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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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OSSIOfiber® Compression Staple is indicated for fixation of arthrodesis, osteotomies and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization.

The number and size of the OSSIOfiber® Compression Staples must be adapted to the indication.

The OSSIOfiber® Compression Staple is a fixation implant made of degradable poly (L-lactide-co-D,Llactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. 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 decradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Compression Staples are supplied sterile, for single patient use only, and nonpyrogenic. The additional devices included in this submission are: 9 x 10mm, and 11 x 10 mm.

The OSSIOfiber® Compression Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.

The provided document is a 510(k) Premarket Notification summary for the OSSIOfiber® Compression Staple. It describes the device, its intended use, and the non-clinical data used to demonstrate substantial equivalence to predicate devices. However, this document does not contain information related to an AI/ML-driven medical device, digital health software, or any study involving human readers or ground truth established by experts.

The primary focus of this submission is on the physical and mechanical properties of a medical implant (a compression staple) and its biocompatibility. The acceptance criteria discussed are related to the mechanical performance of the staple and its degradation profile.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample size used for a test set or data provenance for an AI/ML device.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi Reader Multi Case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
• Sample size for the training set or how ground truth was established for a training set (as this is not an AI/ML device).

The document specifically mentions:

• Non-Clinical Data: "Static bending, bending fatique and pull-out testing were performed to verify the strength and fixation properties of the OSSIOfiber® Compression Staple, and to compare them to those of the primary predicate device, the OS2®-VP Varisation Staple (K153770). Testing on the subject device were done initially and following in-vitro degradation. The in-vitro degradation profile was characterized."
• Biocompatibility: "Biocompatibility for the implants was established primarily based on the referenced ISO 10993 data from the previously cleared predicate and reference devices (K212594, K203465) as well as a rationale."

These are standard engineering and biocompatibility tests for physical medical devices, not performance metrics for AI/ML algorithms.

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The OSSIOfiber® Suture Anchors are indicated for fixation of suture (soft tissue) to bone in the shoulder, footlankle, knee, hand/wrist, and elbow in the following procedures:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
• I Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair and Bunionectomy.
• I Knee: Anterior Cruciate Ligament Repair (4.75-5.5 Anchors Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary or adjunct fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 Anchors only).
• . Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
• . Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair (Tennis Elbow).

The OSSIOfiber® Suture Anchor consists of an eyelet and anchor body preloaded on an inserter. The anchor body and eyelet are made from poly (L-lactide-co-D,L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by 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 are sterile, single-use, and non-pyrogenic.

The provided text is a 510(k) summary for the OSSIOfiber® Suture Anchor, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device (like an AI model) meets acceptance criteria based on performance metrics such as sensitivity, specificity, or reader improvement.

Therefore, I cannot provide the information requested in your prompt based on the provided text, as the document describes a mechanical medical device (suture anchor) and its non-clinical testing for substantial equivalence, not a study involving AI or human reader performance.

The request asks for details like:

• A table of acceptance criteria and reported device performance (in terms of AI metrics)
• Sample size and data provenance for a test set
• Number and qualifications of experts for ground truth
• Adjudication methods
• MRMC comparative effectiveness study results (AI vs. human)
• Standalone algorithm performance
• Type of ground truth used (e.g., pathology, outcomes)
• Training set sample size and ground truth establishment

None of this information is present in the provided 510(k) summary for the OSSIOfiber® Suture Anchor, which is a physical implant, not a diagnostic AI device. The "non-clinical data" section pertains to mechanical tests (static pull-out, cyclic pull-out, torsional strength, driving torque, insertion testing) and biocompatibility, which are relevant for a suture anchor but not for the type of AI-driven diagnostic device your prompt describes.

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OSSIOfiber ® Compression Screws 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.

The OSSIOfiber® Compression Screws are cannulated bone screws made of degradable poly (Llactide-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 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® Compression Screws are supplied sterile, for single patient use only. The screws are partially threaded and have a cannulated design. The additional devices included in this submission are: 14- 50 mm long, and 3.5 mm diameter.

The OSSIOfiber® Compression Screws are designed to be used with commonly available orthopedic surgical tools such as ISO 5835/ISO 9714 compatible instrumentations.

This document describes the OSSIOfiber® Compression Screw, 3.5mm, a medical device used for bone fixation. The provided text is a 510(k) summary submitted to the FDA to gain clearance for marketing. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than a study proving the device meets specific performance acceptance criteria in a clinical setting.

Therefore, the requested information elements related to clinical study design, expert evaluation, and AI performance metrics are not applicable to this document, as it outlines a pre-market notification process for a physical medical device based on non-clinical (mechanical) testing and comparison to existing devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to predicate devices, particularly the Tyber Medical Compression Screw (K133842) for mechanical performance. The "performance" here refers to mechanical properties, not clinical outcomes.

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

The document does not specify a "test set" in the context of clinical data for AI, but rather references non-clinical (mechanical) testing.

• Sample Size: Not explicitly stated for each test (e.g., number of screws tested for pull-out). It states "Pull-out testing was performed..." and "Torsional testing and rationale were also provided...".
• Data Provenance: Non-clinical laboratory testing. No geographical or temporal provenance is mentioned, which is typical for such mechanical bench tests. This is not a human observational study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This is a physical medical device clearance based on non-clinical mechanical testing and comparison to predicate devices, not an AI or diagnostic imaging device requiring expert ground truth for image interpretation.

4. Adjudication Method

• Not Applicable. As above, no expert adjudication was involved.

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

• Not Applicable. This is not an AI-assisted diagnostic device.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• Not Applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Mechanical Testing Results: Quantitative measurements of pull-out strength, torsional strength, and driving torque.
• Comparison to Predicate Devices: Demonstrating equivalence or superiority in these mechanical properties to already cleared devices.
• Validated Pre-clinical Studies: For biocompatibility and in-vitro degradation, referenced from the primary predicate and reference devices.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning model.

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

• Not Applicable. As above, there is no training set.

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