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The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX EndoAnchor system is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.

The EndoAnchor may be implanted at the initial endograft placement, or during a secondary (i.e., repair) procedure.

The Heli-FXTM EndoAnchor™ Systems are each comprised of the respective Heli-FX Applier with EndoAnchor Cassette, containing ten EndoAnchor implants; the respective Heli-FX Guides; and the Ancillary EndoAnchor Cassette, containing five EndoAnchor implants.

The Heli-FX EndoAnchor System comprises the EndoAnchor implant, an intravascularly-applied suture, supplied with the Heli-FX Applier in a Cassette containing ten (10) EndoAnchor implants, or separately in an Ancillary Cassette containing five (5) EndoAnchor implants; the Heli-FX Applier, a catheter-based device for placement of the EndoAnchor; and the Heli-FX Guide, a deflectable sheath to position the Applier.

The EndoAnchor is an endovascularly-placed suture designed to attach aortic endografts to the native vessel wall. The EndoAnchor is manufactured from medical-grade nickel-cobalt wire and is wound in a helical shape. The leading end is sharpened to a conical point to act as an integral needle facilitating atraumatic deployment through the graft material and vessel wall. The proximal end of the EndoAnchor includes a diagonal crossbar, which functions as a suture anchor designed to prevent over penetration of the EndoAnchor. Ten (10) EndoAnchor implants are prepackaged into a cassette, which is supplied with the Heli-FX Applier. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter. EndoAnchor implants are also supplied separately in an Ancillary Cassette containing five (5) additional EndoAnchor implants.

The Heli-FX Applier is designed to implant the EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchor implants in a single patient. The Applier is designed for use with the Heli-FX Guide. The Applier is a 12Fr (OD) catheter with an integrated control handle. Two Applier lengths are available for anchoring in different regions of the aorta.

The Heli-FX Guide is a sterile, single use, disposable device designed to direct the Heli-FX Applier to the desired location for EndoAnchor implantation. The device is compatible with a 0.035" Guide wire. The Heli-FX Guide consists of a 12 Fr-compatible (inner diameter) Guide sheath with integrated control handle, and a matching 12 Fr OD obturator. Deflection of the distal tip of the catheter is accomplished by rotating the Control Knob located on the control handle. The Guide is available in both 62cm (16Fr OD) and 90cm (18Fr OD) working lengths. Multiple deflectable tip lengths are available to accommodate a range of aortic diameters. The Obturator is used during vessel access and is designed to follow the Guide wire and provide access through tortuous vasculature.

This document is a 510(k) summary for the Heli-FX EndoAnchor System, which is an endovascular suturing system. The purpose of this 510(k) submission is to demonstrate substantial equivalence to a previously cleared device (K171427) by stating that the Heli-FX EndoAnchor System is compatible with the Valiant Navion Stent Graft System.

Based on the provided text, the document states that "no new testing with the Valiant Navion Stent Graft System was needed" because "Adequate rationale was provided to support the compatibility of these systems based on the previously provided testing with the endografts that are currently listed as compatible with the Heli-FX EndoAnchor System in its IFU."

Therefore, the acceptance criteria and study information would refer to the previous submission (K171427) or prior testing, which is not detailed in this specific document. This document only describes the device and its intended use, and then asserts substantial equivalence based on prior testing and rationale.

Since the document explicitly states "no new testing," it does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, or ground truth for a new study.

To provide the requested information, the details from the original 510(k) submission (K171427) would be required.

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The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is regain or maintain adequate aneurysm exclusion.

The EndoAnchor may be implanted at the initial endograft placement, or during a secondary (i.e., repair) procedure.

The Heli-FXTM and Heli-FX Thoracic EndoAnchor™ Systems are each comprised of the respective Heli-FX Applier with EndoAnchor Cassette, containing ten EndoAnchor implants; the respective Heli-FX Guides, and the Ancillary EndoAnchor Cassette, containing five EndoAnchor implants.

The Heli-FX EndoAnchor System comprises the EndoAnchor implant, an intravascularly-applied suture, supplied with the Heli-FX Applier in a Cassette containing ten (10) EndoAnchor implants, or separately in an Ancillary Cassette containing five (5) EndoAnchor implants; the Heli-FX Applier, a catheter-based device for placement of the EndoAnchor; and the Heli-FX Guide, a deflectable sheath to position the Applier.

