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The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures; blood flow and other devices within the heart.

The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The reprocessed ViewFlex Xtra is a sterile, single use, temporary, intracardiac catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anterior-to-posterior deflection. The handle of the device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II, ViewMate Z and Philips CX50 ultrasound consoles. Each device is marked and tracked and taken out of service once the maximum number of cycles has been reached.

The provided text is a 510(k) summary for the Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter, a reprocessed medical device. It does not contain information about an AI/ML-driven device, nor does it specify "acceptance criteria" in the context of diagnostic performance metrics like sensitivity or specificity. Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, many of the requested details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, or effects of AI assistance, are not applicable or cannot be extracted from this particular document.

However, I can extract the "performance" details in the context of the non-clinical testing conducted to prove substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence)

The document primarily focuses on demonstrating that the reprocessed device performs comparably to the original predicate device through various non-clinical tests. These tests effectively serve as the "acceptance criteria" for demonstrating substantial equivalence rather than diagnostic performance in an AI/ML context.

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

Not applicable. This document describes a reprocessing approval based on non-clinical engineering and biological tests, not statistical analysis of patient data or diagnostic performance of an AI model. There is no "test set" in the sense of a dataset for an AI model.

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

Not applicable. Ground truth in the context of AI/ML is not relevant here. The "ground truth" for this submission is established through validated scientific methods for medical device performance, safety, and equivalence.

4. Adjudication method for the test set

Not applicable. No adjudication method is described, as there is no "test set" requiring expert consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. This applies to AI/ML devices that assist human readers in diagnostic tasks. The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is a reprocessed physical medical device, not an AI system.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

For this type of device (reprocessed catheter), the "ground truth" is established through:

• Validated engineering specifications: Proving the device meets its design requirements in terms of mechanical, electrical, and dimensional properties.
• Biological safety testing: Ensuring biocompatibility and effective sterilization.
• Functional performance testing: Demonstrating the device performs its intended function (e.g., ultrasound imaging capability) identically to the original device.
• Regulatory standards and guidelines: Adherence to established FDA regulations for reprocessing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. There is no training set for an AI/ML model.

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The Reprocessed ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

The Reprocessed ViewFlex Xtra ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to visualize cardiac structures and blood flow within the heart. The Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The Reprocessed ViewFlex Xtra ICE Catheter shaft is a 9 French catheter with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anteriorto-posterior deflection. The handle of the catheter has two deflection mechanisms that correspond with movement of the distal shaft in the four planes of movement. The Reprocessed ViewFlex Xtra Ice Catheter is compatible with ViewMate Z or ViewMate and Philips CX50 ultrasound consoles via the use of a compatible ViewFlex Catheter interface module.

The provided text does not contain a study that proves the device meets specific acceptance criteria in terms of accuracy or clinical performance. The submission is for a reprocessed medical device (Intracardiac Echocardiography Catheter), and the studies described are primarily focused on demonstrating that the reprocessed device is as safe and effective as the predicate device and operates as originally intended.

Specifically, the document focuses on:

• Bench and laboratory testing: To demonstrate the performance (safety and effectiveness) of the reprocessed device.
• Comparison to a predicate device: Asserting that the reprocessed device is substantially equivalent to legally marketed predicate devices.
• Validation of reprocessing methods: Ensuring cleaning, sterilization, and functional integrity after reprocessing.

Therefore, many of the requested categories for a study demonstrating clinical performance or diagnostic accuracy are not applicable to this submission.

However, I can extract the relevant information regarding the testing performed and the general "acceptance criteria" through comparison to the predicate.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of precise quantitative acceptance criteria (e.g., specific thresholds for image quality metrics) or their exact reported performance values. Instead, it states that the reprocessed device meets the functional and safety requirements to be considered equivalent to the predicate. The "performance" is implicitly "as safe and effective as the predicate" and "operates as originally intended."

