Search Results

The SurgiWrap FROST Bioresorbable Protective 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. This includes, but is not limited to the following procedures: colon and rectal prolapse. 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.

The SurgiWrap FROST Bioresorbable Protective Sheet is a biodegradable surgical mesh for trauma and reconstructive surgical procedures involving soft tissues. The SurgiWrap FROST Bioresorbable Protective Sheet is available in various sizes (50mm x 65mm to 200mm x 130mm with a thickness of 0.02mm to 0.04mm) for use in maintaining the relative position of healing tissues. The device is a solid, semi-transparent thin film sheet that is placed directly on the anatomy. The device has two surfaces, one surface is smooth and the opposite side of the device has a micro-texture. The textured surface of the device allows for controlled gripping with wet gloves. The textured surface of the device readily clings and conforms to surgical tissues. The textured surface also facilitates device placement by minimizing slippage of the device during handling as well as resisting movement of the device during the installation process. The SurgiWrap FROST Bioresorbable Protective Sheet can be cut with scissors to the desired shape and size according to the needs of the physician. The SurgiWrap FROST Bioresorbable Protective 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 SurgiWrap FROST Bioresorbable Protective Sheet and prevent dislocation. The implants maintain the stability of soft tissues during the healing period and are to avoid a second surgical procedure that may otherwise be necessary to remove permanent implants. The implants are not intended for use where permanent implants are required.

This document is a 510(k) summary for the SurgiWrap FROST Bioresorbable Protective Sheet, a surgical mesh device. The provided text describes the device, its intended use, and a comparison to predicate devices, but it does not contain information about acceptance criteria for a specific study, nor does it detail a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or reader improvement.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, which is a different regulatory pathway than proving performance against specific acceptance criteria for a novel device.

Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, details of a study with performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC study results, or training set details) is not present in the provided text.

The closest information available related to "device performance" is:

• "Performance testing was conducted on MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet. Testing demonstrated that the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet is strong enough for its intended use."
• "Mechanical testing was performed on the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet which determined the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions."
• "Biocompatibility studies were conducted per ISO 10993-6 to demonstrate safety and efficacy of the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet material. The biocompatibility studies demonstrated that the MAST Biosurgery SurgiWrap FROST Bioresorbable Protective Sheet materials are safe for its intended use."

These statements indicate that testing was performed to demonstrate "strength enough for its intended use," "substantial equivalence to mechanical strengths," and "safety and efficacy" (biocompatibility), but they do not provide specific quantitative acceptance criteria or detailed results of these tests in a format that could be presented in the requested table or as part of a detailed study description.

The document's purpose is to establish substantial equivalence for regulatory clearance, not to publish results of a performance study against predefined clinical metrics.

Ask a specific question about this device

The Cardio-Wrap Bioresorbable Sheet is intended for reconstruction and repair of defects of the pericardium.

MAST Biosurgery Cardio-Wrap Bioresorbable Sheet is a resorbable implant in sheet form manufactured from polylactic acid (PLA). MAST Biosurgery Cardio-Wrap Bioresorbable Sheet can be cut with scissors to the desired shape and size. The MAST Biosurgery Cardio-Wrap can be used either alone or in conjunction with soft tissue fixation devices such as resorbable sutures, which can also serve to fixate the MAST Biosurgery Cardio-Wrap and prevent dislocation. MAST Biosurgery Cardio-Wrap 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. MAST Biosurgery Cardio-Wrap Bioresorbable Sheet is provided in sheets of 10mm x 10mm 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 Cardio-Wrap Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Cardio-Wrap 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 MAST Biosurgery Cardio-Wrap Bioresorbable Sheet. This type of filing aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo acceptance criteria through a specific clinical study with detailed performance metrics.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable to this type of submission. The provided information focuses on demonstrating equivalence through design characteristics, material composition, and intended use compared to existing cleared devices, not on a standalone performance study with specific acceptance thresholds.

However, I can extract information related to the device description and the basis for its clearance:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This submission relies on substantial equivalence to predicate devices, not a new clinical test set with a defined sample size for performance evaluation against specific criteria. The "In Vitro Testing" and "In Vivo Testing" sections mention "testing" and "studies" but do not provide specific sample sizes or data provenance relevant to a "test set" as typically understood in a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. There is no mention of a "test set" and "ground truth" in the context of expert review for this 510(k) submission.

