(60 days)
The FiberLase Endure CO2 Fiber is intended for use in surgical procedures requiring ablation, vaporization, excision, incision and coagulation of soft tissue. The FiberLase Endure CO2 Fiber is indicated for use in open surgical procedures such as ENT surgery and laparoscopy and endoscopic procedures.
The FiberLase Endure CO2 Fiber is a hollow, semi rigid, lightconducting delivery fiber, 2 meter length, designed to transmit laser energy from the CO2 laser system to the treatment site. The fiber also transmits a low power red diode or helium neon laser aiming beam to assist in targeting the tissue to be treated.
The provided text describes a 510(k) premarket notification for a medical device called "FiberLase Endure CO2 Fiber." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data in the manner typically seen for new diagnostic algorithms or devices with measurable performance metrics like sensitivity/specificity.
Here's an analysis based on the information provided, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported device performance in the traditional sense of a clinical study measuring outcomes like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are implied by the standards the device complies with and the demonstration of substantial equivalence to its predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with various medical device standards (e.g., sterilization, risk management, electrical safety, laser safety). | "FiberLase Endure CO2 Fiber was tested and complies with the following standards: ANSI/AAMI/ISO 11135-1:2007, AAMI TIR30:2001, ISO 14971-1:2007, IEC 60601-2-22 ed3.0:2007, IEC 60825-1:2007, ANSI/AAMI/ISO 17665-1:2006." |
The primary "performance" reported is that:
- "Performance testing demonstrated that the FiberLase Endure CO2 Fiber is as safe and effective as the cleared predicate device."
- "The minor differences do not raise any new questions of safety or efficacy."
2. Sample size used for the test set and the data provenance
This information is not provided in the document. The text refers to "performance testing" generally, but does not detail the nature of these tests, including the sample size, type of data (e.g., biological samples, simulated scenarios), or provenance (country of origin, retrospective/prospective). Given that the device is a laser fiber and the primary change is the sterilization method, the testing likely involved engineering and biocompatibility evaluations rather than clinical trials with human subjects for performance metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided and is not relevant to this type of device submission. The device is a CO2 laser fiber, and its performance testing would not typically involve expert review for diagnostic "ground truth."
4. Adjudication method for the test set
This information is not provided and is not relevant to this type of device submission. Adjudication methods are typically used in studies where human interpretation of medical images or data is involved to establish a ground truth or resolve discrepancies, which is not the case here.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or systems that assist human readers in interpretation. The FiberLase Endure CO2 Fiber is a physical medical device (a laser fiber), not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This question is applicable to AI algorithms. The device discussed is a laser fiber, which is a physical instrument, not an algorithm.
7. The type of ground truth used
The concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., expert consensus, pathology, outcome data) is not applicable to this device. The "ground truth" for this device's performance would relate to its physical properties, sterility, and ability to transmit laser energy safely and effectively, which would be established through engineering tests, sterilization validation, and biocompatibility studies, not clinical outcome data or expert consensus on a diagnosis.
8. The sample size for the training set
This information is not provided and is not applicable. The device is a physical instrument, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable, as there is no training set for a physical laser fiber device.
§ 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.