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The OSSIOfiber® Suture Anchors 2.5-3.5 mm, are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder, in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation. Specific indications are listed below:

• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, AcromioClavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure

• Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers

• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (Tennis Elbow)

The OSSIOfiber® Suture Anchor 2.5-3.5 mm, consists of an anchor preloaded on an inserter. The anchor is made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made from minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the bone. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. Sutures, needles and suture snare may also be provided with the device depending on configuration.

The OSSIOfiber® Suture Anchors 2.5-3.5mm are supplied sterile, for single patient use only.

The OSSIOfiber® Suture Anchors 2.5-3.5mm are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.

The provided text is an FDA 510(k) clearance letter and its associated 510(k) Summary. It describes a medical device, the OSSIOfiber® Suture Anchor 2.5-3.5 mm, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance metrics that would typically apply to AI/ML or diagnostic devices.

The document focuses on demonstrating substantial equivalence for a physical implantable device, which relies on comparing its technological characteristics (intended use, materials, design, principles of operation, manufacturing, sterilization) and performance (mechanical testing, biocompatibility) to already cleared devices. It does not involve a diagnostic or predictive algorithm, thus many of the criteria requested (e.g., test set sample size, expert ground truth, MRMC study, standalone performance) are not applicable.

Here's an analysis based on the information provided, highlighting the differences in context:

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

Since this is a physical medical device clearance, the "acceptance criteria" are not reported as specific numerical benchmarks for diagnostic performance (like sensitivity or specificity). Instead, they relate to demonstrating comparable safety and effectiveness through a combination of:

• Technological Characteristics: The device must have substantially similar or identical intended use, principles of operation, material composition, design, manufacturing, and sterilization methods as predicate devices.
• Performance (Non-Clinical): Mechanical properties (strength, fixation) and biological response (biocompatibility) must be at least equivalent to the predicate device.

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

• Test Set Sample Size: The document does not specify a "test set sample size" in the context of diagnostic performance. For mechanical testing, the number of devices or constructs tested for static and cyclic pull-out is not explicitly stated. The "in-vitro degradation profile" was characterized, but the sample size for this is also not given.
• Data Provenance: The mechanical testing and degradation characterization were performed "in-vitro." Biocompatibility was established based on ISO 10993 data from previously cleared devices and rationales. This suggests laboratory-based testing and references to existing, accepted data.

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 question is not applicable. The device is a surgical implant, not a diagnostic tool requiring expert interpretation of images or data to establish a "ground truth" for a test set. The "ground truth" for a device like this would be established through established engineering and biological standards and clinical experience with predicate devices.

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

This is not applicable as there is no diagnostic or interpretive test set requiring adjudication in this context.

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:

This is not applicable. This is not an AI-assisted diagnostic device, and therefore, no MRMC study or AI assistance effect size is relevant or mentioned.

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

This is not applicable. This is a physical implantable device, not an algorithm.

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

For this type of device, the "ground truth" is typically defined by:

• Established engineering standards: Performance metrics like pull-out strength, cyclic fatigue, and degradation rates are measured against accepted industry standards or the performance of legally marketed predicate devices, which are deemed safe and effective.
• Biocompatibility standards: Compliance with ISO 10993 series for biological evaluation of medical devices, which typically involves in-vitro and/or in-vivo testing, leading to a conclusion of acceptable biological risk.
• Clinical history of predicate devices: The "ground truth" for safety and effectiveness is largely based on the long-term clinical use and acceptance of the predicate technologies (similar design, materials, surgical indications).

8. The sample size for the training set:

This is not applicable. There is no concept of a "training set" for this type of physical medical device in the context of this 510(k) submission.

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

This is not applicable, as there is no training set.

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