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OSSIOfiber® Threaded Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/ or immobilization in adults and children (2-12 vears) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The OSSIOfiber® Threaded Trimmable Fixation Nails are threaded cannulated bone fixation implants made of degradable poly (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 of 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 osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Threaded Trimmable Fixation Nails are supplied sterile, for single patient use only. The implants are available in several sizes and designs.

The OSSIOfiber® Threaded Trimmable Fixation Nails are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instruments.

Based on the provided text, the device in question is the OSSIOfiber® Threaded Trimmable Fixation Nail, which is a bone fixation implant. The 510(k) submission primarily focuses on adding compatible instrumentation and demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a software-based device meets specific acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, or human-in-the-loop performance with AI).

The document details physical and mechanical properties of a medical implant and its equivalence to previously cleared devices. Therefore, many of the requested criteria for a study proving device performance (especially those related to AI/software, expert readers, ground truth establishment, training sets, etc.) are not applicable to this type of device and submission.

However, I can extract the relevant information regarding the device's "performance" in the context of this submission, which primarily involves mechanical testing and biocompatibility.

Here's a breakdown based on the information provided, reinterpreting "acceptance criteria" and "study" in the context of a bone fixation implant and a 510(k) submission for an instrument change:

Device: OSSIOfiber® Threaded Trimmable Fixation Nail

Type of Submission: Traditional 510(k) premarket notification for additional compatible instrumentation.

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

For this type of device, "acceptance criteria" relates to mechanical and material performance rather than diagnostic accuracy. The document states:

"Although there are differences between the subject device and the additional predicate device in regards to design, mechanical pull-out testing demonstrated at least equivalent performance both initially and after in vitro degradation." |
| Biocompatibility | "Biocompatibility and magnetic resonance (MR) safety compatibility was established within the primary predicate submission (K233198)." (Implies, and met, the criteria from the predicate device). |
| Substantial Equivalence to Predicate Devices (Overall Safety & Effectiveness) | "The OSSIOfibe® Threaded Trimmable Fixation Nails are as safe and effective as their predicate devices."

"Non-clinical testing data demonstrate that the OSSIOfiber® Threaded Trimmable Fixation Nails are at least as safe and effective as their predicate devices (K233198, K203465, K231272). Thus, the OSSIOfiber® Threaded Trimmable Fixation Nails are substantially equivalent to it's predicate devices." |

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

• Sample Size: The document does not specify the exact number of samples (nails/implants) used for the mechanical pull-out testing. It only states "Mechanical pull-out testing was performed."
• Data Provenance: The testing appears to be non-clinical (laboratory-based) as it refers to "in-vitro degradation." There is no mention of human or animal study data provenance (e.g., country of origin, retrospective/prospective). This is typical for mechanical testing of implants.

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

• Not Applicable. This is a mechanical/biocompatibility study of an implant, not a study involving human interpretation of medical images or data. Therefore, no experts (e.g., radiologists) were used to establish ground truth for a test set in the diagnostic sense.

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

• Not Applicable. See point 3. This concept applies to human interpretation of data, not to mechanical testing.

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 a software/AI-assisted diagnostic device. No comparative effectiveness study with human readers was performed.

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

• Not Applicable. This is not an algorithm-based device. No standalone algorithm performance was assessed.

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

• For mechanical testing, the "ground truth" is typically the measured physical properties of the materials and devices under controlled conditions, compared against established engineering standards or predicate device performance.
• For biocompatibility, the "ground truth" is established through testing against relevant ISO standards (e.g., ISO 10993) which define acceptable biological responses. The document states biocompatibility was "established within the primary predicate submission (K233198)," implying it met the required standards.

8. The sample size for the training set

• Not Applicable. This is not a machine learning/AI device, so there is no concept of a "training set" in this context.

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

• Not Applicable. See point 8.

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OSSIOfiber® Threaded Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization 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.

The OSSIOfiber® Threaded Trimmable Fixation Nails are threaded cannulated bone implants made of degradable 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 of minerals that are found in natural bone. As the OSSIOTiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Threaded Trimmable Fixation Nails are supplied sterile, for single patient use only. The implants are available in several sizes and designs.

The OSSIOfiber® Threaded Trimmable Fixation Nails are designed to be used with commonly available orthopedic surqical tools such as ISO 9714 compatible instruments.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the OSSIOfiber® Threaded Trimmable Fixation Nail. This type of document does not contain information about AI/ML device performance or the study designs for evaluating such performance.

The content focuses on:

• Device Classification: Class II, regulated under 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener).
• Predicate Devices: Identifying previously cleared devices (Inion FreedomScrew™, OSSIOfiber® Compression Screw, etc.) for comparison.
• Device Description: Material composition (degradable poly (L-lactide-co-D, L-lactide) reinforced with continuous mineral fibers), degradation properties, and sterile single-use nature.
• Indications for Use: Maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts in upper extremity, fibula, knee, ankle, and foot for adults and children/adolescents.
• Non-Clinical Data: Mentions mechanical testing (pull-out, flexural bending, torsional strength, driving torque) and biocompatibility studies (based on ISO 10993) to demonstrate equivalence to predicate devices, especially regarding initial performance and after in-vitro degradation. It also mentions chemical characterization and toxicological risk assessment for pediatric use.
• Conclusion: The FDA determined the device is substantially equivalent to its predicate devices based on non-clinical testing.

Therefore, I cannot provide the requested information regarding acceptance criteria, AI/ML study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these details are not present in the provided text. This document is a regulatory approval letter, not a clinical or technical study report.

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