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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 EndoGuide is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and removal of multiple polyps and/or foreign bodies.

The EndoGuide fits over a pediatric colonoscope and can be converted from a flexible to a rigid configuration on demand. The EndoGuide is back loaded onto the shaft of the colonoscope before the instrument is inserted into the patient. The device was designed to be activated by a vacuum source and needs to be connected to the existing vacuum line in the endoscopy suite. Application of vacuum causes the device to become rigid. In this "active" mode (vacuum on) the rigid insertion tube facilitates the passing of the colonoscope thru the insertion tube and resists colonoscope looping. In the "passive" mode (vacuum off) the insertion tube is very flexible and can be advanced deeper into the colon.

The provided text is a 510(k) summary for the EndoGuide device and does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative performance data. The document states that the device is "substantially equivalent" to a predicate device, focusing on its functional characteristics and intended use.

Here's a breakdown of the available information and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "To support the substantial equivalence determination, a summary of the in-vitro testing to confirm the performance characteristics in comparison with the predicate device has been submitted." However, the actual table of acceptance criteria and the reported device performance from this in-vitro testing is NOT included in the provided text.

The document only notes the functional differences from the predicate device:

• The EndoGuide differs in that it is capable of becoming rigid when required by the physician. When rigid the device facilitates the passing of the endoscope thru the insertion tube and resists endoscopic looping. But when in its flexible state, the insertion tube is can be advanced into the colon.

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

This information is not provided in the document. It only mentions "in-vitro testing" without details on sample size, or whether the data was retrospective or prospective, or country of origin.

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

This information is not provided. The 510(k) summary does not mention any expert review or ground truth establishment related to clinical performance metrics. The focus is on device function compared to a predicate.

4. Adjudication Method:

This information is not provided. Given that no expert review or ground truth establishment relevant to clinical performance is mentioned, an adjudication method would not be applicable in the provided context.

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

An MRMC study was not conducted or reported in this 510(k) summary. The device is a medical instrument (an overtube), not an AI or imaging diagnostic tool that would typically involve human reader performance comparisons.

6. Standalone Performance Study (Algorithm Only):

A standalone performance study was not conducted or reported. As mentioned, this is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

The document refers to "in-vitro testing to confirm the performance characteristics in comparison with the predicate device." This implies that the "ground truth" for the device's technical performance would be defined by engineering specifications and comparative functional assessments against the predicate device's established performance. There is no mention of clinical outcomes data, pathology, or expert consensus being used as ground truth for this type of device in the provided summary.

8. Sample Size for the Training Set:

This information is not applicable and not provided. There is no "training set" as this device is a physical instrument, not an AI or machine learning model.

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

This information is not applicable and not provided as there is no training set for this type of device.

In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence of a physical medical device (EndoGuide) to a predicate device (Guardus™ Overtube) based on its operational characteristics and intended use. It explicitly mentions "in-vitro testing" for performance comparison but does not detail the specific acceptance criteria, test results, or methodology (like sample sizes, expert involvement, or ground truth establishment). It does not involve AI or diagnostic imaging algorithms, hence no MRMC or standalone algorithm performance studies are relevant or reported.

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