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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):

Breakdown of Information as per Request (adapted to the available data for a surgical device):

1. 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.

2. 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.

3. 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.

4. 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.

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 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.

6. 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.

7. 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.

8. 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.

9. 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.

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The C2 CryoBalloon Ablation System is 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 dysplasia.

The subject device is a cryosurgical unit with a nitrous oxide cooled balloon that is compatible with commercially available endoscopes with a minimum working channel 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 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 is 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.

This document describes a 510(k) summary for the PENTAX Medical C2 CryoBalloon Ablation System. The submission focuses on modifications to the controller's hardware and software. Here's a breakdown of the information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document states "Design verification and validation testing was performed" (P. 5, VI) and "The modified controller of the C2 CryoBalloon Ablation System was subjected to the Software Verification and Validation testing" (P. 5, VIII). However, specific sample sizes for the test set or the data provenance (e.g., country of origin, retrospective/prospective) are not provided in this 510(k) summary. The testing appears to be internal validation of hardware and software changes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not explicitly provided. The testing described focuses on engineering validation (physical, reliability, safety, EMC, ES, software verification) rather than clinical validation that would typically involve expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. As noted above, the testing appears to be technical verification and validation, not a study involving human interpretation of clinical outputs that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was done or mentioned. This submission concerns a cryosurgical ablation system, not an AI-assisted diagnostic or interpretive device. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a CryoBalloon Ablation System, meaning it is a medical device that performs a physical action (ablation). It is not an algorithm-only device. Performance evaluation for such devices involves assessing the device's technical specifications and intended function, not standalone algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed appears to be:

• For physical, reliability, and safety: Engineering specifications and performance standards.
• For EMC and electrical safety: Compliance with recognized international standards (IEC 60601-1-2:2014 and ANSI/AAMI/IEC/EN 60601-1-2:2014).
• For software verification and validation: Software requirements and design specifications.

This is not clinical ground truth (e.g., pathology, outcomes data, expert consensus on images).

8. The Sample Size for the Training Set

No training set is mentioned as this is not an AI/machine learning device that requires a training set. The document describes changes to hardware and software of a cryosurgical system.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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The C2 CryoBalloon™ Ablation System is 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 dysplasia.

The C2 CryoBalloon Ablation System is a cryosurgical device, which consists of four (4) components: (i) a single-use, sterile balloon Catheter that is inserted through the working channel of an endoscope with a minimum inner diameter (ID) of 3.7 mm and a maximum working length of 100 cm; (ii) a hand-held reusable Controller with a liquid crystal display (LCD) touch screen interface; (iii) a reusable Foot Pedal that is plugged into mains, provides power for the Controller, and allows the user to operate system functions such as ablation targeting, nitrous oxide flow control, and balloon deflation; and (iv) single-use Nitrous Oxide Cartridge that provides users with cryogen for each treatment.

The C2 CryoBalloon Ablation System uses nitrous oxide as a cryogen to cause necrosis of targeted tissue in a controlled manner. The low operating pressure inflates the compliant balloon against the lumen ID. Nitrous oxide is directed at the targeted tissue and it evaporates on the inner surface of the balloon and freezes the tissue. The nitrous oxide is fully contained within the balloon and the resultant gas exhausts through the Catheter shaft and vents through the Controller.

There are four (4) Catheter configurations that distribute nitrous oxide focally (focal diffuser), over a quarter of the lumen circumference (90° diffuser), over half of the lumen circumference (180° diffuser), or over the full circumference of the lumen (360° diffuser). The user selects the Catheter with the desired diffuser type, removes it from the sterile packaging and inserts it through the working channel of an endoscope until the balloon portion exits the distal end of the endoscope.

The connector portion of the Catheter is inserted into the Controller and the radiofrequency identification (RFID) communication system in the Catheter connector and the Controller allows the Controller to perform functions specific to the Catheter. The LCD touch screen allows the user to set desired dosimetry, and communicates system status to the user.

The user tightens the Controller Cap against the Controller, which pierces the nitrous oxide Cartridge. Nitrous oxide is contained in the Controller until the user steps on the Foot Pedal to allow the Controller to release it into the Catheter. The user visualizes the targeting and ablation via the inflated balloon and the images provided by the endoscope. The balloon is held in contact with the treatment area during the ablation. Upon conclusion of the procedure the balloon is deflated and withdrawn into the endoscope.

The provided text describes the C2 CryoBalloon Ablation System and its performance data submitted to the FDA for 510(k) clearance. However, the document does not contain information about an AI-powered device or a study involving human readers with and without AI assistance. It focuses on the physical, electrical, software, and biological safety and efficacy of the cryoablation system itself.

