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The pREBOA-PRO Catheter is intended for temporary partial or complete occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The pREBOA-PRO™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a semi-compliant balloon, in-line pressure relief valve (safety valve), atraumatic distal tip (P-tip™), dual lumen catheter shaft and a hub with extension lines to provide access to each lumen.

The pREBOA-PRO™ Catheter is designed with flow channels to enable precise, smooth control of inflation and deflation of the balloon. Instructions for how to titrate the balloon for partial occlusion, if so desired by the clinician, are included in the Instructions for Use.

The device has an effective length of 72 cm and is compatible with 7 Fr introducer sheaths as shown in the compatibility section of the IFU. The catheter has a unibody design and is intended to be placed and advanced without a guidewire. In addition, the catheter is compatible with guidewires up to 0.025" that may be used to facilitate subsequent vascular procedures after a REBOA procedure. An orange peel-away sheath is preloaded on the catheter shaft covering the balloon to ease insertion of the catheter's P-tip™ into an introducer sheath hemostasis valve. A catheter shaft provides appropriate stiffness with a distal tip (P-tip™) designed for atraumatic advancement of the catheter in a blood vessel. Pad printed marks on both sides of the outer catheter shaft indicate distance to the center of the balloon as well as average insertion depth ranges to the center of aortic Zones 1 and 3 to facilitate proper placement. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate and visualize accurate balloon placement when used with imaging. The proximal end of the catheter has a hub and extension lines. The arterial line lumen is used to monitor blood pressure above the balloon. Below the balloon core aortic pressure monitoring is possible through the side arm of the sheath. The balloon lumen is used to inflate and deflate the balloon as needed. An in-line safety valve is connected to the balloon lumen stopcock and is designed to help prevent over-inflation of the balloon. The stopcocks provide control to each of the catheter's two lumens. The orange peel-away sheath can be separated from the catheter shaft after insertion if needed. The device is a single-use, sterile device.

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The Bridge Plus Occlusion Balloon catheter is is indicated for temporary vessel occlusion of the Superior Vena Cava (SVC) and Inferior Vena Cava (SVC) in applications including perioperative occlusion and emergency control of hemorrhage.

The Bridge Plus Occlusion Balloon is designed to be delivered percutaneously to the superior vena cava (SVC) or the inferior vena cava (IVC) for the purpose of providing occlusion, emergency control of hemorrhage and perioperative occlusion in the event of an SVC or IVC tear or perforation during a vascular procedure.

The Bridge Plus Occlusion Balloon catheter is constructed of a compliant polyurethane balloon mounted on a 12Fr dual lumen nylon shaft. This guidewire lumen is used to pass the catheter over a guidewire. The balloon has a length of 80mm and inflation diameter ranging from 20-29mm. Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC or IVC prior to inflation.

This FDA 510(k) clearance letter pertains to a medical device, the Bridge Plus Occlusion Balloon, and therefore the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the performance specifications and verification/validation testing described in the submission, rather than clinical study endpoints for AI/software devices. The provided document does not describe a study involving human readers or AI algorithms.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various Design Verification and Validation Testing categories. For these types of medical devices, the "acceptance criteria" would be the pre-defined performance specifications for each test, which the device must meet to be considered safe and effective and substantially equivalent to a predicate device. The "reported device performance" indicates that the Bridge Plus Occlusion Balloon met these specifications.

Note: The document does not provide the specific quantitative acceptance criteria or detailed numerical performance results for each test. Instead, it states that "Performance testing data have demonstrated that the Bridge Plus Occlusion Balloon meets performance specifications to support substantial equivalence to the predicate devices." and that the conducted tests "validate and verify that the subject device met all specifications."

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

The document describes laboratory and bench testing rather than clinical studies with "test sets" of patient data. Therefore, the concept of sample size for a test set of data and data provenance (country of origin, retrospective/prospective) is not applicable in the context of this device's submission. The testing was conducted on the physical device itself.

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

Since this is a physical medical device (occlusion balloon) and not an AI/software device, the concept of "ground truth established by experts" for a test set is not applicable. Device performance was evaluated against engineering specifications and industry standards.

