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The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

The Intra-Operative Positioning System (IOPS) consists of a surgical navigation technology and a number of associated accessories. The navigation technology is a non-contact reusable multi-patient use device. The associated accessories are single use devices provided sterile (EtO).

The IOPS displays the position and orientation of sensor equipped catheters, guidewires, and tracking pad utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously acquired CT scan data. IOPS registers the location and orientation of the sensors in real time, superimposing navigation of the catheters and guidewires to the patient's vascular map displayed on a monitor. The system is for use as an adjunct to fluoroscopy and does not make a diagnosis.

The associated accessories include:

• Guidewire
• Catheters
• Fiducial Tracking Pad
• Guidewire Handle

The provided text is a 510(k) summary for the Intra-Operative Positioning System (IOPS®). It outlines the device, its indications for use, and a comparison to predicate devices, focusing on the justification for substantial equivalence. However, it does not contain a detailed study report with specific acceptance criteria and performance data in the structured format requested.

The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to existing devices, highlighting that changes in indications for use and software versions do not raise new questions of safety or effectiveness. It states that "Software verification was conducted to establish equivalency to the predicate device in safety and effectiveness" and "Design Validation, including usability testing, was performed to support the inclusion of all peripheral, aortic and aortic side branch vasculature vessels in the indications for use statement and to establish equivalency to the predicate device in safety and effectiveness."

Without a specific performance study report, I cannot provide a table of acceptance criteria and reported device performance, nor can I detail the sample sizes, data provenance, expert qualifications, or adjudication methods for a test set, nor can I provide information on MRMC studies or effect sizes. The document explicitly states "No animal testing was completed as a part of this submission," and "No clinical testing was completed as a part of this submission."

Therefore, based solely on the provided text, a comprehensive answer to your request is not possible. The information regarding acceptance criteria and performance data, as typically found in a detailed study, is not present here.

However, I can interpret what is provided and explain why the specific details you're asking for are missing from this type of FDA document:

This document is an FDA 510(k) clearance letter and summary. Its purpose is to demonstrate "substantial equivalence" of a new device to an already legally marketed predicate device, not necessarily to present a full, detailed clinical or performance study with all the metrics you've requested.

The "performance data" section states:

• Bench Testing: "Software verification was conducted to establish equivalency to the predicate device in safety and effectiveness." "Design Validation, including usability testing, was performed to support the inclusion of all peripheral, aortic and aortic side branch vasculature vessels in the indications for use statement and to establish equivalency to the predicate device in safety and effectiveness." It mentions that "physician targeting of three regions for cannulation" and "technicians were given test case scenarios and asked to place the tracking pad" were part of these studies.
• Animal Testing: "No animal testing was completed as a part of this submission."
• Clinical Testing: "No clinical testing was completed as a part of this submission."

This implies that the "proof" for meeting acceptance criteria was primarily based on:

1. Software Verification: Ensuring the new software version functions correctly and reliably, likely against pre-defined software requirements and potentially compared to the predicate's software performance. The acceptance criteria would be internal software validation metrics (e.g., bug rates, functional correctness tests).
2. Design Validation / Usability Testing (Benchtop): Assessing if the device, with its expanded indications, can be used safely and effectively as intended. This would involve simulated use cases. Acceptance criteria would likely relate to successful navigation/targeting within specified tolerances, ease of use, and lack of critical errors.

Based on the available text, here's what can be inferred or stated directly, along with what is missing:

Acceptance Criteria and Device Performance (Inferred/General from Text):

Detailed Study Information (Based on provided text):

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

   • As shown above, the document infers acceptance criteria from the statements about "software verification" and "design validation/usability testing" for "equivalency" and "safety and effectiveness" for the expanded indications.
   • Specific quantitative acceptance criteria (e.g., "accuracy > X mm") and their corresponding reported values are NOT detailed in this summary document. This level of detail would typically be found in the full submission, not the public-facing summary.

