(114 days)
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.
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance (Summary from submission) |
|---|---|
| Safety: | |
| Biocompatibility/Material Safety | Fabricated from polylactic acid (PLA). Animal studies demonstrated materials are safe. |
| Stability after heating (for shaping) | In vitro testing showed viscosity stayed within appropriate range over 120 minutes at 60℃ in saline. |
| Effectiveness/Functionality: | |
| Mechanical Strength | Aging testing demonstrated strength for indications. Mechanical testing found substantial equivalence to predicates. |
| Ability to be shaped | Fully malleable when heated to ~55℃. Can be cut with scissors. |
| Resorbability | Bioresorbable (from device name and description). |
| Minimizes tissue attachment | Resorbable Protective Film minimizes tissue attachment (from Indications for Use). |
| Equivalence to Predicate Devices: | |
| Indications for Use | Shares identical indications for use language with predicate devices. |
| Design principles (flexible, semi-rigid) | Substantially equivalent physical designs (flexible, semi-rigid, polymeric). |
| Material composition | Fabricated from PLA. Predicates are also bioresorbable. |
| Size/Thickness range | Shares similar size ranges (25x25mm to 500x500mm) and thickness (0.02mm to 1.0mm) with predicates. |
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.
§ 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.