(163 days)
Ablation and hemostasis in the treatment of gynecological and urological conditions, as well as multiple applications in gastroenterology and general surgery.
The StrateFire™ Reusable Optical Fiber is a fiberoptic laser energy delivery system intended for use with any surgical laser equipment fitted with SMA-905 compatible connectors and designed to operate at wavelengths between 532 and 1400 nm. The StrateFire™ Reusable Optical Fiber consists of a 400, 600, 800 or 1,000 micron diameter fused silica optical fiber with a proximal SMA-905 connector for attaching to a medical laser. Fibers are supplied sterile in heat-sealed Tyvek and may be reused after cleaning and sterilization as directed in the labeling.
The provided text is a 510(k) summary for the StrateFire™ Reusable Optical Fibers, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a detailed clinical study with AI components. Therefore, many of the requested sections about AI study design and endpoints will not be applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state numerical acceptance criteria for performance metrics. Instead, it relies on demonstrating comparable performance to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Comparable optical performance to predicate devices | "Optical performance testing has demonstrated comparable performance of the [StrateFire™] to the SideFire™ - Tipped Optical Fiber." |
| Safe for intended use (ablation and hemostasis) | "concluded that the StrateFire™ Reusable Optical Fibers are safe and effective for their intended use" |
| Effective for intended use (ablation and hemostasis) | "concluded that the StrateFire™ Reusable Optical Fibers are safe and effective for their intended use" |
| Performs at least as well as legally marketed predicate devices | "perform at least as well as legally marketed predicate devices" |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "optical performance testing" but does not specify the sample size for this testing. It also does not mention data provenance (e.g., country of origin, retrospective or prospective data) as it's not a clinical study involving patient data. This testing would involve laboratory-based measurements of the optical fibers themselves.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the analysis is based on physical and optical performance testing of a medical device, not on interpreting medical images or data that would require expert ground truth.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study typically involves human readers interpreting cases, often with and without AI assistance, to measure diagnostic performance. The StrateFire™ Reusable Optical Fiber is a physical laser delivery system, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
This is not applicable. The device is an optical fiber, not an algorithm. The "optical performance testing" mentioned refers to the physical and functional characteristics of the fiber itself, not the performance of an AI algorithm.
7. Type of Ground Truth Used
The ground truth for this type of device would be established through engineering and scientific measurements of the optical fiber's properties (e.g., power transmission, output beam profile, integrity after sterilization cycles, etc.) and comparison to the specifications and performance of the predicate devices. It is not based on expert consensus, pathology, or outcomes data in the typical sense for diagnostic or prognostic devices.
8. Sample Size for the Training Set
This is not applicable as there is no AI algorithm being trained for this device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no AI algorithm being trained for this device.
Summary of the Study (as described in the 510(k) summary):
The manufacturer, MyriadLase, Inc., performed "optical performance testing" on the StrateFire™ Reusable Optical Fibers. The goal of this testing was to demonstrate that the device's optical performance was comparable to its legally marketed predicate device, the SideFire™ - Tipped Optical Fiber. The 510(k) submission states that the testing showed comparable performance, leading to the conclusion that the StrateFire™ fibers are safe and effective for their intended use and perform at least as well as the predicate devices. The specific details of this testing (e.g., methods, exact parameters measured, number of units tested) are not provided in this summary.
§ 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.