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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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