4. Adjudication method for the test set

• Not Applicable. As no specific "test set" requiring adjudication is described.

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 bioresorbable sheet, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

• Not Applicable. The "ground truth" for this submission is effectively the established performance and safety profiles of the legally marketed predicate devices to which the Cardio-Wrap Bioresorbable Sheet claims substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not Applicable. As above, this is not an AI/ML device.

Ask a specific question about this device

The MAST Biosurgery Ortho-Wrap 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 MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery, including reinforcement of the flexor or extensor tendons of the fingers, thumb and wrist, rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. MAST Biosurgery Ortho-Wrap is NOT intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the flexor or extensor tendons of the fingers, thumb and wrist, rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. The MAST Biosurgery Ortho-Wrap reinforces soft tissue and provides a remodelable scaffold that is replaced by the patients own soft tissue.

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 Ortho-Wrap Bioresorbable Sheet is a resorbable implant in sheet form manufactured from polylactic acid (PLA). The Ortho-Wrap Bioresorbable Sheet can be cut with scissors to the desired shape and size. The Ortho-Wrap 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 Ortho-Wrap 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 Ortho-Wrap Bioresorbable Sheet and prevent dislocation.

The MAST Biosurgery Ortho-Wrap 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 Ortho-Wrap 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 Ortho-Wrap Bioresorbable Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Ortho-Wrap Bioresorbable Sheet is provided in solid sheets. The borders of the sheets may be aligned with holes to attach suture material.

This document describes the premarket notification (510(k)) for the MAST Biosurgery Ortho-Wrap Bioresorbable Sheet. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and efficacy criteria through a clinical study with acceptance criteria in the typical sense for AI/software devices.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that this submission is for a medical device (surgical mesh), not an AI/software device. Therefore, the concept of "acceptance criteria" and "reported device performance" as typically applied to AI models (e.g., accuracy, sensitivity, specificity thresholds) is not applicable here. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to legally marketed predicate devices.

The device's performance is demonstrated through in-vitro and in-vivo testing, primarily to show that it functions as intended and is comparable to its predicates.

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

• Test Set Sample Size: Not applicable in the context of a 510(k) for a physical medical device. The "tests" are described as in-vitro and in-vivo (animal) studies, not a human clinical test set for AI performance.
• Data Provenance:
  • In Vitro Testing: Performed with the device itself.
  • In Vivo Testing: Conducted via "Animal studies." No country of origin is specified for these studies, but they were likely conducted under controlled laboratory conditions.
  • Retrospective/Prospective: The in-vitro and in-vivo tests would be considered prospective as they were specifically designed and executed for this submission.

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

Not applicable. "Ground truth" in the context of expert consensus, which is common for AI evaluation, is not relevant here. The ground truth for the in-vitro tests relies on objective measurements and established scientific principles. For in-vivo animal studies, efficacy and safety endpoints are determined by veterinary and scientific protocols, not human expert consensus on diagnostic images or data interpretations.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication method" in the sense of resolving disagreements among human readers or experts for device performance data for this type of submission. Performance is assessed through direct physical, chemical, and biological testing.

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 physical medical device (surgical mesh), not an AI or software device that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for demonstrating substantial equivalence for this physical device relies on:

• Objective measurements and chemical/physical properties: For in-vitro tests (e.g., viscosity, mechanical strength, aging properties). These are based on established scientific measurement techniques.
• Animal study results: For in-vivo safety and efficacy. These outcomes are typically assessed through histological analysis, gross observations, and potentially functional assessments in the animal models, ultimately interpreted by veterinary pathologists and researchers.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As there's no AI model, there's no training set or associated ground truth establishment process.

Ask a specific question about this device

The Surgi-Wrap MAST Tendon 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 Surgi-Wrap MAST Tendon Sheet is also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Surgi-Wrap MAST Tendon Sheet is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. The Surgi-Wrap MAST Tendon Sheet reinforces soft tissue and provides a remodelable scaffold that is replaced by the patients own soft tissue.

