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The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters 8F, 8FG, 10F 10FG are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with compatible CARTO 3 EP Navigation Systems, the SOUNDSTAR eco Catheter provides location information.

The Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters 8F, 8FG, 10F, 10FG are licensed for single use only. Models differ in shaft diameter (8F or 10F) and ultrasound system compatibility (Siemens [8F and 10F] or GE [8FG and 10FG]). The catheter consists of a CARTO connector, SwiftLink (ultrasound) connector, handle and shaft. In the distal tip of each catheter's shaft are a 64-element ultrasound transducer providing 2D imaging and a 3D location sensor providing location information to the compatible CARTO 3 Electrophysiology (EP) Navigation System. The deflection and tension knobs on the handle are used to articulate the distal tip and control the image plane orientation with four-directional (anterior-posterior, left-right) deflection.

The provided FDA 510(k) clearance letter pertains to the Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters. This document outlines the regulatory review and approval process for a reprocessed medical device, asserting its substantial equivalence to original predicate devices.

However, the provided text does not contain any information regarding specific acceptance criteria for AI/ML performance, nor does it describe a study involving AI assistance or standalone AI performance evaluation. The "Non-clinical Testing Summary" focuses on the physical, electrical, and reprocessing aspects of the reprocessed catheter itself (e.g., functional performance, electrical safety, cleaning validation, biocompatibility, sterilization validation, packaging and shelf life). It explicitly states: "The current submission does not include consoles or any other system components as part of this respective submissions." The device subject to clearance is an ultrasound catheter, not an AI-powered diagnostic system.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for AI/ML device performance based on the provided document. The document pertains to a physical medical device (an ultrasound catheter) and its reprocessing, not an AI/ML-driven diagnostic or assistive technology.

If you have a document describing an AI/ML device and its performance study, I would be happy to analyze it according to your requested criteria.

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The NES Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter utilizes a cylindrical ultrasound transducer array close to the distal tip to radiate acoustic energy into the surrounding tissue. By using the information gathered from the ultrasonic echoes, the device can generate real-time images of the coronary and peripheral vessels.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter tracks over a 0.018" (0.46mm) guide wire by through an internal lumen. Approximately 31 cm from the catheter tip is a guidewire port for the exiting guidewire. The NES Reprocessed Visions PV .018 Digital IVUS Catheter is introduced into the vascular system percutaneously or via surgical cutdown.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter may only be used with the Volcano s5 Series or CORE Series of Systems Operator's Manual. If connect to another system, the catheter will not operate.

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is intended to be reprocessed one (1x) time.

The provided FDA 510(k) clearance letter and summary for K250592 describes a reprocessed medical device, the NES Reprocessed Visions PV .018 Digital IVUS Catheter. This document does not detail acceptance criteria or the study that proves the device meets AI/Machine Learning performance standards, as it is a traditional medical device (an Intravascular Ultrasound Catheter) and not an AI-enabled device.

Therefore, many of the requested categories regarding AI model performance, ground truth establishment, expert adjudication, MRMC studies, and training/test set sizes are not applicable to this submission.

However, I can extract the relevant information regarding the device's functional and safety testing as described in the 510(k) summary, which serves as the "study" proving the device meets its acceptance criteria for a reprocessed medical device.

Summary of Device Acceptance Criteria and Performance (for a Reprocessed Medical Device, not AI)

The NES Reprocessed Visions PV .018 Digital IVUS Catheter is a reprocessed version of a predicate device. The acceptance criteria and "study" proving the device meets these criteria focus on demonstrating that reprocessing does not compromise the device's safety and effectiveness compared to the original device. The "study" involves various bench and laboratory tests.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary states that "The test methods, requirements and acceptance criteria used for the .018 IVUS are the same used in cleared K200195 (reprocessed .014 IVUS)." It also indicates that there are "no changes to the claims, clinical applications, patient populations, performance specifications, or method of operation." This implies that the acceptance criteria are met if the reprocessed device performs comparably to a new device (or the predicate reprocessed device K200195) across all specified tests.

