(276 days)
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.
§ 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.