4. Adjudication Method for the Test Set

As this is not an AI/software device or a clinical study with subjective assessments, an "adjudication method" for a test set is not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic AI products where human reader performance is being evaluated with and without AI assistance. The Bridge Plus Occlusion Balloon is a physical medical device for temporary vessel occlusion.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

For this physical medical device, the "ground truth" is defined by engineering specifications, recognized industry standards (e.g., ISO for sterilization and biocompatibility), and performance benchmarks established by predicate devices. The device's physical and mechanical properties were tested against these pre-defined quantifiable criteria.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this physical medical device. Training sets are used for machine learning algorithms.

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

Since there is no "training set" for this physical device, the method for establishing its "ground truth" is not applicable.

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The preCARDIA device is intended for use in selectively stopping or controlling blood flow of the inferior and superior vena cava in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring.

The preCARDIA System is for use in selectively stopping or controlling blood flow of the inferior and superior vena cava, in applications including perioperative procedures in patients requiring emergency control of hemorrhage, and for blood pressure monitoring. The System includes a Balloon Occlusion Catheter (Catheter), Controller and Console. The Catheter has an atraumatic endovascular balloon that has been attached to the proximal portion of a commercially available Thermodilution (TD) Catheter. The single use, 110 cm disposable catheter comes in two balloon locations, 34 and 36 cm measured from the distal end of the catheter and is provided sterile. The catheter placement procedure is performed under fluoroscopy by clinicians trained in endovascular techniques. The balloon includes proximal and distal radiopaque markers to allow for visualization and confirmation of proper placement in the IVC or SVC. Following placement and securement of the catheter, the patient can be transferred to the operating room or other appropriate care location where selectively stopping or controlling blood flow in the SVC or IVC will continue alongside other standard of care treatments. The primary operating principle of the preCARDIA System is the selective stopping or controlling of the blood flow in the IVC or SVC through either sustained inflation or successive inflation and deflation cycles of the balloon as regulated by the Controller.

The provided text is a 510(k) summary for the preCARDIA Occlusion System. It details the device, its intended use, and a comparison with predicate devices. While it lists various performance tests conducted, it does not contain specific acceptance criteria or the reported device performance for an AI/ML-based device.

The document outlines bench testing and an animal study to evaluate the performance of the preCARDIA Catheter. However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for a test set or data provenance for an AI/ML context.
• Information on expert ground truth establishment (number of experts, qualifications, adjudication method).
• Details on MRMC studies or a standalone algorithm performance.
• The type of ground truth used relevant to AI/ML (e.g., pathology, outcomes data).
• Sample size for a training set or how ground truth was established for AI/ML training data.

The text is for a physical medical device (vascular clamp/occlusion system), not an AI/ML algorithm. Therefore, the concepts requested in the prompt, such as "acceptance criteria for an AI/ML model," "training set," "test set," "ground truth," "expert consensus," and "MRMC study," are not applicable to the content provided.

Based on the provided document, I cannot fulfill the request as it pertains to AI/ML device validation. The document describes the regulatory submission for a physical medical device and its associated non-AI/ML performance testing.

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The LANDMARK REBOA Catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

The LANDMARK REBOA Catheter is a 67cm, 59cm working length, 6.5 Fr (2.2mm), single lumen balloon catheter for temporary intravascular vessel occlusion in patients requiring emergency control of hemorrhage. Radio-opaque markers are provided on the catheter shaft at the proximal and distal ends of the balloon for radiological location of the device is additionally provided with depth markings referenced from the balloon to provide positioning information similar to the predicate device prior to confirmation of placement through radiological means. The device is intended to be deployed through a 7F introducer sheath placed into the femoral artery through normal vascular access procedures.

