(86 days)
The C2 Therapeutics CryoBalloon Focal 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 Focal Ablation System (modified device) is a cryosurgical unit with a nitrous oxide cooled balloon probe intended to focally destroy unwanted tissue by application of extreme cold. The system is a single-patient use device and is intended for use with commercially available endoscopes with a minimum working channel inner diameter (ID) of 3.7 mm. The handle releases the nitrous oxide, which inflates the balloon probe at the end of the catheter. The pre-inflated balloon probe comes in contact with tissue and unwanted tissue is visualized through the balloon wall via the endoscope. Tissue selection is aided through the handle and focal distribution of nitrous oxide ablates the unwanted tissue. Nitrous oxide is fully contained within the balloon probe and exits the patient through the proximal end of the catheter. The system is comprised of the following main components:
- CryoBalloon Focal Ablation Catheter (REF FG-1009). The catheter is supplied sterile.
- CryoBalloon Focal Ablation Handle (REF FG-1007). The handle is supplied non-sterile.
- CryoBalloon Ablation Cartridge (REF FG-1010) contains liquid nitrous oxide. The cartridge is disposable and is supplied non-sterile.
The provided text describes a 510(k) Summary for the CryoBalloon Focal Ablation System, emphasizing its substantial equivalence to a predicate device (CryoBalloon Ablation System cleared under K101825). The document focuses on regulatory approval based on the device's modifications and its intended use, rather than a detailed study demonstrating performance against specific acceptance criteria.
Therefore, many of the requested details about acceptance criteria, test set, training set, and study methodologies are not available in the provided text.
Here is the information that can be extracted or deduced from the text, with an acknowledgment that much of the requested information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through FMEA and non-clinical design verification activities, rather than presenting a performance study against specific, quantified acceptance criteria for features like accuracy, precision, or efficacy.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document states that "non-clinical design verification activities demonstrate that the design outputs of the modified device meet the design input requirements" and relies on Failure Modes and Effects Analysis (FMEA). It does not mention a test set with patient data or a specific sample size.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. As there's no mention of a clinical test set requiring expert adjudication for ground truth, this detail is absent.
4. Adjudication Method for the Test Set
This information is not provided. Without a clinical test set and expert review, an adjudication method is not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This information is not provided. The document does not describe any MRMC studies or comparative effectiveness studies of human readers with vs. without AI assistance. The device described is a cryosurgical tool, not an AI diagnostic system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable/not provided. The device is a cryosurgical tool, not an algorithm, so "standalone performance" in the context of AI is not relevant here. The "CryoBalloon Focal Ablation System" itself is the standalone device performance being verified. The document states that "Non-clinical design verification activities demonstrate that the design outputs of the modified device meet the design input requirements." This broadly implies standalone performance verification through engineering tests, but specifics are missing.
7. The Type of Ground Truth Used
For the "non-clinical design verification activities," the "ground truth" would likely be engineering specifications, design input requirements, and performance standards for the device's components and overall function (e.g., proper inflation, cooling effectiveness, nitrous oxide containment, compatibility with endoscopes). It is not based on expert consensus, pathology, or outcomes data in the traditional sense of a clinical study.
8. The Sample Size for the Training Set
This information is not provided. The device is a physical cryosurgical tool, not an AI model, so the concept of a "training set" in this context is not applicable.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reason as above; there is no training set for an AI model.
§ 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.