(266 days)
ProFlex CO2 Laser Fiber is indicated for the ablation, coagulation, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.
ProFlex CO2 Laser Fibers are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, a hollow glass tube having a dielectric coating (silver/silver iodide) in the bore and a fluoropolymer outer coating and an ethylene tetrafluoroethylene copolymer (ETFE, Tefzel™) protective jacket.
ProFlex CO2 Laser Fibers are packaged in a coiled and tubular, high-density polyethylene (HDPE) carrier providing improved ease of dispensing within the surgical field while maintaining sterility. Coils are contained within non-woven/impermeable polymer, e.g. Tyvek/Mylar, sterile pouches, validated for three-year shelf life, and protected with an outer, nonsterile fiberboard carton. Both sterile pouch and carton are labeled.
All ProFlex CO2 Laser Fiber materials of construction are USP Class VI biocompatible and are compatible with ethylene oxide (EtO) sterilization.
ProFlex CO2 Laser Fibers are for prescription use only.
The provided document is a 510(k) Premarket Notification from the FDA for the ProFlex CO2 Laser Fiber. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving independent performance against acceptance criteria in the manner typically associated with novel AI/ML medical devices or complex diagnostic tools.
Therefore, the document does not contain the information requested regarding acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test/training sets, expert qualifications, ground truth establishment, or effect sizes for human reader improvement.
The document primarily shows:
- Device Name: ProFlex CO2 Laser Fiber (Model: S-COF500)
- Intended Use: Ablation, coagulation, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.
- Predicate Device: CO2 Laser WaveGuide (K100384) from Lumenis Ltd.
- Demonstration of Substantial Equivalence: Achieved through a comparison of technical characteristics and non-clinical bench testing.
Specifically, regarding the requested information:
- A table of acceptance criteria and the reported device performance: This document does not present acceptance criteria or reported device performance in the context of a clinical study or specific performance metrics typically associated with AI/ML or diagnostic devices (e.g., sensitivity, specificity, AUC). It focuses on physical and functional characteristics matching the predicate.
- Sample sizes used for the test set and the data provenance: Not applicable. The "testing" referred to is non-clinical bench testing, not clinical studies with "test sets" in the diagnostic sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for this type of device and submission.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 a laser fiber, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable. This device does not involve machine learning or AI with training sets.
- How the ground truth for the training set was established: Not applicable.
Instead, the document details:
- Non-Clinical Testing (Section 8): This "testing" served to verify that the proposed device met design specifications and was substantially equivalent. It included:
- Bench Testing for labeling and performance verification (e.g., Instructions for Use, Fiber Design Verification, Packaging Design Verification).
- Performance Qualification for sterility (ISO 11135:2014) and ethylene oxide sterilization residuals (ISO 10993-7:2008).
- Clinical Testing (Section 9): "No clinical study is included in this submission." This explicitly states that clinical performance data was not part of this 510(k).
In summary, the provided document is a regulatory clearance for a physical medical device (laser fiber), not a study report for an AI/ML or diagnostic device that would feature the requested 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.