The LANDMARK REBOA Catheter consists of five elements:

• . Occluder Balloon Inflation Lumen with female luer (DEHP free PVC)
• Catheter Handle (PA 12)
• Catheter Shaft (polyimide and stainless steel) with Marker Bands (stainless steel)
• Occluder Balloon (polyurethane)
• Guide J-tip (stainless steel, nitinol, acrylic) ●

The provided text is a 510(k) summary for the LANDMARK REBOA Catheter. While it outlines non-clinical testing performed to establish substantial equivalence to a predicate device, it does not contain information about studies involving human readers, AI assistance, or the use of expert consensus for ground truth. This device, a physical medical catheter, is evaluated based on its physical performance characteristics and biocompatibility, not on diagnostic accuracy derived from image analysis or human interpretation.

Therefore, many of the requested points regarding acceptance criteria and studies would not be applicable in this context. The document focuses on demonstrating that the new device performs comparably to a legally marketed predicate device through bench testing and an animal model, rather than validating a diagnostic algorithm's performance.

Here's an attempt to answer the applicable points based on the provided text, with an explanation for the missing information:

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

The document doesn't present a specific table of "acceptance criteria" with quantitative performance metrics for each test in the way one might for a diagnostic AI. Instead, it states that "Performance bench testing was conducted to ensure that the LANDMARK REBOA Catheter met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system."

The tests performed and implicitly, the criteria for passing them, are:

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

• Test Set Sample Size: Not explicitly stated for each bench test. The "In Vivo Testing" mentions an "acute Porcine model," implying a number of animals were used, but the specific count is not provided.
• Data Provenance: The bench testing and simulated use are laboratory-based, not patient data. The In Vivo testing was conducted using a Porcine (pig) model. The country of origin for the data is not specified, but the company is based in Salt Lake City, Utah, USA. The studies are prospective in nature, as they involve testing the manufactured device.

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

Not applicable. This device is a physical medical instrument, and its performance is assessed through engineering and biological in-vivo tests, not through expert interpretation of images or other data for diagnostic accuracy. "Ground truth" for this type of device relates to its physical performance meeting specifications (e.g., does the balloon burst at X pressure, does it occlude the vessel completely).

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

Not applicable. As this isn't an algorithm or diagnostic study relying on human interpretation or consensus, there's no adjudication process as described (e.g., for reconciling differing expert opinions).

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 device does not involve AI assistance for human readers or interpretation of medical images.

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 consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance in engineering and biological tests is derived from:

• Pre-defined engineering specifications and standards (e.g., pressure tolerances, material properties, dimensional accuracy).
• Observed physical and physiological responses in the animal model (e.g., successful occlusion, lack of damage to vessel walls, device integrity after deployment).
• Compliance with recognized standards like ISO 14971:2019 (risk analysis) and ISO 10993 (biocompatibility).

8. The sample size for the training set

Not applicable. This device is not an AI model requiring a training set.

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

Not applicable. This device is not an AI model.

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The Fogarty Occlusion Catheters are indicated for temporary vessel occlusion.
The Large Occlusion Catheters are intended to be used for temporary occlusion in the aorta, vena cava and internal jugular vein.
The Small Occlusion Catheters are intended to be used for temporary occlusion in the peripheral vascular system.

Models: 620403F, 620404F, and 620405F
The Fogarty Small Occlusion Catheters (4F, 5F) consist of a single-lumen polyvinylchloride catheter body with a latex balloon at the distal end and a gate valve at the proximal end. The 3F Fogarty Occlusion Catheter is made of Nylon. The catheter lumen is used for inflation of the balloon via a syringe connected to the gate valve. A removable stainless-steel stylet is provided with each catheter to maintain the straight catheter shape and to ensure that the lumen remains opened during storage of the product.
Models: 62080814F and 62080822F
The Fogarty 8F Large Occlusion Catheters consist of a single-lumen polyvinylchloride catheter body with a latex balloon at the distal end and a gate valve at the proximal end. The catheter lumen is used for inflation of the balloon via a syringe connected to the gate valve. A removable stainless-steel stylet is provided with each catheter.

