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Synergy™ Tissue Matrix is intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures.

The device is also 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,

Synergy Tissue Matrix 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.

Synergy Tissue Matrix is an implantable biologic mesh comprised of non-crosslinked bovine pericardium. Synergy Tissue Matrix undergoes proprietary processing that allows neo-collagen formation and neo-vascularization of the implanted device and permits replacement of the device with host tissue, or remodeling.

Here's a breakdown of the acceptance criteria and study information for the Synergy™ Tissue Matrix, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of clinical studies with human subjects or a defined dataset for AI evaluation. The evaluations are primarily based on:

• Bench Testing: Mechanical properties (tensile strength, burst strength, suture pull-out) would involve samples of the device itself. No specific sample sizes are mentioned.
• Animal Implant Studies: These are in vivo (live animal) studies. The number of animals used is not specified.
• Biocompatibility Testing: Conducted in vitro (laboratory) or in vivo (animal) according to ISO 10993-1. Specific sample sizes are not provided.
  The provenance of the data is not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical/laboratory-based and animal studies, not human clinical trials. They are likely prospective for the specific tests performed on the Synergy™ Tissue Matrix.

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

Not applicable. This device is a surgical mesh; the ground truth for its performance is established through objective physical, chemical, and biological testing as well as animal studies, not through expert consensus on interpreting data (like images).

4. Adjudication Method for the Test Set

Not applicable, as the evaluation methods are objective measurements and animal observations, rather than interpretation by multiple experts.

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 medical device (surgical mesh), not an AI/software-as-a-medical-device (SaMD) that involves human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

• Objective measurement standards: For biocompatibility (e.g., ISO 10993-1), pyrogenicity, residual chemicals.
• Engineered performance metrics: For biomechanical properties (tensile strength, burst strength, suture pull-out).
• Histopathological and physiological observations: From animal implant studies (normal tissue healing, remodeling capability).
• Chemical and physical characterization: Material composition, structure, etc.

These are established by recognized scientific and engineering principles and standards, not expert consensus on ambiguous data.

8. The Sample Size for the Training Set

Not applicable. This type of device does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no "training set" for this device.

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PROseries™ Bioimplants are intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, suture-line reinforcement and other reconstructive procedures.

The device is also 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.

PROseries Bioimplants are 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.

PROseries Bioimplants are comprised of collagen matrix reinforced by a woven polymer to provide permanent durability. The collagen matrix, derived from equine pericardial tissue, has been decellularized and crosslinked and the entire device has been exposed to a liquid chemical sterilant. The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use following the procedures described in the Instructions for Use.

The provided text is a 510(k) summary for a medical device (PROseries Bioimplants) and it explicitly states that the device is "substantially equivalent" to a predicate device. This type of submission relies on demonstrating similarity to an already approved device rather than presenting a de novo study with acceptance criteria and a detailed study proving those criteria were met in the way a clinical trial for a novel drug or a new AI diagnostic would.

Therefore, many of the requested sections (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this type of regulatory submission and information is not available in the provided document.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of acceptance criteria and the reported device performance

For a 510(k) submission based on substantial equivalence, the "acceptance criteria" are typically met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparisons across various attributes. Specific quantitative acceptance criteria for performance as in a clinical trial are generally not provided in this type of summary.

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

• Not Applicable / Not provided. This information is typically relevant for studies designed to establish de novo safety and effectiveness, or for AI/diagnostic devices that require large datasets for validation. For a substantial equivalence claim based on physical device characteristics, this detailed information about "test sets" or "data provenance" in the context of clinical data is not expected in this summary. The "testing" referred to is laboratory and in vivo performance testing.

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 / Not provided. No ground truth established by experts in this manner is described as part of this submission, as it's not an AI or diagnostic device requiring such evaluation.

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

• Not Applicable / Not provided. Not relevant for this type of device and submission.

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 / Not provided. This is a physical surgical mesh, not an AI-assisted diagnostic or imaging device.

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

• Not Applicable / Not provided. This is a physical surgical mesh, not an algorithm.

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

• Not Applicable / Not provided. The "truth" for this device revolves around its physical, chemical, and biological properties (biocompatibility, biomechanical strength, sterility) matching the predicate device and meeting relevant standards. It's not about diagnostic accuracy against a clinical ground truth.

8. The sample size for the training set

• Not Applicable / Not provided. This device is not an AI model, so there is no concept of a "training set."

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

• Not Applicable / Not provided. As there is no training set, this question is not applicable.

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The Synovis Orthopedic and Woundcare Unite® Biomatrix is an animal-derived extracellular matrix (xenograft) intended for the management of moderately to severely exudating wounds, including:

• · Partial and full thickness wounds
• · Draining wounds
• Pressure sores/ulcers .
• · Venous ulcers
• · Chronic vascular ulcers
• · Diabetic ulcers
• · Trauma wounds (e.g., abrasions, lacerations, partial thickness [seconddegree] burns, skin tears)
• . Surgical wounds (e.g., donor sites/grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, dehisced surgical incisions)

The Unite® Biomatrix is a decellularized equine pericardial extracellular matrix (xenograft) which has been crosslinked and exposed to a liquid chemical sterilant. The product has passed the USP sterility test and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use. The device is for single use, single patient application only.