Note: The document states that the "NES Reprocessed Visions PV .018 Digital IVUS Catheter is as safe and effective as the predicate devices described herein," which is the overarching conclusion of meeting all acceptance criteria.

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

• Sample Size: Not explicitly stated for each test, but standard for device validations. For a reprocessed device, this would typically involve a statistically significant number of reprocessed units across multiple reprocessing cycles.
• Data Provenance: The tests are described as "Bench and laboratory testing," implying controlled, experimental data generated specifically for this submission. There is no mention of patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• N/A: As this is a traditional medical device (not an AI/ML device), expert establishment of ground truth in the context of image interpretation or diagnostic accuracy is not relevant. The "ground truth" for the device's performance would be established by validated test methods and engineering specifications.

4. Adjudication Method for the Test Set

• N/A: Adjudication is typically relevant for subjective assessments (e.g., in AI or clinical studies). For bench and lab testing of a physical device, performance is measured against objective, predetermined specifications rather than requiring expert consensus or adjudication.

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

• N/A: An MRMC study is relevant for evaluating the impact of AI on human reader performance. This device is an IVUS catheter and does not involve AI assistance for image interpretation.

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

• N/A: This question pertains to AI algorithm performance. This device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Performance Standards: The "ground truth" for this device's performance is compliance with established engineering specifications, safety standards (e.g., sterilization, biocompatibility), and functional performance benchmarks (e.g., image acuity, acoustic output) that are deemed equivalent to the original predicate device. This is determined through objective bench and laboratory testing.

8. The Sample Size for the Training Set

• N/A: No training set is applicable as this is not an AI/ML device.

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

• N/A: Not applicable.

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The Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only not treatment delivery, during cardiac interventional percutaneous procedures.

The Medline ReNewal Reprocessed Siemens AcuNav Diagnostic Ultrasound Catheters 10F are licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheters are to be used only on systems with which they have been tested and found compatible.

This document is a 510(k) premarket notification for a reprocessed medical device, specifically an ultrasound catheter, not a new device involving AI or complex software. As such, the information requested in your prompt regarding acceptance criteria and studies that prove a device meets acceptance criteria specifically for AI/Software performance is not present in this document.

The 510(k) submission for the Medline ReNewal Reprocessed Siemens ACUSON AcuNav Ultrasound Catheter 10F focuses on demonstrating substantial equivalence to a predicate device (the original, single-use Siemens AcuNav Diagnostic Ultrasound Catheter). This is achieved through non-clinical testing to show that the reprocessed device performs as safely and effectively as the original.

Therefore, many of the specific points you've asked for, such as sample size for a test set for AI performance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, and ground truth for training data, are not applicable to this type of device and submission.

However, I can extract information related to the non-clinical testing performed to establish substantial equivalence for this reprocessed device, which serves as its "proof" of meeting performance criteria.

Here's an interpretation based on the provided document:

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

The document doesn't present a formal table of quantitative acceptance criteria with numerical performance data. Instead, it lists the types of non-clinical tests performed to demonstrate that the reprocessed device's functional characteristics are substantially equivalent to the predicate device. The implied acceptance criterion for each test is that the reprocessed device performs comparably to the original to ensure safety and effectiveness.

2. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: The document does not specify the exact number of units/samples used for each type of non-clinical test. This level of detail is typically found in the full testing reports submitted to the FDA, not in the public 510(k) summary.
• Data Provenance: The tests were conducted by Medline ReNewal. While not explicitly stated, such tests are generally conducted at their facilities or certified labs. The country of origin of the data would be the USA (Oregon, specifically, as per the address). The data is prospective in the sense that Medline ReNewal specifically conducted these tests to support this 510(k) submission for their reprocessed device.

