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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.

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