber wavequide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel.
The provided document is a 510(k) Summary for the LightScalpel LS-10 CO2 Laser System. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria in the context typically seen for AI/ML medical devices.
The information primarily describes the device, its intended use, and a comparison of its technological characteristics to predicate devices. It does not contain the specific type of acceptance criteria and performance study details usually associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC, etc.).
Here's an attempt to extract relevant information based on the prompt, acknowledging the limitations of the document:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the document, the "acceptance criteria" appear to be defined by showing similar technological characteristics and performance to predicate devices and compliance with relevant safety and performance standards. The "reported device performance" is essentially the LightScalpel LS-10's specifications and features.
| Acceptance Criteria (Inferred from Predicate Equivalence) | LightScalpel LS-10 Reported Performance |
|---|---|
| Technological Characteristics: | |
| Laser Medium: CO2 | CO2 |
| Wavelength: 10.6 µm | 10.6 µm |
| Laser Drive Source: RF/DC | RF |
| Output Power (CW Power): Range | 2 - 10 Watts |
| Pulsed Power: Range | 2 - 10 Watts |
| Gated Pulse Widths: Range | 5 - 500 msec |
| Gated Repetition Rate: Range | 1 or 2 - 20 pps |
| Superpulse Power (avg.): Range | 2 - 5 Watts |
| Superpulse Peak Power: Range | 30 Watts |
| Beam Delivery System: Flexible Fiber Waveguide / Articulated Arm | Flexible Fiber Waveguide |
| System Dimensions (HxWxD): Comparison | 34" x 15" x 15" (~ similar to predicate ranges) |
| System Weight: Comparison | |
| Mobility: 4 Wheels & Handle | 4 Wheels & Handle |
| Electrical Power: 115 VAC | 115 VAC |
| Intended Use: Incision, Excision, Vaporization, Ablation, or Coagulation of Soft Tissue | Incision, Excision, Vaporization, Ablation, or Coagulation of Soft Tissue |
| Safety and Performance Standards Compliance: | |
| 21 CFR 1040, Performance Standards for Light-emitting Products | Verified (stated in 510(k) Summary) |
| IEC 60601-1, Medical Electrical Equipment Part 1 | Verified (stated in 510(k) Summary) |
| IEC 60601-2-22, Medical electrical equipment Part 2-22 | Verified (stated in 510(k) Summary) |
| IEC 60825-1, Safety of laser products Part 1 | Verified (stated in 510(k) Summary) |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "Device performance evaluation did not involve Animal or Clinical Testing." This indicates there was no "test set" in the traditional sense of patient or sample data for evaluating clinical performance. The evaluation was based on verification and validation tests per product requirements and specifications, and inspections and tests derived from applicable regulations and safety standards. Details on the specific "sample size" of components tested or the nature of these verification/validation tests are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable, as no animal or clinical testing was conducted. The "ground truth" for demonstrating equivalence was based on meeting established engineering specifications and compliance with international standards, which would be assessed by engineers and regulatory experts, not clinical experts establishing ground truth for a medical image or diagnostic output.
4. Adjudication Method for the Test Set:
Not applicable, as no animal or clinical testing was conducted that would require an adjudication method by expert reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC study was not done. The device is a CO2 laser system, not an AI/ML diagnostic or assistive tool that would typically be evaluated with MRMC studies for human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
The concept of "standalone performance" as it relates to AI algorithms is not applicable here. The device is a surgical instrument. Its "performance" is inherent in its physical operation (e.g., power output, wavelength, safety features) and its ability to achieve the intended surgical effects when operated by a clinician.
7. The Type of Ground Truth Used:
The "ground truth" in this context refers to engineering specifications, safety standards, and the established performance characteristics of the predicate devices. For instance, the stated power output (2-10 Watts CW) is verifiable through direct measurement, representing its "ground truth" for that parameter. Compliance with standards like IEC 60601-2-22 serves as a "ground truth" for safety and essential performance requirements.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that undergoes "training." The device is a manufactured hardware system.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.