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 Tendon Sheet is a resorbable implant in sheet form manufactured from poly (L-lactide-co-D,L-lactide) 70:30 (PLA). The Surgi-Wrap MAST Tendon Sheet can be cut with scissors to the desired shape and size. The Surgi-Wrap MAST Tendon 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 Tendon 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 Tendon Sheet and prevent dislocation. The Surgi-Wrap MAST Tendon Sheet may be used in conjunction with various MAST Biosurgery Class I manual instruments (forceps, scissors, clamps, etc.).

The MAST Biosurgery Surgi-Wrap MAST Tendon 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 Tendon 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 Tendon Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Surgi-Wrap MAST Tendon 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 a medical device called the Surgi-Wrap MAST Tendon Sheet. This type of document is for premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, rather than a clinical study establishing novel acceptance criteria and performance against those.

Therefore, the document does not contain a traditional study that defines specific acceptance criteria with corresponding performance metrics that would be typically found in a clinical trial or a performance study for a new, non-substantially equivalent device.

Instead, the submission demonstrates "substantial equivalence" to existing, legally marketed predicate devices. This means the device is considered as safe and effective as a predicate device and does not raise different questions of safety and effectiveness. The "acceptance criteria" here are effectively met by demonstrating similarity to the predicate devices through material composition, design characteristics, intended use, and various testing (in vitro and in vivo).

However, I can extract the information that is present and frame it as closely as possible to your request.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, explicit quantitative acceptance criteria with corresponding performance metrics are not defined in the same way as a de novo clinical study. Instead, the "acceptance criteria" can be inferred as similarity or equivalence to the predicate devices in terms of properties and function. The "reported device performance" is essentially the evidence presented to support this equivalence.

Due to the nature of a 510(k) submission for substantial equivalence based on in vitro and animal studies, most of the detailed information requested regarding sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth for human-centric clinical trials is not applicable or not provided in this document.

Here's an assessment based on the available information:

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

• Sample Size (Test Set): Not specified for the in vitro or in vivo (animal) studies. The document only states that "testing was performed" and "animal studies were conducted."
• Data Provenance:
  • In Vitro Testing: Performed on the device material itself, likely in a laboratory setting.
  • In Vivo Testing: Animal studies. The country of origin for these studies is not specified, but the submission is to the US FDA.
  • Retrospective or Prospective: Not explicitly stated, but in vitro and in vivo animal studies are generally prospective by design.

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

• Not applicable / Not provided. The studies described (in vitro and animal) do not involve human expert interpretation of clinical data in the way implied by this question. The "ground truth" for these studies would be defined by the experimental setup and measurements (e.g., direct measurement of viscosity, mechanical strength tests, histological analysis in animals).

4. Adjudication Method for the Test Set

• Not applicable / Not provided. Adjudication methods like "2+1" or "3+1" are relevant for human reader studies interpreting complex data (e.g., medical images). The testing described here does not involve such a process.

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

• No. An MRMC study is not mentioned or implied. This type of study would involve human readers evaluating clinical cases with and without AI assistance to measure improvement in diagnostic performance. The Surgi-Wrap MAST Tendon Sheet is a physical implantable device, not an AI diagnostic tool.

6. If a Standalone (Algorithm Only) Performance Study was done

• Not applicable / Not provided. This question generally pertains to AI algorithms. The "standalone" performance here would refer to the device's inherent physical and biological properties as demonstrated in the in vitro and in vivo (animal) tests, without human interaction during the test itself (though human surgeons implant the device).

7. The Type of Ground Truth Used

• In Vitro Testing: The "ground truth" for in vitro tests would be the direct measurements of properties like inherent viscosity and mechanical strength using standardized laboratory methods and equipment.
• In Vivo Testing (Animal Studies): The "ground truth" from these studies would be based on observations of safety (e.g., biocompatibility, adverse reactions) and efficacy (e.g., tissue integration, healing response, absence of substantial adverse events) in the animal models, likely confirmed by macroscopic and microscopic (histopathological) examination.

8. The Sample Size for the Training Set

• Not applicable / Not provided. The concept of a "training set" is relevant for machine learning algorithms. The provided document describes testing of a physical medical device.

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

• Not applicable / Not provided. As explained above, there is no "training set" in the context of this device's submission.

Ask a specific question about this device

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