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The BioBrace™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The BioBrace™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps tendons. 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 BioBrace™ implant is a bioresorbable, biocomposite 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 um filament diameter). The BioBrace implant is 80% porous, average density of 0.2 grams/cm³, and median pore diameter of 19 µm. The highly-porous collagen sponge comprises the majority of implant surface area (0.7 m²/gram) versus the PLLA filaments alone (0.2 m²/gram), creating a large biologic matrix for cellular ingrowth. BioBrace implants are approximately 3 mm thick, provided in two rectangular sizes of 5 x 250mm and 23 x 30mm, and are designed for soft tissue and tendon augmentation and reinforcement. The BioBrace implant is single-use and supplied sterile with SAL of 10°.

The provided text describes the BioBrace™ Implant, a bioresorbable, biocomposite scaffold intended for reinforcement of soft tissue. The document focuses on demonstrating the substantial equivalence of the BioBrace™ Implant to a predicate device (STR GRAFT, K121216) and several reference devices rather than establishing novel acceptance criteria for a new type of device. Therefore, the information provided relates to testing parameters and comparable performance, rather than distinct acceptance criteria for the device's function as an AI or diagnostic tool.

The document does not describe a study involving an AI algorithm or human-in-the-loop performance, so many of the requested categories for AI-related studies are not applicable.

Here's the information extracted from the provided text, primarily focusing on the performance data and comparative studies as they relate to device safety and effectiveness.

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

The document does not explicitly present a table of "acceptance criteria" with direct quantitative thresholds that the device had to meet to be proven effective in a standalone capacity. Instead, it details performance tests conducted and compares the results to predicate/reference devices or established biological norms. The implied acceptance criteria are that the BioBrace™ Implant performs equivalently to the predicate device and demonstrates acceptable biocompatibility, mechanical integrity, and biological response.

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

• In vitro mechanical testing: No specific sample sizes for each mechanical test are provided, but the document mentions testing at t=0 and after degradation at 6, 12, and 26 weeks.
• Ovine studies (rotator cuff repair and extensor tendon model):
  • Rotator cuff repair: Not explicitly stated, but the document mentions comparing "all sheep and time points" for macroscopic observations and "all test groups and time points" for radiography/micro-CT. It also mentions "6- and 12-weeks post implantation" for the BioBrace implant and comparison to "contralateral native control tendons." For the side-by-side evaluation, it refers to "subject and predicate devices at 6- and 12-weeks."
  • Extensor tendon in vitro model: The pull-out strength and stiffness results are presented as "656 ± 87" and "457 ± 70 N" or "175 ± 22" and "124 ± 29 N/mm" respectively, implying a sample size large enough for statistical comparison (P<0.05). However, the exact 'n' is not provided.
• Biocompatibility (ISO 10993 tests): Standardized tests; specific sample sizes for each in vitro and in vivo test within the ISO 10993 battery are not detailed.
• Data Provenance: The studies are described as "in vitro" and "in vivo ovine studies." The country of origin of the data is not specified, but the applicant (BioVera, Inc.) is based in Canada and the manufacturer (Biorez, Inc.) in the USA. The studies appear to be prospective for the purpose of demonstrating device performance and safety for this submission.

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 information is not provided. For animal studies, "ground truth" is typically established through direct observation, standardized histological analysis, and mechanical testing following established protocols. The interpretation of these results is done by researchers and pathologists, but their specific number and qualifications are not detailed in this summary.

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

Not applicable. This device is a surgical implant, not an AI or diagnostic device that requires expert adjudication of outputs.

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 not an AI-assisted device.

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

Not applicable. This is not an AI algorithm. The device's performance was evaluated in standalone in vitro tests and in vivo studies without human intervention as a reader or interpreter of algorithm output.

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

The "ground truth" for the device's performance and safety was established through:

• Pathology/Histology: For tissue response, cellular infiltration, inflammation, and new tissue formation in the ovine model.
• Macroscopic and Radiographic Observations: For general healing response and absence of adverse reactions in the ovine model.
• Mechanical Testing: Quantitative measurements of ultimate tensile strength, tear resistance, suture pull-through, ball burst strength, pull-out strength, and stiffness.
• Chemical Characterization: To identify extractables and leachables for toxicological risk assessment.
• Standardized Biocompatibility Tests (ISO 10993): Which use specific biological endpoints as ground truth.
• Comparison to Predicate Device: The performance and biological response of the BioBrace were directly compared to the predicate device to establish equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device that requires a training set.

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