(60 days)
The D.O.R.C. Harmony CryoStar Cryosurgical System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment or anterior segment including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retinopathy of prematurity.
The D.O.R.C. CryoStar Cryosurgical System consists of a cryogen gas bottle, a console, an ophthalmic probe, a footswitch and necessary interconnections. The console controls delivery of the gas to the probe. It also processes signals from the footswitch, enabling the probe to freeze and defrost.
This is a 510(k) premarket notification for a medical device called the D.O.R.C. CryoStar Cryosurgical System. It claims substantial equivalence to predicate devices, and therefore no clinical study was performed.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Acceptance Criteria (Implied) | D.O.R.C. CryoStar Cryosurgical System (Reported Performance) |
|---|---|
| Console Technology | Electro-mechanical |
| Software Content | Non-programmable firmware |
| Pressure Control | Manual |
| Temperature Measurement | Thermocouple (for some probes in range only) |
| Indicator Panel: Timer | Digital display |
| Indicator Panel: Pressure | LED array |
| Indicator Panel: Temperature | LED array |
| Power Source | Mains |
| Gas Inlet | Screw connection |
| Gas Outlet | Barbed fitting |
| Probe Connection | Screw fitting |
| Probes | Ophthalmic standard freeze and end-freeze, some with thermocouples. Re-usable when sterilized by autoclaving. |
| Probe Adaptor | Universal (suits probes with or without thermocouples) |
| Consumable Cryogen Gases (Nitrous Oxide) | Medical grade, vapour withdrawal gas |
| Consumable Cryogen Gases (Carbon Dioxide) | Medical grade, vapour withdrawal gas |
Study Proving Device Meets Acceptance Criteria:
The provided document is a 510(k) submission, not a study report. The "study" that proves the device meets the acceptance criteria is a demonstration of substantial equivalence to predicate devices. This means the manufacturer presented evidence that the D.O.R.C. CryoStar Cryosurgical System has the same intended use and similar technological characteristics to previously cleared devices (D.O.R.C. Cryo 1500 and Keeler Cryo Master) and that any differences do not raise new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. This is not a clinical study involving a test set of data. The submission relies on a comparison of technical specifications and intended use.
- Data Provenance: Not applicable. The data is descriptive information about the device itself and a comparison to predicate devices, not data collected from a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. No ground truth was established by experts for a test set in this context. The determination of substantial equivalence is made by the FDA based on the provided technical information and comparison to predicate devices.
4. Adjudication Method for the Test Set:
Not applicable. There was no test set or adjudication process as part of a clinical study.
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 cryosurgical system, not an AI-powered diagnostic tool engaging human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used:
Not applicable in the typical sense of a clinical study. The "ground truth" in this 510(k) submission is the established safety and effectiveness of the predicate devices (D.O.R.C. Cryo 1500 and Keeler Cryo Master) based on their prior FDA clearance. The new device is deemed substantially equivalent if it can demonstrate it performs safely and effectively like these predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning study requiring a training set.
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.