(273 days)
CO2 Laser System is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiaty, otolaryngology, 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 Laser System is a computer controlled radiofrequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The CO2 Laser System is comprised of multiple components, including the control unit and handpieces. Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.
The provided document is a 510(k) summary for a CO2 Laser System (Models: PureLase and VanLase). It describes the device, its indications for use, and a comparison to a predicate device to demonstrate substantial equivalence.
However, the document does not contain any information about acceptance criteria, device performance metrics (e.g., accuracy, sensitivity, specificity), sample sizes for testing or training, data provenance, expert ground truth establishment, or any kind of statistical study (like MRMC or standalone performance). It primarily lists the non-clinical tests performed to ensure the device meets design specifications and relevant safety/performance standards (e.g., IEC 60601 series, ISO 10993).
Therefore, I cannot provide the requested table and study details. The information about the study that proves the device meets the acceptance criteria is not present in this 510(k) summary. The document focuses on showing substantial equivalence based on technical specifications and adherence to safety/performance standards, not on clinical performance metrics typically associated with AI/software-as-a-medical-device (SaMD) clearances that often require clinical performance studies.
Here's what I can extract based on the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not provided. The document lists non-clinical tests (IEC standards, biocompatibility, software V&V, bench testing) but does not present specific quantitative acceptance criteria (e.g., accuracy > X%, sensitivity > Y%) or the results of such performance against a test set. This type of information is typically found in clearance documents for devices relying on diagnostic performance (like AI algorithms).
2. Sample size used for the test set and the data provenance:
- Not provided. No information about a "test set" or "training set" of data (e.g., images, patient records) is mentioned. The tests conducted are primarily engineering and safety compliance tests, not clinical performance studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. Since there's no mention of a test set based on clinical data, there's no information about experts establishing ground truth for such data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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 provided. No MRMC study is mentioned. This device is a laser system, not an AI software intended to assist human readers in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This is a hardware device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not provided.
8. The sample size for the training set:
- Not provided.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
§ 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.