(90 days)
The C2 Therapeutics CryoBalloon Ablation System is intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.
The CryoBalloon Ablation System ("System") is used to destroy unwanted tissue by application of extreme cold. Upon activation by a physician, the balloon probe at the end of the catheter is simultaneously inflated and cooled with nitrous oxide. The balloon probe comes in contact with the wall of the esophagus and ablates unwanted tissue. Nitrous oxide is fully contained within the balloon probe and does not contact the esophagus. The nitrous oxide gas exits the patient through the proximal end of the catheter. The CryoBalloon Ablation System is designed for one time, continuous application use (single patient) in conjunction with a therapeutic endoscope (3.7mm accessory channel ID). The System is comprised of the following main components:
- CryoBalloon Ablation Catheter (REF FG-1000) consists of a connector, catheter . shaft, balloon probe, and protective sheath. This is supplied sterile.
- CryoBalloon Ablation Handle (REF FG-1001) contains the cartridge heater and . refrigerant delivery valve which is controlled via the trigger. The unit is internally powered (9VDC non-replaceable lithium battery pack) and supplied non-sterile.
- CryoBalloon Ablation Cartridge (REF FG-1002) contains liquid nitrous oxide. The . Cartridge is supplied non-sterile and contains enough refrigerant for one to two ablation sites.
The provided document is a 510(k) summary for the C2 Therapeutics CryoBalloon Ablation System. It details the device's description, indications for use, and a comparison to predicate devices to establish substantial equivalence. However, it does not contain acceptance criteria in the traditional sense of specific performance metrics with PASS/FAIL thresholds.
Instead of acceptance criteria, the document states that "Biocompatibility, performance and animal test results demonstrated the safety and effectiveness of the CryoBalloon Ablation System." This general statement indicates that various tests were conducted to support the device's safety and effectiveness, which are the overall goals of such studies rather than specific numerical acceptance criteria.
Therefore, many of your requested items cannot be extracted directly from this document due to the nature of a 510(k) summary, which often summarizes testing without providing explicit raw data or detailed methodologies.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred/General Goals) | Reported Device Performance |
|---|---|
| Safety | Demonstrated by biocompatibility, performance, and animal test results. |
| Effectiveness | Demonstrated by biocompatibility, performance, and animal test results. |
| Substantial Equivalence to Predicates | Achieved, based on similar indications for use, device operation, and technical/functional capabilities. |
Rationale: The document states: "Biocompatibility, performance and animal test results demonstrated the safety and effectiveness of the CryoBalloon Ablation System." This implies these were the overarching "acceptance criteria" met by the studies, but no specific numerical targets (e.g., "temperature must reach X within Y seconds") are provided. The primary goal of the 510(k) in this context is to show substantial equivalence, which was "found."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document mentions "biocompatibility, performance and animal test results," implying multiple tests, but the number of animals or test samples is not given.
- Data Provenance: Not specified. It doesn't mention the country of origin or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of information is typically relevant for studies involving human assessment, like image interpretation or clinical outcomes judged by specialists. The document refers to "biocompatibility, performance and animal test results," which are usually evaluated against engineering specifications, biological standards, or observed physiological responses, not typically "ground truth" established by human experts in the same way an AI diagnostic device would.
4. Adjudication method for the test set:
- Not Applicable. Similar to point 3, adjudication methods like N+1 consensus are used when multiple human evaluators assess subjective or semi-subjective data (e.g., image findings). This is not described for the "biocompatibility, performance and animal test results."
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study is not mentioned. This type of study is specifically designed for evaluating diagnostic devices, especially those involving AI for human readers. The CryoBalloon Ablation System is a surgical tool, not an AI diagnostic device, so an MRMC study is not relevant to its type of evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. The device described is a physical surgical tool (CryoBalloon Ablation System) that is operated by a physician ("Upon activation by a physician"). It does not involve an "algorithm" in the sense of a standalone AI software. Therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used:
- For biocompatibility: Ground truth would typically be established by standardized cytotoxicity, sensitization, irritation, and systemic toxicity tests, often comparing results against established biological safety limits.
- For performance: Ground truth would be based on engineering specifications (e.g., temperature achieved, inflation pressure, cryogen flow rate, ablation zone size).
- For animal test results: Ground truth would be based on histological examination of tissue, observation of physiological responses, and measurement of ablation effects and potential damage to surrounding tissue, usually compared against desired therapeutic outcomes and safety margins.
8. The sample size for the training set:
- Not Applicable. The CryoBalloon Ablation System is a physical medical device, not an AI/machine learning model. Therefore, it does not have a "training set" in the context of AI development.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no AI training set, this question is not relevant.
§ 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.