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XYLOS™ Vessel Guard is indicated as a cover for vessels during anterior vertebral surgery.

XYLOS™ Vessel Guard is a flexible, non-resorbable, implantable sheet composed of microbialderived cellulose. The device is presented ready-to-use in a sterile double-pouched package. It is intended for one time use.

The provided K100984 510(k) summary for the XYLOS™ Vessel Guard focuses on demonstrating substantial equivalence to predicate devices through material similarity and biomechanical testing, rather than clinical performance based on a study with acceptance criteria often associated with AI/software devices. Therefore, a direct response to some of the specific questions is not possible from the provided text, as they pertain to aspects that are not relevant to this type of medical device submission.

However, I can extract the relevant information and indicate where details regarding AI-specific criteria are not applicable.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not applicable/not provided in the context of this 510(k) submission. The device is a physical implantable sheet, and its substantial equivalence was demonstrated through benchtop biomechanical testing and material comparison, not through a clinical study with a "test set" of patient data or clinical outcomes.

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

This information is not applicable/not provided. Ground truth, in the context of AI or diagnostic studies, refers to a definitive diagnosis or outcome, usually established by experts. For this device, "ground truth" would relate to the established material properties and biomechanical performance standards of the predicate devices. These are typically assessed by engineers and materials scientists in laboratory settings.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert opinions when establishing ground truth in clinical or image-based studies. Since this submission relies on benchtop testing and material comparisons, such adjudication is not relevant.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers in interpreting data or images. The XYLOS™ Vessel Guard is an implantable surgical aid, and its effectiveness is demonstrated through its physical properties and biological compatibility, not through an assessment of human reader performance.

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

No, a standalone performance study was not done. This concept applies to AI algorithms that operate independently. The XYLOS™ Vessel Guard is a passive physical device.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

• Established Material Composition: The chemical and biological identity to the predicate MTA™ Protective Sheet.
• Established Biomechanical Performance Standards: The tensile strength and suture pull-out performance as demonstrated by the predicate devices (Replication Medical Vessel Guard, PRECLUDE® IMA Sleeve, PRECLUDE® Vessel Guard).

Essentially, the ground truth for this submission is the well-characterized properties and performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The concept of a "training set" applies to machine learning or AI models, where data is used to teach the algorithm. This device is a physical product, not an algorithm.

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

This information is not applicable/not provided for the same reasons as #8.

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The GORE HYBRID Vascular Graft is indicated 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 HYBRID Vascular Graft is an ePTFE vascular prosthesis that has a section reinforced with nitinol The nitinol reinforced section (NRS) is partially constrained to allow for easy insertion and deployment into a vessel to form an end-to-end anastomosis. The constraint is made up of an ePTFE fiber which is knitted into a tubular shape. The GORE HYBRID Vascular Graft with a continuous lumen and has immobilized heparin bonded to the luminal surface.

The provide document is a 510(k) premarket notification for the GORE HYBRID Vascular Graft, which is a medical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than establishing new acceptance criteria or conducting studies that prove the device meets acceptance criteria against novel performance standards.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria tables, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a diagnostic device.

The document outlines in vitro and in vivo testing performed to demonstrate that the new device is comparable to existing predicate devices. This testing is for design verification and validation to show substantial equivalence, not to establish or meet independent acceptance criteria in the way a diagnostic AI/ML device would.

Here's what the document does provide in relation to the prompt's themes, and why it doesn't directly answer them:

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

   • No such table is provided. The document lists various in vitro tests (e.g., Wall thickness, Suture Retention, Burst Testing, Corrosion Testing) and states that "The results from these tests demonstrate that the technological characteristics and performance criteria of the GORE HYBRID Vascular Graft are comparable to the predicate devices." It does not provide specific numerical acceptance criteria or the reported performance values for each test.

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

   • Not applicable in the context of this device. The "test set" concept with data provenance is relevant for diagnostic algorithms. For this physical medical device, verification and validation testing was done. The in vivo study was conducted in a "canine model," which implies animal testing, not human data. The sample size for this canine study is not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. The concept of "ground truth" established by experts is for diagnostic devices where human interpretation is the gold standard. For this vascular graft, performance was assessed via physical measurements (in vitro) and direct observation/palpation by the surgeon (in vivo). The "surgeon" is an expert, but not in the context of establishing diagnostic ground truth on a test set.

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

   • Not applicable. This relates to diagnostic interpretation consensus and is not relevant for the physical performance testing of a vascular graft.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC study was done. This type of study is specifically for evaluating the effectiveness of AI-assisted diagnostic tools and is not relevant for this physical implantable device.

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

   • Not applicable. This device is a physical implant and does not have an "algorithm only" or "human-in-the-loop" component in the diagnostic sense.

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

   • For the in vitro tests, the "ground truth" would be the engineering specifications and established test methods (e.g., ISO standards), with the device passing or failing based on meeting those specifications.
   • For the in vivo canine study, the "ground truth" was visual assessment and palpation by the surgeon ("The implanted device remains patent and in position throughout the in-life period in the canine model. This was assessed visually and via palpation by the surgeon.") as well as observation of biocompatibility and lack of deleterious tissue response. This is essentially direct observation and clinical assessment by a qualified professional.

8. The sample size for the training set:

   • Not applicable. The concept of a "training set" is for machine learning models. This device is a manufactured physical product, not an AI/ML algorithm.

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

   • Not applicable. (See point 8).

In summary, the provided document describes a traditional medical device (vascular graft), and the regulatory submission (510(k)) focuses on demonstrating substantial equivalence through a battery of in vitro physical property tests and a limited in vivo animal study. The framework of acceptance criteria, sample sizes, expert adjudication, and ground truth establishment, as typically applied to diagnostic AI/ML devices, simply does not fit this type of product or its regulatory pathway.

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