Search Results

Veritas Collagen Matrix (Dry) 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 Collagen Matrix (Dry) can be used for reinforcement of staple lines during lung and bronchus resection, during gastric, bariatric, small bowel, mesentery, colon and colorectal procedures, and cardiac surgery (for example, occlusion of the left atrial appendage during open chest procedures.

Veritas Collagen Matrix (Dry) minimizes tissue attachment to the device in case of direct contact with viscera.

Veritas Collagen Matrix is an implantable surgical mesh comprised of non-crosslinked bovine pericardium. Veritas Collagen Matrix bovine pericardium is procured in the United States from cattle less than 30 months of age.

Veritas Collagen Matrix allows for neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling. Veritas Collagen Matrix also minimizes tissue attachment to the device in case of direct contact with viscera.

This document is a 510(k) summary for the Veritas® Collagen Matrix (Dry). It states that the device is acting as its own predicate, meaning it's substantially equivalent to a previously cleared version of the same product. The submission focuses on a new method of attachment of the buttress to the stapler (an adhesive).

Given this, the document does not describe a study to prove the device meets acceptance criteria related to its primary function as a surgical mesh. Instead, the testing described is limited to the new adhesive.

Therefore, for most of your requested points, the answer will be "Not applicable" or "No information provided" as the provided text doesn't contain a detailed study proving the overall device performance against specific acceptance criteria.

However, I can extract information related to the scope of the current submission.

Here's a breakdown based on the provided text:

1. Table of acceptance criteria and the reported device performance

Note: The document explicitly states: "Veritas Collagen Matrix (Dry) is unchanged and previous testing applies." This means the core functionality of the collagen matrix as a surgical mesh was not re-evaluated in this submission, as it was already cleared in previous 510(k)s (K041669 and K062915).

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

• Sample size: Not specified.
• Data provenance: 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 study is on device components (adhesive biocompatibility and functionality), not on human-interpreted clinical data requiring expert ground truth establishment in the traditional sense of diagnostic AI.

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

• Not applicable. (See #3)

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. This is a medical device for surgical mesh and adhesive, not an AI or diagnostic imaging device that would typically involve MRMC studies.

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

• Not applicable. (See #5)

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

• Not applicable. The evaluation relates to physical and biological properties of the adhesive (biocompatibility, functional performance), not clinical ground truth in the context of disease detection or diagnosis.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable. (See #8)

Ask a specific question about this device

Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies: this includes but is not limited to the following:

Buttressing and reinforcing staple lines during lung resection (e.g., wedge lobectomy, bullectomy, bronchial resection, blebectomy, resection, segmentectorny, pnuemonectorny, pneumoreduction) and other incision and excision of the lung and bronchus.

Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional. inquinal. lumbar, paracolostomy, scrotal, umbilical).

Veritas Collagen Matrix minimizes tissue attachment to the device in case of direct contact with viscera.

An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas® Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.

The provided text does not contain a table of acceptance criteria or specific performance metrics of the device as would typically be found in a formal study. Instead, it describes a 510(k) Premarket Notification for the Veritas® Collagen Matrix, which asserts substantial equivalence to previously marketed predicate devices.

However, based on the provided text, we can infer some information relevant to the "acceptance criteria" through the lens of a substantial equivalence determination and the single study mentioned.

Here's an attempt to structure the information based on your request, highlighting what is present and what is not:

Acceptance Criteria and Device Performance for Veritas® Collagen Matrix

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided document. The text only states "An animal study was conducted."
• Data Provenance: The study was an "animal study," implying pre-clinical data (not human clinical data). The location/country of origin is not specified. It is inherently prospective as it was conducted for this specific submission to evaluate the new indication.

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

• This information is not provided. As an animal study for a pre-market notification, the "ground truth" would likely be established by the researchers/veterinarians involved in the study, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided. Given that it's an animal study assessing physical characteristics (tissue attachment), formal adjudication methods like 2+1 or 3+1 are typically not applicable in the same way they would be for image-based diagnostic studies. The evaluation method would be part of the individual study's protocol.

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

• No, a MRMC comparative effectiveness study was not done. The study described is an animal study, not a human clinical trial involving multiple readers. Therefore, there is no effect size of human readers improving with AI assistance vs. without AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not applicable. This document describes a physical medical device (surgical mesh), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant here. The "standalone" performance here would refer to the device's functional characteristics in the animal model.

7. Type of Ground Truth Used

• The ground truth for the animal study (regarding tissue attachment) would be based on direct observation and histopathological analysis (implied) of the animal tissues post-implantation, assessing the degree of attachment. This would fall under direct scientific observation and potentially pathology.

8. Sample Size for the Training Set

• Not applicable/Not provided. This is a physical device, not an AI algorithm, so there is no "training set" in the machine learning sense. The device itself is "trained" through its manufacturing process and design based on prior knowledge and predicate devices.

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

• Not applicable. As above, there is no training set for an AI algorithm. For the development of the device itself (manufacturing, processing), ground truth is established through extensive material science testing, bio-compatibility studies, and prior pre-clinical/clinical data from its own previous iterations and predicate devices, ensuring it meets specified material properties and safety profiles. The specific animal study discussed was for a new indication, not for the fundamental development/training of the device itself.

Ask a specific question about this device

Veritas Collagen Matrix is intended for use as an implant for the surgical repair of soft tissue deficiencies, this includes but is not limited to the following:

Buttressing and reinforcing staple lines during lung resection (e.g., wedge resection, blebectomy, lobectomy, bullectomy, bronchial resection. segmentectomy, pnuemonectomy/pneumectomy, pneumoreduction) and other incision and excision of the lung and bronchus.

Reinforcement of the gastric staple line during the bariatric surgical procedures of gastric bypass and gastric banding.

Abdominal and thoracic wall repair, muscle flap reinforcement, rectal prolapse excluding rectocele, reconstruction of the pelvic floor excluding transvaginal organ prolapse repair, and repair of hernias (e.g., diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, umbilical).

An implantable surgical patch comprised of non-crosslinked bovine pericardium. Veritas Collagen Matrix undergoes proprietary processing that allows neo-collagen formation and neovascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.

The provided text does not contain information about acceptance criteria or a study proving the device meets them, as would be relevant for a diagnostic or AI-powered medical device.

The document is a 510(k) summary for a Surgical Mesh (Veritas Collagen Matrix), which is a physical implant. The approval process for such a device focuses on demonstrating substantial equivalence to a previously approved predicate device, primarily based on technological characteristics and intended use, rather than performance metrics from clinical studies in the same way a diagnostic algorithm would be evaluated.

Therefore, the requested information elements (acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) are not applicable and not present in the provided text for this specific type of medical device approval.

The "Technology/Device Testing" section only states: "The Veritas Collagen Matrix is substantially equivalent to the predicate device in terms of testing." This implies that the testing performed was sufficient to demonstrate substantial equivalence, but it does not detail specific performance metrics or studies in the way requested for a diagnostic AI.

Ask a specific question about this device