(158 days)
The MacroPore Surgi-Wrap (TS) 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: vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral colposuspension.
MacroPore Surgi-Wrap (TS) is a resorbable implant in sheet form manufactured from polylactic acid (PLA). MacroPore Surgi-Wrap (TS) can be cut with scissors to the desired shape and size. The MacroPore Power Pen can also be used to cut or weld the MacroPore Surgi-Wrap (TS) to the desired shape or size. MacroPore Surgi-Wrap (TS) is fully malleable when heated to approximately 55°C (for example, by the use of warm water), and thus can be conformed to anatomic structures. MacroPore Surgi-Wrap (TS) can be rolled into a tube or used as a flat sheet. It can be fixated with tissue fixation devices such as resorbable sutures, which also can serve to fixate the MacroPore tissue fixation devices such as resorbable sutures. MacroPore Surgi-Wrap (TS) may be used in conjunction with various MacroPore manual instruments.
MacroPore Surgi-Wrap (TS) is provided in sheets of 10mm to 120mm x 120mm and will be provided in other shapes and sizes in accordance to the region to be treated. The thickness of the MacroPore Surgi-Wrap (TS) is provided with and without macroporous holes from 0.02 mm to 2.0 mm according to the region to be treated. The macroporous holes range in size from 50 microns to 3,000 microns in diameter and the sheets may be aligned with holes to attach suture material.
The provided document is a 510(k) summary for the MacroPore Surgi-Wrap (TS), seeking substantial equivalence to existing surgical meshes. This type of regulatory submission (from 2001) primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed acceptance criteria and standalone clinical study results for novel device performance.
Therefore, much of the requested information regarding acceptance criteria, specific study designs (like MRMC), expert consensus, and ground truth establishment, which are common in de novo or PMA submissions for novel or high-risk devices, is not present in this 510(k) summary.
The document primarily focuses on establishing substantial equivalence based on:
- Indications for Use: Demonstrating the same intended use as predicate devices.
- Design and Materials: Showing comparable physical characteristics and material composition.
- Performance Data: Presenting in-vitro and in-vivo non-clinical testing to support the functional equivalence and safety.
Here's an attempt to answer the questions based on the provided text, explicitly stating when information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission focused on substantial equivalence to predicate devices, explicit quantitative acceptance criteria with specific thresholds for device performance are not detailed in the provided summary in the manner usually seen for new device or algorithm performance evaluations. Instead, the document reports that the device "meets" or is "substantially equivalent" to the predicate devices based on various tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Materials are appropriate for implantation. | Animal studies demonstrated that the MacroPore Surgi-Wrap (TS) materials are biocompatible and appropriate for the indications for use. |
| Mechanical Strength: Strong enough for indications for use. | Aging testing demonstrated the MacroPore Surgi-Wrap (TS) is strong enough for the indications for use. Mechanical testing performed determined the MacroPore Surgi-Wrap (TS) to be substantially equivalent to the mechanical strengths of the predicate devices under indication for use conditions. |
| Material Stability (Heating): Viscosity remains appropriate. | Testing determined the effect of prolonged heating in saline at 60°C. Data demonstrated that viscosity stayed within an appropriate range over 120 minutes, indicating brief surgical exposure will not significantly affect mechanical properties. |
| Design Characteristics: Comparable to predicate devices. | "Shares indications and design principles with the following predicate devices... Designs... are substantially equivalent, consisting of a thin semi-rigid sheet that allows for contouring." "Thickness ranges are essentially a subset of the predicate device." "Mechanical characteristics are also substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- In Vitro Testing: Not explicitly stated (e.g., number of samples for viscosity, aging, or mechanical strength tests).
- In Vivo (Animal) Testing: Not explicitly stated (e.g., number of animals, number of implants).
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be non-clinical (in vitro and animal), not human clinical data, and there's no indication of the studies being retrospective or prospective in the human clinical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not available in the provided 510(k) summary. Given the non-clinical nature of the studies discussed (in vitro and animal), expert consensus in the form of radiologists or other clinicians establishing ground truth for a test set (as would be relevant for an AI/CAD device) is not applicable here. Ground truth for the animal studies would likely come from histopathological analysis and macroscopic observation by veterinarians or pathologists, but specifics are not provided.
4. Adjudication Method for the Test Set
This information is not available and not applicable to the non-clinical studies described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers or assessments to resolve discrepancies, which are not detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance and is irrelevant for this device (surgical mesh), which is not an AI/CAD system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical surgical mesh, not an algorithm.
7. The Type of Ground Truth Used
- For In Vitro Testing: The "ground truth" implicitly refers to the quantifiable physical and chemical properties of the material (e.g., viscosity, mechanical strength, material composition) measured against established scientific standards or the performance of predicate devices.
- For In Vivo (Animal) Testing: The "ground truth" for biocompatibility and appropriateness for use would typically be established through histological analysis, gross pathological examination, and possibly functional observation by trained veterinarians and pathologists. The summary only states that studies "demonstrated that the MacroPore Surgi-Wrap (TS) materials are biocompatible and appropriate for the indications for use."
8. The Sample Size for the Training Set
This information is not applicable and not available. This device is not an AI/ML algorithm that requires a training set. The data described comes from laboratory and animal testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not available as the device is not an AI/ML algorithm.
§ 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.