The EndoAnchor is an endovascularly-placed suture designed to attach aortic endografts to the native vessel wall. The EndoAnchor is manufactured from medical-grade nickel-cobalt wire and is wound in a helical shape. The leading end is sharpened to a conical point to act as an integral needle facilitating atraumatic deployment through the graft material and vessel wall. The proximal end of the EndoAnchor includes a diagonal crossbar, which functions as a suture anchor designed to prevent over penetration of the EndoAnchor. Ten (10) EndoAnchor impants are prepackaged into a cassette, which is supplied with the Heli-FX Applier. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter. EndoAnchor implants are also supplied separately in an Ancillary Cassette containing five (5) additional EndoAnchor implants.

The Heli-FX Applier is designed to implant the EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchor implants in a single patient. The Applier is designed for use with the Heli-FX Guide. The Applier is a 12Fr (OD) catheter with an integrated control handle. Two Applier lengths are available for anchoring in different regions of the aorta.

The Heli-FX Guide is a sterile, single use, disposable device designed to direct the Heli-FX Applier to the desired location for EndoAnchor implantation. The device is compatible with a 0.035" Guide wire. The Heli-FX Guide consists of a 12 Fr-compatible (inner diameter) Guide sheath with integrated control handle, and a matching 12 Fr OD obturator. Deflection of the distal tip of the catheter is accomplished by rotating the Control Knob located on the control handle. The Guide is available in both 62cm (16Fr OD) and 90cm (18Fr OD) working lengths. Multiple deflectable tip lengths are available to accommodate a range of aortic diameters. The Obturator is used during vessel access and is designed to follow the Guide wire and provide access through tortuous vasculature.

I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details for the Heli-FX EndoAnchor System.

The document is a 510(k) premarket notification decision letter and a 510(k) summary. It primarily focuses on the substantial equivalence of the device to previously cleared predicate devices, particularly due to a change in the sterilization facility.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

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The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion. The EndoAnchor may be implanted at the time of the initial endograft placement, or during a secondary (i.e., repair) procedure.

The Aptus® Heli-FX™ and Heli-FX Thoracic EndoAnchor Systems are each comprised of the respective Heli-FX™ Applier with EndoAnchor Cassette (containing ten EndoAnchors™), the respective Heli-FX™ Guides, and the Ancillary EndoAnchor Cassette (containing five EndoAnchors).

The Heli-FX EndoAnchor System comprises the EndoAnchor implant (an intravascularly-applied suture, supplied with the Heli-FX Applier in a Cassette containing 10 EndoAnchors or separately in an Ancillary Cassette containing 5 EndoAnchors), the Heli-FX Applier (a catheter-based device for placement of the EndoAnchor), and the Heli-FX Guide (a deflectable sheath to position the Applier).

The Aptus EndoAnchor is an endovascularly-placed suture designed to attach aortic endografts to the native vessel wall. The EndoAnchor is manufactured from medical-grade nickel-cobalt wire and is wound in a helical shape. The leading end is sharpened to a conical point to act as an integral needle facilitating atraumatic deployment through the graft material and vessel wall. The proximal end of the EndoAnchor includes a diagonal crossbar, which functions as a suture anchor designed to prevent over penetration of the EndoAnchor. Ten (10) EndoAnchors are pre-packaged into a cassette, which is supplied with the Heli-FX Applier. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter. An EndoAnchors are also supplied separately in an Ancillary Cassette containing five (5) additional EndoAnchors.

The Heli-FX Applier is designed to implant the Aptus EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchors in a single patient. The Applier is designed for use with the Heli-FX Guide. The Applier is a 12Fr (OD) catheter with an integrated control handle. Two Applier lengths are available for anchoring in different regions of the aorta.

The Heli-FX Guide is a sterile, single use, disposable device designed to direct the Heli-FX Applier to the desired location for EndoAnchor implantation. The device is compatible with a 0.035" guide wire. The Heli-FX Guide consists of a 12 Fr-compatible (inner diameter) guide sheath with integrated control handle, and a matching 12 Fr OD obturator. Deflection of the distal tip of the catheter is accomplished by rotating the Control Knob located on the control handle. The Guide is available in both 62cm (16Fr OD) and 90cm (18Fr OD) working lengths. Multiple deflectable tip lengths are available to accommodate a range of aortic diameters. The Obturator is used during vessel access and is designed to follow the guide wire and provide access through tortuous vasculature.