This document is a 510(k) premarket notification for the Fogarty Occlusion Catheter, indicating substantial equivalence to a predicate device. It's important to note that a 510(k) clearance does not involve clinical studies with human participants where AI performance is measured against human readers or a ground truth established by experts. Instead, it focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

In this specific case, the submission emphasizes that the new device is identical to the predicate device in terms of intended use, indications for use, and technology. The changes proposed are related to new model numbers for existing devices, a new alternative packaging configuration, new labels, and updates to the Instructions For Use (IFU). Therefore, the "acceptance criteria" and "study" described are focused on proving that these packaging and labeling changes do not alter the device's performance or safety from the established predicate.

Given this context, many of the typical questions for AI/CADe devices regarding acceptance criteria, ground truth, expert involvement, and MRMC studies are not applicable.

Here's an interpretation based on the provided document:

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

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

• The document does not specify sample sizes for each test mentioned (e.g., how many packages were tested for integrity, how many catheters were tested for performance).
• The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. These tests are typically conducted in a laboratory setting by the manufacturer.

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 510(k) submission. The "ground truth" here is compliance with established engineering and manufacturing standards (e.g., ISO standards) and performance specifications of the predicate device. There is no expert review of images or clinical data to establish a diagnostic ground truth.

4. Adjudication method for the test set:

• This question is not applicable. As there is no "ground truth" based on expert consensus for clinical interpretation, there is no need for an adjudication method. The tests are objective measurements against predefined standards.

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 question is not applicable. This submission is for a physical medical device (an occlusion catheter) and does not involve AI or any form of image interpretation where human readers would be "assisted" by AI.

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

• This question is not applicable. This device does not have an algorithm or standalone performance in the context of AI.

7. The type of ground truth used:

• The "ground truth" in this context refers to compliance with recognized industry standards (e.g., ISO 11607-1, ISO 11135:2014, ISO 10993-7:2008) and engineering performance specifications that are identical to the predicate device.

8. The sample size for the training set:

• This question is not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device submission.

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

• This question is not applicable. As there is no training set, there is no ground truth establishment for it.

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The RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapentic agents, to selected sites in the peripheral vascular system. The RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vesses ranging between 3mm to 11mm in diameter.

The diagnostic and/or therapents are to be used in accordance with specifications outlined by the respective agent manufacturer.

The RenovoCath is a multi-lumen, dual-balloon catheter with a two-part handle that is designed for targeted delivery of fluids, including radiopaque material and therapeutic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The effective length is 75cm to 85cm (adjustable). Radiopaque markers are located between the balloons to allow for identification of targeted site and position adjustment under fluoroscopic guidance. The RenovoCath is intended to be used with 6 Fr guide sheaths and 7 Fr guide catheters and is compatible with 0.014" guidewires.

Here's a breakdown of the acceptance criteria and study information for the RenovoCath device, based on the provided text:

Key Takeaway: This submission is for a device that is substantially equivalent to a previously cleared device. The "study" here refers to bench testing performed to demonstrate that the new device performs comparably to the predicate device (the previously cleared version) despite minor design changes. Therefore, there isn't a typical "study" in the sense of a clinical trial with human subjects, AI assistance, or complex ground truth establishment as might be seen for novel AI/ML devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission seeking substantial equivalence to a predicate device, the "acceptance criteria" are implicitly that the subject device performs functionally the same as the predicate device across various performance measures. The "reported device performance" demonstrates this equivalence.

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

• Sample Size: The document does not specify exact sample sizes for each of the bench tests (Dimensional Inspection, Insertion and Tracking Testing, Balloon Testing, Infusion Flow Rate Testing, Simulated In-Vivo Testing). It generally refers to these as "testing" using "the same methods previously established."
• Data Provenance: The data is from bench testing performed by RenovoRx, Inc. It is prospective testing designed to evaluate the new device against the predicate. The country of origin for the testing would be the USA, where RenovoRx, Inc. is located.

