(73 days)
The bovine pericardial vascular patch is intended for use as a surgical patch material for: vascular reconstruction and repairs; peripheral vascular reconstruction and repairs; and suture-line buttressing.
The pericardial patch is comprised of a piece of bovine pericardium that has been preserved in a phosphate buffered glutaraldehyde solution. The Duravess patch comes in three sizes and configurations for vascular reconstruction and repair purposes. Model DP08X8: 0.8 cm x 8 cm, rectangular with round corners and a tapered end Model DP1X6: 1 cm x 6 cm, rectangular with round corners Model DP2X9: 2 cm x 9 cm, rectangular with round corners
The provided text describes the 510(k) premarket notification for the Duravess Bovine Pericardial Vascular Patch. It does not contain information about acceptance criteria for a device's performance that would typically be evaluated in a study with metrics like sensitivity, specificity, or reader performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device through shared characteristics and successful functional and performance testing.
Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth establishment, and expert involvement are not applicable to the information provided in this document.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., specific thresholds for tensile strength, burst pressure, etc.) that the device must meet, nor does it present device performance in a numerical format against such criteria. It states:
- Acceptance Criteria (Implied): The device successfully pass functional and performance testing demonstrating that it satisfies the same performance requirements as the predicate device.
- Reported Device Performance: "The Duravess bovine pericardial vascular patch has successfully passed functional and performance testing, demonstrating that the subject device satisfies the same performance requirements as the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "functional and performance testing" but does not detail the sample sizes, data provenance, or study design for these tests.
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)
This information is not provided as the type of "test set" and "ground truth" typically associated with expert review (e.g., for diagnostic AI devices) is not applicable here. The testing referenced is likely material science and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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 type of study is not applicable to a vascular patch device. The document describes a biological implant, not an AI or imaging diagnostic tool that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not detail specific "ground truth" as it relates to clinical outcomes or expert diagnoses. For a vascular patch, "ground truth" for performance would be established through laboratory testing based on predetermined specifications or standards for material properties (e.g., tensile strength, burst pressure, suture retention) and biocompatibility, as well as potentially animal studies. The text states it "successfully passed functional and performance testing."
8. The sample size for the training set
This is not applicable as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML device requiring a training set.
Summary of available information regarding the "study" (functional/performance testing):
- Device Tested: Duravess Bovine Pericardial Vascular Patch
- Purpose of Testing: To demonstrate that the device satisfies the same performance requirements as the predicate device (Edwards bovine pericardial patch; K082139) to establish substantial equivalence.
- Outcome: "successfully passed functional and performance testing."
- Details Not Provided:
- Specific quantitative acceptance criteria or performance results.
- Details of the functional and performance tests performed.
- Sample sizes used for testing.
- Specific methodologies for establishing "ground truth" beyond meeting predefined performance requirements.
- Information related to expert involvement or clinical study design, which are not relevant for this type of device's 510(k) submission focused on substantial equivalence to a predicate.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).