(222 days)
The Cryo1 cryo-ablation probe is a sterile, single use device intended for use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.
The Cryo1 cryo-ablation probe is a sterile, single use, cryosurgical device to be used in conjunction with the frigitronics CCS-200 Cardiac Cryosurgical Console to freeze target tissue, blocking the electrical conduction pathways by creating an inflammatory response or cryonecrosis.
The provided text describes a 510(k) premarket notification for the Cryo1 cryo-ablation probe. While it details the device's indications for use, its equivalence to predicate devices, and regulatory approval, it does not contain information about specific acceptance criteria or a dedicated study proving the device meets those criteria in the format requested.
The document states: "Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices." However, it does not provide details about what those specifications are, the methods used to test them, the results of the testing, or any statistical analysis that would typically be found in a study demonstrating such conformance.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be inferred or explicitly stated based on the provided text, alongside the unavailable information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified. The document only mentions "Appropriate product testing was conducted."
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, as no clinical study with ground truth establishment is described. The clearance is based on substantial equivalence to predicate devices, not on a novel clinical performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as no clinical study with expert adjudication is described.
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
- No MRMC comparative effectiveness study was done. This device is a cryo-ablation probe, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no clinical study with ground truth establishment is described. The clearance is based on substantial equivalence to predicate devices.
8. The sample size for the training set
- Not applicable, as this is not an AI/machine learning device that would have a "training set."
9. How the ground truth for the training set was established
- Not applicable, as this is not an AI/machine learning device.
Additional points from the document:
- Type of Study: The clearance is based on a substantial equivalence claim to predicate devices (frigitronics CCS-200 Cardiac Cryosurgical System 3011 Maze Linear Probe (K811390), the Heartport Maze System (K970496) and the CryoCath SurgiFrost Cryosurgical 10cm Device (K053436)). This means the manufacturer demonstrated that the new device is as safe and effective as the legally marketed predicate devices, rather than conducting new efficacy trials against specific performance criteria.
- Material Testing: "All materials used in the manufacture of the Crvo-ablation probe are suitable for this use and have been used in numerous previously cleared products. Testing was conducted in accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials." This indicates biocompatibility testing was performed per a standard, which itself has implicit acceptance criteria. However, the specific criteria and results are not detailed.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.