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

• Not applicable. This relates to AI/software performance evaluation where human experts establish ground truth for image interpretation or diagnosis. For a reprocessed physical device, "ground truth" is established by adherence to engineering specifications, performance standards, and established test methodologies (e.g., AAMI standards for sterilization, ISO standards for biocompatibility). The "experts" involved would be engineers, microbiologists, and other technical personnel who design and execute these tests, and interpret the results against pre-defined success criteria.

4. Adjudication method for the test set:

• Not applicable. This refers to consensus-building among medical experts for labeling data, which is not relevant for the physical performance testing of a reprocessed medical device. Test results are compared against objective criteria and engineering specifications.

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 type of study is relevant for AI-powered diagnostic devices. This submission is for a reprocessed ultrasound catheter.

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

• Not applicable. This refers to the performance of a software algorithm.

7. The type of ground truth used:

• For this reprocessed device, "ground truth" is based on engineering specifications, established performance standards (e.g., mechanical strength, electrical safety, acoustic performance), and validated manufacturing processes (e.g., cleaning efficacy, sterilization efficacy). The original predicate device's performance also serves as a benchmark for comparison.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set."

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The Medline ReNewal Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheter is inteacardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The Medline ReNewal Reprocessed AcuNav Diagnostic Ultrasound Catheters 8F are licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization. The catheters are to be used only on systems with which they have been tested and found compatible.

The provided text is a 510(k) summary for a reprocessed medical device, specifically an ultrasound catheter, and does not describe an AI/ML powered device. Therefore, information regarding acceptance criteria and studies proving the device meets those criteria for an AI/ML powered device cannot be extracted from this document.

The document focuses on demonstrating substantial equivalence of a reprocessed device to a legally marketed predicate device, primarily through non-clinical testing of functional performance, material characteristics, cleaning validation, biocompatibility, and sterilization validation. It does not contain details about a study evaluating an AI/ML algorithm's performance.

To answer your request, if this were an AI/ML powered device, the following information would typically be present in a separate study report or detailed within the 510(k) submission, and would not be found in a standard summary like the one provided:

• Acceptance Criteria Table and Reported Performance: This would specify metrics like sensitivity, specificity, AUC, F1-score, accuracy, etc., and the target thresholds, along with the actual performance achieved by the AI model.
• Sample Size and Data Provenance: Details on the number of cases/samples in the test set, and whether the data was retrospective or prospective, and its geographical origin.
• Ground Truth Experts: The number and qualifications of experts who established the ground truth labels for the test set.
• Adjudication Method: How discrepancies among experts were resolved (e.g., 2+1, 3+1, majority vote).
• MRMC Comparative Effectiveness Study: If human readers were involved, details on a multi-reader, multi-case study to assess AI's impact on human performance, including effect sizes.
• Standalone Performance: If the AI algorithm's performance was evaluated independently without human intervention.
• Type of Ground Truth: The method used to establish the true diagnosis (e.g., expert consensus, biopsy, surgical findings, long-term outcomes).
• Training Set Sample Size: The number of data points used to train the AI model.
• Training Set Ground Truth: How the ground truth for the training data was established (often a multi-stage process, possibly involving automated methods, expert review, or existing clinical records).

In summary, the provided document relates to a reprocessed physical medical device and not an AI/ML enabled device. Therefore, it does not contain the information required to answer your specific questions about an AI/ML device's acceptance criteria and validation study.

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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 Vein360 Reprocessed Visions® PV .014P RX (85910P), Visions® PV.014P RX (014R), Eagle Eye Platinum RX, and Eagle Eve Platinum ST RX Digital IVUS catheters are all designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. These devices are not currently indicated for use in the cerebral vessels.

The Vein360 Reprocessed Visions® PV .014P RX (85910P), Visions® PV.014p RX (014R), Eagle Eye Platinum RX, and Eagle Eye Platinum ST RX RX Digital IVUS catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The subject devices are reprocessed single use devices. After clinical use of the predicate devices (Manufactured by Philips), the devices are shipped to Vein360 per established Vein360 instructions. Upon receipt, the subject devices are cleaned, inspected, hydrophilic coated, functionally tested, packaged, and sterilized using ethylene oxide (EO) gas.

