(159 days)
The C2 CryoBalloon™ Ablation System is intended to be used as a cryosurgical tool in the field of general surgery. specifically for endoscopic applications, to include ablation of Barrett's Esophagus with dysplasia and treatment and management of Gastric Antral Vascular Ectasia (GAVE).
The subject device is a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working chamel inner diameter of 3.7 mm and maximum length of 105 cm. The subject device is a cryosurgical system comprised of four components including a Catheter (sterile, single use), Controller (non-sterile, reusable), Foot Pedal (non-sterile, reusable), and Cartridge (non-sterile, single use). The system also includes NitroClip as an accessory that is intended to reduce the nitrous oxide exposure in the room.
The subject device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter comes in contact with tissue and is inflated with nitrous oxide. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected by adjusting the endoscope and Controller. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.
The provided document is a 510(k) Premarket Notification from the FDA for the C2 CryoBalloon Ablation System. It outlines the device's indications for use, technological characteristics, and performance data. However, it does not contain specific acceptance criteria with quantifiable metrics, nor does it detail a study explicitly designed to prove the device meets pre-defined acceptance criteria for an AI/CADe device.
The document describes clinical testing to support the device's safety and effectiveness for new indications (GAVE) and a new treatment dose for Barrett's Esophagus. This is different from the type of study typically performed to validate an AI/CADe system against specific performance metrics for diagnostic accuracy.
Therefore, I cannot fulfill all parts of your request as the provided text does not describe an AI/CADe system or a study proving its acceptance criteria in the manner you've requested. The device described, the C2 CryoBalloon Ablation System, is a cryosurgical tool and not an AI or CADe system.
However, I can extract and structure the information available regarding the performance studies that were conducted for this surgical device.
Based on the provided document, here's an analysis of the performance data for the C2 CryoBalloon Ablation System, interpreted in the context of what was evaluated, rather than specific AI/CADe acceptance criteria:
The performance data presented in the document pertains to the surgical effectiveness and safety of the C2 CryoBalloon Ablation System for its stated indications, not the diagnostic performance of an AI system.
Summary of Device Performance and Related Studies:
The document describes:
- Bench Testing: To verify temperature profiling, spray radius, and spray uniformity of the 180 Standard catheter at different speeds (1.0 mm/s and 1.2 mm/s).
- Clinical Testing:
- Gastric Antral Vascular Ectasia (GAVE): A multi-center retrospective study.
- 180° Catheter Treatment Dose (Barrett's Esophagus): Two studies, one dose-finding (1.0mm/s) and one multi-center (1.2mm/s).
As there are no specific "acceptance criteria" provided in a table format for an AI/CADe device, nor a study proving meeting those, I will present the key outcomes and performance metrics reported for the clinical studies.
Simulated Table of "Acceptance Criteria" and Reported Device Performance (based on clinical outcomes, not AI/CADe metrics):
| Performance Metric (Analogous to Acceptance Criteria) | Reported Device Performance (for CryoBalloon Ablation System) |
|---|---|
| I. GAVE Treatment | |
| Technical success rate | 100% |
| Device malfunctions | 0 |
| Serious adverse events (SAEs) | 0 |
| Efficacy at 6 months (transfusion independence) | 71% |
| Endoscopic success at 6 months (GAVE eradication) | 88% |
| Mean CryoBalloon ablation treatments | 2.4 |
| Blood hemoglobin increase (CryoBalloon vs APC/RFA) | 4.6 g/dl (vs 2.55 g/dl with APC/RFA) |
| Monthly PRBC transfusions decrease (CryoBalloon vs APC/RFA) | 0.77 units (vs 1.45 units with APC/RFA) |
| II. Barrett's Esophagus Treatment (1.0mm/s dose) | |
| Median BE regression (8-10 weeks, single treatment) | 90% (95% CI 70%-90%) |
| Technical success (per protocol) | 96% |
| Stricture requiring dilation | 1/23 (4%), resolved with two dilations |
| Severe bleeding, perforation, other SAEs | 0 |
| Adverse events (total) | 5 (3 moderate strictures not requiring dilation, 1 dark stools, 1 chest pain) |
| III. Barrett's Esophagus Treatment (1.2mm/s dose) | |
| Average BE surface regression (3-month follow-up) | 95% |
| Serious adverse events (SAEs) | 1 (post-procedure bleeding due to double-dosed anticoagulation, resolved) |
| Strictures requiring dilation | 0 |
| Mild adverse events | 2 (no treatments required) |
| IV. Bench Testing (for 180 Standard catheter) | |
| Temperature profiling data verification | Passed all acceptance criteria |
| Spray radius and uniformity verification | Confirmed for 1.0 and 1.2 mm/s speeds |
| Temperature distribution consistency & accuracy | Demonstrated consistently and accurately |
Breakdown of Information as per Request (adapted to the available data for a surgical device):
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A table of acceptance criteria and the reported device performance:
- See the simulated table above. The "acceptance criteria" are inferred from the outcomes measured and deemed acceptable by the manufacturer and FDA for substantial equivalence. These are not AI/CADe specific accuracy metrics.