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

The document does not specify exact sample sizes for the "test set" (e.g., number of reprocessed catheters tested for each criterion). The testing would have been done on a sufficient number of reprocessed devices to validate the reprocessing methods and ensure consistency. The data provenance is from bench and laboratory testing conducted by Stryker Sustainability Solutions, which is prospective data generation for the purpose of demonstrating substantial equivalence. The country of origin of the data is not explicitly stated but is implied to be within the US (given FDA submission).

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

This information is not applicable/not provided as the submission is for a reprocessed device and describes technical and functional testing, not a clinical study involving diagnostic accuracy with expert-established ground truth.

4. Adjudication method for the test set

This information is not applicable/not provided as the submission is for a reprocessed device and describes technical and functional testing, not a clinical study.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, a MRMC comparative effectiveness study was not conducted or described. The focus is on the substantial equivalence of the reprocessed device to its predicate through engineering and functional testing.

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

This information is not applicable/not provided. The device is an Intracardiac Echocardiography Catheter, not an AI algorithm. The functional testing described is effectively a standalone performance assessment of the physical device.

7. The type of ground truth used

The "ground truth" for the functional and safety testing would be:

• Engineering specifications of the original device.
• Industry standards and regulatory requirements for medical device safety and performance (e.g., biocompatibility standards, sterilization efficacy).
• The performance characteristics of the new/unreprocessed predicate device.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of this device submission, as it relates to a physical medical device and its reprocessing, not a machine learning algorithm.

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

This information is not applicable/not provided for the same reason as above.

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The reprocessed ViewFlex™ Xtra ICE catheter is in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

The Reprocessed ViewFlex™ Xtra ICE catheter is a temporary intracardiac ultrasound catheter intended for use in patients to accurately visualize cardiac structures, blood flow and other devices within the heart when connected to a compatible intracardiac ultrasound console via the compatible ViewFlex™ Catheter Interface Module. Examples of the types of other devices that can be visualized include, and are not limited to, intracardiac catheters, septal occluders, delivery wires, delivery sheaths, sizing balloons and transseptal needles. The use of these images is limited to visualization with no direct or indirect diagnostic use.
The Reprocessed ViewFlex™ Xtra ICE catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A10F introducer is recommended for use with this catheter for insertion into the femoral or jugular veins. The catheter tip has four-directional deflection allowing for Left-Right and Posterior-Anterior deflection, with an angle of at least 120 degrees in each direction.

The provided text describes the regulatory clearance for a reprocessed medical device, specifically the Reprocessed ViewFlex™ Xtra ICE Catheter (K190478). This document primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical performance and safety tests. It does not pertain to an AI/ML-driven device or a study involving human readers or efficacy in diagnosing conditions. Therefore, many of the requested categories in the prompt are not applicable.

Here's an analysis based on the information available:

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

The document details various tests performed to ensure the reprocessed device is substantially equivalent to the original predicate device. The "acceptance criteria" are implied to be that the reprocessed device performs "as originally intended" and meets the same functional and safety characteristics as the new, original (OEM) device.

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 exact sample sizes for each particular test (e.g., number of catheters tested for electrical leakage). It refers to "representative samples of reprocessed devices" for functional testing. The data provenance is implied to be from internal lab testing conducted by Sterilmed, Inc. No information on country of origin or retrospective/prospective nature of the testing is provided beyond it being part of the 510(k) submission process for a reprocessed device.

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 is not applicable. The study described is a non-clinical, bench-top engineering and biocompatibility study comparing a reprocessed device to a new device, not a diagnostic study requiring expert interpretation of medical images or data. Therefore, there is no "ground truth" established by medical experts for a test set in the context of diagnostic accuracy.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or diagnostic studies to resolve discrepancies in expert interpretation. This document describes physical, chemical, and functional engineering tests.

