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The 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 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 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. 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 Staples are supplied sterile, for single patient use only. They are available in several sizes: 9-25 mm bridge lengths, and 10-22 mm leg lengths. The OSSIOfiber® Compression Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations.

The provided text is a 510(k) summary for a medical device (OSSIOfiber® Compression Staple) and does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm. It is a submission for a physical orthopedic implant seeking to expand its indications for use to include pediatric patients, based on substantial equivalence to previously cleared devices.

Therefore, I cannot extract the information requested regarding acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these concepts are not relevant to this type of device submission.

The document discusses:

• Device: OSSIOfiber® Compression Staple (an orthopedic implant)
• Purpose of Submission: To add pediatric patient populations (children 2-12 years and adolescents 12-21 years) to the indications for use.
• Basis for Clearance: Substantial equivalence to previously cleared predicate devices (K212594, K233302) and an additional predicate (K210582), as well as reference devices (K231272).
• Non-Clinical Data: Biocompatibility was established in prior clearances and referenced from other devices. No additional mechanical performance testing was deemed necessary because the expanded indication did not present a "new worst case" compared to already cleared predicates.

In summary, the information requested is not present in the provided text because the device and its submission type do not involve an AI/ML component or diagnostic testing that would require such performance evaluation metrics.

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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® 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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The Arthrex Bio-Transfix is intended to provide ACL graft fixation in the femur in orthopaedic procedures.

The Arthrex Bio-Transfix, composed of poly(L-lactide), is a cannulated pin having a diameter of approximately 5 mm and an overall length of 50 mm. One end is tapered 11.684 mm to a minor diameter of 1.422 mm. The other end has three barbs for cortical fixation and a spherical fitting for its driver.

The provided text is a 510(k) premarket notification for the Arthrex Bio-Transfix device, a non-metallic fixation pin for ACL graft fixation. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies.

Therefore, the requested information regarding acceptance criteria, study details, and performance metrics for the device in isolation (i.e., standalone performance, MRMC studies, sample sizes for test/training sets, expert qualifications, adjudication methods, and ground truth establishment) is not present in the provided document.

The document states that:

"The differences between the Arthrex Bio-Transfix and the predicate device do not raise any different questions regarding safety and effectiveness. Furthermore, the material is well characterized, and has been used in predicate devices with similar indications. The device, as designed, is as safe and effective as the predicate devices."

This indicates that the acceptance criteria for this 510(k) submission revolve around demonstrating material characterization and similarity to existing, legally marketed predicate devices that have already established their safety and effectiveness. The study to "prove the device meets the acceptance criteria" in this context is the substantive equivalence comparison presented in the 510(k) summary, rather than independent clinical trials with specific quantitative performance targets.

In summary, none of the requested detailed information regarding acceptance criteria, study design, performance metrics, ground truth, or expert involvement can be extracted from this 510(k) submission because its purpose is to demonstrate substantial equivalence, not to conduct a de novo performance study against explicit acceptance criteria.

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