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

   • Sample Size: Not specified for the software verification or design validation/usability testing. It mentions "physician targeting of three regions" and "technicians were given test case scenarios," implying a small, representative sample, likely for a benchtop study, but no numbers are given.
   • Data Provenance: Implied to be prospective benchtop testing conducted specifically for this submission. Country of origin is not explicitly stated, but the company is US-based.

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

   • The document refers to "physician targeting" and "technicians." It does not specify the number or detailed qualifications beyond "physician" and "technician."
   • No "ground truth" in the sense of a diagnostic consensus is mentioned, as the device "does not make a diagnosis." The "ground truth" for these performance tests would likely be the known anatomical targets in the 3D models and potentially physical measurements of the device's accuracy during tracking.

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

   • Not applicable/Not mentioned. The testing described is operational/performance testing, not diagnostic interpretation requiring adjudication among readers.

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 MRMC study was done, nor is the device described as an AI or diagnostic device that assists human readers. The device is a "real time tip positioning and navigation system" that is an "adjunct to fluoroscopy." It does not involve human readers interpreting images with or without AI assistance.

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

   • The "Software verification" and underlying accuracy measurements (though not detailed here) would represent the standalone performance of the algorithm for tracking and positioning without human interaction, but its intended use is always human-in-the-loop as a navigation aid.

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

   • For this type of navigation device, the "ground truth" would be the physical accuracy of the electromagnetic tracking system relative to a known model or phantom, and the real-time overlay accuracy onto pre-acquired 3D CT scan data. This is an engineering and spatial accuracy ground truth, not a diagnostic or pathological ground truth as seen in imaging AI.

8. The sample size for the training set:

   • Not applicable/Not mentioned as this device is not described as a machine learning/AI device that requires a training set of images or data in the conventional sense. Its function is based on electromagnetic tracking and anatomical registration, not on learning from a large dataset to identify patterns or make predictions.

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

   • Not applicable, as there is no mention of a training set or machine learning components requiring labeled data.

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The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and quidewires used in endovascular interventions in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

IOPS Fiducial Tracking Pad is a sterile, single use tracking pad intended for use with the Intra-Operative Positioning System (IOPS), manufactured by Centerline Biomedical. It is equipped with a single tracking sensor allowing IOPS to track gross patient motion to allow maintenance of patient registration during a procedure. It will not track minor patient motion such as breathing or cardiac movement. The tracking pad is equipped with radiopaque beads which allow registration of a conebeam CT scan of the patient in their current position to a previously acquired CT scan.

IOPS Guidewire Handle is a sterile, single use, non-sensorized device intended for use with the Intra-Operative Positioning System (OPS) and its sensorized 0.035″ guidewire, manufactured by Centerline Biomedical. It is meant to be connected to an IOPS sensorized guidewire to allow detection and visualization of the guidewire tip position, in real time, on a 3D rendering of the patient's vascular map.

The provided text is an FDA 510(k) summary for the Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad) and Intra-Operative Positioning System (IOPS®) (Guidewire Handle). It describes the device, its intended use, comparison to predicate devices, and a summary of non-clinical testing.

However, the document does not contain information regarding detailed acceptance criteria, specific device performance metrics against those criteria, or a study that proves the device meets the acceptance criteria with quantitative results. It primarily focuses on demonstrating substantial equivalence to predicate devices through a comparison of technological characteristics and a list of conducted non-clinical tests.

Therefore, many of the requested fields cannot be directly extracted from the provided text. I will answer based on the information available and indicate where information is not present.

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

The document lists "Accuracy Testing with IOPS per ASTM F2554" as a conducted test, implying accuracy is an acceptance criterion. However, specific acceptance criteria values (e.g., "accuracy shall be less than X mm") and the reported device performance against these criteria are not provided in this summary.

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

This information is not provided in the given text. The document only lists the types of non-clinical tests performed.

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 given text. The device is a positioning system, and the "ground truth" would likely be based on physical measurements or established anatomical references, not expert interpretation of data.

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

This information is not provided in the given text. This type of adjudication is typically relevant for studies involving human interpretation or clinical outcomes, which are not detailed here for the non-clinical 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in the provided text, as this is a non-clinical evaluation for device substantial equivalence. The device is a "Programmable Diagnostic Computer" for positioning and is indicated "as an adjunct to fluoroscopy," but the submission focuses on hardware components (Fiducial Tracking Pad, Guidewire Handle) and their non-clinical validation.