Here's a summary of the acceptance criteria and study information for the Aptus Heli-FX Ancillary EndoAnchor Cassette based on the provided text:

This submission is for an Ancillary EndoAnchor Cassette, which is essentially additional EndoAnchors packaged separately. The core device (Heli-FX EndoAnchor System) has been previously cleared. Therefore, the testing focuses on demonstrating that the new packaging and configuration of the Ancillary Cassette are substantially equivalent to the existing device.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria (e.g., specific tensile strength values, leakage rates, etc.) and corresponding performance data. Instead, it describes overarching performance categories evaluated for substantial equivalence. The acceptance criterion is implied as "no new risks" and "substantially equivalent" to the predicate devices.

Study Details

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

  • Test Set Sample Size: Not explicitly stated as a numerical value (e.g., N=X units). The text mentions "samples that underwent exposure to transportation simulation." This suggests a sufficient number of units were tested to support the claims.
  • Data Provenance: The testing was "bench top testing." The country of origin of the data is not specified, but the manufacturer is based in Sunnyvale, CA, USA. The testing is prospective as it was conducted specifically for this submission to evaluate the new configuration.

• 2. 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)

  • Not applicable. This was bench testing of packaging and device functionality, not a clinical study requiring expert ground truth for diagnostic or clinical outcomes.

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

  • Not applicable. This was bench testing, not a clinical study requiring adjudication of expert interpretations.

• 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

  • Not applicable. This submission is for a medical device (endovascular suturing system component), not an AI/imaging diagnostic device.

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

  • Not applicable. This is a medical device, not an algorithm. However, the bench testing did evaluate the device's performance in a standalone manner (without a human in a clinical setting).

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

  • The "ground truth" for this bench testing was the established performance and integrity benchmarks for medical device packaging and functionality. These benchmarks are based on industry standards and regulatory requirements.

• 7. The sample size for the training set

  • Not applicable. This is not an AI/machine learning model but a physical medical device.

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

  • Not applicable. This is not an AI/machine learning model.

In summary, the study presented for this 510(k) submission primarily consisted of bench-top testing to demonstrate the substantial equivalence of the new Ancillary EndoAnchor Cassette packaging to existing predicate devices. The focus was on ensuring that the new packaging configuration did not introduce new risks regarding visual integrity, seal strength, and the subsequent functionality of the EndoAnchors after transportation simulation. The assessment relied on comparing the new configuration's performance to the known and cleared performance of the predicate devices.

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The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.
The EndoAnchor may be implanted at the time of the initial endograft placement, or during a secondary (i.e., repair) procedure.

The Heli-FX EndoAnchor System comprises the EndoAnchor with EndoAnchor Cassette, the Heli-FX Applier, and the Heli-FX Guide.
The Heli-FX EndoAnchor System comprises the EndoAnchor implant (an intravascularly-applied suture, supplied in a Cassette containing 10 EndoAnchors), the Heli-FX Applier (a catheterbased device for placement of the EndoAnchor), and the Heli-FX Guide (a deflectable sheath to position the Applier).
The Aptus EndoAnchor is an endovascularly-placed suture designed to attach aortic endografts to the native vessel wall. The EndoAnchor is manufactured from medical-grade nickel-cobalt wire and is wound in a helical shape. The leading end is sharpened to a conical point to act as an integral needle facilitating atraumatic deployment through the graft material and vessel wall. The proximal end of the EndoAnchor includes a diagonal crossbar, which functions as a suture anchor designed to prevent over penetration of the EndoAnchor. Ten (10) EndoAnchors are pre-packaged into a cassette, which is supplied sterile to the user. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter.
The Heli-FX Applier is designed to implant the Aptus EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchors in a single patient. The Applier is designed for use with the Heli-FX Guide. The Applier is a 12Fr (OD) catheter with an integrated control handle. Two Applier lengths are available for anchoring in different regions of the aorta.
The Heli-FX Guide is a sterile, single use, disposable device designed to direct the Heli-FX Applier to the desired location for EndoAnchor implantation. The device is compatible with a 0.035" guide wire. The Heli-FX Guide consists of a 12 Fr-compatible (inner diameter) guide sheath with integrated control handle, and a matching 12 Fr OD obturator. Deflection of the distal tip of the catheter is accomplished by rotating the Control Knob located on the control handle. The Guide is available in both 62cm (16Fr OD) and 90cm (18Fr OD) working lengths. Multiple deflectable tip lengths are available to accommodate a range of aortic diameters. The Obturator is used during vessel access and is designed to follow the guide wire and provide access through tortuous vasculature.

