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The Surgi-Wrap MAST Tendon 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 Surgi-Wrap MAST Tendon Sheet is also indicated for reinforcement of soft tissues repaired by suture or suture anchors, during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. Surgi-Wrap MAST Tendon Sheet is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the 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 Surgi-Wrap MAST Tendon Sheet 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 Surgi-Wrap MAST Tendon Sheet is a resorbable implant in sheet form manufactured from poly (L-lactide-co-D,L-lactide) 70:30 (PLA). The Surgi-Wrap MAST Tendon Sheet can be cut with scissors to the desired shape and size. The Surgi-Wrap MAST Tendon 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 Tendon 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 Tendon Sheet and prevent dislocation. The Surgi-Wrap MAST Tendon Sheet may be used in conjunction with various MAST Biosurgery Class I manual instruments (forceps, scissors, clamps, etc.).

The MAST Biosurgery Surgi-Wrap MAST Tendon 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 Tendon 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 Tendon Sheet ranges from 0.02 mm to 1.0 mm according to the region to be treated. The MAST Biosurgery Surgi-Wrap MAST Tendon 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 a medical device called the Surgi-Wrap MAST Tendon Sheet. This type of document is for premarket notification to demonstrate substantial equivalence to a legally marketed predicate device, rather than a clinical study establishing novel acceptance criteria and performance against those.

Therefore, the document does not contain a traditional study that defines specific acceptance criteria with corresponding performance metrics that would be typically found in a clinical trial or a performance study for a new, non-substantially equivalent device.

Instead, the submission demonstrates "substantial equivalence" to existing, legally marketed predicate devices. This means the device is considered as safe and effective as a predicate device and does not raise different questions of safety and effectiveness. The "acceptance criteria" here are effectively met by demonstrating similarity to the predicate devices through material composition, design characteristics, intended use, and various testing (in vitro and in vivo).

However, I can extract the information that is present and frame it as closely as possible to your request.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission based on substantial equivalence, explicit quantitative acceptance criteria with corresponding performance metrics are not defined in the same way as a de novo clinical study. Instead, the "acceptance criteria" can be inferred as similarity or equivalence to the predicate devices in terms of properties and function. The "reported device performance" is essentially the evidence presented to support this equivalence.

Due to the nature of a 510(k) submission for substantial equivalence based on in vitro and animal studies, most of the detailed information requested regarding sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth for human-centric clinical trials is not applicable or not provided in this document.

Here's an assessment based on the available information:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size (Test Set): Not specified for the in vitro or in vivo (animal) studies. The document only states that "testing was performed" and "animal studies were conducted."
• Data Provenance:
  • In Vitro Testing: Performed on the device material itself, likely in a laboratory setting.
  • In Vivo Testing: Animal studies. The country of origin for these studies is not specified, but the submission is to the US FDA.
  • Retrospective or Prospective: Not explicitly stated, but in vitro and in vivo animal studies are generally prospective by design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not applicable / Not provided. The studies described (in vitro and animal) do not involve human expert interpretation of clinical data in the way implied by this question. The "ground truth" for these studies would be defined by the experimental setup and measurements (e.g., direct measurement of viscosity, mechanical strength tests, histological analysis in animals).

4. Adjudication Method for the Test Set

• Not applicable / Not provided. Adjudication methods like "2+1" or "3+1" are relevant for human reader studies interpreting complex data (e.g., medical images). The testing described here does not involve such a process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is not mentioned or implied. This type of study would involve human readers evaluating clinical cases with and without AI assistance to measure improvement in diagnostic performance. The Surgi-Wrap MAST Tendon Sheet is a physical implantable device, not an AI diagnostic tool.

6. If a Standalone (Algorithm Only) Performance Study was done

• Not applicable / Not provided. This question generally pertains to AI algorithms. The "standalone" performance here would refer to the device's inherent physical and biological properties as demonstrated in the in vitro and in vivo (animal) tests, without human interaction during the test itself (though human surgeons implant the device).

7. The Type of Ground Truth Used

• In Vitro Testing: The "ground truth" for in vitro tests would be the direct measurements of properties like inherent viscosity and mechanical strength using standardized laboratory methods and equipment.
• In Vivo Testing (Animal Studies): The "ground truth" from these studies would be based on observations of safety (e.g., biocompatibility, adverse reactions) and efficacy (e.g., tissue integration, healing response, absence of substantial adverse events) in the animal models, likely confirmed by macroscopic and microscopic (histopathological) examination.

8. The Sample Size for the Training Set

• Not applicable / Not provided. The concept of a "training set" is relevant for machine learning algorithms. The provided document describes testing of a physical medical device.

9. How the Ground Truth for the Training Set was Established

• Not applicable / Not provided. As explained above, there is no "training set" in the context of this device's submission.

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