(106 days)
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
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Material Properties | Inherent Viscosity after Heating: Implicit acceptance criteria: Viscosity should remain within an "appropriate range" after prolonged heating in saline at 60℃ for 120 minutes, indicating mechanical properties are not significantly affected by surgical preparation. | Inherent Viscosity after Heating: "The testing demonstrates that viscosity staved within an appropriate range over 120 minutes. The relatively brief exposure anticipated during the surgical preparation of MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is not expected to have a significant effect on its mechanical properties." |
| Mechanical Strength | Aging Testing: Implicit acceptance criteria: The device must remain "strong enough for the indications for use" after aging. | |
| Mechanical Testing (Equivalence): Implicit acceptance criteria: Mechanical strengths must be "substantially equivalent" to predicate devices under indication for use conditions. | Aging Testing: "Testing demonstrated that the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet is strong enough for the indications for use." | |
| Mechanical Testing (Equivalence): "Mechanical testing was performed on the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet which determined the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions." | ||
| Safety and Efficacy | Animal Studies (Safety & Efficacy): Implicit acceptance criteria: The materials should be demonstrated to be "safe and efficacious" for the indications for use in animal studies. | Animal Studies (Safety & Efficacy): "The animal studies demonstrated that the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet materials are safe and efficacious for the indications for use." |
| Substantial Equivalence | Indications for Use: Identical indications for use principles as predicate devices. | |
| Design and Materials: Physical designs substantially equivalent to predicate devices (thin semi-rigid sheets, resorbable materials, identical fit/form/function with some predicates, contourable when heated, similar thickness/shapes/sizes, can be cut). | ||
| Mechanical Characteristics: Substantially equivalent to predicate devices. | Indications for Use: "The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet shares identical indications for use principles with the predicate devices as the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet and the predicate devices are indicated for the same surgical procedures." | |
| Design and Materials: "The physical designs of MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet and the predicate devices [...] are substantially equivalent, consisting of thin semi-rigid sheets that are fabricated from resorbable materials. The MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet and the MacroPore Surgi-Wrap MAST Bioresorbable Sheet and MacroPore Surgi-Wrap (TS) predicate device are identical in fit, form, and function as all devices are manufactured with the same process and fabricated from the identical raw material." Also notes contourability, similar dimensions (thickness from 0.02mm to 1.0mm, sizes from 25mm x 25mm to 500mm x 500mm), and cut-ability. | ||
| Mechanical Characteristics: "The mechanical characteristics of the MAST Biosurgery Surgi-Wrap MAST Bioresorbable Sheet are substantially equivalent to the predicate devices." |
Study Details
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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.
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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.
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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.
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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.
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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.
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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.
- The "ground truth" in this context is established through:
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The sample size for the training set:
- Not applicable. This relates to machine learning/AI models. The device is a physical surgical implant.
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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.
§ 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.