(15 days)
The Straight Fire Holmium Laser Fiber is indicated for use in laser-based surgical applications, including, but not limited to endoscopic, laparascopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue.
The Straight Fire Holmium Laser Fiber is designed for use with holmium (Ho:YAG) lasers with a standard SMA-905 connector that have been cleared for surgical use.
The Straight Fire Holmium 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 Ho:YAG laser systems with a standard SMA 905 connector that have been cleared for surgical use. Recommended Ho: YAG lasers are Dornier and New Star.
This document is a 510(k) Pre-market Notification for the Straight Fire Holmium Laser Fiber by Boston Scientific Corporation. This type of submission is focused on demonstrating substantial equivalence to a currently marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel, high-risk device.
Therefore, the structure of the provided text does not contain the specific information you've requested regarding acceptance criteria and a study proving device performance in the context of diagnostic accuracy, human reader performance, or standalone algorithm performance.
Here's an explanation based on the provided text, addressing your points where applicable and explaining why other points are not present:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. A 510(k) submission for a device like a laser fiber typically focuses on demonstrating that the new device has the same technological characteristics and performs as well as predicate devices, through bench testing (e.g., power output, fiber integrity) and materials characterization. Specific "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy (like sensitivity, specificity, AUC) or clinical outcomes are not typically part of this type of submission for this class of device. The document states: "The Straight Fire Holmium Laser Fiber is as safe, as effective, and performs as well as the predicate devices." This is the core claim of substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present. As explained above, this submission is not based on a clinical trial with a "test set" in the sense of patient data. Performance is typically evaluated through laboratory-based engineering and materials testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not present. This is not relevant to a 510(k) submission for a laser fiber. Ground truth adjudicated by experts is typically for diagnostic imaging or similar devices where interpretation is involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present. This is not relevant for this type of device and submission.
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
This information is not present. An MRMC study is not applicable to a laser fiber, which is a surgical instrument, not a diagnostic imaging or AI-assisted interpretation device. AI is not mentioned or implied in this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not present. This is not relevant. The device is a physical laser fiber, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not present. The concept of "ground truth" as typically discussed in diagnostic studies is not relevant here. Performance is assessed against engineering specifications and comparison to the predicate device's known characteristics.
8. The sample size for the training set
This information is not present. No "training set" is applicable for this type of device submission.
9. How the ground truth for the training set was established
This information is not present. No "training set" or "ground truth" in this context is applicable for a laser fiber.
Summary based on the document:
The 510(k) submission for the Straight Fire Holmium Laser Fiber focuses on establishing "Substantial Equivalence" to legally marketed predicate devices (AccuFlexTM Laser Lithotripsy Fibers and SlimLineEZ™ Fiber Device).
The core of the "study that proves the device meets the acceptance criteria" in this context is demonstrated by:
- Technological Characteristics Comparison: The document states, "The Straight Fire Holmium Laser Fiber has the same technological characteristics (i.e. SMA 905 connector, length of fiber optic cable, and strain relief) as the predicate devices." This implies that the design and components are critically similar.
- Performance Characteristics: The document claims the device "performs as well as the predicate devices." While no specific performance data is included in this summary, a typical 510(k) for such a device would include bench testing data comparing parameters like power transmission, durability, and compatibility with specified laser systems, against the predicate devices or established engineering standards. The acceptance criteria would likely be defined by these engineering specifications and a demonstration of equivalence to the predicate's performance under various test conditions. For example, acceptance criteria might include a specified power output tolerance, bending radius tolerance without damage, or tensile strength, with the associated testing demonstrating the fiber meets these. However, these specific details are not provided in the public 510(k) summary.
- Intended Use Equivalence: The intended use statement for Straight Fire Holmium Laser Fiber closely mirrors the general applications of existing Holmium laser fibers, involving "vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue." This demonstrates that the device is intended for the same clinical applications as its predicates.
In conclusion, for this specific device and submission type, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence in technological characteristics, intended use, and performance to predicate devices through engineering and materials testing, rather than clinical studies with human subjects or AI algorithm performance assessments.
§ 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.