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

This type of information is generally not applicable to this 510(k) submission. The "ground truth" for this device, which is a physical catheter, is its physical and functional specifications. The "ground truth" for its performance is derived from bench testing that measures physical characteristics and operational performance against predefined engineering specifications and comparison to the predicate device's known performance. This does not involve clinical "experts" establishing ground truth in the way an AI/ML diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. The 'adjudication' in this context is the comparison of bench testing results to the predicate device's performance and to engineering specifications. There is no mention of a human adjudication process for interpreting results in a subjective manner.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (catheter), not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to this submission.

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

Not applicable. This is a physical medical device. There is no algorithm or AI component.

7. The Type of Ground Truth Used

The ground truth used for the subject device is its engineering specifications and the established performance characteristics of the legally marketed predicate device (RenovoCath® K191606). The goal of the testing was to demonstrate that the new device met its own specifications and performed comparably to the predicate.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no training set in the context of AI/ML.

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

Not applicable. As there is no training set in the AI/ML sense, this question is not relevant.

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The AortaSTAT Occulsion Device is indicated for temporary vessel occlusion in the suprarenal and infrarenal aorta in applications for perioperative occlusion and emergency control of hemorrhage

The RenalPro Medical AortaSTAT Occlusion device allows continued distal perfusion of the aorta while occluding the entrance into the target side branch arteries.

The RenalPro Medical AortaSTAT Occlusion Device is comprised of a polymeric thin film membrane covering a self-expanding Nitinol scaffold connected to a stainless-steel central lumen, contained within a stainlesssteel braid-reinforced, Pebax outer shaft lined with PTFE for lubricity. The outer shaft and central lumen are attached to a deployment handle. The AortaSTAT Occlusion Device is provided sterile and non- pyrogenic and is for single patient use only.

The AortaSTAT device is delivered to the targeted vasculature location under fluoroscopy using standard endovascular techniques over a commercially available 0.018″ Guidewire. Once the device is positioned, the covered scaffold is deployed by actuating the handle to slide the outer shaft back, allowing the scaffold to expand and providing radial occlusion of the target vessel. The AortaSTAT has a radiopaque marker near the distal ends of the nitinol scaffold, and another marker encapsulated at the distal end of the outer shaft to enable visualization under fluoroscopy.

The AortaSTAT device is 8 Fr compatible in four diameters of occluding scaffolds: 19mm, 22mm, 25mm, and 28mm. The device has a 55 ± 5mm occlusive length and a 65cm working length.

The document provided is a 510(k) summary for the AortaSTAT Occlusion Device. It outlines the device description, intended use, technological characteristics, and performance data from non-clinical testing. However, it does not include specific acceptance criteria or a study that directly proves the device meets those criteria from a performance efficacy standpoint with human data. The provided document details bench testing and animal studies as part of the substantially equivalent justification for regulatory clearance, but it is not a clinical study report with detailed performance metrics against pre-defined acceptance criteria.

Therefore, many of the requested items cannot be extracted from this document, as it primarily focuses on comparing the new device to a predicate device using non-clinical performance data and animal studies to establish substantial equivalence.

Based on the provided text, here's what can be extracted:

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

The document does not provide a table with explicit acceptance criteria for efficacy or pre-defined performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be found in a clinical study report. Instead, it lists the types of non-clinical tests performed to demonstrate safety and performance.

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

For the non-clinical tests, specific sample sizes are not provided. The animal study was conducted in a "swine model," which indicates an animal study, not human data. The data provenance is from laboratory testing and animal studies, not human clinical trials.

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

Not applicable. The document describes non-clinical and animal testing, not studies involving human experts establishing ground truth for diagnostic or interventional performance.

4. Adjudication method for the test set

Not applicable. This is typically relevant for studies with human readers or evaluators, not for the types of non-clinical tests described.

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 document pertains to a medical device (vascular clamp/occlusion device), not an AI-assisted diagnostic or interventional system, and thus an MRMC study is not relevant to the described performance evaluation.

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

Not applicable. This is a physical medical device, not a standalone algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be established by the performance standards and specifications against which the device was tested. For the animal study, the ground truth was the observable safety and performance of the device in the swine model, compared to a predicate device.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a machine learning or AI device.

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

Not applicable for the same reason as above.