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

A standalone performance evaluation of the algorithm and system was implicitly done through the "Non-Clinical Testing" which included "Accuracy Testing with IOPS per ASTM F2554" and "Device Functionality and Essential Performance." However, specific details of the standalone performance are not provided in the given text, such as quantitative metrics.

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

For the non-clinical tests listed, the ground truth would likely be established through physical measurements against known standards or validated instruments (e.g., for accuracy, tensile strength, dimensions). The exact methods for establishing this ground truth for each test are not specified in the provided text.

8. The sample size for the training set

This information is not provided in the given text. The document describes a non-clinical evaluation for substantial equivalence, not a machine learning model development process requiring a distinct training set.

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

This information is not provided in the given text, as no training set for an AI/ML model is mentioned.

Ask a specific question about this device

The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor-equipped compatible catheters and guidewires used in endovascular interventions in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

The IOPS Viewpoint Catheters are sterile, single use 6 Fr catheters intended for use with the Intra-Operative Positioning System (IOPS), manufactured by Centerline Biomedical. They are designed to be inserted into the femoral artery, brachial artery, or axillary artery and navigate through vasculature in the descending aorta to access branch vessels near to, or involved in, the lesion during endovascular procedures. The IOPS Viewpoint Catheters are available in two tip shape configurations (Simple and Double). Each tip shape is available in two lengths (75cm and 125cm). All models are equipped with multiple tracking sensors allowing the loPS to detect and visualize the catheter tip position and shape, in real time, on a 3D rendent's vascular map. The catheters have a radiopaque marker near the distal tip and a luer locking hub on the proximal end.

The provided text describes a 510(k) premarket notification for the Intra-Operative Positioning System (IOPS®) Viewpoint Catheters. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria for an AI/algorithm-based diagnostic device.

Therefore, many of the requested details regarding acceptance criteria, study design for AI evaluation (e.g., sample sizes for training/test sets, expert ground truth establishment, MRMC studies, standalone performance), and ground truth methodologies are not available within this document. The document primarily reports on non-clinical testing to ensure the physical and functional aspects of the catheter meet safety and performance standards for a medical device.

Here's a breakdown based on the provided text, highlighting what is and isn't available:

Acceptance Criteria and Device Performance

The document does not present a table of specific acceptance criteria for an AI/algorithm's performance (e.g., sensitivity, specificity, accuracy targets). Instead, it lists various non-clinical tests performed on the catheter device itself to establish its safety and effectiveness. The "device performance" reported is the successful completion of these tests, indicating the catheter performs as intended.

Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing of the Catheter):

Details Not Available in the Provided Text (Pertaining to AI/Algorithm Performance):

The document describes the IOPS Viewpoint Catheters, which are "sensor-equipped compatible catheters and guidewires" used with the "Intra-Operative Positioning System (IOPS)". The IOPS system itself "visualize[s] the catheter tip position and shape, in real time, on a 3D renders vascular map." This suggests that the "IOPS" has an underlying algorithm for positioning and navigation, but the provided text focuses on the catheters as the subject devices for the 510(k) submission. Therefore, information typical for an "AI/algorithm performance study" is absent.

2. Sample size used for the test set and the data provenance: Not applicable/not provided for AI algorithm evaluation. The document mentions "simulated use in an abdominal aorta model" as a test for the catheter, but not as an AI test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/not provided. The device is an "adjunct to fluoroscopy" for real-time tip positioning and navigation, not a diagnostic AI system assisting human readers in interpreting medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided explicitly for the algorithm. The "Sensor functionality, placement, and accuracy" and "Accuracy testing with IOPS per ASTM F2554" of the catheter itself imply testing of the system's ability to track the catheter, but not a standalone AI diagnostic performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided for an AI algorithm. For the catheter, the ground truth for testing would be physical measurements and established engineering standards.
8. The sample size for the training set: Not applicable/not provided.
9. How the ground truth for the training set was established: Not applicable/not provided.

