Search Results

Mesofol® Surgical Sheet is indicated when temporary wound support is required to reinforce soft tissues where weakness exists, or in conjunction with hernia repair or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. The resorbable protective sheet minimizes tissue attachment to the device in case of direct contact with the viscera.

Mesofol® Surgical Sheet is an implantable, resorbable, polymeric surgical sheet manufactured by ITV Denkendork in Germany. Mesofol® Surgical Sheet is offered in various sizes 4cm x 4cm to 20cm x 25cm and is 40jum in thickness. Mesofol® Surgical Sheet can be cut into different sizes and shapes by the end user. The sheet can be fixed with degradable suture material in situations where the anatomical conditions of the wound area are not suited to adequately fix the sheet. Mesofol® Surgical Sheet is manufactured from a lactide-caprolactone copolymer. Mesofol® Surgical Sheet is chemically broken down by hydrolytic cleavage of the polymer, giving rise to three monomers: 6-hydroxycaproic acid, D-lactic acid, and Llactic acid. 6-Hydroxycaproic acid is broken down to acetyl-CoA units via ß-oxidation (fatty acid metabolism) for further dearadation via the Krebs cycle. L-Lactate is broken down in the Cori cycle (lactic acid cycle) to qlucose via pyruvate. These two monomers are thus degraded to products that are physiologically metabolized by the body.

The provided text does not contain information about acceptance criteria for device performance, a study to prove meeting acceptance criteria, or any of the other specific questions laid out in the request regarding sample sizes, expert involvement, or ground truth.

The document is a 510(k) summary for the Mesofol® Surgical Sheet, focusing on establishing substantial equivalence to predicate devices based on device description, intended use, and non-clinical testing (biocompatibility). It explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, I cannot extract the requested information from the provided text.

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

The VivoSorb Sheet is indicated for the use as a temporary wound support, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

The VivoSorb Sheet is designed to be a flexible and transparent resorbable Device poly (DL-lactide-co-s-caprolactone) sheet to provide support to soft tissue Description where weakness exists. The VivoSorb Sheet is provided sterile in Tyvek pouch packages in a variety of sizes.

This document is a 510(k) summary for the VivoSorb Sheet, a medical device. It does not describe an AI/ML powered device, therefore the standard acceptance criteria for such a device are not applicable.

Here's an analysis of the provided information, focusing on the device's performance claims and the study used to support them, based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" in a quantitative manner as would be expected for an AI system, nor does it present specific numerical performance targets. Instead, it relies on demonstrating substantial equivalence to predicate devices through various tests.

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

• Sample Size for Test Set: The document does not specify the sample sizes used for the "design verification tests" or "animal tests." It only lists the types of tests performed (e.g., in vitro suture retention, degradation, aging, mechanical, biocompatibility, animal tests).
• Data Provenance: The document does not provide details on the country of origin of the data or whether the studies were retrospective or prospective. It only mentions "design verification tests and analyses" and "animal tests."

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

This information is not applicable to this document as it describes a physical medical device and its performance, not an AI/ML system that requires ground truth established by experts. The "ground truth" here would be the physical properties and biological responses observed in the tests.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. No expert adjudication method is described or required for the device's physical and biological testing.

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

This information is not applicable. The device is a physical surgical mesh, not an AI system intended to assist human readers. Therefore, an MRMC study is not relevant.

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

This information is not applicable. The device is a physical surgical mesh, not an algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" was established through:

• Objective Measurement/Pathology: This would include direct measurements from the "in vitro suture retention testing," "in vitro degradation testing," "aging testing," and "mechanical testing." For "biocompatibility testing" and "animal tests," "pathology" (histological analysis, observation of biological responses) would be used to assess safety and interaction with biological tissues.
• Literature and Predicate Device Comparison: The determination of "substantial equivalence" also relies on the established performance and safety profiles of the predicate devices and existing scientific literature.

8. The Sample Size for the Training Set

This information is not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

This information is not applicable. As it's not an AI/ML model, there is no "training set" and associated ground truth in that context. The "ground truth" for the device's development would be based on engineering principles, material science, and biological understanding, informed by pre-clinical testing mentioned in point 7.

Ask a specific question about this device