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The Neurescue device is intended for temporary occlusion of large vessels and blood pressure monitoring including patients requiring emergency control of hemorrhage.

The NEURESCUE device is a large vessel occlusion catheter comprised of two main components: The NEURESCUE Catheter and the NEURESCUE Assistant.

The Catheter is an occlusion balloon catheter and the Assistant is a hub for interfacing with the operation of the Catheter. During normal use the device can be operated automatically. Alternatively, the device can be operated manually.

For manual use the interface consists of two Luer lock ports for:

• Manual inflation and deflation of the balloon with saline -
• -Flushing of the arterial FLUSH port with saline

Inflation and deflation of the balloon can be accomplished by an automatic filling and deflation function (automatic operation with a peristaltic pump) or manually.

Whether the filling is performed manually or automatically, the user is informed of the pressure at the tip of the Catheter. The device has a built-in alarms system.

The provided text describes the 510(k) summary for the Neurescue device, which is a vascular clamp. It outlines performance testing (bench and in vivo) to support its safety and effectiveness and its substantial equivalence to a predicate device. However, it does not provide specific acceptance criteria or reported device performance in the format of a table, nor does it detail a clinical study with human subjects (multi-reader multi-case, standalone, etc.) that would prove the device meets acceptance criteria related to diagnostic or assistive performance with AI.

The document focuses on engineering and animal model testing to demonstrate the device's technical specifications and physical performance (e.g., balloon inflation, pressure sensing, material integrity) and its intended use for temporary occlusion of large vessels and blood pressure monitoring.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and type of ground truth used for AI-related performance, are not applicable or not available in this FDA 510(k) summary because the device is a physical medical device (vascular clamp), not an AI-driven diagnostic or assistive software.

However, I can extract the information related to the acceptance criteria and performance testing that is mentioned, recognizing that it pertains to the device's physical and functional attributes rather than AI performance.

Acceptance Criteria and Device Performance (Based on Provided Text)

Given the nature of the device (a physical vascular clamp, not an AI software), the "acceptance criteria" discussed in the document are primarily related to its mechanical performance, functionality, and safety in in vitro (bench) and in vivo (animal) testing, rather than diagnostic accuracy or human reader improvement. The document summarizes categories of tests and states that the device "meets applicable design and performance requirements" or "demonstrate[s] that the NEURESCUE device has been designed for and tested to conform to its intended use," implying these were the acceptance criteria for each test.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Bench Testing: The specific sample sizes for each in vitro (bench) test are not provided in this summary. The tests are described as being "carried out" or "verified," implying sufficient samples were used to meet internal validation requirements.
• In Vivo Testing: One "GLP Study to Evaluate the Performance of the NEURESCUE Catheter in the Aorta of an Acute Naïve Porcine Model" was conducted. The exact number of porcine models (sample size) is not specified.
• Data Provenance: The tests are part of the premarket notification (510k) submission by Neurescue Aps, located in Copenhagen, Denmark. The data would thus originate from their internal testing or contracted testing facilities. All testing described is of a prospective nature (designed and conducted specifically for this submission). No reference to retrospective data is made.

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

• For the technical and performance testing (bench and in vivo), "ground truth" is established by engineering specifications, physical measurements, and observed functional performance rather than expert (e.g., radiologist) interpretation.
• The radiopacity test mentions "real users" with human cadavers; however, the number or qualifications of these users/experts are not specified. Their role seemed to be to confirm visibility, not to establish a diagnostic ground truth.

4. Adjudication Method for the Test Set

• Not applicable as the testing involves objective measurements, mechanical performance, and animal studies, not human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-driven diagnostic or assistive devices where human reader performance is a key outcome. The Neurescue device is a physical medical device.

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

• No, a standalone study (in the context of AI performance) was not done. The device's "automatic inflation and deflation function" and "built-in alarm system" are functionalities of the device itself, not an AI algorithm that makes diagnostic predictions. Performance of these automated functions would be part of the bench and software testing, but not a standalone AI performance study.

