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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 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:

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.

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SWIp is a software option intended for use on Achieva and Ingenia 1.5T & 3.0T MR Systems. It's indicated for magnetic resonance imaging of the Brain. SWIp is a technique using phase information to enhance contrast between tissues presenting susceptibility differences, such as deoxygenated blood or some mineral deposits (e.g. calcium deposits). Due to this contrast enhancement, SWIp images are sensitive for structures containing venous blood such as cerebral venous vasculature. When used in combination with other clinical information, SWIp may help the expert radiologist in the diagnosis of various neurological pathologies.

SWIp (Susceptibility Weighted Imaging with Phase enhancement) exploits the susceptibility differences between tissues. It is based on a 3D FFE acquisition, multiecho compatible, generating high resolution magnitude and phase images.

Phase images are unwrapped to create Susceptibility Weighted Phase (SW-P) images highlighting phase changes due to local susceptibility differences. The magnitude images and SW-P information are combined to generate Susceptibility Weighted Magnitude (SW-M) images with enhanced susceptibility contrast. SW-M images show de-oxygenated blood, such as veins, as hypo-intense signals.

The feature requires:

• Specific parameter settings for the 3D FFE sequence, within cleared parameter limits, to acquire the MR signals
• A new calculation function to generate SW-M and SW-P images. This function uses a set of MR images as input that is generated in a cleared manner from the acquired MR signals.
• The new images need to be stored and displayed with the appropriate labels (SW-M and SW-P), applying the facilities provided by the cleared platform.

Here's an analysis of the provided text regarding the acceptance criteria and study for the SWIp device, formatted to answer your specific questions.

Important Note: The provided document is a 510(k) Summary, which is a premarket notification to the FDA. It often summarizes validation and verification activities rather than providing detailed clinical study protocols and results. As such, some of the information you've requested regarding specific clinical trial methodologies (like MRMC study effect size, concrete acceptance criteria tables with performance metrics) is not explicitly present in this type of document. The summary focuses on demonstrating substantial equivalence to predicate devices based on non-clinical and clinical tests confirming safety and intended use.

Based on the available information:

Acceptance Criteria and Device Performance

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

   The document does not present a formal table of quantitative acceptance criteria and corresponding reported device performance metrics in the way one might see in a detailed clinical trial report for an AI/CAD product. Instead, it refers to successful completion of non-clinical and clinical tests, with conclusions drawn about the device's acceptable performance for its intended use.

   Implicit Acceptance Criteria and Reported Performance:

   Criteria Category	Implicit Acceptance Criteria	Reported Device Performance
   Non-Clinical Performance	Device functions as designed without crashes, hang-ups, or workflow issues.	"All the tests performed for SWIp were successful. While using SWIp, the system didn't crash or hang-up. Workflow was smooth and no problems occurred." (DHF176222 Verification Test Report)
   Clinical Performance	Device meets all clinical user needs on specified MR systems (Achieva and Ingenia 1.5T and 3.0T systems) and helps expert radiologists in diagnosis. SWIp images sensitive for structures containing venous blood, enhancing contrast for susceptibility differences.	"The clinical validation of SWIp has completed successfully. All clinical user needs are passed for Achieva and Ingenia. 1.5T and 3T systems." (DHF176223 Validation Test Report). "SWIp images are sensitive for structures containing venous blood such as cerebral venous vasculature."
   Safety & Effectiveness	Device is safe, effective, and performs as well as or better than legally marketed predicate devices; does not introduce new indications or hazards.	"The nonclinical and clinical tests have demonstrated that the device is safe and works according to its intended use." "The SWIp software does not introduce new indications for use, nor does the use of the device result in any new potential hazard."
   Parameter Compliance	Specific parameter settings for 3D FFE sequence are within cleared parameter limits.	"Specific parameter settings for the 3D FFE acquisition, multiecho compatible, generating high resolution magnitude and phase images... within cleared parameter limits, to acquire the MR signals."
   Image Generation/Display	New calculation function generates SW-M and SW-P images accurately; images are stored and displayed with appropriate labels.	"A new calculation function to generate SW-M and SW-P images... The new images need to be stored and displayed with the appropriate labels (SW-M and SW-P), applying the facilities provided by the cleared platform."

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   The document does not explicitly state the sample size (number of patients/scans) used for the clinical validation test set (DHF176223 Validation Test Report). It also does not specify the country of origin of the data or whether the data was retrospective or prospective. It generally refers to "clinical user needs are tested as part of the validation."

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)

   The document does not specify the number or qualifications of experts used to establish ground truth for the clinical validation. It mentions that SWIp "may help the expert radiologist in the diagnosis of various neurological pathologies," implying radiologists are the target users, but provides no details on how their expertise was leveraged for ground truth in the study.

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 for the test set.

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 MRMC comparative effectiveness study is described in this 510(k) summary. The device, SWIp, is a new image acquisition and processing technique (Susceptibility Weighted Imaging with Phase enhancement) that generates new image types (SW-M and SW-P images), not an AI/CAD system assisting human readers directly. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply in the context of this specific device's described function.

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

   SWIp is described as a "new calculation function to generate SW-M and SW-P images" based on acquired MR signals, which are then "stored and displayed." This function is inherent to the MR system's reconstruction capabilities. The validation focuses on the successful generation and utility of these images for clinical interpretation. In essence, the "algorithm only" performance is evaluated by whether the resulting images are correct, interpretable, and serve their intended purpose for the expert radiologist. The document confirms the "new calculation function" generates the new output images and that these images "are sensitive for structures containing venous blood."

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

   The specific type of ground truth used is not detailed. The language "may help the expert radiologist in the diagnosis of various neurological pathologies" suggests that ground truth would ultimately be related to established clinical diagnoses, likely confirmed by expert radiologist interpretation (possibly consensus, but not explicitly stated) and potentially in conjunction with other clinical information, as SWIp "is used in combination with other clinical information." Pathology or outcomes data are not mentioned as direct ground truth sources for the image validation itself.

8. The sample size for the training set

   The document does not mention a training set, as SWIp appears to be a deterministic image reconstruction algorithm rather than a machine learning model that requires a distinct training phase.

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

   Not applicable, as a training set for machine learning is not mentioned for this device.

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