(215 days)
The PHAKOS Disposable Retinal Cryo Probe is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataraction, and cryo destruction of lash follicles for trichiasis.
The PHAKOS Disposable Retinal Cryo Probe is a single use item used with cryopexy equipment. It produces an ice ball at the tip of the pencil allowing you to treat the detachment of the retina by welding the tissues together. The ice ball is the result of a specific gas released at a high pressure, N2O or CO2, allowing the welding of the tissues by burn.
The provided text describes a 510(k) premarket notification for the PHAKOS Disposable Retinal Cryo Probe. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on its own performance metrics. Therefore, many of the requested categories for a study proving device performance are not applicable or cannot be extracted from this document directly.
Here's a breakdown of the information that can be extracted and a clear statement where information is not available within the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria as a quantitative benchmark for the PHAKOS Disposable Retinal Cryo Probe's own performance (e.g., a specific ice ball size or temperature achieved in a defined time). Instead, it focuses on demonstrating that its characteristics are identical to a legally marketed predicate device.
Therefore, the "acceptance criteria" are implied to be "being identical to the predicate device in terms of intended use, design, materials used, mechanical safety, and performances." The "reported device performance" is then its similarity to the predicate.
| Characteristic | Acceptance Criteria (Implied: Identical to Predicate) | PHAKOS Disposable Retinal Cryo Probe Performance (Statement) |
|---|---|---|
| Indications for Use | Same as Keeler Cryomaster Probes | Same |
| Disposable | Yes | Yes |
| Cryogen Type | CO² or N²O | CO² or N²O |
| Freeze System Pressure Regulation | Automatic | Automatic |
| Freeze Control | Footswitch | Footswitch |
| Purge Cycle | Automatic | Automatic |
| Auto Clean | Yes | Yes |
| Audible Indicator | Yes | Yes |
| Cryo Probe Connection Mechanism | Quick release | Quick release |
| Disposable Probe Connection | Connected to console via disposable probe adapter | Connected to console via disposable probe adapter |
| Freeze Zone | End freeze | End freeze |
| Construction (Materials) | Same materials as Keeler Cryomaster Probes | Probe tip: Stainless steel; Connector: Polyacetal; Sleeve: Aluminum; Tube: PVC; Nozzle: Stainless steel; Adapter: Stainless steel |
| Dimensions | Same as Keeler Cryomaster Probes | Same |
| Sterilization | EO sterilized | EO sterilized |
| Overall Equivalence | Strictly equivalent to predicate in design, materials, processing, and similar IFU | The PHAKOS Disposable Retinal Cryo Probe is fully identical to the predicate device in terms of intended use, design, materials used, mechanical safety and performances. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical bench testing, not a human-subject study with a "test set" in the context of clinical data. The non-clinical tests performed were:
- Operation of adapters for single-use cryodes on different equipment.
- EO residual measurement.
- Pyrogenicity evaluation using the Limulus amebocyte lysate (LAL) assay.
The sample sizes for these bench tests are not specified in the document. The data provenance is also not specified, though the manufacturer (PHAKOS) is based in France.
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 was a non-clinical bench study, not a study involving expert-established ground truth for diagnostic or interpretative performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was not a study requiring adjudication of expert opinions.
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 is not an AI-assisted device, nor was an MRMC study performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (cryo probe), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be established by standardized laboratory methods and specifications (e.g., maximum allowable endotoxin levels for pyrogenicity, acceptable ranges for EO residuals, functional integrity during operation). The document states the device "meets the recommended maximum endotoxin level," which implies comparison against an established standard.
8. The sample size for the training set
Not applicable, as this is a physical medical device and not a machine learning model.
9. How the ground truth for the training set was established
Not applicable, as this is a physical medical device and not a machine learning model.
Summary of Key Findings from the Document:
The PHAKOS Disposable Retinal Cryo Probe underwent non-clinical bench testing to demonstrate its substantial equivalence to its predicate device, the Keeler Cryomaster Probes. The "acceptance criteria" were primarily focused on demonstrating identical characteristics and performance to the predicate device in aspects like indications for use, disposable nature, cryogen type, freeze system, control mechanisms, construction materials, dimensions, and sterilization method.
Specific non-clinical tests included evaluating the operation of adapters, measuring EO residuals, and assessing pyrogenicity using the LAL assay, with the device reportedly meeting recommended maximum endotoxin levels. No clinical studies were performed for this 510(k) submission, and therefore, there are no details on clinical efficacy, human reader performance, or AI-related metrics.
§ 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.