7. The Type of Ground Truth Used

• Engineering Specifications and Physical Measurements: For bench tests (e.g., dimensions, tensile strength, burst volume, pressure accuracy, inflation time, battery life).
• Observed Functional Performance: For tests like kink resistance, deployment, occlusion, and alarm functions.
• Biocompatibility Standards: For biocompatibility tests.
• Animal Physiological Response/Survival: For the in vivo GLP study in porcine models, performance would be assessed against physiological parameters and outcomes in the animal model.
• User Observation/Feedback: For radiopacity testing ("real users with human cadavers").

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI-driven system that requires a "training set" in the context of machine learning. The software testing mentioned refers to traditional software development and validation (unit testing, system testing, software validation) for controlling the device's functions, not for training a predictive model.

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

• Not applicable. See point 8.

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The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

The COBRA-OS™ is a large vessel occlusion device and includes a 4 French Custom Sheath Introducer Kit and a 10 cc syringe.
The occlusion device consists of a stiff inner guidewire with an atraumatic floppy distal J-tip that is housed in a compliant occlusion balloon with proximal and distal necks. The inner guidewire provides adequate stiffness. No other guidewires are required. The proximal neck of the balloon is connected to an overmolded hub and stopcock for balloon inflation and deflation. Suture tabs on the overmolded hub are used to secure the device to the patient's skin with sutures. A J-tip straightener is included and preloaded on the distal neck to facilitate the introduction of the device into the 4 French introducer sheath hemostasis valve. Pad printing marks on the outer occlusion device shaft indicate distance to the desired location.

The provided text does not contain information about acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The document is primarily a 510(k) premarket notification letter from the FDA, followed by an "Indications for Use" statement and a "Traditional 510(k) Summary".

This type of document outlines the regulatory approval process for a medical device and describes its general characteristics and intended use, but it does not typically detail specific performance acceptance criteria, the methodology of studies, or the results in a way that would allow filling out the requested table and answering all questions.

Specifically, the document states:

• "The following performance bench and in vivo (animal) testing were performed to support the substantial equivalence of COBRA-OS to the identified predicate."
• "Performance testing was also conducted in vivo (swine model). The COBRA-OS™ meets applicable design and performance requirements."

However, it does not provide:

• A table of acceptance criteria and reported device performance.
• The specific performance metrics, thresholds, or actual results from these tests.
• Details about the sample size (other than "swine model" for in vivo) or data provenance.
• Information about experts, adjudication methods, or MRMC studies.
• Information about training sets or how their ground truth was established.

Therefore, I cannot provide the requested information based on the given input.

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The Bridge Occlusion Balloon catheter is indicated for use for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.

Any use for procedures other than those indicated in the instructions is not recommended.

The Bridge Occlusion Balloon catheter is designed to be delivered percutaneously to the superior vena cava (SVC) for the purpose of providing occlusion of the SVC and providing emergency control of hemorrhage and perioperative occlusion in the event of an SVC tear or perforation during a lead extraction procedure.

The Bridge Occlusion Balloon catheter is constructed of a compliant polyurethane balloon mounted on a dual lumen polyurethane shaft.

The hub port, marked BALLOON, is connected to the balloon inflation lumen. The unmarked hub port is connected to the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. A strain relief is mounted to the catheter shaft just distal of the proximal hub.

Three platinum-iridium radiopaque markers are placed within the balloon segment of the catheter to provide visual reference points for balloon positioning within the SVC prior to inflation.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (Bridge Occlusion Balloon). It discusses the device's indications for use, comparison to a predicate device, and the basis for its substantial equivalence.

However, it does not contain details about a study that proves the device meets specific acceptance criteria based on performance data. Specifically, the document states:

• "No preclinical or clinical data was needed to support this submission."
• "The shelf-life extension and packaging changes are supported by test data demonstrating that the device and packaging adhere to the same acceptance criteria used in the predicate 510(k) after aging equivalent to 2 years."

This indicates that any "test data" referred to is related to shelf-life and packaging changes, not a performance study of the device itself with acceptance criteria for a new or modified functionality. There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided text.

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