(328 days)
The D.O.R.C. Disposable Cryo Probe is intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery of the posterior segments including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retionopathy of prematurity.
The D.O.R.C. Disposable Cryo Probe is a single-use, handheld medical device intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery. When the foot pedal of the CryoStar Console is pressed, high pressure gas (CO2 or N2O) is supplied via a small aperture to target tissue.
Here's a breakdown of the acceptance criteria and the study information for the D.O.R.C. Disposable Cryo Probe, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Freeze Rate: After 10s operation, an ice ball diameter shall be at least 4mm when immersed 2mm in water of 20°C with both CO2 and N₂O. | Freeze Performance: The Disposable Cryo Probe (1540.D) produced an ice ball of on average 4.9mm after 10s operation when immersed in water of 20°C with both CO2 and N2O. This meets the "at least 4mm" criterion. |
| Defrost Rate: Within 5s, the ice ball of at least 4mm shall be released when the defrost function is activated with both CO2 and N₂O. | Defrost Performance: The Disposable Cryo Probe (1540.D) released the ice ball of at least 4mm within 5s after activation of the defrost function with both CO2 and N2O. This meets the "within 5s" criterion. |
| Biocompatibility: In accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. | Biocompatibility Evaluation: The biocompatibility evaluation of the D.O.R.C. Disposable Cryo Probe was conducted in accordance with the specified FDA memorandum and International Standard ISO 10993-1, as recognized by FDA. While specific test results (e.g., cytotoxicity, irritation, sensitization) are not detailed here, the statement indicates compliance. |
| Compatibility with Cryostar Cryosurgical System: Demonstrated compatibility. | Both the 'freeze performance' test and the 'defrost performance' test were performed using the Cryostar (1500.III), "showing the compatibility of the Disposable Cryoprobe (1540.D) with this Cryosurgical System." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size (number of probes tested) for the freeze and defrost performance tests. It refers to the "Disposable Cryo Probe (1540.D)" and "Reusable Cryoprobe (1540)" generically, indicating these were the devices tested.
Data Provenance: The studies were laboratory (bench) performance tests, conducted internally by the manufacturer (D.O.R.C. Dutch Ophthalmic Research Center International B.V.). There is no indication of country of origin of the data beyond the manufacturer's location in The Netherlands. The studies are prospective in the sense that they were conducted for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a surgical instrument. The performance testing (freeze/defrost rate) involved objective measurements (ice ball diameter, time to release) rather than subjective assessment requiring expert interpretation or "ground truth" to be established by experts.
4. Adjudication Method for the Test Set
Not applicable. As the performance tests involved objective measurements, there was no need for adjudication involving human experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for interpretative devices (e.g., AI for image diagnosis) where human readers' performance with and without AI assistance is compared. The D.O.R.C. Disposable Cryo Probe is a surgical tool, and its performance is evaluated through objective physical parameters.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was done in the sense that the performance of the device itself (the D.O.R.C. Disposable Cryo Probe) was evaluated objectively through laboratory (bench) tests without human intervention as part of the primary measurements (freeze and defrost rates). The study directly measured the physical output (ice ball size, defrost time) of the probe when operated with the Cryostar system.
7. Type of Ground Truth Used
The "ground truth" for the performance tests was based on objective physical measurements rather than clinical outcomes, pathology, or expert consensus.
- Freeze Performance: The ground truth was the measured diameter of the ice ball (in mm).
- Defrost Performance: The ground truth was the measured time (in seconds) for the ice ball to release.
8. Sample Size for the Training Set
Not applicable. This device is a physical surgical tool and does not employ a machine learning algorithm or AI that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to be established for it.
§ 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.