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The BioBrace® RC Delivery System is intended for use in rotator cuff surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace® Implant is intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during rotator cuff tendon repair surgery. The BioBrace® Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.

The Disposable Inserter is intended to facilitate the delivery and positioning of the implant during soft tissue repairs.

The BioBrace® RC Delivery System is comprised of a BioBrace® Implant pre-stitched with HI-FI® suture, a threader assembly that facilitates passing sutures through the BioBrace® Implant, and an inserter to facilitate placement of the BioBrace® Implant into the subacromial space.

The previously cleared BioBrace® Implant is a bioresorbable, reinforced Implant composed of a highly porous collagen sponge made from insoluble bovine tendon type-1 collagen and reinforced with poly-L-lactic-acid (PLLA) multifilament yarn. The BioBrace® Implant is 80% porous with a median pore diameter of 19 µm. BioBrace® implants are approximately 3 mm thick and provided in two rectangular sizes of 23 x 25 mm and 35 x 25 mm.

The BioBrace® RC Delivery System is single-use and supplied sterile (ETO).

The provided text is a 510(k) clearance letter for a medical device called the BioBrace® RC Delivery System. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study for novel acceptance criteria.

Therefore, the document does not contain the information requested regarding detailed acceptance criteria for diagnostic performance, a specific study proving the device meets those criteria, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established in the context of diagnostic accuracy.

The document describes performance testing that focused on demonstrating the functional equivalence and safety of the new delivery system and integrated implant compared to the previously cleared implant. This testing includes:

1. Table of Acceptance Criteria and Reported Device Performance (based on provided text):

Since the document does not present quantitative diagnostic performance metrics or acceptance criteria for such, the table below reflects the types of performance aspects mentioned for this delivery system and implant combination. All "reported device performance" are stated as having been successfully completed and demonstrating equivalence/effectiveness/safety.

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

The document does not specify sample sizes for any test sets in the context of diagnostic performance. The studies mentioned appear to be engineering and biological performance tests rather than clinical diagnostic studies. Data provenance (country of origin, retrospective/prospective) is also not provided.

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

This information is not applicable as the document describes performance testing for a surgical mesh delivery system and implant, not a diagnostic device requiring expert-established ground truth for classification.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC study was not conducted (or at least not reported in this document), as this is not a diagnostic imaging device intended for interpretation by human readers.

6. Standalone (Algorithm Only) Performance:

This information is not applicable as the device is a physical surgical mesh delivery system, not an algorithm or AI software within a diagnostic context.

7. Type of Ground Truth Used:

This information is not applicable as the described tests relate to material properties, sterility, packaging, and functional delivery of a surgical implant, not diagnostic accuracy. For the biocompatibility claims, "ground truth" would be established by the ISO 10993-1 standards themselves.

8. Sample Size for the Training Set:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the reasons stated above.

In summary: The provided 510(k) clearance letter details the regulatory submission for a surgical implant delivery system. The "performance data" section refers to a range of engineering, biological, and functional tests demonstrating that the physical device meets safety and effectiveness requirements and is substantially equivalent to a predicate. It does not contain the kind of diagnostic performance study information that would typically involve acceptance criteria for accuracy, ground truth establishment, or human reader performance for AI software.

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BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists. BioBrace® is also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extraarticular ligaments. BioBrace® is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, soring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

The BioBrace® implant is a bioresorbable and bioinductive scaffold composed of a highly-porous collagen sponge made from insoluble bovine tendon type-1 collagen, and reinforced with poly- L-lactic-acid (PLLA) multifilament yarn (75 denier, 15 micron filament diameter). The BioBrace implant is 80% porous, average density of 0.2 grams/cm3, and median pore diameter of 19 microns. The highly porous collagen sponge comprises the majority of implant surface area (0.7 m2/gram) versus the PLA filaments alone (0.2 m2/gram), creating a large biologic matrix for cellular ingrowth, tissue regeneration, and healing. BioBrace implants are approximately 3 mm thick, provided in multiple sizes, and provide for soft tissue and tendon augment, and clinically relevant strengthening of the surgical repair. The BioBrace implant is single-use and supplied sterile with SAL of 10-6.

This document is a 510(k) Summary for the BioBrace® surgical mesh. It details the device, its intended use, and comparative studies for substantial equivalence. However, it does NOT contain the specific information required to answer your prompt about acceptance criteria and the study that proves the device meets those criteria.

The 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing specific performance acceptance criteria for a new, AI-based device and then proving them. The prompt asks about an AI/algorithm-based device and its performance metrics, such as sensitivity, specificity, or reader improvement. This document describes a surgical mesh, which is a physical implant, not an AI or software device.

Therefore, I cannot provide the requested information based on this document. The document primarily discusses:

• Device Description: Bioresorbable and bioinductive scaffold made of collagen and PLLA yarn.
• Intended Use/Indications for Use: Reinforcement of soft tissue, particularly in tendon and ligament repair, including expansion to extra-articular ligaments.
• Technological Comparison: Emphasizes that the subject device is identical to the primary predicate (K203267) in design, materials, manufacturing, and sterilization, with new sizes and expanded indications for use being the primary changes.
• Non-Clinical and/or Clinical Tests Summary & Conclusions: Mentions cadaver-based studies, an in-vivo study in sheep, and literature reviews to support the expanded indications and performance characteristics like bioinductivity, strengthening, and stiffness.

There are no details related to an AI/algorithm device, its acceptance criteria (like sensitivity, specificity, AUC), test set characteristics (sample size, data provenance), ground truth establishment by experts, or MRMC studies, as would be expected for an AI device submission.

Ask a specific question about this device

Ask a specific question about this device