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The EndoSonics Trak Back is intended for use as a pull back accessory to the EndoSonics Intravascular Ultrasound Imaging Catheters. The Trak Back Device withdraws the imaging catheter from the vessel through the guide catheter.
The Trak Back can be used with the Visions Five-64 series ultrasound imaging catheter. The Trak Back withdraws the imaging catheter from the vessel through the guide catheter.

The Trak Back is a battery powered device that is used in the catheterization laboratory during intravascular ultrasound assessment. The Trak Back has a nominal linear travel distance which is only limited by the catheter length, and provides a uniform, slow pull back rate of the catheter's imaging element. The speed is selectable between 1 mm/sec or 0.5mm/sec. The Trak Back has no direct patient contact. The device is constructed of materials common to the medical industry for both patient and non-patient contact devices and equipment.

The provided text is related to a 510(k) Premarket Notification for the EndoSonics Trak Back Device, an accessory for intravascular ultrasound imaging. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, or details about the study that proves the device meets the acceptance criteria, based on the provided text.

The document is a regulatory submission for a medical device and primarily focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed performance study results against specific criteria.

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The Visions catheters are 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 Visions ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide:

• An image of the vessel lumen and wall structures. (1)
• (2) Dimensional measurements from the image.

The Visions 8.2F PV catheter is a diagnostic device intended for use in diagnostic ultrasound imaging of the peripheral vasculature.

The Visions 8.2F PV is available in an over-the-wire design. The catheter has a 7.0F shaft with a maximum distal diameter of 8.2F.

The provided text describes a 510(k) premarket notification for the EndoSonics Visions 8.2F PV Intravascular Imaging Catheter. The submission aims to establish substantial equivalence to predicate devices, rather than proving performance against specific acceptance criteria through a clinical study for an AI/ML device.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable and not found within this document. This is because the device being reviewed is a physical medical device (an ultrasonic imaging catheter), not an AI/ML software.

However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its safety and performance based on the provided text.

Here's a summary of the available information structured to best fit your request:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested points (relevant for AI/ML studies):

• 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device submission, not an AI/ML study. The testing mentioned (radiopacity, tensile strength, etc.) would be performed on a sample of manufactured devices, not on a "test set" of patients or data in the AI sense.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for diagnostic accuracy in the AI/ML context is being established here. Performance is based on engineering and safety specifications.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 not an AI-assisted device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device type would relate to objective engineering measurements rather than clinical interpretations/diagnoses.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular, Other (Specify) Intravascular

The EndoSonics Resolve option for the Oracle Imaging system is designed for use in conjunction with imaging catheters for use during diagnostic ultrasound imaging of the peripheral and coronary vasculature to provide an alternative 2D display of ultrasound information. This additional display information is provided in addition to the standard 2D echo image. Information collected during uniform withdrawal of the imaging catheter from the artery is presented in a longitudinal display. The Resolve option also provides a computer assisted boundary detection function which helps identify boundaries within the image, which the operator must explicitly accept or correct before measurements can be performed on these boundaries.

This 510(k) summary for the EndoSonics Resolve Option for the Oracle InVision Intravascular Imaging System does not contain detailed acceptance criteria or a study that rigorously proves the device meets specific performance metrics. It primarily focuses on demonstrating substantial equivalence to predicate devices, which is the core requirement for 510(k) clearance.

However, based on the provided text, we can infer some aspects related to the device's function and potentially implied "acceptance criteria" through its description and comparison to predicate devices. It is crucial to understand that this is an interpretation based on limited information, and not explicit performance data.

Here's a breakdown of what can be extracted:

Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, explicit quantitative acceptance criteria for image analysis software are rarely presented in the summary itself. Instead, the focus is on functional equivalence and safety.

Study Details (Based on the Provided Text)

Unfortunately, the provided 510(k) summary does not describe a specific scientific study with a defined test set, ground truth, or expert review process to demonstrate the performance of the "Resolve Option" software in terms of its longitudinal display or boundary detection capabilities.

The primary "study" or justification for clearance in a 510(k) is the demonstration of substantial equivalence to predicate devices. This typically involves:

1. Comparison of Indications for Use: The Resolve option is for "diagnostic ultrasound imaging of the peripheral and coronary vasculature to provide an alternative 2D display...", which is considered equivalent to existing systems.
2. Comparison of Technological Characteristics: The software adds an "alternative 2D display" and "computer assisted boundary detection." The key argument is that the acoustic output remains unchanged.
3. Performance Data (if applicable): For software features like "computer assisted boundary detection," robust clinical performance studies might be expected in more recent submissions, but this document (1998) does not detail one. The implicit 'performance' is that the operator can accept or correct the boundaries successfully.