The subject devices are rapid exchange intravascular imaging catheters containing an ultrasound transducer located at the distal end of the catheter. This transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.

The subject devices utilize an internal lumen that allows the catheter to track over the 0.014" (0.36mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The subject devices are introduced percutaneously or via surgical cutdown into the vascular system.

Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge, starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy.

The subject devices may only be used with Volcano s5 Series or CORE Series imaging systems.

The subject device is packaged with a flushing tool that is equivalent to the predicate and is used for flushing the device's lumen with heparinized normal saline.

The subject devices are reprocessed once and permanently marked to indicate it has been reprocessed by Vein360.

This document describes the Vein360 Reprocessed Visions PV.014P RX Digital IVUS Catheter (85910P, 014R), and Vein360 Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter, and Vein360 Reprocessed Eagle Eye Platinum ST RX Digital IVUS Catheter. This device is a reprocessed single-use intravascular imaging catheter.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" for each performance test in a quantitative manner. Instead, it states that "results of performance testing demonstrate the subject devices are substantially equivalent to the predicate devices which are safe and effective for their intended use." This implies that the acceptance criteria for each test was to match or not degrade from the performance of the original predicate devices.

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

The document does not explicitly state the sample sizes used for each specific test set. It mentions "subject devices were clinically used and then soiled with artificial test soil" for cleaning and performance validation. However, the number of devices, cases, or specific data points for these tests is not provided.

• Data Provenance: The devices are "reprocessed single use devices" that were "after clinical use of the predicate devices (Manufactured by Philips)". This indicates that the initial data (the predicate devices themselves) came from clinical use, and then the reprocessed devices were subjected to further testing. The geographical origin of the initial clinical use data is not specified, but the reprocessing company is based in the US (Ohio). The tests conducted are prospective in the sense that they are performed on reprocessed devices to demonstrate their continued performance.

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

The document does not mention the use of experts to establish ground truth for a test set. The evaluation seems to be focused on physical, electrical, and imaging characteristics compared to baseline (predicate device) performance, rather than an interpretation of medical images by human experts.

4. Adjudication Method:

Since no experts were mentioned for establishing ground truth, there is no adjudication method described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is more common for AI-powered diagnostic tools where human interpretation is a key component. This submission relates to the reprocessing of physical medical devices.

6. Standalone (Algorithm Only) Performance:

No, a standalone (algorithm only) performance study was not done. This device is an IVUS catheter, a physical device that generates images, not an AI algorithm itself. The imaging system (Volcano s5 Series or CORE Series) has its own algorithms, but the study focuses on the reprocessed catheter's ability to produce comparable images.

7. Type of Ground Truth Used:

The ground truth used for assessing the reprocessed device's performance is the original performance and specifications of the predicate (unreprocessed) devices. The studies aimed to demonstrate that the reprocessed devices maintained "form, fit, or function" comparable to the new predicate devices. This includes:

• Physical measurements (dimensional integrity, mechanical integrity)
• Functional performance (simulated use, cross/re-cross, electrical integrity, acoustic output, image quality)
• Safety parameters (cleaning efficacy, sterility, endotoxin levels, biocompatibility, electrical safety)

For cleaning validation, the "ground truth" was the absence of physical soil, demonstrated objectively.

8. Sample Size for the Training Set:

This is not applicable as the device is a physical, reprocessed IVUS catheter, not an AI algorithm that requires a training set.

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

This is not applicable, as there is no mention of a training set for an AI algorithm.

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The Vein360 Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels.

The Vein360 Reprocessed Visions PV .018 Digital IVUS Catheter is designed for use as an adjunct to conventional anglographic procedures to provide an image of the vessel lumen and wall structures. The catheter is designed for use on adult patients (greater than 21 years of age).

