(18 days)
The FlexivaTM TracTip Laser Fibers are 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 Flexiva TracTip Laser Fibers are fiber optic laser energy delivery devices consisting of a SMA-905 connector, strain relief, and a silica core fiber jacketed with ethylene tetrafluoroethylene (ETFE). The Flexiva TracTip fibers are equipped with a polished and reinforced ball-shaped output tip. These fibers may be used in a variety of laser-based surgical cases as an integral part of laser systems.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Flexiva™ TracTip Laser Fiber, structured according to your request:
Acceptance Criteria and Study for Flexiva™ TracTip Laser Fiber
This device notification focuses on demonstrating substantial equivalence to a predicate device, rather than establishing de novo performance criteria against a disease. Therefore, the "acceptance criteria" discussed here relate to the device's ability to perform equivalently to the predicate device in specific bench tests, rather than clinical efficacy against a medical condition.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Performance Metric) | Reported Device Performance (Flexiva™ TracTip) |
|---|---|
| Tip Fracture Resistance (Equivalence to Predicate) | Performance demonstrates equivalence to the predicate Flexiva laser fibers |
| Scope Testing (Equivalence to Predicate) | Performance demonstrates equivalence to the predicate Flexiva laser fibers |
| Power Rating/Output Efficiency Testing (Equivalence to Predicate) | Performance demonstrates equivalence to the predicate Flexiva laser fibers |
| Aiming Beam Testing (Equivalence to Predicate) | Performance demonstrates equivalence to the predicate Flexiva laser fibers |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a specific number of units for each test within the provided document. The text mentions "samples aged at T=0 and T=13 months accelerated aging," implying a comparison between new devices and devices subjected to accelerated aging.
- Data Provenance: The testing was conducted by Boston Scientific Corporation, suggesting it was internal bench testing. The country of origin for this testing is not specified, but Boston Scientific is a U.S.-based company, making it likely the testing was performed within the U.S. The testing is retrospective in the sense that it evaluates the manufactured device's physical properties, not prospective clinical outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable and not provided in the document. The "ground truth" for this type of device (laser fiber) is its physical performance and ability to deliver energy as intended, which is assessed through engineering and bench testing, not expert clinical interpretation of images or patient outcomes.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided in the document. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving interpretation of data (e.g., imaging studies) by multiple human readers to establish a consensus ground truth. For bench testing of a physical device, the performance is measured objectively.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a laser fiber used in surgical procedures, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This device is a physical surgical instrument, not a software algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this study is effectively defined by the objective measurements and engineering specifications of the predicate device. The performance of the Flexiva™ TracTip Laser Fiber is compared directly against the established performance characteristics of the predicate device (Flexiva™ Modified Straight Fire Laser Fiber) through bench testing. The goal is to demonstrate "equivalence" in physical and functional performance, not clinical outcomes or pathology.
8. The Sample Size for the Training Set
- This information is not applicable and not provided in the document. This is not a machine learning or AI-driven device, so there is no "training set." The device's design is based on engineering principles and comparison to a predicate, not data training.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable and not provided in the document, as there is no training set for this type of 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.