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The Reprocessed Acunav Diagnostic Ultrasound Catheter is intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients,

The reprocessed device is not indicated for use with pediatric patients.

The Reprocessed AcuNav Diagnostic Ultrasound Catheters distal end has an ultrasound transducer providing 2-D imaging. A steering mechanism controls the image plane orientation through four-way articulation of the tip.

This FDA 510(k) summary describes the reprocessed AcuNav Diagnostic Ultrasound Catheters (K153090) and demonstrates their substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" for performance metrics like sensitivity, specificity, or image quality as would be expected for an AI/CADe device. Instead, the focus is on demonstrating that the reprocessed device performs equivalently to the original predicate device and meets safety standards after reprocessing. The "reported device performance" is essentially the successful completion of various validation tests.

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

The document does not specify a "test set" in the context of clinical data for performance evaluation (e.g., a set of patient images). Instead, the "testing" refers to bench and laboratory validation of the reprocessed physical device. The sample sizes for each specific functional and safety test (e.g., how many catheters were subjected to biocompatibility testing, cleaning validation, etc.) are not explicitly stated in this summary.

The provenance of this "data" is from bench and laboratory testing performed by Innovative Health, LLC. It is not clinical data from an in-vivo study on human subjects; rather, it uses reprocessed devices themselves. The country of origin of the data is implicitly the USA, where Innovative Health, LLC is located.

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 here. There is no "ground truth" derived from expert review of images or clinical outcomes in the traditional sense for an AI/CADe device. The "ground truth" for this reprocessing device is established by engineering specifications, validated test methods (e.g., sterilization effectiveness, dimensional accuracy), and regulatory standards for safety and performance of medical devices.

4. Adjudication Method for the Test Set:

This information is not applicable. There is no adjudication method described as this is not a study involving human reader interpretation or clinical outcomes adjudicated by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not conducted. This submission is for a reprocessed medical device, not an AI or CADe system that assists human readers in interpretation.

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

This information is not applicable. This is not an AI algorithm; it's a physical medical device.

7. The Type of Ground Truth Used:

The "ground truth" for this device is based on:

• Engineering Specifications: Original device design and performance specifications.
• Regulatory Standards: Compliance with FDA regulations for device safety, sterilization, biocompatibility, and electrical safety.
• Validation Test Results: Data showing that the reprocessed devices meet objective performance criteria through bench and laboratory testing.

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this device does not involve machine learning or AI.

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

This information is not applicable. Since there is no training set, there is no ground truth established for one.

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Reprocessed Diagnostic Ultrasound Catheters are intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. The device is intended for use in the right heart only.

Diagnostic Ultrasound Catheters are specially designed ultrasonic catheters that provide two-dimensional imaging using an ultrasound transducer. The ultrasound transducer is at the distal tip of the catheter and can be positioned for ultrasound imaging by a steering mechanism that rotates the catheter tip and variable deflection. Diagnostic Ultrasound Catheters incorporate a handpiece, a flexible shaft and a distal tip section containing an ultrasound transducer. The Ultrasound Catheter is 10 French with 90 cm insertion length.

The provided text is related to the 510(k) submission for a Reprocessed Diagnostic Ultrasound Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of a novel device to meet specific performance criteria. Therefore, most of the information requested in your prompt (e.g., sample sizes, expert ground truth, MRMC study, training set details) is not applicable or cannot be extracted from this type of document.

The document states that the reprocessed device is "identical to the predicate devices" in terms of design, materials, intended use, mechanism of action, and performance specifications. The performance data presented are primarily bench and laboratory tests to confirm that the reprocessing maintains the original device's performance, safety, and effectiveness.

Here's an attempt to answer your questions based on the provided text, with many fields marked as "Not Applicable" or "Not Provided" due to the nature of the submission.

Acceptance Criteria and Study Details for Reprocessed Diagnostic Ultrasound Catheter (K063076)

1. Table of Acceptance Criteria and Reported Device Performance

For this 510(k) submission, the "acceptance criteria" are implied by the need to demonstrate that the reprocessed device performs "as originally intended" and is "safe and effective" and "substantially equivalent" to the predicate device. Specific quantitative acceptance criteria are not explicitly stated in a table format in the provided text. The "reported device performance" is a general confirmation that these criteria were met through various tests.

