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MTF Fascia is intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

MTF Fascia 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.

MTF Fascia is for single patient use only.

MTF Fascia is dehydrated, decellularized human allograft fascia minimally processed to preserve the extracellular matrix of the fascia. The fascia is reinforced with a resorbable Poly-L-Lactic Acid (PLLA) fiber woven into the fascia to enhance suture retention of the fascia. MTF Fascia is aseptically processed-no terminal sterilization is conducted. The device passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for medical devices. The device must be rehydrated prior to use following the procedures described in the Instructions for Use.

This document is a 510(k) summary for the MTF Fascia device. It is a premarket notification for a medical device seeking clearance from the U.S. Food and Drug Administration (FDA) and is not a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a diagnostic device, for example.

The purpose of a 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device. This means it is as safe and effective as another legally marketed device. The acceptance criteria in this context are related to demonstrating this substantial equivalence, rather than a quantifiable performance metric for a specific medical condition.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission for a surgical mesh, the "acceptance criteria" are implicitly defined by the requirements for demonstrating substantial equivalence to predicate devices regarding material composition, biocompatibility, and biomechanical properties. The "reported device performance" refers to the results of tests demonstrating these aspects.

• ISO 10993 testing of the PLLA fiber.
• Cytotoxicity Study Using the ISO Elution Method (demonstrated not cytotoxic).
• Risk Analysis for MTF Fascia.
• Subchronic toxicity tests (animal studies).
• Established history of using the material components. |
  | Biomechanical and Histologic Outcomes Equivalence | Demonstrated through:
• Clinical (cadaver) studies.
• Preclinical in vivo models.
• Data presented in peer-reviewed journals and submitted within the 510(k) supported substantial equivalencies between MTF Fascia and Synthasome X-Repair in these outcomes.
• Not intended to provide full mechanical strength, but for reinforcement; sutures provide biomechanical strength. |
  | Sterility | Aseptically processed. Passes USP Sterility Tests. Satisfies FDA requirements for LAL endotoxin limit. |
  | Intended Use Equivalence | Intended for reinforcement of soft tissues during tendon repair surgery (rotator cuff, patellar, Achilles, biceps, quadriceps, etc.). Stated to be substantially equivalent to OrthADAPT PR in indication for use. |

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "clinical (cadaver)" and "preclinical in vivo models" for biomechanical and histologic outcomes, and "animal studies" for subchronic toxicity. However, specific sample sizes for these tests are not provided in the summary.

• Test Sets: Cadaver studies, preclinical in vivo models (animals), and in-vitro tests (ISO 10993, Cytotoxicity).
• Data Provenance: Not explicitly stated, but typically these types of studies are conducted in laboratories or research institutions, potentially in the USA or internationally. The document does not specify if data was retrospective or prospective.

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)

This type of information (expert involvement in establishing ground truth) is usually found in clinical trials or diagnostic accuracy studies. For a 510(k) for a surgical mesh, "ground truth" is typically established through:

• Standardized testing procedures: e.g., ISO, USP standards.
• Histopathology analysis: Performed by qualified pathologists, but the number and qualifications are not specified here.
• Biomechanical testing protocols: Carried out by engineers or researchers in controlled environments.

This 510(k) summary does not mention a number of experts or their specific qualifications for establishing ground truth for any test sets.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication methods are typically associated with resolving discrepancies in expert interpretations, common in diagnostic imaging studies. For a surgical mesh, the "adjudication" (if any) would be embedded within the scientific rigor of the laboratory testing and pathology review processes. The document does not describe any specific adjudication method for the test sets.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any study involving human readers/AI assistance was not done for this device. This type of study is relevant for diagnostic devices that interface with human interpretation (e.g., radiology AI). The MTF Fascia is a surgical implant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable to a surgical implant device like MTF Fascia. "Standalone" performance with an algorithm relates to AI/software as a medical device (SaMD).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The types of "ground truth" used for demonstrating substantial equivalence for MTF Fascia primarily include:

• Standardized material properties: Measured against established industry standards (e.g., ISO for PLLA fiber).
• Biocompatibility test results: Based on standardized cytotoxicity assays and animal studies.
• Histologic outcomes: Likely assessed by comparing tissue responses in animal or cadaver models to known characteristics, implying pathology review (though not explicitly detailed regarding how it established ground truth).
• Biomechanical test results: Measured tensile strength, suture retention, etc., in cadaveric or in-vitro models.
• Compliance with FDA regulations: (e.g., USP sterility tests, LAL endotoxin limits).

8. The sample size for the training set

This concept (training set) is primarily relevant for machine learning/AI models. As MTF Fascia is a physical surgical implant and not an AI-driven diagnostic or therapeutic system, there is no "training set" in this context.

9. How the ground truth for the training set was established

As there is no training set for MTF Fascia, this question is not applicable.

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