Therefore, I cannot extract the information required to answer your prompt, as it is predicated on the device being an AI-powered system and the study being an MRMC comparative effectiveness study with human readers.

The document describes the device, its intended use, comparison to predicate devices, and the results of various non-clinical (bench) tests to demonstrate safety and effectiveness.

Here's what can be inferred from the provided text regarding device acceptance criteria and performance, as it relates to the physical cryoablation system, not an AI:

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

The document doesn't provide a specific table of quantitative acceptance criteria with corresponding performance metrics in a pass/fail format within the "Performance Data" section. Instead, for each "Testing Type," it lists "Objectives" which can be interpreted as the acceptance criteria, and then "Results," which state whether the objectives were met.

For example, for "Bench Testing":

• Verify system hold pressure is maintained with no leakage.
• Verify controller reliability after 1-year of reuse.
• Verify balloon and Catheter dimensions.
• Verify Catheter able to pass through 3.7mm or larger accessory channel.
• Verify rated burst pressure of balloon is sufficiently greater than nominal operating pressure.
• Tensile test all of the Catheter bonds.
• Verify balloon reliability after repeated inflations. | The subject C2 CryoBalloon Ablation System passed all functional testing and met all product specification requirements. (This implies all objectives were met). |
  | Software | Perform testing to verify conformance to Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Guidance for Industry and FDA Staff, May 11, 2005. | The subject C2 CryoBalloon Ablation System met all software test requirements for software with a Major Level of Concern. |
  | Electrical Safety | Perform testing to verify conformance to ES 60601-1:2005/(R)2012 And A1:2012, IEC 60601-1-2:2007, IEC 60601-1-6 Edition 3.1 2013 10. | The subject C2 CryoBalloon Ablation System met the electrical safety, electromagnetic compatibility, and coexistence test requirements and is fully compliant with all of the listed standards. |
  | Controller Reprocessing | Perform testing to verify conformance to Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and FDA Staff, March 17, 2015.
  Perform microbial ingress testing to confirm contaminated (interior and exterior) Controller does not cross-contaminate the Catheter. | The subject C2 CryoBalloon Controller's intermediate level cleaning and disinfection processes have been validated per FDA guidance.
  The microbial ingress testing demonstrated that a contaminated Controller does not cross-contaminate the Catheter. |
  | Biocompatibility | Perform testing to verify conformance to ISO 10993-1, ISO 10993-5:2009, ISO 10993-10:2010. | The subject C2 CryoBalloon Ablation System met the cytotoxicity, irritation, and sensitization requirements. The subject device materials are the same as the predicate devices. |
  | Catheter Sterilization | Perform testing to verify conformance to ISO 11135:2014. | The subject C2 CryoBalloon Catheter met the sterilization and residuals requirements. |
  | Packaging/Shelf Life | Perform testing to verify conformance to ISO 11607-1:2006 (Catheter only), ASTM D4332-14, ASTM D4169-14, ASTM F2096-11 (Catheter only), ASTM F88-15 (Catheter only), ASTM F1929-15 (Catheter only). | The subject C2 CryoBalloon Ablation System met the packaging test requirements. |
  | Usability | Perform testing to verify conformance to Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and FDA Staff, February 3, 2016. | The subject C2 CryoBalloon Ablation System was found to be safe and effective for the intended user, uses, and use environment. Residual risks do not require device modification. |

For the remaining points, based on the provided text, the answer is that the information is not present or not applicable as the document describes a physical medical device, not an AI system.

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

• Not applicable / Not provided: The document describes "nonclinical testing" and "bench testing." Sample sizes for these types of tests (e.g., number of catheters tested for burst pressure, number of cycles for controller reliability) are not specified. Data provenance like country of origin or retrospective/prospective is not relevant for these bench tests.

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)

• Not applicable / Not provided: This concept of "ground truth" established by experts is typically relevant for studies validating diagnostic or AI interpretation devices against a clinical standard. The tests described are engineering and performance characteristic tests of a cryosurgical tool.

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

• Not applicable / Not provided: Adjudication methods are relevant for subjective interpretations, often in clinical studies or AI validation. This document details objective bench testing.

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 cryosurgical ablation system, not an AI-assisted diagnostic or interpretative tool. Therefore, there's no comparison of human readers with or without AI assistance.

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

• Not applicable / Not provided: The device is a physical cryosurgical system; it does not involve algorithms for standalone performance in the context of interpretation or diagnosis.