The Vein360 Reprocessed Visions PV .018 Digital IVUS catheter (subject device) is a reprocessed single use device. After clinical use of the Visions PV .018 Digital IVUS Catheter (Manufactured by Philips), the IVUS catheter is shipped to Vein360 per established Vein360 instructions. Upon receipt, the subject device is cleaned, inspected, functionally tested, packaged and sterilized using ethylene oxide (EO) qas.

The subject device is an intravascular imaging catheter containing an ultrasound transducer located at the distal end of the catheter. This transducer utilizes a 64element cylindrical array that radiates acoustic energy into the surrounding tissue and detects subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels.

The subject device utilizes an internal lumen that allows the catheter to track over the 0.018"(0.46mm) guide wire. The guide wire exits from the guide wire lumen approximately 31 cm proximal to the catheter tip. The subject device is introduced percutaneously or via surgical cutdown into the vascular system.

The catheter's working length is 135 cm and includes three (3) non-radiopaque positioning markers. The subject device maintains all mechanical and electrical properties of the predicate device after reprocessing operations.

The subject device may only be used with Volcano s5 Series, CORE, and IntraSight imaging systems.

The subject device is packaged with a flushing tool that is equivalent to the predicate and is used for flushing the device's lumen with heparinized normal saline.

The subject device can only be reprocessed once and is permanently marked to indicate it has been reprocessed.

The provided documents describe the Vein360 Reprocessed Visions PV .018 Digital IVUS Catheter. This device is a reprocessed single-use device, and the submission's goal is to demonstrate its substantial equivalence to the original, unused version of the same product. The acceptance criteria and the study that proves the device meets these criteria are primarily focused on the reprocessing aspects and ensuring the reprocessed device performs identically to the new device.

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

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

The document details various validation studies and performance testing conducted to demonstrate that the reprocessed device maintains the same performance characteristics as the predicate device. The acceptance criteria essentially infer that the reprocessed device must pass these tests, demonstrating identical or equivalent performance to the predicate.

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

The document does not explicitly state the specific sample sizes for each test set. It mentions that "subject devices were clinically used and then soiled with artificial test soil" for cleaning validation and performance validation. This indicates a prospective approach for the testing, where devices were intentionally reprocessed and then tested. The country of origin of the data is not specified, but given the FDA submission, it implicitly aligns with U.S. regulatory standards.

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 section is not applicable as the evaluation of this medical device (a reprocessed IVUS catheter) is based on technical performance testing and validation, not on interpretations or diagnoses by medical experts to establish a "ground truth" for a diagnostic task. The "ground truth" here is the original specifications and performance of the new device.

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

This section is not applicable for the reasons stated above. Adjudication methods are typically used in clinical studies involving interpretation of medical images or data by multiple experts.

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 section is not applicable. The device is an Intravascular Ultrasound (IVUS) catheter, which is a diagnostic tool, not an AI-assisted diagnostic system. No MRMC study involving human readers and AI assistance was conducted or described in the provided text. The study focuses purely on the physical and functional performance of the reprocessed device compared to the original.

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

This section 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' for this submission is the original design specifications and established performance characteristics of the new, unused predicate device (Visions® PV .018 Digital IVUS Catheter - K150442). The studies aimed to prove that the reprocessed device adheres to these same performance standards after reprocessing. This is evidenced by statements like: "Electro-mechanical performance testing was performed to demonstrate that the reprocessing operations did not adversely affect the predicate device's form, fit, or function."

8. The sample size for the training set

This section is not applicable. The evaluation of this device does not involve a "training set" in the context of machine learning or AI models. The testing described is for physical device validation.

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

This section is not applicable for the same reasons as point 8.

