(92 days)
ProFlex® Laser Fibers are intended for use in laser-based surgical applications including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, hemostasis, excision, resection and incision and of soft and cartilaginous tissues. While designed primarily for holmium (Ho:Y AG) lasers, ProFlex laser fibers may be used with any laser wavelength between 500 nm and 2200 nm that have been cleared for surgical use including, but not limited to frequency doubled Nd: Y AG (KTP) lasers, argon lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.
Subject devices and primary predicate devices are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, doubly step index clad optical fiber (fluoroacrylate over fluorine doped fused silica) with an ethylene tetrafluorethylene (ETFE, Tefzel™) protective jacket and are available in five nominal fiber core diameters (200 um, 273 µm, 365 µm, 550 um, 910 um, and 940 um), three nominal lengths (3 meters, 3.5 meters and 4.25 meters) and two laser-formed working tips (flat and orb). Subject devices and primary predicate devices are equipped with spatial and angular laser launch overfill protection -- a protective and guiding quartz ferrule, fused about the fiber input face upon which an input lens is laser-formed for high laser and physical damage threshold and for collimation of the laser focus energy within the optical fiber - and ruggedized output tips designed for ease of transit in flexible ureteroscopes and stone basket channels. Smaller fibers (where base fiber cores are smaller than laser foci) are equipped with tapered inputs where larger fibers are straight terminations.
Subject devices are packaged in a coiled high density polyethylene (HDPE) tube carrier providing ease of dispensing within the surgical field while maintaining sterility. All materials of construction are USP Class VI biocompatible and are compatible with flash autoclave and ethylene oxide (EtO) sterilization.
This document is a 510(k) Premarket Notification from the FDA for a medical device called "ProFlex® Laser Fibers." It's a regulatory clearance letter, not a study report demonstrating the device meets acceptance criteria.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully provided from this document. This letter states that the device is substantially equivalent to a predicate device, meaning it has similar indications, technological characteristics, and performs as well as a legally marketed device. It does not contain a detailed report of a study designed to prove specific acceptance criteria against a defined performance metric.
However, I can extract the relevant information that is present regarding performance and comparison:
1. A table of acceptance criteria and the reported device performance:
This document does not specify quantitative acceptance criteria. Instead, it relies on substantial equivalence. The reported performance is a comparative statement.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance |
|---|---|
| Safe and Effective (at least as good as predicate) | "Subject devices performed as well than the predicate devices in all cases." |
| "Subject devices are as safe, as effective and perform as well the predicate devices." | |
| Laser Power Delivery (relaxed configuration) | Performed as well as predicate |
| Laser Power Delivery (strained/bent configuration) | Performed as well as predicate |
| Shelf Life | Determined to be 2 years (per accelerated aging tests) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated. The document mentions "Subject and predicate fibers were laser power tested," implying a sample of fibers was used, but the quantity is not provided.
- Data Provenance: The testing was conducted by InnovaQuartz, whose manufacturing facility is in Phoenix, Arizona, USA. The document doesn't specify if the testing was prospective or retrospective, but typically, premarket testing for substantial equivalence would be prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is a technical performance study of a physical device (laser fibers), not an assessment requiring expert interpretation of medical images or patient outcomes for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a technical performance study, not a ground truth establishment process involving multiple readers.
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:
Not applicable. This device is a laser fiber, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" here is the measured performance of the laser fibers (e.g., laser power delivery) compared to a predicate device. This is based on bench testing/empirical measurements of physical characteristics, not medical "ground truth" typically established in diagnostic studies.
8. The sample size for the training set:
Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. (See #8)
§ 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.