This is a 510(k) premarket notification for the Unite® Biomatrix from Synovis Orthopedic and Woundcare, Inc. The document states that the device is substantially equivalent to a previously cleared device. Therefore, a de-novo study is not required.

Here's an analysis of the provided text in relation to your request:

1. Table of acceptance criteria and reported device performance:

The document does not specify explicit "acceptance criteria" in terms of statistical thresholds (e.g., sensitivity, specificity, accuracy percentages) for clinical performance. Instead, the substantial equivalence decision is based on:

2. Sample size used for the test set and data provenance:

• Sample size: Not applicable. This document is a 510(k) submission based on substantial equivalence to existing devices, not a new clinical study with a "test set" and outcome data for the device itself.
• Data provenance: Not applicable for a new clinical study. The "provenance" here relates to the predicate devices which are already cleared for commercial distribution in the United States.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

• Not applicable. No new test set for clinical performance was generated for this 510(k) submission.

4. Adjudication method for the test set:

• Not applicable. No new test set for clinical performance was generated.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers with vs. without AI assistance:

• Not applicable. This device is a biomatrix, not an AI or imaging diagnostic tool. No MRMC study was performed.

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

• Not applicable. This device is a biomatrix, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for this 510(k) submission is the established safety and efficacy of the predicate devices (Unite® Biomatrix, K071425, and Oasis® Wound Matrix, K061711) which have already been cleared by the FDA. The new device is deemed substantially equivalent based on its identical characteristics to the primary predicate.

8. The sample size for the training set:

• Not applicable. This is not a study involving a training set for machine learning.

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

• Not applicable. This is not a study involving a training set for machine learning.

In summary:

The provided document is a 510(k) premarket notification for a medical device (Unite® Biomatrix) seeking clearance based on substantial equivalence to already legally marketed predicate devices. It does not describe a new clinical study or a study to demonstrate performance against specific numerical acceptance criteria. The "study" mentioned is the comparison to predicate devices, focusing on fundamental characteristics like intended use, technology, design, materials, and performance, along with basic safety tests (sterility and endotoxin). The acceptance criteria are therefore implicitly based on demonstrating that the new device shares these essential characteristics with the cleared predicates, and meets basic safety standards.

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Intended for the reattachment of soft tissue to bone in the shoulder, foot/ankle, knee, elbow and hand/wrist for the following indications:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Scparation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Revair, Hallux Valgus Reconstruction, Mid-Foot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpal Ligament Reconstruction and Repair, Tendon Transfer in the Hand/Wrist

The PRO Fixation™ System is a sterile single use device intended for the reattachment of soft tissue to bone. The PRO Fixation System is comprised of an implantable non-absorbable anchor and a disposable inserter. The anchor allows for placement, suture tensioning, and fixation of soft tissue into bone. Anchors will be available in a range of sizes.

This submission is for a traditional 510(k) for the PRO Fixation™ System, a sterile single-use device intended for the reattachment of soft tissue to bone. Since this is a traditional 510(k), there is no AI/ML algorithm involved, therefore, questions regarding AI/ML studies are not applicable.

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

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

The submission does not specify the exact sample sizes used for the laboratory testing. The data provenance is laboratory testing focused on mechanical and biocompatibility properties of the device itself, rather than human or animal study data. Therefore, country of origin and retrospective/prospective designations are not applicable in the typical sense.

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. Ground truth in this context typically refers to clinical or image-based diagnoses. This submission is for a mechanical medical device, and the "ground truth" for its performance is established through objective laboratory testing against established engineering and material science standards and comparison to predicate devices, not expert consensus on medical conditions.

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

Not applicable. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by experts) where there might be disagreement. This submission involves laboratory testing with quantifiable results.

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 traditional 510(k) for a medical implant (suture anchor system), not an AI/ML powered device.

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

Not applicable. This is a traditional 510(k) for a medical implant (suture anchor system), not an AI/ML powered device.

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

The "ground truth" for the device's performance is based on established engineering and material science standards relevant to medical devices, as well as the performance characteristics of
legally marketed predicate devices. This includes:

• Biocompatibility Standards: Evaluating the device's interaction with biological systems according to recognized standards.
• Mechanical Performance Standards: Quantifiable metrics for pull-out strength, suture integrity/tensile strength, suture slip resistance, and anchor and driver integrity.
• Predicate Device Comparison: Establishing equivalence to existing, legally marketed devices with a known safety and efficacy profile.

8. The sample size for the training set

Not applicable. This is a traditional 510(k) for a medical implant; there is no "training set" in the context of AI/ML or image processing.

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

Not applicable. This is a traditional 510(k) for a medical implant; there is no "training set" or corresponding ground truth establishment in this context.

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