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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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The C2 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 subject device is the Catheter used as part of a cryosurgical unit 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 maximum length of 100 cm. The subject Catheter is part of a cryosurgical system comprised of three components including a Catheter (sterile, single use), Controller (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 is 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 is a 510(k) summary for the C2 CryoBalloon™ Focal Pear Catheter, indicating FDA clearance based on substantial equivalence to a predicate device (CryoBalloon Focal Ablation System, K131523). It does not contain a study proving the device meets acceptance criteria in the sense of a clinical trial with performance metrics against a pre-defined acceptance threshold.

Instead, the document details a design verification testing approach to establish substantial equivalence.

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding performance results in the format typically seen for algorithm performance. Instead, it states that "Design verification testing, based on results of risk analysis, was performed on the C2 CryoBalloon™ Focal Ablation System to evaluate the physical, reliability, and safety specifications."

The performance data mentioned are:

• Dimensional verification
• Balloon integrity
• Balloon fatigue
• Bond and connector tensile strength and integrity

The "reported device performance" is summarized by the conclusion that "The performance data results demonstrate that the subject C2 CryoBalloon™ Focal Ablation System should perform as intended in the specified use conditions and should perform comparably to the legally marketed predicate that is currently marketed for the same intended use."

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

Not applicable. This is a medical device clearance document based on engineering and design verification testing, not a study involving human or image data. The testing was likely conducted in a lab environment.

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

Not applicable. Ground truth in the context of expert consensus on medical images or clinical outcomes is not relevant here. The "ground truth" for the engineering tests would be established by validated test methods and specifications.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (e.g., 2+1) are for cases where human experts review and agree on a consensus label, typically in image interpretation studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This device is a cryosurgical tool, not an AI or imaging interpretation device that would involve human readers.

6. Standalone Performance Study:

A "standalone" performance study in the context of an algorithm's performance without human intervention is not applicable. This document describes the performance of a physical medical device. The "design verification testing" could be considered a form of standalone performance evaluation for the device's functional integrity.

7. Type of Ground Truth Used:

The "ground truth" for this type of device clearance is based on engineering specifications, established test methods, and industry standards for physical, reliability, and safety evaluations of medical devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI or machine learning device that requires a training set of data.

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

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

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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 for use as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

The modified device is the Catheter used as part of a cryosurgical unit 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 maximum length of 100 cm. The modified Catheter is part of a system comprised of three components including a Catheter (sterile, single use), Handle (non-sterile, reusable), and Cartridge (non-sterile, single use). The modified device is used to ablate unwanted tissue by application of extreme cold. The balloon at the distal end of the Catheter is 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 Handle. The nitrous oxide spray cools the balloon to ablate the unwanted tissue, and the nitrous oxide exhausts through the Handle.

The provided document focuses on the K153541 C2 Therapeutics, Inc. Coldplay CryoBalloon® Ablation System and its substantial equivalence to a predicate device, rather than presenting a study proving a device meets specific acceptance criteria for diagnostic performance or AI model evaluation.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth for training set, etc.) are not applicable to this document's content.

However, I can extract information related to the device's performance data and a comparison to its predicate.

Here's a summary based on the provided text, while noting the limitations:

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

The document does not explicitly state quantitative acceptance criteria for clinical efficacy or diagnostic accuracy, as it's a 510(k) submission for a non-diagnostic device. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

The reported "performance" is primarily related to physical, reliability, and safety specifications, which were evaluated through "Design verification testing." The document asserts that the modified device performs "as intended" and "comparably" to the predicate.

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

This information is not provided in the document. The "Design verification testing" refers to engineering and bench testing, not a clinical study on a patient test set.

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)

This information is not applicable/not provided. The document describes a cryoablation device, not a diagnostic tool requiring expert ground truth for a test set.

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

This information is not applicable/not provided.

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

This information is not applicable/not provided. This is not an AI-assisted diagnostic device, nor is an MRMC study mentioned.

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

This information is not applicable/not provided. This is not an algorithm, but a medical device.

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

This information is not applicable/not provided in the context of diagnostic performance. For a medical device, the "ground truth" for its performance would typically come from engineering specifications, bench testing results, and potentially animal or human clinical data demonstrating its ability to achieve its intended therapeutic effect (e.g., tissue destruction), but such specific data for establishing "ground truth" in a structured way is not detailed here for a 510(k) summary. The document relies on "Design verification testing" to demonstrate functionality and safety against pre-defined specifications.

8. The sample size for the training set

This information is not applicable/not provided. This device does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable/not provided.

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The Boa Endoscopic Valve™ is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.

The Boa Endoscopic Valve™ is used with endoscopes and endoscopic devices with a maximum outer diameter up to 0.167 in. Endoscopic devices are inserted through the Boa Endoscopic Valve™ and through the endoscope. The Boa Endoscopic Valve™ forms a seal around endoscopic devices, supports the endoscopic device, and maintains the position relative to the endoscope biopsy channel port. It is compatible with biopsy port valves and is positioned against the biopsy valve of the endoscope. The Boa Endoscopic Valve™ is non-sterile and is designed for single patient use.

The provided document is a 510(k) summary for the Boa Endoscopic Valve™. It states that the device is substantially equivalent to a predicate device (EndoChoice Seal Biopsy Valve, K111821).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text, using the structure you requested:

The document does not specify "acceptance criteria" in terms of performance metrics like sensitivity, specificity, accuracy, or specific thresholds for leakage rates or device passage force. Instead, the "acceptance criteria" in this context appear to be met by demonstrating substantial equivalence to a predicate device through various non-clinical tests.

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

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

The document does not specify sample sizes for any of the bench or biocompatibility tests. It also does not mention data provenance (country of origin) or whether the tests were retrospective or prospective, as these are non-clinical studies.

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. This device is a mechanical endoscopic valve, and the evaluation involved non-clinical performance and biocompatibility testing, not expert interpretation of medical images or data requiring ground truth established by medical experts in that context.

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

Not applicable. As noted above, this was a non-clinical evaluation that did not involve human adjudication for ground truth.

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

Not applicable. This is a medical device (endoscopic valve), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This is a medical device, not a standalone algorithm.

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

The "ground truth" for this type of device would be established by engineering specifications, material standards, and performance test methods. For example:

• Biocompatibility: Adherence to ISO 10993 standards and FDA guidance.
• Physical/Simulated Use/Reliability/Safety: Meeting pre-defined engineering specifications and performance benchmarks (e.g., specific force to pass a device, seal integrity tests, durability tests) that are typically established by the manufacturer and validated by test results.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.

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

Not applicable. As there is no training set for a machine learning model, this question is not relevant.

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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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