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

• Sample Size for Test Set: Not specified. The document mentions "bench and laboratory testing" but does not quantify the number of units or tests performed.
• Data Provenance: Not explicitly stated. Given it's internal testing for a 510(k) submission, it's presumed to be internal, prospective testing related to the reprocessing procedure. The country of origin of the data is not mentioned.

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

• Number of Experts: Not applicable. This type of submission relies on objective engineering and biological tests (biocompatibility, sterility, function) rather than expert interpretation of medical images or outcomes.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Adjudication methods like "2+1" typically apply to expert reviews of medical data, which is not the primary focus of this submission. The tests performed have definitive pass/fail criteria.

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

• MRMC Comparative Effectiveness Study: No, this was not done. The device is a diagnostic ultrasound catheter, not an AI-powered diagnostic tool.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical medical device (a reprocessed catheter), not an algorithm.

7. The type of ground truth used

The "ground truth" for this submission is established through objective engineering, chemical, and biological testing standards to confirm the device's physical and functional integrity, sterility, and biocompatibility after reprocessing. It relies on:

• Standardized methods for evaluating biocompatibility.
• Validation protocols for reprocessing efficacy (e.g., cleaning effectiveness).
• Sterilization validation protocols.
• Functional test specifications to ensure the catheter performs as intended (e.g., imaging capability, steering mechanism).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document describes the reprocessability validation of an existing device, not the development of a machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable.

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Reprocessed Diagnostic Ultrasound Catheters are intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. The device is intended for use in the right heart only.

Reprocessed Diagnostic Ultrasound Catheters are indicated for visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart, as well as measurement of blood flow. The Reprocessed Diagnostic Ultrasound Catheter is intended for use in the right side of the heart only.

Diagnostic ultrasound catheters are specially designed ultrasonic catheters that provide two-dimensional imaging using an ultrasound transducer. The ultrasound transducer is at the distal tip of the catheter and can be positioned for ultrasound imaging by a steering mechanism that rotates the catheter tip and variable deflection. Diagnostic ultrasound catheters incorporate a handpiece, a flexible shaft and a distal tip section containing an ultrasound transducer. The ultrasound catheter is 10 French with 90 cm insertion length.

The provided text describes the reprocessed ultrasound catheter by Alliance Medical Corporation and references a 510(k) submission (K033436). However, the document does not contain specific acceptance criteria, detailed results of a study proving the device meets those criteria, or information on specific statistical analyses like MRMC studies or effect sizes for human readers.

The document primarily focuses on establishing substantial equivalence to a predicate device (AcuNav™ Diagnostic Ultrasound Catheter, K992631) based on identical design, materials, intended use, clinical applications, performance specifications, and method of operation.

Here's an attempt to answer the questions based on the available information, noting where data is absent:

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

The document states that "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Ultrasound Catheters." The performance data reported are categories of testing, not specific quantitative criteria or results.

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 the sample size for any of the performance tests (biocompatibility, reprocessing validation, sterilization validation, function tests, packaging validation). It also does not explicitly state the provenance of the data (country of origin) or whether the tests were retrospective or prospective. Given the nature of bench and laboratory testing, it is generally prospective.

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 provided in the document. The document describes technical performance tests, not studies involving expert interpretation of medical images or data.

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

This information is not applicable and not provided. The testing described is technical performance validation, not human-read clinical evaluation requiring adjudication.

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 such study (MRMC comparative effectiveness with human readers and AI assistance) is mentioned or implied in the document. This device is a reprocessed physical medical device, not an AI diagnostic tool.

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

This question is not applicable as the device is a reprocessed physical medical device, not an algorithm or AI system.

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

For the technical performance tests mentioned (biocompatibility, reprocessing, sterilization, function, packaging), the "ground truth" would be established by validated test methodologies and specifications, comparing the reprocessed device's performance against the original device's specifications or established safety standards. It does not involve expert consensus on medical images, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This question is not applicable to this type of device. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable.

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