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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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APTUS Hand Scaphoid Plates are indicated for fractures and non-unions of the scaphoid.

The purpose of this submission is to obtain marketing clearance for an additional device design to expand the range of the Medartis APTUS® Hand Plates, previously cleared under K102537.
The subject device APTUS Hand Scaphoid Plates is available in three designs - small, standard, large - all with 6 screw holes. All plates have anatomical designs that are appropriate for the scaphoid. The subject device plates are compatible with screws and k-wires previously cleared in K102537, K051567, K232144 (for srews), K092038, K202589 and K232144 (for k-wires).
The subject device plates are manufactured from unalloyed titanium conforming to ASTM F67, and are provided non-sterile and sterile.

This document is a 510(k) Premarket Notification from the FDA regarding the "APTUS Hand Scaphoid Plates." It outlines the regulatory review and states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI/Software as a Medical Device (SaMD) product.

Instead, this document pertains to a physical medical device (bone fixation plates) and references mechanical testing to demonstrate performance and substantial equivalence to predicate devices, not AI performance.

Therefore, I cannot fulfill your request as the required information (acceptance criteria for an AI/SaMD product, details of an AI performance study, number of experts, ground truth establishment, etc.) is absent from the provided text.

The document explicitly states: "Clinical data were not provided in this submission." and refers to "Mechanical fatigue and static testing" as the non-clinical testing performed.

To complete your request, I would need a regulatory submission document for an AI/SaMD product that discusses its performance characteristics, acceptance criteria, and the study conducted to demonstrate its capabilities.

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APTUS® Cannulated Compression Screws and headed Cannulated Compression Screws are indicated for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size in the shoulder, elbow, wrist, hand, knee, and the foot and ankle.

APTUS® K-Wire System is intended for use in fixation of bone reconstruction, and as guide pins for insertion of other implants.

The purpose of this submission is to obtain marketing clearance for APTUS® Cannulated Compression Screw, and APTUS® K-Wire System designs to expand the range of Medartis APTUS fixation devices previously cleared in K133460. K110658. K092038 and K202589.

This submission includes for APTUS® Cannulated Compression Screws (non-sterile):

• additional thread lengths for previously cleared thread diameters (2.2 mm, 3.0 mm, and 4.0 mm) - fully threaded screws for two previously cleared thread diameters (2.2 mm and 3.0 mm)

Additionally, the purpose of this submission is to obtain marketing clearance for various APTUS® Kwire designs (non-sterile and sterile) to expand the range of the Medartis APTUS® K-Wire System, previously cleared in K092038, K133460 and K202589, to include longer versions in two (2) diameters (0.8, 1.1 mm). The K-wires are compatible with the subject device cannulated compression screws and APTUS® Cannulated Compression Screws previously cleared in K110658, K133460 and K202589.

All subject device cannulated compression screws are manufactured from titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum- 4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401), the same material for screws previously cleared in K110658, K133460 and K202589.

The subject device K-wires are manufactured from stainless steel conforming to ASTM F138, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673), the same material for K-wires previously cleared in K092038, K133460 and K202589.

The provided text describes a 510(k) premarket notification for a medical device (APTUS Cannulated Compression Screws Line Extension and APTUS K-Wire System Line Extension). This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data.

Crucially, this document does NOT contain information about an AI/ML device, nor does it detail acceptance criteria or a study design for evaluating AI/ML performance.

The "Performance Data" section explicitly states: "Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: Mechanical testing according to ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws, ASTM F1839-08(2021) Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments and FDA Guidance "Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway". Based on the results of the testing, the performance of the subject device was judged to be substantially equivalent to the predicate devices K202589, K110658 and K963192. Clinical data were not provided in this submission."

Therefore, I cannot extract the information required to answer your specific questions (e.g., acceptance criteria for AI performance, sample size for test sets of an AI, number of experts, MRMC studies, standalone AI performance, ground truth establishment, training set details) because the provided text is for a hardware medical device (screws and K-wires) and does not involve AI or any form of algorithmic performance evaluation with clinical data.

I am unable to provide the requested table and study details because the provided input does not describe an AI/ML medical device or its performance evaluation.

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APTUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.

The purpose of this submission is to obtain marketing clearance for an additional device design to expand the range of the Medartis APTUS® Ulna Plates, previously cleared under K 103332. The subject device APTUS Distal Ulna Plates is available in four (4) designs with 10 or 12 screw holes. All plates have anatomical designs that are appropriate for either the right ulna. The 10 and 12 hole plates have a length of 53 mm and 66 mm, respectively. The maximum thickness of the plates is 1.6 mm and the maximum width is 15 mm.

The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The subject device plates are compatible with screws and K-wires previously cleared in K051567 (TriLock), K103332 (cortical), and K092038 (K-wires).

The subject device plates are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67, and are provided non-sterile and sterile.

This FDA 510(k) summary for the APTUS 2.5 TriLock Distal Ulna Plates does not describe a study involving an AI/Machine Learning device or a diagnostic device. Instead, it describes a medical implant device (bone fixation plates) and its equivalence to previously cleared predicate devices based on mechanical performance data.