This 510(k) summary for the Aptus Heli-FX EndoAnchor System describes modifications to product packaging and confirms substantial equivalence to previously cleared devices. It does not present a new clinical study with acceptance criteria and device performance results as typically requested for AI/software devices.

Instead, the document focuses on demonstrating that the new packaging for the Heli-FX devices meets acceptance criteria for substantial equivalence to the original packaging.

Here's an analysis based on the provided text, addressing your questions where applicable to the packaging modification study:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify exact sample sizes for the packaging tests (e.g., how many packages were tested for bubble emission or seal strength). It states "samples that underwent exposure".
• Data Provenance: The data is from benchtop testing, performed by the manufacturer, Aptus Endosystems, Inc. The location is implied to be within the company's testing facilities (e.g., Sunnyvale, CA). This is prospective testing designed to evaluate the new packaging.

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

• This question is not applicable to this submission. The study is a benchtop engineering test of packaging, not a clinical study requiring expert assessment of medical images or patient outcomes to establish ground truth. "Ground truth" in this context would be the measured physical properties of the packaging (e.g., seal strength, absence of leaks), which are objective.

4. Adjudication Method for the Test Set

• Not applicable. As this is a benchtop test evaluating packaging properties against objective criteria (e.g., quantitative seal strength values, visual inspection for defects), an adjudication method as used in clinical or image-based studies is not relevant.

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

• No, an MRMC study was not done. This submission is for packaging modifications of an existing medical device, not a new diagnostic or interventional AI.

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

• No, this is not an algorithm or AI device. Therefore, "standalone performance" in the context of AI is not applicable.

7. The Type of Ground Truth Used

• The ground truth used for this packaging study was objective physical measurements and observations (e.g., seal strength values, presence/absence of bubbles during emission testing, visual integrity of package and product) against pre-defined engineering and quality specifications, demonstrating non-inferiority to the previous packaging.

8. The Sample Size for the Training Set

• Not applicable. This study is not performing machine learning or training an algorithm, so there is no "training set."

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

• Not applicable. As there is no training set, this question is irrelevant.

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The Heli-FX Aortic Securement System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.
The EndoAnchor may be implanted at the time of the initial endograft placement, or during a secondary (i.e., repair) procedure.

The Heli-FX.Aortic Securement System comprises the EndoAnchor with EndoAnchor Cassette, the Heli-FX Applier, and the Heli-FX Guide.
The Heli-FX Aortic Securement System comprises the EndoAnchor implant (an intravascularlyapplied suture, supplied in a Cassette containing 10 EndoAnchors), the Heli-FX Applier (a catheter-based device for placement of the EndoAnchor), and the Heli-FX Guide (a deflectable sheath to position the Applier).
The Aptus EndoAnchor is an endovascularly-placed suture designed to attach aortic endografts to the native vessel wall. The EndoAnchor is manufactured from medical-grade nickel-cobalt wire and is wound in a helical shape. The leading end is sharpened to a conical point to act as an integral needle facilitating atraumatic deployment through the graft material and vessel wall. The proximal end of the EndoAnchor includes a diagonal crossbar, which functions as a suture anchor designed to prevent over penetration of the EndoAnchor. Ten (10) EndoAnchors are pre-packaged into a cassette, which is supplied sterile to the user. The cassette is designed to facilitate easy and accurate loading of the EndoAnchor into the Applier catheter.
The Heli-FX Applier is designed to implant the Aptus EndoAnchor. The Applier implants one EndoAnchor at a time, and can be used to implant multiple EndoAnchors in a single patient. The Applier is designed for use with the Heli-FX Guide. The Applier is a 12Fr (OD) catheter with an integrated control handle. Two Applier lengths are available for anchoring in different regions of the aorta.
The Heli-FX Guide is a sterile, single use, disposable device designed to direct the Heli-FX Applier to the desired location for EndoAnchor implantation. The device is compatible with a 0.035" guide wire. The Heli-FX Guide consists of a 12 Fr-compatible (inner diameter) guide sheath with integrated control handle, and a matching 12 Fr OD obturator. Deflection of the distal tip of the catheter is accomplished by rotating the Control Knob located on the control handle. The Guide is available in both 62cm (16Fr OD) and 90cm (18Fr OD) working lengths. Multiple deflectable tip lengths are available to accommodate a range of aortic diameters. The Obturator is used during vessel access and is designed to follow the guide wire and provide access through tortuous vasculature.

