(134 days)
The CO2 laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology, neurosurgery, orthopedics, general and thoracic 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, 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 tags, 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 Er: YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. The Er: Y AG handpiece attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.
The provided document is a 510(k) summary for the Cortex Laser System, which is a medical laser device. It outlines the device's indications for use, technological characteristics, and claims of substantial equivalence to predicate devices. However, this document does not contain information related to acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The document explicitly states: "Performance Data: None submitted." This means that no clinical performance data was provided or reviewed for this 510(k) submission. Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies proving the device meets them based on the provided text.
Based on the document, I can only provide the following:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the document.
- Reported Device Performance: "Performance Data: None submitted."
2. Sample sized used for the test set and the data provenance: Not applicable, as no performance data or test sets were submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth establishment for a test set is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set data requiring adjudication was submitted.
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. The device described is a surgical laser, not an AI-assisted diagnostic tool for human readers. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a surgical laser, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance data requiring ground truth was submitted or its establishment described.
8. The sample size for the training set: Not applicable, as no training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable, as no training set for an algorithm is mentioned.
In summary, the provided FDA 510(k) document for the Cortex Laser System focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than presenting clinical performance data or studies against specific acceptance criteria.
§ 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.