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

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

The OSSIOfiber® Staple is a fixation implant made of degradable poly (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 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® Staples are supplied sterile, for single patient use only, and non-pyrogenic. They are available in several sizes: 11-25 mm bridge lengths, and 15-22 mm leg lengths.

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

This document, K212594, is a 510(k) Premarket Notification for the OSSIOfiber® Staple. It outlines the FDA's determination of substantial equivalence to a legally marketed predicate device. This document focuses on the mechanical and material properties of the absorbable staple, not on an AI/ML-driven device or study involving human readers analyzing images. Therefore, many of the requested points regarding AI/ML study design, reader performance, ground truth establishment for AI training sets, etc., are not applicable to the content of this document.

However, I can extract information related to the device's performance based on non-clinical data and the rationale for its acceptance.

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

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

The document does not provide a direct table of numerical "acceptance criteria" against "reported performance" for the device in the typical AI/ML context (e.g., sensitivity, specificity thresholds). Instead, it states that the device's performance was evaluated through non-clinical mechanical testing and compared to a predicate device. The acceptance criterion is "at least equivalent performance" to the predicate.

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

This document details non-clinical laboratory testing of mechanical properties, not a clinical study on human subjects or an AI/ML test set. Therefore, concepts like "test set sample size" (in terms of patient data) and "data provenance" (country of origin, retrospective/prospective) are not applicable. The testing was conducted in a laboratory setting. The specific number of samples for each mechanical test (e.g., number of staples tested for bending) is not detailed in this summary, but standards like ASTM F564-17 typically specify minimum sample sizes for such tests.

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 is not applicable as the device is an implant, and the testing involves mechanical and material properties, not interpretation of medical images or data by experts to establish a "ground truth" for an AI model. "Ground truth" here refers to the measured physical properties of the device.

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

Not applicable. This is not an AI/ML study involving human readers and adjudicated interpretations. Mechanical tests have objective outputs (e.g., force, displacement, cycles to failure).

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 document describes a medical device (an absorbable staple), not an AI-driven diagnostic or assistive tool, and therefore no MRMC study was conducted.

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 "standalone performance" refers to the intrinsic mechanical properties of the device itself.

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

For the mechanical testing, the "ground truth" is defined by the measured physical properties (e.g., ultimate bending strength, fatigue life, pull-out force) determined through standardized laboratory tests (e.g., ASTM F564-17). For biocompatibility, the ground truth is established by compliance with ISO 10993 standards and a rationale.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires training data.

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

Not applicable. As above, this is not an AI/ML device.

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OSSIOfiber® Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization implants, cast, brace).

OSSIOfiber® Cannulated Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis, and bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The OSSIOfiber® Cannulated Trimmable Fixation Nail is a fixation device 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 fibers are made from materials 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® Cannulated Trimmable Fixation Nails are cannulated, supplied sterile, for single patient use only, and non-pyrogenic. They are available in several sizes: 10-70 mm long, and 2.80-4.60 mm nominal diameter (core diameter of 2.4-4.00 mm).

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

This document describes a medical device clearance rather than a study evaluating device performance against acceptance criteria for an AI/ML powered device. Therefore, much of the requested information regarding AI/ML studies (such as sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, or standalone performance results) is not applicable or present in this provided text.

Based on the provided text, the device in question is the OSSIOfiber® Cannulated Trimmable Fixation Nail. This device is a bone fixation fastener, not an AI/ML powered medical device. The document is a 510(k) summary, which outlines the substantial equivalence of this new device to legally marketed predicate devices.

Here's the relevant information that can be extracted from the provided text:

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

Since this is a 510(k) submission for a physical medical device and not an AI/ML software, "acceptance criteria" here refers to the performance of the device in mechanical testing compared to a predicate device, rather than diagnostic accuracy metrics typically seen with AI. Specific numeric acceptance criteria are not explicitly stated in the summary, but the general criterion is "at least equivalent performance" to the predicate.

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

• Sample Size for Test Set: Not specified for the mechanical testing mentioned. The data provenance is pre-clinical studies and bench testing. The country of origin for the studies is not specified in this document.
• Data Provenance: Pre-clinical studies and in-vitro mechanical testing.

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)

• Not applicable as this is a physical device being evaluated through mechanical and pre-clinical testing, not an AI/ML diagnostic device requiring expert ground truth for image interpretation.

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

• Not applicable.

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

• No, an MRMC study was not done as this is not an AI/ML diagnostic device with human readers.

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

• Not applicable as this is not an AI/ML algorithm.

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

• For the mechanical tests, the "ground truth" would be the measured physical properties (e.g., strength, stiffness) as determined by standardized laboratory methods, compared against the properties of the predicate device.
• For biocompatibility, the ground truth is established through adherence to ISO 10993 standards and a rationale.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

In summary, the provided text details the FDA clearance of a physical medical device based on its substantial equivalence to an existing predicate device, primarily through mechanical and biocompatibility testing, rather than a study for an AI/ML product.

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OSSIOfiber™ Compression Screws 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.

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 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 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, and are available in several sizes: 26-60 mm long, and 3.5-6.5 mm diameter. The screws are partially threaded, cannulated design.

The OSSIOfiber™ Compression Screws are designed to be used with commonly available orthopedic surgical tools such as ISO 5853/ISO 9714 compatible instrumentations.

The provided text describes the OSSIOfiber™ Compression Screw and its substantial equivalence to a predicate device, focusing on non-clinical testing for mechanical properties and biocompatibility. It does not contain information about a study involving acceptance criteria related to device performance in an AI/software context.

Therefore, I cannot fulfill the request as it pertains to acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these details are not present in the provided document for this medical device.

The document focuses on the regulatory clearance process for a physical medical device (bone screw) based on demonstrating substantial equivalence through mechanical testing and biocompatibility assessment, not on a software or AI-driven device requiring performance metrics like sensitivity, specificity, or reader studies.

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