(124 days)
The LightScalpel LS-1005 & LS-2010 CO2 Laser Systems are in laser surgery procedures for incision, excision, vaporization, ablation, and/or coagulation of soft tissue in specialties such as; general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, neurosurgery, podiatry, and urology.
The LightScalpel LS-1005 / LS-2010 laser systems are mobile platforms 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 and 2 to 20 Watts Continuous Wave (CW) respectively. The systems differ only in the laser tube used, pre-programmed values in the controlling software, which allow higher laser tube drive for the LS-2010 system, and physical height and weight. Laser energy is conducted to the point of application by a flexible fiber waveguide 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.
This document is a 510(k) premarket notification for the LightScalpel® LS-1005 & LS-2010 CO2 Laser Systems. It aims to demonstrate substantial equivalence to previously legally marketed devices, rather than establishing acceptance criteria or proving device performance through specific studies in the way an AI/ML device would.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable to this submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document does not define specific "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) that would be common for AI/ML devices. Instead, the "performance" discussed relates to the device's technical specifications and intended use comparison to predicate devices.
| Characteristic | LightScalpel® LS-1005 / LS-2010 (K141658) |
|---|---|
| Laser Medium | CO2 |
| Wavelength (um) | 10.6 |
| Laser Drive Source | RF |
| Output Power (W) | 2-10 / 2-20 |
| Pulsed Power (W) | 2-10 / 2-20 |
| Gated PW (ms) | 5-500 |
| Gated Rep. Rate (pps) | 1 or 2-20 |
| Superpulse (W) | 2-5 / 2-10 |
| Superpulse Peak (W) | 30 / 60 |
| Beam Delivery System | Flexible Fiber Waveguide |
| System HxWxD (in) | 34x15x15 / 40x15x15 |
| System Weight (lb) | 35 / 47 |
| Mobility | 4 Wheels & Handle |
| Intended Use | Incision, Excision, Vaporization, Ablation, and/or Coagulation of Soft Tissue in various specialties |
| Line Voltage - Nom. | 100-240 VAC |
The acceptance criteria are implicitly that these specifications meet recognized standards for medical laser devices and are substantially equivalent to predicate devices. The "reported device performance" is the list of technical characteristics as presented in the table.
2. Sample size used for the test set and the data provenance:
Not applicable. This is a medical device (laser system), not an AI/ML diagnostic or predictive algorithm. There is no "test set" in the context of evaluating an AI model with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. See point 2.
4. Adjudication method for the test set:
Not applicable. See point 2.
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 not an AI/ML tool designed to assist human readers. It is a CO2 laser system for surgical procedures.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. See point 5.
7. The type of ground truth used:
Not applicable. In the context of a 510(k) for a physical medical device like a laser, "ground truth" would refer to established engineering and performance standards for laser systems, and comparison to legally marketed predicate devices. The document states: "Each LS-1005 and LS-2010 laser system is tested for electrical safety and output characteristics." These tests would confirm the device's technical specifications against engineering standards.
8. The sample size for the training set:
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
Summary of Device Equivalence Study (as per the document):
The submission relies on a non-clinical performance data assessment and a technological characteristics comparison to predicate devices to establish substantial equivalence.
- Non-clinical performance data: "Each LS-1005 and LS-2010 laser system is tested for electrical safety and output characteristics. Representative data is presented in the Bench Testing section of this report." (The "Bench Testing section" is not provided in the extracted text).
- Clinical performance data: "None. Clinical testing was determined to be unnecessary, as the performance parameters are consistent with predicate CO2 laser systems and technology."
- The argument for substantial equivalence is based on the devices being equivalent to predicate laser systems in:
- Emission wavelength
- Control parameters
- Relative output power
- Delivery accessories
- Physical size
- Intended Uses
In essence, this is a documentation of a physical medical device's technical specifications and its comparison to similar, already approved devices, rather than a performance evaluation of an AI/ML algorithm.
§ 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.