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The APTUS Elbow Dorsal Olecranon Plates are indicated for fractures and osteotomies, in particular for the ulna.

The subject device APTUS Elbow Dorsal Olecranon Plates are available in three (3) designs: Standard, Medium and Extended. The designs differ in the shape of the proximal ends of the Standard Plates are available in 6 lengths; The Medium Plates are available in 2 lenghts and the Extended Plates are available in 3 lenghts, each for left and right. All plates have appropriate for the olecranon. The subject device plates are compatible with screws and k-wires previously cleared in K051567, K09332, K112560, K232144 (for screws) and K092038 (for k-wires).

The subject device plates are manufactured from titanium alloy, conforming to ASTM F136. All plates are provided sterile and selected plates are provided non-sterile aswell.

The provided text describes a 510(k) premarket notification for a medical device (APTUS Elbow Dorsal Olecranon Plates), which focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance-based acceptance criteria through clinical studies or AI algorithm validation. Therefore, the information needed to answer many of your questions, particularly those related to AI performance, ground truth establishment, expert adjudication, and MRMC studies, is not present in this document.

However, I can extract information regarding non-clinical testing and general regulatory context, and then explain why other requested details are absent.

Here's a breakdown based on the provided text, and an explanation of what cannot be answered:

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

The document mentions non-clinical (mechanical) testing based on a specific ASTM standard and FDA guidance, but it does not provide a table of acceptance criteria and reported performance values. It only states a general conclusion:

• Acceptance Criteria Mentioned: Minimum requirements pointed out in the "FDA guidance for Industry and Food and Drug Administration Staff, Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway (2022)" and ASTM F382.
• Reported Device Performance: "The mechanical test results show that the bending structural stiffness of the Dorsal Olecranon Medartis APTUS Elbow Plates are higher than the acceptance values indicated in the relative FDA guidance..."
• Specific Values: No specific numerical acceptance criteria or reported device performance values (e.g., in N/mm or similar units) are provided in this regulatory letter.

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

• Sample Size: Not specified for non-clinical (mechanical) tests. For clinical studies, the document explicitly states: "Clinical data were not provided in this submission." This means there was no clinical test set for patient data.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable as no clinical data or patient test sets were used or provided.

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 information would be relevant for studies involving human interpretation or AI algorithm validation using expert-labeled data, which were not part of this 510(k) submission. No clinical ground truth was established from patient data.

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

• Not applicable. Adjudication methods are used to establish ground truth in clinical or imaging studies, which were not conducted for this 510(k) submission.

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. The document explicitly states: "Clinical data were not provided in this submission." An MRMC study, especially one involving AI assistance, would fall under clinical data. This submission is for a traditional medical device (bone plates), not an AI/ML-driven diagnostic or therapeutic device that would typically undergo such a study.

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

• No. This study type is for AI/ML algorithms. The device submitted is a mechanical orthopedic implant, not an algorithm.

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

• For the non-clinical mechanical testing, the "ground truth" or reference for evaluating performance was defined by the stated FDA guidance and ASTM standards for mechanical properties (e.g., bending stiffness). There was no "ground truth" concerning patient outcomes, pathology, or expert consensus on clinical imaging, as no clinical data was used.

8. The sample size for the training set

• Not applicable. This applies to AI/ML algorithms that require training data. This submission is for a physical medical device.

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

• Not applicable for the same reason as point 8.

Summary of Device Acceptance & Study

The acceptance of this device by the FDA (K240613) is based on its substantial equivalence to legally marketed predicate devices (K120070, K193633, K193639, K193554) and successful completion of non-clinical (mechanical) testing.

• Acceptance Criteria for Substantial Equivalence: Similar intended use, similar technological characteristics (design, principle of operation, material), and comparable safety and effectiveness, supported by non-clinical testing.
• Study Proving Acceptance:
  • Study Type: Non-clinical (mechanical) testing.
  • Objective: To demonstrate that the bending structural stiffness of the APTUS Elbow Dorsal Olecranon Plates is at least "higher than the acceptance values indicated in the relative FDA guidance for Industry and Food and Drug Administration Staff, Orthopedic Fracture Fixation Plates – Performance Criteria for Safety and Performance Based Pathway (2022)" and meets ASTM F382.
  • Results: The mechanical tests confirmed that the device's stiffness was higher than the specified acceptance values.
  • Clinical Data: No clinical data or studies were performed or submitted. The FDA 510(k) process for traditional devices like bone plates often relies on substantial equivalence and non-clinical data if the technological characteristics are well-understood.

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The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

The subject device plates are provided in a variety of anatomical designs, in various lengths, widths and thicknesses. The plate thickness varies from 1.6 mm to 2.0 mm depending on the design. The screw holes of the subject device plates are designed to accommodate appropriately sized subject device screws, or screws presently marketed as part of the APTUS System and previously cleared under K091479. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are used with TriLock locking screws and cortical (nonlocking) screws. All subject device screws are self-tapping and self-drilling and provided in diameters of 2.0, 2.8 and 3.5 mm, and in various lengths from 8 to 45 mm.

The subject device plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The subject device screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

This document is a 510(k) Premarket Notification from Medartis AG for their APTUS® Foot System. It aims to demonstrate substantial equivalence to previously marketed devices. While it describes performance data, it does not explicitly define acceptance criteria as a standalone statement with pass/fail thresholds. Instead, the "performance data" section outlines the types of testing conducted to support substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit acceptance criteria are not provided, I will infer them based on the types of tests conducted and the general objective of demonstrating substantial equivalence to predicate devices regarding safety and effectiveness. The reported device performance is based on the information provided in the "PERFORMANCE DATA" section.

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

• Sample Size: Not explicitly stated for any of the tests. The document only mentions "subject device screws were tested" and "Dynamic mechanical testing of the subject and predicate plate designs also was performed."
• Data Provenance: Not explicitly stated. The tests were performed to support a 510(k) submission for a device manufactured by Medartis AG, located in Basel, Switzerland. The data would have been generated as part of their product development and regulatory submission process. It is generally retrospective for the purpose of a 510(k) submission, meaning the tests were conducted on pre-market devices to gather data for equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not Applicable. This submission does not involve a clinical study or a judgmental process requiring expert consensus on a test set (e.g., image interpretation). The "ground truth" for the mechanical and engineering performance data is established by the results of the standardized tests (e.g., ASTM F543) themselves and the comparative analysis against predicate devices.

4. Adjudication Method for the Test Set:

• Not Applicable. No human adjudication method was described as the performance data consisted of dimensional, engineering, finite element analysis, and mechanical testing, not clinical outcomes requiring expert review.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. An MRMC comparative effectiveness study was not done. This submission focuses on the mechanical and design equivalence of a bone fixation system, not on an algorithm or imaging device that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This device is a bone fixation system, not a software algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance is based on engineering standards, material specifications, and objective mechanical test results. For example:
  • ASTM F67 for commercially pure titanium (plates).
  • ASTM F136 for titanium alloy (screws).
  • ASTM F543 for metallic bone screws test methods (insertion torque, maximum torque, pull-out).
  • Comparison to the performance of legally marketed predicate devices (K091479, K071264, K100776, K090949, K101700).

8. The Sample Size for the Training Set:

• Not Applicable. This submission is for a physical medical device (bone fixation system), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply here.

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