(31 days)
The Straight Fire Laser Fiber is designed for use with Ho:YAG and Nd:YAG lasers for indications that are cleared for these laser systems, including, but not limited to endoscopic, laparoscopic, and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection, incision of soft and cartilaginous tissue, and fragmentation of urinary and biliary calculi (Ho:YAG wavelength only). The fiber is designed for use with a standard SMA-905 connector that have been cleared for surgical use.
The proposed modified Straight Fire Laser Fiber is a fiber optic laser energy delivery device consisting of a silica core fiber jacketed with ethelylene tetraflouroethylene (ETFE) and a SMA 905 connector. It is equipped with a polished, flat output tip. This fiber may be used in a variety of laser based surgical cases as an integral part of laser systems.
For use with holmium (Ho:YAG) and neodymium (Nd:YAG) lasers with a standard SMA 905 connector that have been cleared for surgical use. Recommended lasers are Lumenis VeraPulse® PowerSuite™ Laser Systems.
This document is a 510(k) summary for a modified laser fiber, focusing on its substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment for novel device performance is not present.
However, I can extract information related to the device's characteristics and the basis for its clearance, which is substantial equivalence.
Here's an attempt to answer your questions based only on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" due to the nature of this submission:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on "substantial equivalence" to a predicate device, explicit quantitative acceptance criteria for new performance tests are not typically presented in the publicly available summary unless a specific performance characteristic is modified and requires new testing. The general acceptance criterion for a 510(k) is that the device is "as safe, as effective, and performs as well as" the predicate device.
The document states: "The proposed modified Straight Fire Laser Fiber is as safe, as effective, and performs as well as the predicate device."
| Performance Characteristic (Implied) | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Safety | As safe as predicate | Meets (Substantially Equivalent) |
| Effectiveness | As effective as predicate | Meets (Substantially Equivalent) |
| Performance | Performs as well as predicate | Meets (Substantially Equivalent) |
| Technological Characteristics | Same as predicate (SMA 905 connector, length of fiber connector type, fiber core, and strain relief) | Same as predicate |
| Intended Use | Same as predicate | Same as predicate |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not provided. The submission focuses on demonstrating substantial equivalence through technological and intended use comparisons, not a specific performance study with a test set of data.
- Data Provenance: Not provided. The submission does not describe a clinical or lab study as the basis for clearance, but rather a comparison to an already cleared device.
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 submission does not describe a study involving a test set with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This submission does not describe a study involving a test set requiring adjudication.
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 is a medical device (laser fiber), not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (laser fiber), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The clearance is based on substantial equivalence, not on validating performance against a specific ground truth in a clinical study. The "ground truth" here is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
§ 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.