Therefore, many of the requested details, such as those related to AI/ML device testing (e.g., test set sample size, ground truth establishment, MRMC studies, training set details), are not applicable to this document.

However, I can extract information relevant to the performance data provided for this specific type of device.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

For this type of device (bone fixation plates), the "acceptance criteria" and "device performance" are typically related to mechanical integrity and biocompatibility, not diagnostic accuracy.

2. Sample Size and Data Provenance

• Sample Size for Test Set: The document does not specify the sample size for the mechanical testing (e.g., how many plates were tested). It simply states that "Mechanical testing Fatigue Bending Test and Static Bench Testing" were performed.
• Data Provenance: The mechanical testing was "non-clinical testing data," meaning it was benchtop testing, not involving human subjects. The country of origin for this testing data is not explicitly stated, but the manufacturer (Medartis AG) is based in Switzerland. The data is retrospective in the sense that it supports a new device's clearance based on established methods and comparison to existing predicates.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. This is not a diagnostic AI/ML device that requires expert review for ground truth establishment. The "ground truth" for mechanical testing is derived from engineering principles and standards.

4. Adjudication Method for Test Set

• Not Applicable. This is not a diagnostic AI/ML device study requiring adjudication of expert opinions.

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

• Not Applicable. This is not a diagnostic AI/ML device. "Clinical data were not provided in this submission."

6. Standalone Performance (Algorithm only)

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

7. Type of Ground Truth Used

• For mechanical testing: Engineering standards and established benchmarks (comparison to predicate device performance).
• For biocompatibility: Material standards and proven safety of identical materials used in cleared predicate devices.

8. Sample Size for Training Set

• Not Applicable. This is not an AI/ML device with a "training set."

9. How Ground Truth for Training Set was Established

• Not Applicable.

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The APTUS® Foot 2.8-3.5 System is intended for use in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.

The subject device includes: various designs of bone plates (23 plates); wedges and screws for use with various plates for use in performing an opening wedge osteotomy (8 wedges); additional lengths of 3.5 TriLock Screws (locking screws, other lengths cleared in K110908); a new design of 3.5 Cortical Screws (non-locking) in various lengths; and a new design of 4.0 Cancellous Screws in various lengths.

The subject device plates are provided in multiple anatomic designs that vary in length, width, and thickness. The overall dimensions of the plates vary in width from approximately 12 mm to 29 mm, and in length from approximately 25 mm to 92 mm. The plates vary in thickness from 1.6 mm to 2.5 mm.

The subject device plates are used with TriLock locking screws and non-locking screws (cortical and cancellous), including subject device screws and previously cleared Medartis screws. Compatible TriLock locking screws and non-locking cortical screws have a diameter of 2.8 mm and overall lengths ranging from 8 mm to 60 mm. The subject device non-locking cancellous screws have a diameter of 4 mm and overall lengths ranging from 10 mm to 60 mm. The 2.8 Cortical Screws (non-locking), the 3.5 Cortical Screws (non-locking), and the 4.0 Cancellous Screws (non-locking) all have a double-lead thread design. All TriLock Screws (locking) have a double-lead thread design. The subject device plates also are compatible with Medartis K-Wires cleared under K092038.

The subject device screws include screws with the same design as 3.5 TriLock Screws cleared in K110908, with a diameter of 3.5 mm and provided in additional lengths of 10 mm, 12 mm, and 14 mm. The subject device screws also include a new design of 3.5 Cortical Screws provided with a diameter of 3.5 mm and lengths of 10 mm to 60 mm, and a new design of 4.0 Cancellous Screws, with a diameter of 4.0 mm and lengths of 10 mm to 60 mm.

The subject device also includes wedges that are used to support fixation of an opening wedge osteotomy. The wedges are stabilized by corresponding wedge screws that are placed through a plate. The subject device wedges are provided in two size series. The small wedges are 7 mm wide and vary in thickness from 4 mm to 7 mm. The large wedges are 10 mm wide and vary in thickness from 6 mm to 12 mm. The corresponding wedge screws are provided in two sizes: the small wedge screw is used to attach a wedge using an HD7 plate hole (2.8 mm screw hole), and the large wedge screw is to attach a wedge using an HD15 plate hole (3.5 mm screw hole).

The subject device plates, wedges, and screws are manufactured from unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136.

Here's an analysis of the provided text regarding the acceptance criteria and study for the APTUS® Foot 2.8-3.5 System:

Summary of Acceptance Criteria and Device Performance (Based Only on Provided Text):

The provided text does not explicitly state quantitative acceptance criteria or a direct study that proves the device meets specific acceptance criteria in a numerical or statistical manner as might be seen for an AI/CADe device. Instead, the "acceptance criteria" are implied to be the demonstration of substantial equivalence to predicate devices through various tests and comparisons.

