(116 days)
It is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.
Dermatology, Plastic Surgery and General Surgery procedures:
- Laser skin resurfacing.
- Treatment of furrows and wrinkles.
- Removal of skin taqs, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
- Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
- Blepharoplasty.
- Site preparation for hair transplants.
- The fractional scanner is for skin resurfacing.
The MATRIX LS-40 CO2 Surgical laser System incorporating a permanently articulated arm that delivers CO2 laser power in a wavelength of 10,600nm in its normal operations. The device is activated by means of a footswitch.
The Laser System is designed for use in an office or a clinic, which shall be a clean, dry and well-ventilated room with a door.
This document describes a 510(k) premarket notification for the "Matrix LS-40 CO2 Laser System". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent clinical efficacy or diagnostic accuracy with extensive studies. Therefore, many of the requested elements for a study proving device performance (like acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) are not typically included or required in this type of submission.
Based on the provided document, here's what can be extracted and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it focuses on demonstrating technological equivalence to a predicate device and compliance with safety standards.
The technological characteristics comparison between the Matrix LS-40 CO2 Laser System and the predicate device (Cortex Laser System K150587) can be viewed as demonstrating performance parity in key technical specifications:
| Items | Matrix LS-40 CO2 Laser System | Cortex Laser System in K150587 |
|---|---|---|
| Technology Characteristics | ||
| Laser Type | Sealed CO2 Laser Tube | Sealed CO2 Laser Tube |
| Wavelength | 10.6 micron (10,600nm) | 10.6 micron (10,600nm) |
| Laser Operation Mode | Continuous Wave (CW), Blend (PW), Super Pulse (SP) | Continuous Wave, Blend (PW), Super Pulse |
| Power to Tissue (CW) | 0.5-40W | 0.5-40W |
| Power to Tissue (PW) | 0.5-30W | 0.5-30W |
| Power to Tissue (SP) | 0.5-15W | 0.5-15W |
| Frequency Range (PW) | 30Hz | 30Hz |
| Frequency Range (SP) | 20-240Hz | 20-240Hz |
| Peak Power | 200W | 200W |
| Repetition Rate | 1-8 Hz/240 Hz Super Pulse | 1-8 Hz/240 Hz Super Pulse |
| SuperPulse Duration | 10-1000ms | 10-1000ms |
| Aiming Beam | 3mW (650nm diode) adjustable | 3mW (650nm diode) adjustable |
| Spot Size (surgical handpiece) | 100µm | 100µm |
| Spot Size (fractional handpiece) | 150µm | 150µm |
| Articulated Arm | 7-joint articulated arm | 7-joint articulated arm |
| Cooling Type | Closed Loop Liquid | Closed Loop Liquid |
| User Interface | LCD Touch Screen | LCD Touch Screen |
| Power Input | 110 - 120 VAC, 10 A, 50-60 Hz | 110 - 120 VAC, 10 A, 50-60 Hz |
Differences observed:
- Dimension: Matrix LS-40 (34cm46cm96cm) vs. Cortex Laser System (150cm46cm 31cm)
- Weight: Matrix LS-40 (46.5Kg) vs. Cortex Laser System (60kg)
The document asserts that "the subject device is substantially equivalent to the predicate device K150587" based on "performance testing, indication for use, and technology." The "performance testing" mentioned likely refers to the non-clinical tests described in Section 8.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a laser surgical instrument, and the provided document details a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device through engineering and safety testing, not a clinical study on human subjects with a "test set" in the context of diagnostic performance. The document only refers to non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This type of information is pertinent to diagnostic devices and clinical studies establishing ground truth, which is not the focus of this 510(k) submission for a surgical laser.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, for the same reasons as above.
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-powered diagnostic tool, and no MRMC study is mentioned or relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a surgical laser system, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. Ground truth for diagnostic accuracy is not the subject of this 510(k). The "ground truth" here is compliance with established electrical, EMC, and radiation safety standards, and equivalence in technical specifications to the predicate device.
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.