The provided document (K130677) is a 510(k) summary for modifications to the Aptus Heli-FX Aortic Securement System. This type of submission relies on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a new clinical study with acceptance criteria, ground truth, or multi-reader studies for device performance.

The document states:

• "The various components of the Heli-FX System covered in this submission are substantially equivalent in materials, method of operation, and intended use as the prior Heli-FX Systems cleared via K102333 and K121168. Where specific dimensional and performance differences exist, bench testing has shown that these differences do not present new risks."
• "Data relied upon to demonstrate substantial equivalence of the modified Heli-FX System to the predicates, and to demonstrate conformance to special controls, includes the following: Performance and simulated use testing; Mechanical characterization testing."

Therefore, the submission does not detail a clinical study with acceptance criteria, ground truth establishment, sample sizes for training/test sets, or information about expert readers as would be typical for an AI/CADe device. Instead, it relies on bench testing and simulated use to show that the modified device is still substantially equivalent to its already cleared predecessors.

Based on the provided document, the following information cannot be extracted:

1. A table of acceptance criteria and reported device performance (in the context of clinical efficacy; only bench testing and simulated use are mentioned for substantial equivalence).
2. Sample sizes for a clinical test set, data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a clinical test set.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including human reader improvement with AI.
6. Standalone algorithm performance (as this is a mechanical device, not an algorithm).
7. Type of ground truth used (pathology, expert consensus, outcomes data – not applicable to this type of device and submission).
8. Sample size for a training set (not applicable for this type of device submission).
9. How ground truth for a training set was established (not applicable).

In summary, this 510(k) submission is for a medical device that provides mechanical fixation and sealing, not an AI/CADe device that would typically involve the detailed study information requested in the prompt. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence through bench testing and simulated use, rather than clinical performance metrics for an AI system.

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The Aptus 18Fr HeliFX Aortic Securement System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The 18Fr HeliFX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.

The Aptus 18Fr HeliFX Aortic Securement System comprises the EndoAnchor with EndoAnchor Cassette, the 18Fr HeliFX Applier, and the 18Fr HeliFX Guide.

This 510(k) summary describes a medical device, the Aptus 18Fr HeliFX Aortic Securement System, and states its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in terms of accuracy or efficacy against a defined ground truth, especially not in the context of an AI/ML algorithm.

Here's why and what information is missing:

• No AI/ML Algorithm: The document describes a physical medical device (an endovascular suturing system) for mechanical fixation and sealing of aortic grafts. It is not an AI/ML powered device. Therefore, concepts like AI performance, test sets, training sets, ground truth establishment by experts, adjudication, or MRMC studies do not apply.
• Focus on Substantial Equivalence: The primary goal of this 510(k) summary is to demonstrate that the new Aptus 18Fr HeliFX Aortic Securement System is "substantially equivalent" to a previously cleared predicate device (Aptus HeliFX Aortic Securement System per K102333). This typically involves showing similar materials, method of operation, and intended use, and that any differences do not raise new questions of safety or effectiveness.
• "Data Relied Upon" is Different: The "Data relied upon for substantial equivalence" section lists performance and simulated use testing, mechanical integrity testing, endograft compatibility testing, sterilization, biocompatibility, and shelf-life evaluations. These are standard engineering and biological tests for a physical medical device, not performance metrics for an AI algorithm.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, and AI/ML performance because the provided document does not pertain to an AI/ML device and does not contain that type of information.

