(57 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.
The provided text describes a 510(k) premarket notification for the MIRA Adapter, a mechanical accessory used to adapt the PHAKOS Disposable Retinal Cryo Probe to different cryosurgery generators. The submission claims substantial equivalence to predicate devices based on non-clinical testing.
Here's an analysis of the acceptance criteria and the study information as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA letter and the 510(k) summary do not specify numerical performance acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) because this is a mechanical adapter, not an AI or diagnostic device with such quantifiable performance metrics. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence in terms of intended use, design, materials, mechanical safety, and performance as compared to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: The MIRA Adapter's intended use should be the same as other Phakos ADAPTERs and predicate devices. | The MIRA ADAPTER's intended use is documented as "the same as the other Phakos ADAPTERS." The indications for use match the predicate: 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. |
| Material Equivalence: The materials used should be the same as other PHAKOS ADAPTERs. | The PHAKOS MIRA ADAPTER uses "the same material as the other PHAKOS ADAPTERS," specifically Stainless steel per ASTM F899 and Polyoxymethylene (acetal) per ASTM D6778. |
| Design Equivalence: Similar in shape to other PHAKOS ADAPTERs. | The MIRA ADAPTER and other PHAKOS ADAPTERs are "equivalent in terms of shape." The description notes the rear end receiving the cryoprobe is the same for all ADAPTERs. |
| Disposable Probe Connection Performance: Enables proper connection of disposable cryo probes to the console. | The disposable cryo probes "are connected to the console via the MIRA ADAPTER and the other PHAKOS ADAPTERS." |
| Mechanical Performance/Safety: Demonstrated by specific analyses. | Non-clinical analysis reported: "creation of the ice ball." The summary states "The results of these evaluations indicate that the MIRA ADAPTER is equivalent to predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not detail a "test set" in the context of clinical data or AI algorithm evaluation. The non-clinical testing involved "creation of the ice ball." The sample size for this specific test, and the number of repetitions or conditions tested, are not specified.
Data Provenance: This is a mechanical device, and the testing described is non-clinical performance (e.g., mechanical functionality and ice ball creation). Thus, there is no "country of origin of the data" or "retrospective/prospective" label applicable in the usual sense for clinical or AI studies. The tests would have been performed in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This is a non-clinical evaluation of a mechanical adapter. There is no "ground truth" established by human experts in the context of diagnostic accuracy or AI performance. The ground truth for mechanical performance would be objective measurements of physical properties or functional outcomes (e.g., ice ball size, secure connection).
4. Adjudication Method for the Test Set
Not applicable, as there is no expert-based ground truth or test set requiring adjudication in this context.
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 versus without AI assistance
No. This device is a mechanical adapter, not an AI or diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is a mechanical device, not an algorithm.
7. The type of ground truth used
For the non-clinical tests (e.g., "creation of the ice ball"), the ground truth would be based on objective physical measurements and engineering specifications, demonstrating that the adapter allows the cryo probe to function as intended (i.e., reliably create an ice ball). This is not "expert consensus, pathology, or outcomes data" in the typical sense.
8. The sample size for the training set
Not applicable. This is a mechanical device, not an AI/machine learning model, 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.
§ 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.