(128 days)
Veritas Dry Staple Line Reinforcement is intended for use as a prosthesis for the surgical repair of soft tissue deficiencies using surgical staplers when staple line reinforcement is needed.
Veritas Dry can be used for reinforcement of staple lines during lung and bronchus resections and during bariatric surgical procedures.
Veritas Dry can be used for reinforcement of staple lines during gastric, small bowel, mesentery, colon, and colorectal procedures.
Veritas Dry is intended to be used for reinforcement of suture-lines and staple-lines (for example: occlusion of the left atrial appendage during open chest procedures) during cardiac surgery.
Veritas Dry is intended to be used as a staple line buttress. Veritas Dry is composed of dehydrated non-crosslinked bovine pericardium, to facilitate easy loading of the pericardium strips onto the stapler forks, an anvil and a cartridge strip are secured in a mounting unit. One mounting unit is used for each stapler firing. Each Veritas Dry unit is provided sterile in a double pouch.
The provided text is a 510(k) summary for a medical device (Veritas Dry Collagen Matrix) and the associated FDA approval letter. This type of document is for premarket notification of a device claiming substantial equivalence to a predicate device, not for a de novo marketing authorization or a PMA. As such, it does not involve the kind of clinical study with acceptance criteria, ground truth establishment, or AI performance metrics that your request is looking for.
Instead, the submission focuses on demonstrating substantial equivalence to already approved devices. This is typically done through:
- Comparison of technological characteristics: Showing that the new device has similar materials, design, and intended use as the predicate devices.
- Performance testing: Conducting non-clinical (e.g., mechanical, biocompatibility) tests to demonstrate that the device performs as safely and effectively as the predicate devices.
Therefore, many of the requested fields are not applicable to this type of regulatory submission.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense. This document doesn't define explicit "acceptance criteria" for clinical performance that would be met by a study with human participants or a machine learning algorithm.
- Implied Acceptance Criteria: The implicit acceptance criterion for a 510(k) is "substantial equivalence" to the predicate devices in terms of safety and effectiveness.
- Reported Device Performance (as stated in the document):
- "Veritas Dry is substantially equivalent to the predicate devices, having equivalent technological characteristics and indications for use."
- "Veritas Dry is substantially equivalent to the predicate devices in terms of physical characteristics and test results."
- The "testing" mentioned would be non-clinical performance tests (e.g., mechanical strength, biocompatibility), not clinical efficacy or diagnostic accuracy. Specific quantitative results of these tests and their acceptance criteria are not provided in this summary but would have been part of the full 510(k) submission.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is not a clinical study on human subjects or an AI model evaluation. The "test sets" would refer to samples used for non-clinical performance testing of the material itself. The specific sample sizes for these tests are not disclosed in this summary.
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. Ground truth in the context of expert consensus is not relevant for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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
- Not Applicable. This is a surgical mesh, not a diagnostic imaging AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable in the clinical sense. For non-clinical performance testing, the "ground truth" would be established by validated test methods and established material science standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there's no training set.
9. How the ground truth for the training set was established
- Not Applicable.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.