(81 days)
The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy procedures in refractory glaucoma, for retinal detachment, cryo destruction, cataract extraction, cryo destruction of lash follicles, extraction of fragments within the eye, and treatment of retinopathy of prematurity (ROP).
Cryomatic System and Probes comprising of: a) Cryomatic Console b) Cryomatic Probes
This looks like a 510(k) premarket notification for a medical device. Based on the provided text, there's no information about a study with acceptance criteria and device performance as typically understood for AI/ML or diagnostic devices.
The submission is for the Cryomatic System and Probes, which is an ophthalmic cryo system. This device is classified as a Class II cryogenic surgical device.
The core of this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices, which are identified as:
The substantial equivalence is based on "similarity of the subject device to the predicate devices in intended use, materials, design and principles of operation."
Therefore, there isn't a "study" in the sense of a clinical trial or performance evaluation with specific acceptance criteria as you've outlined for diagnostic or AI/ML devices. Instead, the "proof" the device meets acceptance criteria (i.e., being safe and effective for its indicated use) is established by its similarity to already approved devices.
To directly answer your questions based only on the provided text:
- Table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence to predicate devices, not performance against specific numerical acceptance criteria.
- Sample sized used for the test set and the data provenance: Not applicable. There's no test set described for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a test set is mentioned.
- Adjudication method: Not applicable.
- 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 is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) submission for a surgical instrument (an ophthalmic cryo system) seeking clearance based on substantial equivalence to existing devices, not unique performance data from a new clinical study.
§ 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.