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The Aptus EndoStapling System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Aptus EndoStapling System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.

The Aptus EndoStapling System is comprised of an endovascular suture (the EndoStaple) and implantation means (the EndoStaple Applier) as well as a steerable guide sheath (the EndoGuide) for access and delivery within the vasculature. The system is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. This is accomplished via selective catheter placement of discrete helical sutures (EndoStaples) through the endograft and into the tissue of the native vessel (aorta) around the circumference of the endograft. Access to the intended implantation site is gained through the use of the Steerable Endoguide, a deflectable guide sheath. The EndoStaples are implanted, one at a time, by the EndoStaple Applier, a battery-powered, software-controlled, catheter-based device.

Here's a breakdown of the acceptance criteria and the studies conducted to demonstrate the device meets these criteria, based on the provided document:

Acceptance Criteria and Device Performance

• Shelf life of one year established through accelerated and real-time aging, meeting visual inspection, simulated use, mechanical integrity, bubble, and peel testing. |
  | III. Non-Clinical and Clinical Performance for Durability, Compatibility, Migration Resistance, Corrosion Resistance, Delivery, and Deployment | Durability:
• 10-year simulated loading (≥ 380 million cycles) on EndoStaple/endograft interface showed no migration, fracture, or endograft damage.
  Compatibility:
• Simulated use testing in an anatomical model demonstrated successful performance per IFU.
  Migration Resistance (Bench & Animal):
• Cadaver study demonstrated improved migration resistance with EndoStaples.
• Animal study (calves) showed safe deployment and fixation, with acceptable biological reaction and no migration.
  Corrosion Resistance:
• Cyclic potentiodynamic polarization testing showed breakdown potential Eb at least [Redacted as (b)(4)] greater than resting potential Er (Eb-Er ≥ 600mV).
  Delivery and Deployment (Clinical):
• Animal study showed reasonable safety of deployment and fixation.
• Clinical study (154 subjects) reported average implantation time of 16.8 min, 0.65% Type I endoleak (one subject, core lab), and one intervention for Type I endoleak.
• 15 device malfunctions reported, none leading to clinical events or adverse patient sequelae. |
  | IV. MR Compatibility | - Satisfactory MR compatibility of the implant demonstrated for RF heating, MR force, MR torque, and image artifact testing per ASTM standards.
• EndoStaples determined to be MR Conditional. |
  | V. Electromagnetic Compatibility (EMC) and Electrical Safety | - Aptus EndoStaple Applier deemed compliant to relevant electrical and electromagnetic safety requirements per IEC 60601-1 and IEC 60601-1-2 through successful completion of testing. |
  | VI. Software Validation | - Independent verification and validation of the firmware/hardware combination successfully completed and deemed acceptable.
• Software provides power-on self-test, cycle counter (limits to 15 deployments), staple deployment monitoring, and error detection/mitigation. |
  | VII. Effectiveness (Clinical) | - Clinical study: Through one-year follow-up, no endograft migration experienced, one subject (of 154) had a Type I endoleak identified, and one subject required intervention for a Type I endoleak.
• No EndoStaple fractures observed through one-year follow-up.
• System demonstrated to be safe and effective as a proximal fixation tool. |

Additional Information on Studies:

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

   • Clinical Study: 155 subjects enrolled (145 male, average age 73 years). 154 subjects received EndoStaple implantation. The study was a prospective, multi-center, single-arm clinical study conducted at 25 centers in the United States.
   • Animal Study: 14 calves.
   • Cadaver Study: One investigational endovascular graft and seven commercially-available endovascular grafts implanted in non-preserved human cadaveric aortas.

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

   • The document does not specify the number or qualifications of experts used to establish ground truth for the clinical core lab (e.g., for endoleak identification or EndoStaple fracture). It only states "identified by the core lab."
   • For the animal and cadaver studies, the document does not specify expert involvement in establishing ground truth beyond the study design and evaluation methods.

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

   • The document does not specify an adjudication method for the clinical core lab findings or other study outcomes.

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is a surgical stapling system, not an AI-powered diagnostic imaging device.

