(54 days)
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.
| Acceptance Criterion Type (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence | Demonstrated performance effectiveness and safety similar to the predicate device. |
| Biocompatibility | Demonstrated compliance (in accordance with ISO 10993-1 for the predicate). |
| Packaging Integrity | Testing completed successfully. |
| Packaging and Labeling User Validation | Completed successfully. |
| Performance Testing (of the delivery system aspects) | Completed successfully. |
| Shelf-life | 12 months (for the proposed device). |
| Sterilization Efficacy | Ethylene Oxide Sterilization achieving a SAL (10-6) (same as predicate). |
| Transportation Integrity | Testing completed successfully. |
| User Validation (of the delivery system) | Completed successfully. |
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.