Search Results

The Surgi-Wrap MAST Bioresorbable Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the tissues.

The device is indicated for open and laparoscopic / endoscopic procedures. Laparoscopic / endoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.

The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is a resorbable implant in sheet form manufactured from polylactic acid (PLA). The Surgi-Wrap MAST Bioresorbable Sheet can be cut with scissors to the desired shape and size. The Surgi-Wrap MAST Bioresorbable Sheet is fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The Surgi-Wrap MAST Bioresorbable Sheet can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which can also serve to fixate the Surgi-Wrap MAST Bioresorbable Sheet and prevent dislocation. The Surgi-Wrap MAST Bioresorbable Sheet may be used in conjunction with various MAST Biosurgery Class I manual instruments (forceps, scissors, clamps, etc.).

The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is provided in sheets of 25mm x 25mm to 500mm x 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.

The provided text describes a 510(k) premarket notification for the "Surgi-Wrap MAST Bioresorbable Sheet." This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the context of a de novo approval or clinical trial for a novel device.

Therefore, many of the requested elements for acceptance criteria and study design are not explicitly available in this type of submission. This document primarily outlines the device description, intended use, and demonstrates equivalence to marketed products through physical characteristics, material composition, and intended uses.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: These are not explicitly stated as numerical performance targets (e.g., sensitivity, specificity, accuracy) like they would be for a diagnostic AI device. Instead, the "acceptance criteria" for a 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices in terms of safety and effectiveness. The criteria revolve around showing similar indications for use, design principles, material composition, and mechanical properties.
• Reported Device Performance: The document describes testing performed to support substantial equivalence, but it doesn't present "performance" in terms of specific metrics like sensitivity or accuracy for a diagnostic device.

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 for Test Set: Not applicable or specified in the context of this 510(k) submission. The testing described (in vitro, animal studies) does not involve a "test set" in the sense of a dataset for AI evaluation.
• Data Provenance: Not applicable or specified for this type of submission. The studies are described as "in vitro testing" and "animal studies" without further detail on origin or type.

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. This device is a surgical mesh, not a diagnostic device requiring expert interpretation for ground truth.

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

• Not applicable. This device is a surgical mesh.

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 device is a surgical mesh, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a surgical mesh.

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

• For the in-vitro testing: Internal laboratory measurements (e.g., viscosity, mechanical strength) served as the "ground truth" for the material properties.
• For the animal studies: Safety and efficacy observations in animals served as the "ground truth." The document states: "The animal studies demonstrated that the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet materials are safe and efficacious for the indications for use." The specific endpoints for "safety" and "efficacious" are not detailed.

8. The sample size for the training set

• Not applicable. This is not an AI-based device and does not involve a training set in that context.

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

• Not applicable. This is not an AI-based device.

Ask a specific question about this device

The Surgi-Wrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse, repair, reconstruction of the pelvic floor and sacral colposuspension. The resorbable Protective Film minimizes tissue attachment to the device in case of direct contact with the viscera. The device is indicated for open and laparoscopic procedures. Laparoscopic procedures are limited to sizes from 0.02mm - 0.2mm in thickness.

MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is a resorbable implant in sheet form manufactured from polylactic acid (PLA). The Surgi-Wrap MAST Bioresorbable Sheet can be cut with scissors to the desired shape and size. The Surgi-Wrap MAST Bioresorbable Sheet Sheet is fully malleable when heated to approximately 55℃ (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The Surgi-Wrap MAST Bioresorbable Sheet can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which can also serve to fixate the Surgi-Wrap MAST Bioresorbable Sheet and prevent dislocation. The Surgi-Wrap MAST Bioresorbable Sheet may be used in conjunction with various MAST Biosurgery Class I manual instruments (forceps, scissors, clamps, etc.).

The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is provided in sheets of 25mm x 25mm to 500mm x 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.

The provided text is a 510(k) Summary for the Surgi-Wrap MAST Bioresorbable Sheet, focusing on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a primary clinical study. Therefore, much of the requested information cannot be found in the provided document.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: Not specified. The document refers to "in vitro testing" and "animal studies" without providing specific sample sizes for these tests. For substantial equivalence, the "test set" is essentially the comparison of the new device to existing predicates. No specific "test set" of patients or images is described in the context of a clinical study.
   • Data Provenance: Not specified. In vitro tests are typically laboratory-based, and animal studies would involve specific animal models, but no country of origin is mentioned. The studies presented are geared towards demonstrating equivalence, not necessarily a human clinical trial.
   • Retrospective or Prospective: Not applicable or not specified, as the studies described are laboratory/animal tests and a comparison to predicate devices, not human clinical trials.

2. 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 ground truth for this device's regulatory submission relies on laboratory test results (in vitro, mechanical) and animal study outcomes, as well as a comparison to the established performance of predicate devices. There is no mention of human expert consensus for a "ground truth" test set as one might find in an AI/diagnostic device submission.