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Sample sizes used for the test set and the data provenance:
- GAVE Study:
- Sample Size: 28 subjects (retrospective study).
- Data Provenance: Not explicitly stated, but compared to a published study of 33 GAVE patients from "three tertiary referral centers in the United States." This suggests the retrospective data for the C2 CryoBalloon system were likely from similar clinical settings, though the specific country of origin is not given. It was a retrospective study.
- BE Study (1.0mm/s dose):
- Sample Size: 25 patients.
- Data Provenance: Not explicitly stated regarding country, but described as a "dose-finding phase."
- BE Study (1.2mm/s dose):
- Sample Size: 25 patients.
- Data Provenance: Described as a "multicenter study." Not explicitly stated regarding country.
- GAVE Study:
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this surgical device. The "ground truth" for GAVE or BE treatment success/eradication would be based on endoscopic findings, histological analysis, and clinical outcomes (e.g., hemoglobin levels, transfusion independence) as determined by treating physicians, not expert readers establishing a consensus for image interpretation. No specific number of experts or their qualifications for "ground truth establishment" are mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not an image-based diagnostic AI/CADe study requiring adjudication of interpretations. Clinical outcomes were measured directly.
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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 study was done, as this is not an AI/CADe device. The comparisons are between the C2 CryoBalloon system and "other modalities" (e.g., APC, RFA) for GAVE treatment, or different doses/catheters for BE treatment.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable; this is a human-operated surgical device, not a standalone algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for these clinical studies relied on:
- Clinical Outcomes Data: Mean number of packed red blood cells (PRBC) transfused, transfusion independence, blood hemoglobin levels for GAVE.
- Endoscopic Findings: GAVE eradication, BE surface regression.
- Adverse Events: Occurrence and severity of complications like strictures, bleeding.
- These are direct clinical and procedural outcomes, not interpretations of diagnostic images.
- The "ground truth" for these clinical studies relied on:
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The sample size for the training set:
- Not applicable. This is a medical device, not a machine learning model that undergoes "training." The described studies are clinical evaluation studies, akin to validation/test sets for demonstrating safety and efficacy.
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How the ground truth for the training set was established:
- Not applicable, as no machine learning training set is involved.
Conclusion based on the provided document:
The provided document refers to the FDA's 510(k) clearance for the C2 CryoBalloon Ablation System, a surgical device. The performance data presented focuses on the safety and effectiveness of the surgical intervention for specific indications (Barrett's Esophagus with dysplasia and Gastric Antral Vascular Ectasia). It outlines clinical study results (retrospective and multi-center studies) and bench testing results. The information requested regarding AI/CADe acceptance criteria, MRMC studies, AI training/test sets, and expert consensus/adjudication for diagnostic ground truth is not applicable to this type of device and the studies described.
§ 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.