(94 days)
SureFlex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). SureFlex is designed primarily for holmium (Ho:YAG) lasers, but may be used with any laser wavelength between 500nm and 2200nm that has been cleared for surgical use, e.g. Nd:YAG, KTP, Alexandrite, Argon, Ruby, Diode
Specific, by Surgical Specialty (most common use first)
Urology -
Urinary Lithotripsy including but not limited to endoscopic and laparoscopic fragmentation, ablation and vaporization of urinary calculi found from the lower pole of the kidney to the urethra and distal impacted fragments of steinstrasse.
Urological Surgery (vaporization, coagulation, hemostasis, excision and incision of soft tissue) including, but not limited to open, endoscopic and laparoscopic surgery for the removal of superficial and invasive bladder tumors and lesions, including condylomas, treatment of ureteral strictures obstructions, polyps, vascularities and hemangioma as well as prostatectomy (BPH).
Gastroenterology -
Laser-based surgical procedures including, but not limited to open, endoscopic and laparoscopic gastroenterological surgery for ablation, vaporization, fragmentation, coagulation, hemostasis, incision, excision, resection, and hemostasis of biliary calculi, lesions, neoplasms, polyps, ulcers, tears, erosions and tumors.
The SureFlex™ Lithotripsy Laser Fiber (SureFlex fiber) is a fiber optic laser delivery device consisting of a patented, high energy termination (Black Hole™); a length of silica/silica fiber with a UV cured polymer secondary cladding and an ethylene tetrafluoro-ethylene copolymer (ETFE) jacket. The standard fiber output is a laser polished tip. SureFlex fibers are designed for use in a wide variety of surgical procedures as an integral part of a surgical laser system.
This document is not about an AI/ML powered medical device, but rather a traditional medical device (laser fibers). Therefore, the requested information regarding acceptance criteria and study details for an AI/ML powered device does not apply directly.
However, I can extract the information pertinent to the described device, the SureFlex Lithotripsy Laser Fibers, from the provided 510(k) summary.
Acceptance Criteria and Study for SureFlex Lithotripsy Laser Fibers (K140679)
This 510(k) pertains to a modification of an existing device (SureFlex Lithotripsy Laser Fibers, K050108), specifically a change in the resin for the fluoroacrylate resin material and a labeling update for the maximum power of the 200 um fiber. As such, the testing focuses on demonstrating that the modified device remains equivalent to the predicate and meets its intended product specifications.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Product Specifications | Met |
| Performance Requirements | Met |
| Shelf Life | Successfully completed |
| Biocompatibility | Successfully completed |
| Performance Testing (Bench): Active Bending Test | Successfully completed |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Bench testing was performed to support this submission." It does not specify a distinct "test set" in the context of clinical data, as no clinical testing was performed. The non-clinical testing appears to have used samples of the device itself. The document does not provide details on the number of samples used for each bench test.
- Data Provenance: Non-clinical bench testing. No country of origin for data or retrospective/prospective nature is applicable as no human data was used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable as no clinical data or expert-adjudicated ground truth was used. The evaluation was based on non-clinical, objective bench testing.
4. Adjudication Method for the Test Set
This is not applicable as no clinical data requiring expert adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted. The device is a physical laser fiber, not an AI/ML algorithm requiring human reader performance evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone algorithmic study was conducted. This device is not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for this device's performance was established through product specifications and performance requirements as demonstrated by non-clinical bench testing.
8. Sample Size for the Training Set
This is not applicable. The device is a physical product and does not involve AI/ML models that require training sets.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for a physical 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.