(30 days)
Flexiva Pulse and Flexiva Pulse TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse and Flexiva Pulse TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use.
Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy. Flexiva Pulse ID and Flexiva Pulse ID TracTip laser fibers are indicated for urologic applications for which the laser systems are cleared, limited to endoscopic procedures involving vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi. The fiber is designed for use with a standard SMA-905 connector and has been cleared for surgical use
Flexiva Pulse, Flexiva Pulse TracTip, Flexiva Pulse ID and Flexiva Pulse ID TracTip Single Use Laser Fibers are fiber optic laser energy delivery devices consisting of a SMA connector (Black Hole design), and an ETFE jacketed silica core fiber. Flexiva Pulse and Flexiva Pulse ID fibers are equipped with a polished, flat output tip (242µm, 365µm, 550µm and 910µm size) and the Flexiva Pulse TracTip and Flexiva Pulse ID TracTip fibers are equipped with a polished and reinforced ball-shaped output tip (242µm size).
These fibers may be used in a variety of laser-based surgical cases. For Flexiva Pulse ID laser fibers, an RFID (Radio-frequency identification) tag enables read/write data storage for compatible RFID-equipped laser systems (closed systems).
The provided FDA 510(k) clearance letter and summary for the Flexiva Pulse Laser Fibers does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and study particulars for a medical device. This document is a premarket notification for laser fibers, which are physical components and not typically subject to the same kind of performance studies as, for example, an AI diagnostic algorithm.
Specifically, it lacks information about:
- Acceptance Criteria for a diagnostic output: As the device is a laser fiber for surgical use, its "performance" is about its physical properties and ability to transmit laser energy, not diagnostic accuracy.
- Study proving device meets acceptance criteria in the context of diagnostic accuracy.
- Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for test and training sets, and training set sample size and ground truth establishment for AI-based devices. These are all concepts related to clinical performance evaluation, particularly for AI/Machine Learning devices, which is not the nature of the Flexiva Pulse Laser Fibers.
The document does describe performance testing related to the physical and functional attributes of the laser fiber. I will present the information contained in the document that most closely aligns with the spirit of your request, interpreting "acceptance criteria" and "reported device performance" in the context of a physical medical device.
Overview of Device Performance and Testing (Flexiva Pulse Laser Fibers)
The document describes a Special 510(k) submission for the Flexiva Pulse Laser Fibers, indicating that it is a modification to a previously cleared device (predicate device K210925). The core of the submission is to demonstrate substantial equivalence to the predicate device, primarily due to a "secondary coating resin material change." Therefore, the "study" described is focused on validating that this material change does not negatively impact the critical performance characteristics of the laser fiber.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (laser fiber), the "acceptance criteria" and "reported device performance" are related to its functional integrity and safety. These are not performance metrics like sensitivity, specificity, or accuracy, which would be relevant for a diagnostic AI device.
| Characteristic Tested | Description / Acceptance Standard (Implicit) | Reported Device Performance |
|---|---|---|
| Bent Transmission | Ensure efficient laser energy transmission even when bent, indicating fiber integrity and stability. | Successfully passed (implied by "Design Verification was executed to support the safe and effective use"). |
| Fiber Durability while Firing | Maintain structural integrity and performance during active laser firing, resisting degradation. | Successfully passed (implied by "Design Verification was executed to support the safe and effective use"). |
| Fiber Connector Temperature | Maintain connector temperature within safe limits during operation to prevent overheating. | Successfully passed (implied by "Design Verification was executed to support the safe and effective use"). |
| Laser System Output Accuracy | Ensure the fiber accurately transmits the intended laser energy output without significant loss or alteration. | Successfully passed (implied by "Design Verification was executed to support the safe and effective use"). |
| Biocompatibility | No new biocompatibility risks from the material change. | Concluded that "there are no biocompatibility risks associated with the proposed Flexiva Pulse/ ID Laser Fiber." |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of fibers tested) for the performance tests (Bent Transmission, Fiber Durability, etc.). It generally states that a "Design Verification was executed." The data provenance is internal testing performed by Boston Scientific Corporation. The studies are by nature prospective in the sense that they are performed on newly manufactured devices with the changed coating resin material to verify their performance. There is no mention of country of origin for test data, but it would typically be conducted at the manufacturer's R&D facilities.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This is not a diagnostic device where expert ground truth is established for clinical outcomes or interpretations. The "ground truth" for the performance tests mentioned above would be engineering and physical measurement standards.
4. Adjudication Method
Not applicable. This is not a diagnostic device requiring adjudication of clinical interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is for evaluating human performance (e.g., diagnostic accuracy) with and without AI assistance, which is irrelevant for a laser fiber.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This refers to the performance of a diagnostic algorithm without human intervention, which is not applicable to a laser fiber.
7. The Type of Ground Truth Used
For the physical performance tests:
- Engineering Specifications/Standards: The "ground truth" is adherence to predefined engineering specifications for power transmission, temperature limits, durability, etc. These would be established based on industry standards, the predicate device's performance, and safety requirements.
- Biocompatibility Standards: For biocompatibility, the ground truth is compliance with recognized biological evaluation standards (e.g., ISO 10993 series), ensuring the materials are safe for human contact.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/Machine Learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for it.
Summary of what the document indicates about the "study":
The study was a "Design Verification" executed by Boston Scientific Corporation to support the "safe and effective use" of the proposed laser fibers after a "secondary coating resin material change." The purpose was to demonstrate that the modified device remains "substantially equivalent" to its predicate device (K210925). The tests involved evaluating the fiber's ability to transmit laser energy (Bent Transmission), its resilience during use (Fiber Durability while Firing), and safety (Fiber Connector Temperature, Laser System Output Accuracy, Biocompatibility). The document implies that all these tests were successfully completed, confirming that the material change did not compromise the device's performance or safety.
§ 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.