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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 ViewFlex™ Eco Reprocessed 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 ViewFlex™ Eco Reprocessed 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 ViewFlex™ Eco Reprocessed ICE Catheter has a useable length of 90 cm, with a 9 French (F) shaft with an ultrasound transducer. A 10F 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 ViewFlex™ Eco Reprocessed ICE Catheter is compatible with the ViewMate™ Z, ViewMate™, ViewMate™ Multi and Philips CX50 ultrasound consoles.
The ViewFlex™ Eco Reprocessed ICE Catheter is reprocessed by Abbott no more than two (2) times. Each catheter includes marking on the proximal handle and connector that identify the catheter status. The device is taken out of service after reaching the maximum number of reprocessing cycles. Abbott restricts its reprocessing to exclude devices previously reprocessed by other reprocessors.

Here's a breakdown of the acceptance criteria and study information based on the provided FDA 510(k) summary for the ViewFlex™ Eco Reprocessed ICE Catheter:

Summary of Acceptance Criteria and Device Performance:

Study Information:

1. Table of Acceptance Criteria and Reported Device Performance: This information is provided in the table above. The document states that all testing performed met the established performance specifications for each category.

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

   • Sample Size: The document does not explicitly state the sample size for the test set used in the non-clinical performance evaluation. It only mentions that "Design verification activities were performed with their respective acceptance criteria."
   • Data Provenance: Not specified, but generally, non-clinical tests like these are conducted in a laboratory setting by the manufacturer (Abbott Medical, USA).

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

   • Not applicable. This device is a medical catheter and the tests described are primarily engineering and biocompatibility evaluations, not diagnostic image interpretation studies requiring expert clinicians to establish ground truth.

4. Adjudication Method for the Test Set:

   • Not applicable. The tests are objective measurements against predefined engineering and material specifications, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. The document explicitly states: "No clinical investigations have been performed for the subject or predicate devices. Clinical data is not required for the demonstration of substantial equivalent based on the risk assessment in Section 10 and verification in Section 12 and validation in Section 13 summarized in this 510(k)." Therefore, no MRMC study was conducted.

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

   • Not applicable. This is a physical medical device (catheter), not an AI algorithm. Its performance is evaluated through engineering, material, and reprocessing verification and validation, not standalone algorithmic performance.

7. The Type of Ground Truth Used:

   • The "ground truth" for the non-clinical studies (biocompatibility, design validation/verification, cleaning validation) would be defined by established engineering specifications, material standards, and regulatory guidance documents. For example, for biocompatibility, it would be adherence to ISO 10993 standards and a lack of adverse biological responses. For cleaning validation, it would be a verifiable reduction in contaminants below a specified threshold.

8. The Sample Size for the Training Set:

   • Not applicable. As this is not an AI/algorithm-based device, there is no "training set" in the context of machine learning. The "development" and "testing" referred to are related to engineering design and physical performance testing.

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

   • Not applicable, as there is no training set for an AI algorithm.

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The Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter is designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter is designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter is a reprocessed single use device. After clinical use of the Visions PV .035 Digital IVUS Catheter (Manufactured by Philips), the IVUS catheter is shipped to Vein360 per established Vein360 instructions. Upon receipt, the Visions PV .035 Digital IVUS catheter is cleaned, inspected, functionally tested, hydrophilic coated, packaged and sterilized using ethylene oxide (EO) gas.

The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter is an over-thewire intravascular imaging catheter containing an ultrasound transducer located at the distal end of the catheter. This transducer utilizes a 64-element cylindrical array that radiates acoustic energy into the surrounding tissue and detects subsequent echoes. The information from the echoes is used to generate real-time images of the peripheral vessels.

The catheter is introduced percutaneously or via surgical cutdown into the peripheral vasculature. The catheter is designed to track over a maximum guidewire of 0.038" (0.97mm).

The catheter is 90cm in working length with 1cm inked markers (non-radiopaque) along the proximal shaft for length assessments during pull back. There are 25 radiopaque markers spaced 1cm apart along the distal shaft for quick length measurements under angiogram imaging. A hydrophilic coating is applied externally to the distal end of the catheter. The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter maintains all mechanical and electrical properties of the predicate device after reprocessing operations.

