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The OsteoCoil™ Nitinol Compression System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of the small bones for wrist, hand, and foot.

This Traditional 510(k) is submitted to introduce the OsteoCoil™ Nitinol Compression System. The system consists of a 4.5mm, 6.5mm and 7.3mm screw available in 30mm in 5mm increment lengths and appropriate instrumentation to support implantation of the OsteoCol™ Nitinol Compression screws. The the OsteoCol™ Nitinol Compression System have the same technological characteristics as the predicate device, the Dynafuse Fixation System (K203595).

The provided text is related to a 510(k) premarket notification for the OsteoCoil™ Nitinol Compression System. It describes the device, its intended use, and a summary of non-clinical tests performed to demonstrate substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving device performance against such criteria in the context of a clinical or standalone performance study involving AI or human readers.

Instead, the document details physical and material properties testing for a medical implant (bone fixation fastener).

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not present in the provided text.

The closest information available is a list of non-clinical mechanical and material tests conducted to demonstrate substantial equivalence:

Non-Clinical Test Summary:

The following non-clinical tests were performed:

• ASTM F543:
  • Torsional Strength
  • Driving and Removal Torque
  • Axial Pullout Strength
  • Self-tapping Force
• ASRM F1264:
  • Bending Fatigue
  • Static 4Pt Bending
• ASTM F2129: Pitting Corrosion Testing
• ASTM F2004: Transformation Temperature Testing
• Additionally:
  • Extension and Compression Force Testing
  • Bacterial endotoxin testing based on an endotoxin limit of 20EU/device per ANSI/AAMI ST72:2011
  • Applicable testing per ISO 10993

Conclusion from the document: "The results demonstrate that the OsteoCoil™ Nitinol Compression System is substantially equivalent to the legalicate devices."

This document focuses on the mechanical and material safety/performance of a physical medical device, not a software or AI-driven diagnostic tool. Therefore, the concepts of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity), ground truth establishment by experts, adjudication, or AI performance studies are not applicable here.

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The Flex-Thread™ Ulna Intramedullary Nail System is intended for use in the fixation of fractures and osteotomies of the ulna.

The Flex-Thread™ Ulna Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the intramedullary canal of the ulnar diaphysis from an antegrade approach and cortical screws to provide stability and articular support in the proximal ulna and olecranon.

The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria for software or AI/ML.

The document is a 510(k) premarket notification for a medical device called "Flex-Thread™ Ulna Intramedullary Nail System". It focuses on establishing substantial equivalence to a predicate device through mechanical testing, not through performance metrics of a software or AI/ML component.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or expert qualifications, as these are not discussed in the context of the provided text. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states that "[n]on-clinical performance testing demonstrates that the Flex-Thread™ Una Intramedullary Nail System is substantially equivalent to the predicate device." The tests mentioned are mechanical tests such as static four-point bend, static torsion, bending fatigue, and bending fatigue of interlocking screws, along with insertion torque and implant tip deflection. These are physical product performance tests, not AI/ML performance evaluations.

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The Flex-Thread™ Distal Fibula Intramedullary Nail System is intended for use in the fixation of fibula fractures and osteotomies.

The Flex-Thread™ Distal Fibula Intramedullary Nail System is comprised of an intramedullary fixation device with a flexible threaded tip to engage the proximal portion of a fibula and cortical screws to further enhance stability and fixation of the fibula.

This FDA 510(k) summary describes a modification to an existing medical device, the Flex-Thread™ Distal Fibula Intramedullary Nail System, rather than the initial clearance of a novel AI/Ml medical device. Therefore, the information typically requested regarding acceptance criteria, study design for AI performance, sample sizes, and ground truth establishment, as it pertains to AI algorithms, is not applicable in this context.

The submission is a Special 510(k) to introduce a larger diameter nail (5.5mm) and an additional end cap (1mm) to an already cleared system. The focus of the provided text is on demonstrating the substantial equivalence of these mechanical modifications to the predicate device, not on the performance of a software algorithm.

Here's a breakdown of why this information is not present and what was done instead:

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

• Not Applicable. This document does not describe performance metrics for an AI algorithm. Instead, it states that "Mechanical testing was performed on the modified Flex-Thread™ Distal Fibula Intramedullary Nail System using the same protocols as those used to verify the Flex-Thread™ Distal Fibula Intramedullary Nail System design as part of K202858." The tests included "Tip Reaction Force, Insertion Torque, and Simulated Use Cadaver Lab." The conclusion is that "The results design inputs meet design outputs and substantial equivalence of the subject device to the predicate." This implies that the acceptance criteria were met for these mechanical tests, but specific quantitative acceptance criteria or detailed results are not provided in this summary.

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

• Not Applicable. This refers to sample sizes for mechanical testing (e.g., number of nails tested, number of cadavers). The document mentions "Simulated Use Cadaver Lab" but does not specify the number of cadavers or the origin of the cadaveric material.

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. This is relevant for AI image analysis or diagnostic devices. No expert review for ground truth is described for this mechanical device modification.

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

• Not Applicable. This pertains to expert review in AI studies.

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 specifically for AI-assisted diagnostic devices.

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

• Not Applicable. This is for AI algorithm performance.

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

• Not Applicable. Ground truth for AI algorithms. For a mechanical device, performance is evaluated against engineering specifications and biomechanical principles.

8. The sample size for the training set:

• Not Applicable. No AI model training is described.

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

• Not Applicable. No AI model training is described.

In summary, the provided document is a regulatory submission for a modification to a mechanical orthopedic implant, not an AI/ML medical device. Therefore, questions related to AI algorithm performance, training, and ground truth are not relevant to this content.

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