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

   • Yes, a form of standalone performance was assessed for the software (firmware) within the EndoStaple Applier. Independent verification and validation of the firmware/hardware combination was successfully completed, confirming the algorithm's control over the motor, self-tests, cycle counting, and error detection functions. This is a standalone assessment of the device's internal software operations, not an AI diagnostic algorithm.

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

   • Clinical Study: Ground truth was primarily based on clinical outcomes data (e.g., endograft migration, Type I endoleak identified by core lab, need for intervention, device malfunctions, absence of EndoStaple fractures) and direct observation/measurements from follow-up scans.
   • Animal Study: Ground truth was based on radiological, gross postmortem, morphometric, and histological findings at 30, 60, and 150-day sacrifices.
   • Cadaver Study: Ground truth was based on mechanical testing results (migration resistance) following modified ISO standards.
   • Bench Testing: Ground truth was based on pre-defined specifications and acceptance criteria for mechanical integrity, functional performance, corrosion resistance, and durability, measured using specialized equipment and simulated conditions.

7. The sample size for the training set:

   • The document does not describe a "training set" in the context of an AI/machine learning model. The clinical study was a single-arm evaluation study, and bench/animal studies were for device validation.

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

   • Not applicable, as no described training set for an AI model. For the device's software (firmware), ground truth for its internal functioning would have been established through software requirements specifications and verified through testing against these requirements.

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The HeRO vascular access device is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts.

The HeRO vascular access device is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are readily identified using the K/DOQI guidelines as patients who:

• Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography.
• Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by history of previous access failures, symptomatic CVS (i.e., via arm, neck, or face swelling) or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. K/DOQI guidelines recommend a minimum Kt/V of 1.4.

The HeRO device is a non-autogenous (i.e., synthetic) vascular access composed of four components: a catheter component, a pre-connected graft assembly, a crimp ring, and a sleeve. The catheter component is made of radiopaque silicone and contains reinforcing filaments that impart kink and crush resistance. The catheter is provided in two different lengths (referred to as left side and right side) to accommodate anatomical variations. During surgery, the catheter length is sized to fit the patient by peeling back the nylon filament and cutting the catheter. The pre-connected graft assembly is a conventional ePTFE hemodialysis graft that has been attached to a titanium connector. The titanium crimp ring is used during surgery to secure the catheter to the graft assembly. The silicone sleeve is placed during surgery to impart kink resistance of the catheter at the connector and to cover the metal crimp ring in silicone.

Additionally, a reusable stainless steel crimp tool is provided to compress the crimp ring for securing the catheter component to the graft assembly during surgery. The crimp tool is provided non-sterile and is steam sterilized before each use.

The provided text describes the HeRO Vascular Access Device and its regulatory submission (K071778) to the FDA. It includes summaries of non-clinical (bench) and clinical performance data.

Here's the breakdown of the acceptance criteria and study information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text generally states that the device "met its acceptance criteria" for non-clinical tests and demonstrated comparable or better performance in clinical evaluation. However, specific numerical acceptance criteria for each test are not explicitly detailed in the given text. Instead, it offers a summary of the types of tests conducted and the overall outcome of meeting these criteria. For clinical performance, it compares the device's outcomes to established literature for catheters and grafts.

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

• Sample Size for Test Set:
  • 36 catheter-dependent subjects (catheter arm)
  • 50 graft subjects (graft arm)
  • Total: 86 patients
• Data Provenance: The text does not explicitly state the country of origin. It indicates it was a clinical evaluation, implying a prospective collection of data from enrolled patients.

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

The text refers to a "clinical evaluation" and "clinical performance data," and comparisons to "catheter and graft literature." It does not mention the use of a panel of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy studies (e.g., for image interpretation). Instead, the clinical outcomes (e.g., adverse events, bacteremia rates, patency, flow rates, dialysis adequacy) are likely direct measurements from patient follow-up, and their "truth" is established by the clinical observation and measurement process itself, then compared against established medical literature benchmarks.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method for the clinical test set outcomes. Clinical outcomes would typically be recorded based on standard medical practice and potentially reviewed by an independent clinical events committee for a larger trial, but such details are not provided here. No mention of 2+1, 3+1, or similar adjudication for establishing ground truth is made, which is consistent with a clinical outcomes study rather than a diagnostic accuracy study.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The study described is a clinical evaluation of the device's safety and performance with human patients, not a study involving multiple human readers interpreting cases with and without AI assistance to measure an effect size of AI.

