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The Coldplay CryoBalloon™ Focal Ablation System, Coldplay CryoBalloon™ Full Ablation System, and Coldplay CryoBalloon™ Swipe Ablation System are 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 high grade dysplasia.

The subject device is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working channel inner diameter (ID) of 3.7 mm and length of 100 cm. The subject device is a system comprised of three components including a Catheter (sterile), Handle (nonsterile), and Cartridge (non-sterile). The subject device is used to ablate unwanted tissue by application of extreme cold to a 360° circumference, 90° circumference, or 45° circumference and is identical to the respective Coldplay CryoBalloon™ Ablation System predicates. 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 Handle. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Handle.

The provided text describes a 510(k) summary for the Coldplay CryoBalloon™ Ablation System, focusing on a modification to its indications for use to include ablation of Barrett's Esophagus with high-grade dysplasia. The information primarily covers the clinical study conducted to support this new indication.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state quantitative acceptance criteria in terms of specific performance metrics with predefined thresholds (e.g., "90% complete response rate"). Instead, the clinical study aimed to demonstrate the device's effectiveness in achieving "complete response" (full conversion of Barrett's epithelium to neosquamous epithelium) and its safety (absence of serious adverse events, manageable pain).

 - 60% for 6-second ablations 
 - 82% for 8-second ablations 
 - 100% for 10-second ablations (P=0.04) 

• Confirmed through biopsy.
• "Effective at demonstrating complete response of high grade dysplasia at follow-up." |
  | Safety: No serious adverse events, manageable adverse events. | - No serious adverse events reported.
• Pain:
  • Immediate post-procedure: 10 patients (27%) reported pain (median score 2.5).
  • 2 days post-procedure: 5 patients (14%) reported pain (median score 4) and pain swallowing (median score 4).
  • 3 patients (8%) used additional pain medication post-procedure.
• No adverse events during follow-up. |

2. Sample size used for the test set and the data provenance

• Sample Size: 37 patients
• Test Set Description: These 37 patients underwent a total of 56 focal ablations. The ablations had different durations: 10 ablations for 6 seconds, 28 for 8 seconds, and 18 for 10 seconds.
• Data Provenance: The study was a prospective, multicenter clinical study. The country of origin is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states, "Conversion was confirmed through biopsy." This implies a pathological assessment was used for ground truth. However, it does not specify the number of experts (e.g., pathologists) involved or their qualifications.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method for establishing ground truth, beyond confirming conversion via biopsy. It doesn't mention multiple readers or a consensus process for the biopsy results.

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 cryoablation system, not an AI-assisted diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone (algorithm only) performance study was not done. This device is a surgical tool, and its effectiveness is inherently tied to its use by medical professionals in a clinical setting.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth used for effectiveness was pathology (biopsy confirmation of full conversion of Barrett's epithelium to neosquamous epithelium). Safety was assessed based on reported adverse events and pain levels, which can be considered a form of clinical outcomes data.

8. The sample size for the training set

The document does not describe any "training set." This study is a clinical efficacy and safety study for a medical device, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

As there was no training set mentioned or implied, this question is not applicable.

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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.

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