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

• Not applicable / Not provided: For the bench tests described, the "ground truth" is defined by engineering specifications, validated test methods for mechanical integrity, electrical safety, software functionality, biocompatibility, sterilization, and reprocessing. It's not a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

• Not applicable / Not provided: This device is not an AI/machine learning system, so there is no concept of a "training set" in the context of algorithms learning from data.

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

• Not applicable / Not provided: As above, there is no training set for this type of device.

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The C2 CryoBalloon™ Ablation System is 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 dysplasia.

The subject device is a cryosurgical system with a nitrous oxide cooled balloon that is compatible with a commercially available endoscope 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 a Catheter (sterile), Controller (non-sterile), and Cartridge (nonsterile). 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 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 preinflated balloon, and the treatment site is selected by adjusting the endoscope and Controller position. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Controller.

Here's an analysis of the acceptance criteria and study detailed in the provided document:

Acceptance Criteria and Device Performance for C2 CryoBalloon™ Ablation System

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on demonstrating substantial equivalence by comparing the subject device's performance to existing predicate devices and other ablation technologies for Barrett's Esophagus with Low-Grade Dysplasia (LGD). While explicit, quantified "acceptance criteria" for the device are not directly stated as distinct thresholds, the document presents reported performance metrics from clinical studies and implicitly aims to show these metrics are "within the same range" as other accepted treatments. Based on the provided text, the key performance metrics and their reported values are:

Rationale for "Acceptance Criteria" interpretation: The document states that "The LGD efficacy rate of 92% and SAE rate of 5% (1/22) for the subject device are within the same range as the safety and efficacy rates for the RFA ablation and other cryoablation devices reported in the literature." This implies that the performance of similar, already cleared devices serves as a de facto acceptance standard for substantial equivalence.

2. Sample Sizes Used for the Test Set and Data Provenance

The "test set" for demonstrating the efficacy and safety for Barrett's Esophagus with LGD comes from two prospective clinical studies:

• Schölvinck 2015:
  • Sample Size (LGD patients): 9 patients (out of 39 total patients in the study)
  • Data Provenance: Not explicitly stated, but it's a published scientific paper, likely international given the author names (e.g., Künzli, Siersema, Vleggaar, Bergman, Weusten often associated with European institutions). The study description implies it's prospective ("safety and feasibility study").
• Canto 2016:
  • Sample Size (LGD patients): 13 patients (out of 40 total patients in the study)
  • Data Provenance: Not explicitly stated but the title and authors (Canto, Lightdale, Cosby, Montgomery) suggest a U.S. context, potentially a multi-center study ("Preliminary Results of a Prospective Clinical Trial"). Described as prospective.

Combined Test Set for LGD: 22 patients (9 from Schölvinck 2015 + 13 from Canto 2016).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not specify the number of experts explicitly used to establish the ground truth for the test set (i.e., for determining resolution of LGD or presence of adverse events). However, it mentions pathologically confirmed BE, indicating that pathologists were involved in the diagnosis and assessment of dysplasia. The qualifications of these pathologists are not detailed.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1, 3+1 consensus) for the test set results (e.g., for determining resolution of LGD or categorizing adverse events). The assessment of LGD resolution was "determined with biopsy," implying a standard pathological review. Adverse events would typically be assessed by the treating clinicians and reported according to study protocols.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The studies presented are clinical trials evaluating the safety and efficacy of the device in patients, not comparing reader performance with and without AI assistance. The device itself is a treatment device, not an AI-assisted diagnostic tool.

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

This refers to the performance of a diagnostic algorithm without human interaction. This is not applicable here as the C2 CryoBalloon™ Ablation System is a cryosurgical treatment device, not a diagnostic algorithm.

7. The Type of Ground Truth Used

For the clinical studies (Schölvinck 2015 and Canto 2016):

• For Dysplasia Diagnosis and Resolution: Pathology (biopsy results) was used for "Pathologically confirmed BE" and for determining "residual LGD as determined with biopsy."
• For Adverse Events: Clinical assessment and follow-up data from the prospective studies, likely involving physician diagnosis and classification of events, along with any necessary objective findings.

For the preclinical study (Schölvinck 2014):

• For Histopathological Effects: Pathology (histopathology from swine models and human biopsies) was used.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI/ML algorithm. This device is a cryosurgical system, and its efficacy and safety are demonstrated through preclinical and clinical studies, not through machine learning model training.

9. How the Ground Truth for the Training Set was Established

As there is no "training set" for an AI/ML algorithm described in the context of this device, this question is not applicable. The device's design and mechanism are based on established scientific principles of cryoablation, and its performance is validated through traditional biological and clinical studies.

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