6. Standalone Performance Done

Yes, a standalone performance evaluation was done. The "Summary of Non-Clinical Performance Data" details in vitro performance testing and biocompatibility evaluations that were conducted on the HeRO device itself to ensure it met its engineering and safety specifications. This represents a standalone evaluation of the device's physical and functional properties. The "Summary of Clinical Performance Data" also describes the standalone clinical performance of the device in human patients, measuring outcomes directly related to the device's use.

7. Type of Ground Truth Used

For the non-clinical (bench) tests, the "ground truth" was based on engineering specifications and ISO standards for material properties and device performance. The device's ability to meet these predefined quantitative criteria served as the ground truth.

For the clinical study, the "ground truth" for evaluating safety and performance was based on observed clinical outcomes and physiological measurements from patients (e.g., actual rates of serious adverse events, measured bacteremia rates, observed patency, measured device flow rates, calculated Kt/V for dialysis adequacy). These outcomes were then compared against performance benchmarks established in published medical literature for similar vascular access methods (catheters and grafts).

8. Sample Size for the Training Set

The text does not mention a training set or how it was established. This device is a physical medical device, not an AI/ML algorithm that requires a training set of data. The "study" refers to a clinical trial/evaluation of its safety and performance in human patients, and a series of bench tests.

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

As no training set is mentioned or applicable for this type of physical medical device submission, this question is not relevant to the provided information.

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The Atrium Graduated Wall Flixene Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.

Atrium Graduated Wall Flixene Graft

This document is a 510(k) clearance letter from the FDA for a medical device (Atrium Graduated Wall Flixene Graft). It does not contain any information about acceptance criteria, device performance testing, or studies conducted to prove the device meets specific criteria.

The letter primarily:

• States that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
• Outlines post-market requirements and regulations the manufacturer must adhere to.
• Provides contact information for various FDA offices.
• Includes an "Indications For Use" statement.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Results of a standalone algorithm performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is a regulatory approval, not a technical report detailing performance studies.

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GORE PROPATEN VASCULAR GRAFT is intended for use as a vascular prosthesis for replacement or bypass of diseased vessels in patients suffering occlusive or aneurysmal diseases, in trauma patients requiring vascular replacement, for dialysis access, or for other vascular procedures.

The GORE PROPATEN Vascular Graft is constructed from the same materials used in the predicate devices: the GORE-TEX Vascular Graft, the GORE-TEX Stretch Vascular Graft, and the FEP Ringed GORE-TEX Stretch Vascular Graft with Removable Rings, which have a successful history of clinical use and were cleared for use in the United States through the Premarket notifications K830806, K903931 and K933943.

The GORE PROPATEN Vascular Graft is a biocompatible device comprised of expanded polytetrafluoroethylene (ePTFE) with covalently bound, luminal, bioactive heparin. The heparin used in creating this device has been derivatized by a proprietary process established by Carmeda AB, Stockholm, Sweden. The heparinization process is based upon the Carmeda Bioactive Surface (CBASTM) technology. Heparin activity is retained in a binding process that does not interfere with the heparin active site.

The provided document is a 510(k) summary for the GORE PROPATEN Vascular Graft, not a study report. It states that the device has been tested to meet applicable sections of AAMI/ANSI/ISO 7198:1998/2001(R) 2004, which is a performance standard for cardiovascular implants, specifically vascular prostheses. However, the document does not contain the acceptance criteria or reported device performance in a table format, nor does it describe a specific study proving the device meets those criteria.

Therefore, I cannot extract the information required for your request. The document focuses on demonstrating substantial equivalence to predicate devices based on material composition and intended use, rather than detailing a specific performance study with acceptance criteria and results.

To directly answer your numbered points based on the absence of this information in the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document states only that "The GORE PROPATEN VASCULAR GRAFT has been tested, or rationale has been provided, to meet all applicable sections of Cardiovascular Implants-Vascular Prostheses AAMI / ANSI / ISO 7198:1998/2001(R) 2004." The specific criteria and results are not detailed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This document does not describe a study involving adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device (vascular graft), not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the document. The document refers to meeting a performance standard but does not detail how compliance was verified beyond general "testing or rationale."
8. The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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