Given this, the following points can be addressed with the available information:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified. There is no mention of a test set for evaluating the performance of the "Resolve Option" features (longitudinal display, boundary detection).
   • Data Provenance: Not specified. No country of origin or whether data was retrospective/prospective is mentioned, as no specific performance study is detailed.

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

   • Not applicable. No ground truth establishment process for a test set is described. The "ground truth" for the identified boundaries is ultimately the operator's explicit acceptance or correction, transforming the computer-assisted function into a user-controlled measurement tool.

3. Adjudication method for the test set:

   • Not applicable. No test set or adjudication process is described. The "adjudication" for boundary detection is the singular operator's decision to accept or correct.

4. 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. This type of study is not mentioned or described in the 510(k) summary. The "computer assisted boundary detection function" is presented as an aid that the operator validates, rather than a system designed to improve human reader performance through a comparative effectiveness study.

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

   • No. The description explicitly states the "operator must explicitly accept or correct before measurements can be performed." This indicates the device is not intended for standalone use for final measurements. Its function is to "help identify boundaries," implying an assistance role.

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

   • Not applicable for algorithm performance validation. As mentioned, for the boundary detection feature, the "ground truth" for measurement purposes is established by the operator's explicit acceptance or correction of the computer-identified boundaries. For the overall system, the ground truth for "substantial equivalence" is its clinical utility as perceived by comparison to predicate devices, rather than a specific pathological or outcomes benchmark for the added software features.

7. The sample size for the training set:

   • Not specified. As no detailed algorithmic development or validation study is provided, the training set size for the boundary detection algorithm (if it was a machine learning algorithm, which is unlikely for 1998 in this context) is unknown.

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

   • Not specified. As no training set or algorithm development details are provided, the method for establishing its ground truth is unknown.

Conclusion:

The provided 510(k) summary for the EndoSonics Resolve Option primarily serves to demonstrate substantial equivalence to existing devices for market clearance. It describes the new functional features (longitudinal display and computer-assisted boundary detection) but does not include a detailed scientific study with defined acceptance criteria, test sets, ground truth establishment, or expert reviews to quantify the performance of these features. The "acceptance criteria" are largely implicit in the claim of substantial equivalence and the design that requires operator validation for boundary detection.

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Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intra-Luminal, Peripheral Vascular, Other (Specify)
This system is indicated for intra-luminal use in both peripheral and coronary applications. There is no difference in operation on acoustic outputs when used for coronary or peripheral vascular imaging.

The Endosonics ColorFlo Option for the Oracle Imaging System is designed for use in conjunction with imaging catheters for use during diagnostic ultrasound imaging of the peripheral and coronary vasculature to provide blood flow information. This additional flow information is provided as a color over the standard 2D echo image.
The ColorFlo technology can provide a two dimensional map of relative blood velocity which is overlayed onto the conventional black and white intravascular ultrasound image. Regions which contain faster moving red blood cells are signified by brighter colors, whereas regions of slow motion are less bright. Regions in which there is no or little motion perpendicular to the transducer are presented as clear, or non-colored. These regions appear in grey scale as in the standard display.
The ColorFlo processor detects flow of particles (red blood cells) perpendicular to the imaging plane, or along the long axis of the catheter. This is unlike conventional doppler imaging in which the blood must flow towards or away from the transducer. This is possible by utilizing ultrahigh speed electronics and Endosonics propritary algorithms.
The ColorFlo system can detect blood velocities in the following range:
The lower limit on particle detection is between 12 cm/sec and 5 cm/sec, depending on the intervening attenuation. (The higher limit is obtained with maximum tissue attenuation between the transducer and region of flow.)
The upper limit on particle detection is between 110 cm/sec and 107 cm/sec, depending on the intervening attenuation. (The lower limit is obtained with maximum tissue attenuation between the transducer and region of flow.)
The ColorFlo Option is available on the Endosonics Oracle InVision Imaging System. This option is an internal option, and no changes to the physical appearance of the system are made with the exception of an additional key on the keyboard.

The provided 510(k) summary for the Endosonics ColorFlo Option for the Oracle InVision Intravascular Imaging System does not contain explicit acceptance criteria or a dedicated study section detailing performance metrics against such criteria.

The document focuses on substantiating substantial equivalence to predicate devices and describing the technology. However, it does report specific performance capabilities of the ColorFlo system regarding blood velocity detection. We can infer these reported capabilities act as implicit performance benchmarks.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria are not stated, we will use the reported performance characteristics as the "reported device performance."

