(51 days)
The PHAKOS Disposable Retinal Cryo Probe and Accessories is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, and cryo destruction of lash follicles for trichiasis.
The cryoprobe adapter is a mechanical accessory used to adapt the PHAKOS Disposable Retinal Cryo Probe to different cryosurgery generators found on the market; it is connected to the cryoprobe connector on the generator. The rear end piece receiving the cryoprobe is the same for all adapters; the body varies according to the generator used. The adapter is fitted on the generator in the place of the original cryoprobe, and remains in position, while the PHAKOS Disposable Retinal Cryo Probe is plugged into the universal rear end piece.
This document is a 510(k) premarket notification for a medical device called the "Frigitronics Adapter." It describes the device, its intended use, and demonstrates its substantial equivalence to previously marketed predicate devices.
Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to AI/algorithm performance.
The document states: "No clinical studies were performed" and the "Non-clinical Test Summary" only mentions "creation of the ice ball" and that "The results of these evaluations indicate that the Frigitronics Adapter is equivalent to predicate devices."
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI-powered device, as this document pertains to a mechanical adapter and not an AI/algorithm-driven device.
To directly answer your prompt based on the provided text, the following points are relevant:
- 1. A table of acceptance criteria and the reported device performance: Not applicable. The document assesses substantial equivalence based on intended use, design, materials, mechanical safety, and performance (evidenced by ice ball creation), not specific performance metrics against pre-defined quantitative acceptance criteria in the context of an AI/algorithmic output.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set for an AI/algorithm is described.
- 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. No ground truth for an AI/algorithm test set is described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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. No multi-reader study or AI assistance is mentioned.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
§ 886.4170 Cryophthalmic unit.
(a)
Identification. A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.(b)
Classification. Class II.