The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter may only be used with Volcano s5 Series and CORE Series imaging systems.

The Vein360 Reprocessed Visions PV.035 Digital IVUS catheter is not supplied with any accessories.

The Visions PV .035 Digital IVUS catheter can only be reprocessed once. All Vein360 Reprocessed Visions PV .035 Digital IVUS catheters are permanently marked to indicate it has been reprocessed.

The provided text describes the 510(k) summary for the Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter. This device is a reprocessed single-use device, meaning it is an original device that has been cleaned, inspected, functionally tested, repackaged, and sterilized for re-use. The performance data presented focuses on demonstrating that the reprocessed device is substantially equivalent to the new, unused predicate device.

Here's an analysis based on your request, highlighting what is available and what is not in the provided document:

Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct table of specific numerical acceptance criteria for various performance metrics alongside the reported results. Instead, it states that "Results of performance testing demonstrate the Vein360 Reprocessed Visions PV .035 Digital IVUS catheters are substantially equivalent to the predicate devices which are safe and effective for their intended use."

The types of tests performed indicate the areas where performance was assessed, and the conclusion of substantial equivalence implies that the reprocessed device met the necessary criteria in all these areas.

Inferred Acceptance Criteria (Implied by the tests performed) and Implied Performance:

Important Note: The document confirms that "The Vein360 Reprocessed Visions PV .035 Digital IVUS catheter is validated for one reprocessing cycle after successful completion of the above performance testing."

Study Information:

The provided document describes a bench and laboratory testing study (performance validation) to demonstrate substantial equivalence, rather than a clinical study involving human patients or a reader study typically associated with AI/CADe devices.

1. A table of acceptance criteria and the reported device performance:
   As detailed above, the document implies that acceptance criteria were met for various functional and material properties, but does not provide a specific table with numerical thresholds. The standard for a reprocessed device is typically that it performs "as well as or better than" the predicate device and that reprocessing does not adversely affect its performance, safety, or effectiveness.

2. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated. The document mentions that "Visions PV .035 Digital IVUS catheters were clinically used and then soiled with artificial test soil" for cleaning validation and performance validation. The exact number of catheters used for these tests is not provided.
   • Data Provenance: The studies are laboratory and bench tests on reprocessed devices, some of which were "clinically used" prior to reprocessing. The country of origin of this clinical use data (if it informs the "soiling" step) is not specified. The studies are by nature retrospective in terms of using already-used devices and then testing them.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This question is not applicable in the context of this device and study. The "ground truth" here is the performance of the predicate device (a new, unused IVUS catheter) and established engineering/performance standards for mechanical, electrical, and imaging properties. Experts would be involved in setting these standards and interpreting test results, but likely not in the typical "ground truth" establishment for image interpretation as seen in AI/CADe devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods are typically used in reader studies for diagnostic devices to resolve discrepancies in expert interpretations. This submission focuses on the physical and functional properties of a reprocessed medical device.

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. This type of study is specifically relevant to AI/CADe devices that assist human readers in diagnosis. The Vein360 Reprocessed Visions PV .035 Digital IVUS Catheter is an imaging catheter itself, not an AI diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is not an algorithm or AI device. The "performance" described is the catheter's ability to mechanically and electrically function to produce images, and the quality of those images.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" is primarily based on established engineering specifications and performance benchmarks of the original predicate device (Visions PV .035 Digital IVUS Catheter) and relevant industry standards for safety and performance of reprocessed medical devices. This includes:

   • Absence of residual soil/bioburden.
   • Dimensional accuracy.
   • Mechanical strength and flexibility.
   • Electrical signal integrity.
   • Image quality metrics (though specific metrics are not detailed).
   • Sterility.
   • Biocompatibility.

8. The sample size for the training set:
   Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set for an AI model.

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