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 is not applicable. The device is an intracardiac ultrasound catheter for visualization, not an AI-driven diagnostic tool that assists human readers. No MRMC study was performed.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

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

The "ground truth" in this context is the performance and safety specifications of the original (OEM) predicate device (ViewFlex™ Xtra ICE Catheter, K133853). The reprocessed device is tested to ensure it meets these established technical specifications and performance characteristics, demonstrating "substantial equivalence" rather than diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

This is not applicable. There is no AI/ML algorithm that requires a training set. The study involves reprocessed physical devices.

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

This is not applicable. There is no AI/ML algorithm or training set.

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The Reprocessed ViewFlex™ Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

The Reprocessed ViewFlex Xtra ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to visualize cardiac structures and blood flow within the heart. The Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The Reprocessed ViewFlex Xtra ICE Catheter shaft is a 9 French catheter with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64- element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for leftto-right and anterior-to-posterior deflection. The handle of the catheter has two deflection mechanisms that correspond with movement of the distal shaft in the four planes of movement. The Reprocessed ViewFlex Xtra Ice Catheter is compatible with ViewMate Z or ViewMate and Philips CX50 ultrasound consoles via the use of a compatible ViewFlex Catheter interface module.

The provided text is a 510(k) summary for a reprocessed medical device, specifically a Reprocessed ViewFlex Xtra ICE Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against detailed acceptance criteria for a new AI or diagnostic device.

Therefore, many of the requested elements (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for training) are not applicable to this document as it describes a reprocessed catheter and not a new diagnostic algorithm or AI system.

However, I can extract the relevant information regarding performance testing that was conducted to demonstrate the reprocessed device's safety and effectiveness.

Here's a breakdown of what can be extracted, and where limitations exist based on the document:

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

The document describes the types of tests performed to demonstrate that the reprocessed device performs "as originally intended" and is "effectively identical" to the predicate. It does not provide specific quantitative acceptance criteria or detailed numerical performance results for these tests. The conclusion states the device is "at least as safe and effective as the predicate device," implying it met internal standards for each test.

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

• Sample Size: Not specified. The document states "Each individual device is tested for appropriate function" during reprocessing, and that bench and laboratory testing was conducted. This implies testing on a statistically relevant sample of reprocessed devices, but the exact number isn't given.
• Data Provenance: Not applicable in the context of this device and the types of tests described. These are laboratory/bench tests, not clinical data sets from patients.

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 document describes engineering and laboratory testing for a reprocessed catheter, not a diagnostic algorithm that requires expert ground truth for interpretation.

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

• Not applicable. Adjudication methods are used for interpreting clinical data, particularly in a reader study or when establishing ground truth from multiple experts. This is not relevant for bench testing of a catheter.

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 reprocessed catheter, not an AI or diagnostic imaging device. No MRMC study was mentioned or would be relevant for this type of submission.

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

• Not applicable. There is no algorithm; this is a physical medical device.

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

• Not applicable. The "ground truth" for these engineering tests would be established by validated test methods, adherence to specifications, and comparison to the original device's performance, as measured by calibrated equipment and documented procedures. For instance, the ground truth for electrical safety is adherence to established electrical safety standards.

8. The sample size for the training set:

• Not applicable. This is a reprocessed physical device, not an AI model requiring a training set.

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

• Not applicable. As above, no training set for an AI model is involved.

Summary of the Study:

The study described is a series of bench and laboratory tests designed to confirm that the Reprocessed ViewFlex Xtra ICE Catheter is safe and effective and performs "as originally intended," thereby demonstrating substantial equivalence to the predicate device.

The tests included:

• Biocompatibility
• Validation of Reprocessing
• Sterilization Validation
• Functional Performance Tests
• Acoustic Testing
• Electrical Safety Testing
• Electromagnetic Compatibility Testing
• Packaging Validation

The specific detailed results or quantitative acceptance criteria for each test are not provided in this summary document, only the general statement that the testing "demonstrates that Reprocessed ViewFlex device perform as originally intended" and that the device is "at least as safe and effective as the predicate device." The study essentially aims to prove that the reprocessing process does not negatively impact the device's original validated performance and safety characteristics.

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