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A vascular patch used for reconstructive interventions in the region of the carotid artery, profunda, femoral, arteria iliaca.

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This is an FDA 510(k) clearance letter for the B.Braun Surgical GMBH Uni-Graft® KDV Patch. The letter itself does not contain the detailed study information, acceptance criteria, or performance data you are requesting. It only states that the device is substantially equivalent to legally marketed predicate devices.

To answer your questions, you would need to refer to the original 510(k) submission (K992776) made by Atrium Medical Corporation to the FDA. This submission would contain the details of any studies performed to demonstrate substantial equivalence, including:

1. A table of acceptance criteria and the reported device performance: This would be found in the performance testing section of the 510(k) submission, comparing the new device against the predicate device or a set of defined performance specifications.
2. Sample size used for the test set and the data provenance: Details on test articles, their quantity, and the conditions under which they were tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Less likely to be relevant for a medical device like a vascular patch, where "ground truth" might refer to engineering specifications or material properties rather than clinical expert consensus. This kind of detail is more common for diagnostic algorithms.
4. Adjudication method for the test set: Again, less likely to be relevant for this type of device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is entirely irrelevant for a vascular patch. MRMC studies are for diagnostic imaging devices or AI-powered assistive technologies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Also irrelevant, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a vascular patch, ground truth would likely relate to material properties (e.g., tensile strength, porosity, biocompatibility), performance in in-vitro or in-vivo models (e.g., burst pressure, suture retention), and potentially animal or limited human clinical data demonstrating safety and efficacy comparable to a predicate.
8. The sample size for the training set: Irrelevant, as this is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Irrelevant.

In summary, this document (the 510(k) clearance letter) does not contain the information you are requesting. You would need to access the full 510(k) submission K992776, which is typically a much larger document outlining the device description, comparison to predicate devices, and performance data from engineering tests, biocompatibility studies, and potentially other non-clinical or clinical data as required for substantial equivalence. These submissions are generally not publicly available in their entirety in an easily searchable format, though summaries might be found on the FDA website.

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The Uni-Graft K DV is indicated for use in repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.

This device is a vascular graft intended for use as a replacement conduit for abdominal, thoracic, and larger peripheral arterial reconstruction. It is a polyester terephthalate knitted fiber graft coated with modified cross linked gelatin to establish zero porosity or leakage through the wall.

Here's an analysis of the provided text regarding the Uni-graft® K DV Vascular Graft, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The clinical study mentioned involved 100 patients.
• Data Provenance: The study was conducted in Japan from 1990 - 1993. This is prospective data, as it describes a clinical trial designed to collect new information.

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

The provided text does not explicitly state the number of experts used to establish ground truth in the Japanese clinical study. It also does not specify their qualifications. The results (e.g., patency rate, absence of complications) would have been assessed by the medical professionals involved in the study (surgeons, other clinicians), but the process for establishing a definitive "ground truth" (e.g., adjudicated outcomes) is not detailed.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the clinical study's outcomes.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, nor would it be applicable in this context. This device is a physical vascular graft, not an AI diagnostic tool that human readers would interpret. The studies described are assessing the performance of the device itself in vivo.

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

No, a standalone "algorithm only" performance study was not done. This device is a medical implant, not a software algorithm.

7. The Type of Ground Truth Used

For the clinical study on 100 patients, the ground truth was based on clinical outcomes data. This includes:

• Observation of complications (bleeding, immunological reactions, etc.)
• Results of collagen antibody testing
• Measurement of cumulative patency rate
  These are objective clinical assessments and measurements rather than expert consensus on images or pathology samples.

8. The Sample Size for the Training Set

The document mentions "Over 200,000 implants worldwide" of the Uni-graft® product with an "exemplary record of success." This vast number of implants represents a significant body of real-world experience and historical data that would have informed the development and validation of the device, essentially acting as a broad "training set" of observational data prior to the specific 100-patient clinical study. However, it's not a formally defined "training set" in the context of an AI algorithm.

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

For the "over 200,000 implants worldwide," the ground truth was established through implantation history and patient outcomes observed in the world marketplace. This would involve:

• Retrospective review of patient records.
• Post-market surveillance data.
• Compilation of reports from various human and animal studies (as stated: "Various human and animal reports are included in this submission for review").

This "ground truth" is therefore derived from a very large, diverse, and likely retrospective observational dataset of real-world clinical experience.

Ask a specific question about this device

Ask a specific question about this device