Detailed Information on the Study:

The provided text describes a non-clinical study primarily focused on demonstrating substantial equivalence for a medical orthopedic device (bone fixation system), not an AI/CADe system. Therefore, many of the requested categories (e.g., test set sample size, data provenance, number of experts for ground truth, MRMC study, standalone performance) are not directly applicable or are not detailed in the context of this device's regulatory submission.

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

   • Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical data or AI model evaluation. For the mechanical testing, it refers to "worst-case simulated fracture or osteotomy constructs" and "comparative dynamic testing." The exact number of constructs or tests performed isn't specified.
   • Data Provenance: Not applicable in the human/data sense. The "data" comes from engineering analysis and mechanical testing performed by the manufacturer, Medartis AG (Switzerland).

2. 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 not a study involving human interpretation of data where expert ground truth would be established in this manner. The "ground truth" here is based on engineering principles, ASTM standards, and direct comparison to existing, cleared predicate devices.

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

   • Not applicable. This is not a study involving human interpretation of data requiring adjudication.

4. 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, a multi-reader multi-case study was not done. This is a submission for a mechanical orthopedic device, not an AI/CADe product.

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

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

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

   • The "ground truth" or basis for comparison for this device's performance relies on established engineering standards (ASTM F543), comparison to the mechanical performance of legally marketed predicate devices, biocompatibility standards, and manufacturing process consistency. It's a technical and regulatory "ground truth" rather than a clinical or pathological one.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of an AI model for this device.

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

   • Not applicable. There is no "training set" for this device.

Conclusion from the document:

The study demonstrating the device meets the acceptance criteria is primarily a non-clinical engineering and comparative analysis study. It relies on:

• Biocompatibility and sterilization data from previously cleared devices (predicates K091479, K191848, K181425).
• Engineering analysis.
• Cantilever construct fatigue bend testing of existing products against the predicate.
• Comparative dynamic testing of "worst-case simulated fracture or osteotomy constructs" for subject device plates against specific predicate plates (K061808, K052614).
• Mechanical testing of subject device screws according to ASTM F543 against specific predicate screws (K000684, K052614).
• Demonstration of identical materials and manufacturing processes to the primary predicate device (K091479).

The "study" collectively concludes that based on these non-clinical data, the performance of the APTUS® Foot 2.8-3.5 System was judged to be substantially equivalent to the referenced predicate devices, thereby meeting the necessary criteria for FDA clearance. Clinical data were not provided in this submission.

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APTUS® Wrist 2.5 System is intended for use in hand and forearm fractures, osteotomies, and arthrodeses.

The subject device plates have anatomic designs and are provided in two designs, each for the left and right radius: Lunate Facet Plate and Distal Radius Rim Plate. The Lunate Facet Plates have a maximum thickness of 1.6 mm, and maximum overall dimensions of approximately 19 mm x 47 mm before bending to conform to the anatomy of the distal radius. The Distal Radius Rim Plates have a maximum thickness of 1.8 mm, and maximum overall dimensions of approximately 22 mm x 53 mm before bending to conform to the anatomy of the distal radius. The screw holes of the subject device plates are designed to accommodate appropriately sized bone screws (locking and non-locking) presently marketed as part of the APTUS System and previously cleared under K142906, K103332, and K051567. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are made of unalloved titanium. Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This document is a 510(k) summary for the APTUS® Wrist 2.5 System, a bone fixation device. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting new, unique performance acceptance criteria for an AI-powered diagnostic device. Therefore, the questions related to AI performance, human reader improvement with AI, ground truth establishment, training sets, and adjudication methods are largely not applicable in this context.

The document describes the device's characteristics and performance data related to its mechanical properties compared to a predicate device to establish substantial equivalence.

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

The document does not explicitly state "acceptance criteria" in the sense of specific thresholds for performance metrics that the device must meet to be approved. Instead, it describes comparative performance testing to demonstrate substantial equivalence to a legally marketed predicate device. The implied acceptance criterion is that the subject device's performance is at least equivalent to, or superior to, the predicate device in relevant mechanical tests, and that any differences do not raise new issues of safety or efficacy.

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

The document refers to "non-clinical testing data," "engineering analysis," "static mechanical testing," and "dynamic mechanical testing." It does not specify sample sizes for these tests (e.g., number of plates tested) nor the country of origin or type (retrospective/prospective) of this engineering data. This is common for mechanical testing, where instead of "samples" in a clinical sense, a sufficient number of test articles are manufactured and tested to ensure statistical validity and representativeness of the production process. Clinical data was explicitly not provided in this submission.

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 a mechanical device, not a diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. This is a mechanical device, not a diagnostic device requiring adjudication of human readings.

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 device is a bone fixation system and does not involve AI or human readers for diagnostic interpretation.

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

Not applicable. This device does not involve an algorithm.

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

The "ground truth" for the mechanical performance of this device would be established through objective, standardized laboratory measurements against known engineering principles and ASTM standards. For biocompatibility, it's based on established material properties and biological response data for Titanium Grade 4. The comparison is made against the performance of a predicate device established through similar testing.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning model.

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

Not applicable. This is a mechanical device, not a machine learning model.

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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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