(391 days)
The C2 CryoBalloon™ Ablation System is intended for use as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia.
The C2 CryoBalloon Ablation System is a cryosurgical device, which consists of four (4) components: (i) a single-use, sterile balloon Catheter that is inserted through the working channel of an endoscope with a minimum inner diameter (ID) of 3.7 mm and a maximum working length of 100 cm; (ii) a hand-held reusable Controller with a liquid crystal display (LCD) touch screen interface; (iii) a reusable Foot Pedal that is plugged into mains, provides power for the Controller, and allows the user to operate system functions such as ablation targeting, nitrous oxide flow control, and balloon deflation; and (iv) single-use Nitrous Oxide Cartridge that provides users with cryogen for each treatment.
The C2 CryoBalloon Ablation System uses nitrous oxide as a cryogen to cause necrosis of targeted tissue in a controlled manner. The low operating pressure inflates the compliant balloon against the lumen ID. Nitrous oxide is directed at the targeted tissue and it evaporates on the inner surface of the balloon and freezes the tissue. The nitrous oxide is fully contained within the balloon and the resultant gas exhausts through the Catheter shaft and vents through the Controller.
There are four (4) Catheter configurations that distribute nitrous oxide focally (focal diffuser), over a quarter of the lumen circumference (90° diffuser), over half of the lumen circumference (180° diffuser), or over the full circumference of the lumen (360° diffuser). The user selects the Catheter with the desired diffuser type, removes it from the sterile packaging and inserts it through the working channel of an endoscope until the balloon portion exits the distal end of the endoscope.
The connector portion of the Catheter is inserted into the Controller and the radiofrequency identification (RFID) communication system in the Catheter connector and the Controller allows the Controller to perform functions specific to the Catheter. The LCD touch screen allows the user to set desired dosimetry, and communicates system status to the user.
The user tightens the Controller Cap against the Controller, which pierces the nitrous oxide Cartridge. Nitrous oxide is contained in the Controller until the user steps on the Foot Pedal to allow the Controller to release it into the Catheter. The user visualizes the targeting and ablation via the inflated balloon and the images provided by the endoscope. The balloon is held in contact with the treatment area during the ablation. Upon conclusion of the procedure the balloon is deflated and withdrawn into the endoscope.
The provided text describes the C2 CryoBalloon Ablation System and its performance data submitted to the FDA for 510(k) clearance. However, the document does not contain information about an AI-powered device or a study involving human readers with and without AI assistance. It focuses on the physical, electrical, software, and biological safety and efficacy of the cryoablation system itself.
Therefore, I cannot extract the information required to answer your prompt, as it is predicated on the device being an AI-powered system and the study being an MRMC comparative effectiveness study with human readers.
The document describes the device, its intended use, comparison to predicate devices, and the results of various non-clinical (bench) tests to demonstrate safety and effectiveness.
Here's what can be inferred from the provided text regarding device acceptance criteria and performance, as it relates to the physical cryoablation system, not an AI:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide a specific table of quantitative acceptance criteria with corresponding performance metrics in a pass/fail format within the "Performance Data" section. Instead, for each "Testing Type," it lists "Objectives" which can be interpreted as the acceptance criteria, and then "Results," which state whether the objectives were met.
For example, for "Bench Testing":
| Testing Type | Objectives (Acceptance Criteria - Implicit) | Reported Device Performance |
|---|---|---|
| Bench Testing | - Verify temperature uniformity and depth of penetration during cryogen application. |
- Verify system hold pressure is maintained with no leakage.
- Verify controller reliability after 1-year of reuse.
- Verify balloon and Catheter dimensions.
- Verify Catheter able to pass through 3.7mm or larger accessory channel.
- Verify rated burst pressure of balloon is sufficiently greater than nominal operating pressure.
- Tensile test all of the Catheter bonds.
- Verify balloon reliability after repeated inflations. | The subject C2 CryoBalloon Ablation System passed all functional testing and met all product specification requirements. (This implies all objectives were met). |
| Software | Perform testing to verify conformance to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Guidance for Industry and FDA Staff, May 11, 2005. | The subject C2 CryoBalloon Ablation System met all software test requirements for software with a Major Level of Concern. |
| Electrical Safety | Perform testing to verify conformance to ES 60601-1:2005/(R)2012 And A1:2012, IEC 60601-1-2:2007, IEC 60601-1-6 Edition 3.1 2013 10. | The subject C2 CryoBalloon Ablation System met the electrical safety, electromagnetic compatibility, and coexistence test requirements and is fully compliant with all of the listed standards. |
| Controller Reprocessing | Perform testing to verify conformance to Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and FDA Staff, March 17, 2015.
Perform microbial ingress testing to confirm contaminated (interior and exterior) Controller does not cross-contaminate the Catheter. | The subject C2 CryoBalloon Controller's intermediate level cleaning and disinfection processes have been validated per FDA guidance.
The microbial ingress testing demonstrated that a contaminated Controller does not cross-contaminate the Catheter. |
| Biocompatibility | Perform testing to verify conformance to ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010. | The subject C2 CryoBalloon Ablation System met the cytotoxicity, irritation, and sensitization requirements. The subject device materials are the same as the predicate devices. |
| Catheter Sterilization | Perform testing to verify conformance to ISO 11135:2014. | The subject C2 CryoBalloon Catheter met the sterilization and residuals requirements. |
| Packaging/Shelf Life | Perform testing to verify conformance to ISO 11607-1:2006 (Catheter only), ASTM D4332-14, ASTM D4169-14, ASTM F2096-11 (Catheter only), ASTM F88-15 (Catheter only), ASTM F1929-15 (Catheter only). | The subject C2 CryoBalloon Ablation System met the packaging test requirements. |
| Usability | Perform testing to verify conformance to Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and FDA Staff, February 3, 2016. | The subject C2 CryoBalloon Ablation System was found to be safe and effective for the intended user, uses, and use environment. Residual risks do not require device modification. |
For the remaining points, based on the provided text, the answer is that the information is not present or not applicable as the document describes a physical medical device, not an AI system.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided: The document describes "nonclinical testing" and "bench testing." Sample sizes for these types of tests (e.g., number of catheters tested for burst pressure, number of cycles for controller reliability) are not specified. Data provenance like country of origin or retrospective/prospective is not relevant for these bench tests.
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 / Not provided: This concept of "ground truth" established by experts is typically relevant for studies validating diagnostic or AI interpretation devices against a clinical standard. The tests described are engineering and performance characteristic tests of a cryosurgical tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided: Adjudication methods are relevant for subjective interpretations, often in clinical studies or AI validation. This document details objective bench testing.
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: An MRMC comparative effectiveness study was not done. The device is a cryosurgical ablation system, not an AI-assisted diagnostic or interpretative tool. Therefore, there's no comparison of human readers with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided: The device is a physical cryosurgical system; it does not involve algorithms for standalone performance in the context of interpretation or diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided: For the bench tests described, the "ground truth" is defined by engineering specifications, validated test methods for mechanical integrity, electrical safety, software functionality, biocompatibility, sterilization, and reprocessing. It's not a clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
- Not applicable / Not provided: This device is not an AI/machine learning system, so there is no concept of a "training set" in the context of algorithms learning from data.
9. How the ground truth for the training set was established
- Not applicable / Not provided: As above, there is no training set for this type of device.
§ 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.