(78 days)
The Coldplay 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 modified device is a cryosurgical unit with a nitrous oxide cooled balloon probe that is intended for use with commercially available endoscopes with a minimum working channel inner diameter (ID) of 3.7 mm. It is comprised of three components including a Catheter (sterile), Handle (non-sterile), and Cartridge (non-sterile).
The modified device is used to destroy unwanted tissue by application of extreme cold to either a 360° circumference or a 90° circumference. The balloon probe at the end of the catheter is inflated with nitrous oxide gas and comes in contact with tissue. Tissue is visualized through the pre-inflated balloon, and the treatment site is selected is by manipulation of the endoscope and Handle. The liquid nitrous oxide spray ablates the unwanted tissue. Nitrous oxide is fully contained within the balloon probe and does not directly contact the tissue. The nitrous oxide gas exits the patient through the Catheter lumen and exhausts out the Handle.
The provided document is a 510(k) Summary for the Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System. It describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence.
However, the document does not contain specific acceptance criteria or detailed results from a study that proves the device meets those criteria, as one would find in a clinical trial report or a comprehensive validation study. Instead, it provides a general statement about performance data being provided for substantial equivalence determination.
Therefore, many of the requested items cannot be extracted from this document directly. I will provide what is available and note what is not.
Acceptance Criteria and Study for Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System
The provided 510(k) Summary for the Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System states that "Performance data were provided in support of the substantial equivalence determination including. Design verification and validation testing were performed on the Coldplay CryoBalloon Ablation System to evaluate physical, simulated use, reliability, safety, biocompatibility, sterilization, and shelf life specifications. Software verification and validation were performed."
However, this document does not explicitly define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or detailed results from studies that quantify the device's performance against such criteria. The document's purpose is to establish substantial equivalence to a predicate device (K131523, Cryoballoon Focal Ablation System) based on similar technological characteristics and expected performance, rather than to present a de novo efficacy study with defined acceptance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
As specific, quantifiable acceptance criteria and performance metrics are not detailed in this 510(k) summary, a table cannot be accurately constructed. The document generally states that the device was evaluated for:
| Acceptance Criteria Category | Reported Device Performance (as stated) |
|---|---|
| Physical | Performed as intended |
| Simulated Use | Performed as intended |
| Reliability | Performed as intended |
| Safety | Performed as intended |
| Biocompatibility | Performed as intended |
| Sterilization | Performed as intended |
| Shelf Life | Performed as intended |
| Software Verification | Performed |
| Software Validation | Performed |
Note: The wording "Performed as intended" indicates successful completion of tests, but does not provide specific numerical outcomes or established thresholds.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "Design verification and validation testing" but does not specify the sample sizes (e.g., number of devices, number of simulated use cases) or the provenance of the data (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The device is a surgical tool, not an diagnostic imaging algorithm, so "ground truth" in the context of expert review for diagnostic accuracy is not directly applicable here. The validation likely involved engineering and medical professionals for design verification and simulated use, but details are absent.
4. Adjudication Method for the Test Set
This information is not provided in the document, as it focuses on demonstrating substantial equivalence through design and technological comparisons, not on a human-in-the-loop diagnostic study requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided in the document. An MRMC study is typically performed for diagnostic or AI-assisted imaging devices to assess the impact of the AI on human reader performance. This device is a cryosurgical ablation system, not a diagnostic imaging tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not explicitly detailed in the document in terms of defined standalone performance metrics. The mention of "Software verification and validation were performed" implies testing of the algorithm/software component without human intervention, but specific performance results or metrics are not presented. Given it's a therapeutic device, "standalone performance" would likely refer to its ability to reliably deliver cryoablation under various conditions, which falls under the "Design verification and validation testing" mentioned.
7. Type of Ground Truth Used
The concept of "ground truth" as typically used for diagnostic algorithms (e.g., pathology, expert consensus) is not directly applicable or stated for this therapeutic device. For a surgical device, ground truth would relate to the successful and safe operation of the system as intended, which would be evaluated through physical, simulated use, and potentially in vivo (animal or human, though not detailed in this 510(k) summary as a new clinical study). The substantial equivalence is based on the predicate device's established safety and effectiveness.
8. Sample Size for the Training Set
This information is not provided in the document. "Training set" typically refers to data used to train an AI algorithm. While software is involved, this document does not describe the development of an AI algorithm in that capacity, nor does it specify any data sets for algorithm training.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of AI algorithm development, this information is not provided in the document.
§ 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.