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

This information is not provided in the summary. There is no mention of a specific test set, its sample size, or its provenance (country, retrospective/prospective).

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

This information is not provided. The document does not describe any expert involvement in establishing ground truth for a test set.

4. Adjudication Method

This information is not provided. There is no mention of an adjudication method, as no test set or expert review process is described.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The summary focuses on the technical capabilities of the device itself rather than human-in-the-loop performance or comparison with human readers.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study, in the sense of an algorithm-only evaluation against a ground truth, is implicitly described through the stated velocity detection ranges and acoustic outputs. The summary outlines the technical specifications and capabilities of the ColorFlo processor and associated catheters without human interaction as part of its core description (e.g., "The ColorFlo system can detect blood velocities in the following range..."). However, it's not presented as a formal "study" with a defined methodology, test set, and reported metrics in the way modern AI device submissions typically detail.

7. Type of Ground Truth Used

The ground truth used for verifying the reported velocity detection capabilities and other technical specifications is implied to be derived from physical measurements and engineering validation. For instance, the velocity detection ranges would likely be established in controlled laboratory settings using flow phantoms or calibrated flow systems. The acoustic outputs are typically measured using standardized hydrophones. The document does not refer to expert consensus, pathology, or outcomes data as ground truth for these specific performance claims.

8. Sample Size for the Training Set

This information is not provided. The ColorFlo option utilizes "Endosonics proprietary algorithms," but there is no mention of a training set size, suggesting the algorithms were likely developed based on engineering principles and signal processing, rather than machine learning requiring a distinct training dataset in the modern sense.

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

This information is not provided for the same reasons as point 8. If "proprietary algorithms" were used, their development likely relied on theoretical models, simulations, and empirical testing in laboratory environments, rather than a "training set" with established ground truth as understood in contemporary machine learning.

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The Endosonics Automatic PBD is intended for use as a pull back accessory to the Endosonics Intravascular Ultrasound Imaging catheters. The Automatic Pull Back Device withdraws the imaging catheter from the vessel through the guide catheter.

The Automatic PBD is a battery powered device that is used in the catheterization laboratory during intravascular ultrasound assessment. The Automatic PBD has a nominal linear travel distance of approximately 12 cm and provides a uniform, slow pull back rate of the catheter's imaging element. The speed is selectable between 1 mm/sec or 0.5mm/sec. The Auto PBD has no direct or indirect patient contact. The device is constructed of materials common to the medical industry for both patient and non-patient contact devices and equipment

This 510(k) summary describes a basic accessory device, an "Automatic Pull Back Device," which is used in conjunction with an intravascular ultrasound imaging system. As such, the information typically associated with complex AI/ML device evaluations (like detailed performance studies, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance) is not applicable and therefore not provided in the document.

Here's an analysis based on the provided text, focusing on what can be extracted and explicitly stating what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit "acceptance criteria" in the sense of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI/ML device. For this hardware accessory, substantial equivalence is based on functional characteristics rather than diagnostic performance.

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

This information is not applicable and not provided in the document. The submission is for a hardware accessory, not a diagnostic device requiring a clinical test set with patient data for performance evaluation. The "study" described is a declaration of substantial equivalence based on a comparison of device characteristics to existing legally marketed predicate devices.

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

This information is not applicable and not provided. "Ground truth" in the context of expert review is relevant for diagnostic or AI/ML devices. For this mechanical accessory, there is no "ground truth" to be established by experts in the context of a clinical performance study.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert interpretations for diagnostic studies. This is not relevant for this device.

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

This information is not applicable and not provided. MRMC studies are designed to compare the performance of human readers, often with and without AI assistance, for diagnostic tasks. This device is a mechanical accessory and does not involve human reader interpretation or AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable and not provided. This device is a mechanical pull-back device, not an algorithm or AI system. Therefore, standalone algorithm performance is not a concept that applies here.

7. Type of Ground Truth Used

This information is not applicable and not provided. Again, "ground truth" in the context of pathology, outcomes data, or expert consensus is relevant for diagnostic performance validation, not for a simple mechanical accessory. The "truth" for this device lies in its functional specifications and comparison to predicate devices, not clinical outcomes it determines.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device does not involve machine learning or AI, and therefore, there is no "training set."

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

This information is not applicable and not provided. As there is no training set, there is no ground truth to establish for it.

In summary: The provided 510(k) summary relates to a mechanical accessory and demonstrates substantial equivalence based on functional and technological characteristics compared to predicate devices. It does not involve AI/ML technology, and thus, the detailed performance study and validation criteria typically associated with such devices are completely absent and irrelevant to this submission. The "study" here is essentially a comparative analysis of specifications and intended use against existing market products.

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