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

   • Not applicable. This concept is relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

4. 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 not an AI-assisted diagnostic device, but a surgical mesh. Therefore, an MRMC study is not relevant.

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

   • Not applicable. This is not an algorithm or AI device.

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

   • The "ground truth" in this context is established through:
     • In vitro mechanical and material testing: Directly measured physical and chemical properties.
     • Animal study results: Demonstrating safety and efficacy in an animal model.
     • Performance of predicate devices: Substantial equivalence relies on the established safety and effectiveness of the previously cleared devices.

7. The sample size for the training set:

   • Not applicable. This relates to machine learning/AI models. The device is a physical surgical implant.

8. How the ground truth for the training set was established:

   • Not applicable.

Summary of missing information and reason:

The provided document is a 510(k) summary for a physical medical device (surgical mesh), not for an artificial intelligence or diagnostic imaging device. Therefore, many of the requested categories, such as sample size for test/training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance, are not relevant to this type of submission and are consequently not present in the text. The "acceptance criteria" and "study results" described are focused on material properties, mechanical performance, animal safety/efficacy, and demonstrating substantial equivalence to predicate devices, which are typical for Class II non-AI surgical implants.

Ask a specific question about this device

The MacroPore Surgi-Wrap MAST Bioresorbable Sheet is to be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists, or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging 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.

MacroPore Surgi-Wrap MAST Bioresorbable Sheet is a resorbable implant in sheet form manufactured from poly lactic acid (PLA). MacroPore Surgi-Wrap MAST Bioresorbable Sheet can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or shape the MacroPore Surgi-Wrap MAST Bioresorbable Sheet to the desired shape or size. MacroPore Surgi-Wrap MAST Bioresorbable Sheet is fully malleable when heated to approximately 55°C (for example, by the use of sterile hot water), and thus can be conformed three dimensionally to most any anatomical orientation. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures. which can also serve to fixate the MacroPore Surgi-Wrap MAST Bioresorbable Sheet and prevent dislocation. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet may be used in conjunction with various MacroPore manual instruments.

MacroPore Surgi-Wrap MAST Bioresorbable Sheet is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular surgical procedures. MacroPore Surgi-Wrap MAST Bioresorbable Sheet is provided in sheets of 25mm x 25mm to 500mm and will be provided in other shapes and sizes as needed for particular surgical procedures. The thickness of the MacroPore Surgi-Wrap MAST Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MacroPore Surgi-Wrap MAST Bioresorbable Sheet is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.

The MacroPore Surgi-Wrap MAST Bioresorbable Sheet is a surgical mesh made from polylactic acid (PLA) intended for temporary wound support, soft tissue reinforcement, and repair of hernias or fascial defects.

Here's an analysis of its acceptance criteria and the study that proves it meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes several tests:

• In Vitro Testing (Inherent Viscosity): No specific sample size is provided, but it states "testing was performed." The data provenance is not specified, but it's an in-house lab test ("in vitro").
• In Vitro Testing (Strength): No specific sample size is provided, but it states "testing demonstrates." Data provenance is not specified.
• In Vitro Testing (Mechanical Strength): No specific sample size is provided, but it states "mechanical testing was performed." Data provenance is not specified.
• In Vivo Testing (Animal Studies): No specific species or number of animals are provided, only "Animal studies were conducted." Data provenance is typically internal to the manufacturer or a contract research organization. These are prospective studies on animals.
• Equivalence to Marketed Product: This is a comparison to previously cleared devices (K012025, K002699) and relies on their established performance, not a new test set of patients for the MacroPore Surgi-Wrap MAST Bioresorbable Sheet.

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

The document does not mention the use of human experts to establish ground truth for a test set in the context of the device's performance. The "ground truth" for material properties and animal studies would be established by the results of the scientific tests and observations themselves, as interpreted by the researchers/scientists conducting those studies.

4. Adjudication Method for the Test Set:

No adjudication method is described for any test set, as this is not a study involving human interpretation of data where consensus or adjudication would be required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No MRMC comparative effectiveness study was conducted or described. This type of study is typically done for diagnostic imaging devices where human interpretation is a key factor. This device is a surgical implant.

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

Not applicable. This device is a physical surgical mesh, not a software algorithm.

7. The Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria is primarily based on:

• Empirical Measurement/Laboratory Data: For inherent viscosity, strength, and mechanical properties.
• Biological Observation/Pathology: For the animal studies assessing safety and efficacy in vivo.
• Established Performance of Predicate Devices: For demonstrating substantial equivalence, relying on the known performance and clearance of the MacroPore Surgi-Wrap (TS) and Sofradim Parietex Composite Mesh.

8. The Sample Size for the Training Set:

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

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set mentioned for this type of device.

Ask a specific question about this device