Ask a specific question about this device

The IOPS® (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured via 3D modeling from previously acquired scan data. It is intended for real time tip positioning and navigation using sensor equipped compatible catheters and guidewires used in endovascular interventions in the descending aorta. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.

The IOPS system displays the position and orientation of sensor equipped guidewires and catheters utilizing electromagnetic tracking technology. The system enables mapping of the patient's vascular system utilizing previously acquired CT scan data. IOPS registers the location and orientation of the sensors in real time superimposing navigation of the catheters and guidewires to the patient's vascular map.

The provided text is a 510(k) summary for the Intra-Operative Positioning System (IOPS®). It describes the device, its intended use, technological characteristics, and non-clinical testing performed to establish substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria for performance based on a test set, expert ground truth, or MRMC studies.

Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared device (IOPS 1.0, K190106) due to minor hardware changes (for obsolescence) and a software update. The non-clinical testing mentioned is primarily related to electrical safety, electromagnetic compatibility, and immunity to RFID readers, which are general safety and performance standards rather than specific acceptance criteria for the navigational accuracy or clinical effectiveness in the context of the device's indications for use.

Therefore, I cannot populate the requested table or answer most of the questions, as the information is not present in the provided document. The document confirms:

• No specific acceptance criteria table for device performance (e.g., accuracy, precision) is provided.
• No study proving the device meets clinical performance acceptance criteria is detailed.
• No information about a test set, its sample size, or data provenance for clinical performance evaluation is given.
• No mention of experts establishing ground truth, adjudication methods, or MRMC studies for clinical performance.
• No standalone algorithm performance study is described for clinical outcomes.
• No information on ground truth type (expert consensus, pathology, outcomes data) for clinical performance.
• No details are given about a training set for the software, its size, or how its ground truth was established.

The summary strongly implies that the core navigation technology (Aurora® V3 System) is an off-the-shelf, integrated component, and the submission's focus is on labeling modifications and general safety compliance for the updated IOPS system.

Therefore, the response is:

The provided document, a 510(k) summary for the Intra-Operative Positioning System (IOPS®), does not contain the specific information requested regarding acceptance criteria for device performance, the study methods used to prove these criteria, details on test sets, ground truth establishment, expert involvement, or MRMC studies.

The submission primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (IOPS 1.0, K190106) based on minor hardware updates (for obsolescence) and a software revision. The non-clinical testing mentioned (ANSI AAMI ES60601-1, IEC 60601-1-2, AIM 7351731 Rev. 2.00) relates to general electrical safety, essential performance, electromagnetic compatibility, and RFID immunity, rather than clinical performance metrics of the device's navigation capabilities against a defined ground truth.

Specifically, the following information is not available in the provided text:

1. Table of acceptance criteria and reported device performance: Not provided. The submission states the navigation system has a "high degree of accuracy" and "position error of approximately ±1 mm," which it deems "sufficient," but these are descriptive statements, not formally presented as acceptance criteria for a study.
2. Sample size used for the test set and data provenance: No information on a test set used to evaluate the device's clinical performance against specific acceptance criteria.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no such clinical performance test set or ground truth establishment process is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and effect size: Not described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No information about a standalone performance study for clinical efficacy.
7. The type of ground truth used: For the device's intended use (navigation), the text implies that the Aurora® system calculates sensor positions with high accuracy. For clinical application, the IOPS uses pre-operative CT scans and correlated tracking pad data, alongside real-time sensor readings, to superimpose location on a vascular map. However, there is no explicit mention of ground truth in the context of a performance study to prove the device meets acceptance criteria. The ±1mm accuracy is stated as a system capability, not a study outcome.
8. The sample size for the training set: Not provided. The document mentions "proprietary software" for image generation and processing, but no details on training data.
9. How the ground truth for the training set was established: Not provided.

The key takeaway is that this 510(k) summary focuses on demonstrating substantial equivalence through standard safety and performance testing and minor modifications, rather than a de novo clinical performance study with specific acceptance criteria as might be seen for novel AI-driven diagnostic devices.

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