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APTUS® Ankle Trauma System 2.8/3.5 is indicated for fractures, osteotomies, malunions and non-unions of the distal tibia and fibula.

The subject device includes various designs for internal fixation of the distal tibia and distal fibula; 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 concave washer for use with Medartis 3.5 Cortical Screws. The subject device plates are provided in multiple anatomic designs that vary in length, width, and thickness. The plat designs include: 3.5 TriLock Distal Tibia L Plates and T Plates; 2.8/3.5 TriLock Distal Tibia Plates Medial; 2.8/3.5 TriLock Distal Tibia Plates Anterolateral; 2.8/3.5 TriLock Distal Fibula Plates Lateral, with and without Flap; 2.8 TriLock Distal Fibula Plates Crossed; and 2.8 TriLock Distal Fibula Plates Straight. 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 3.5 mm, and overall lengths ranging from 8 mm to 60 mm. The 2.8 Cortical Screws (non-locking) and 3.5 Cortical Screws (non-locking) 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 in 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. The subject device plates, washer, and screws are manufactured from unalloyed titanium conforming to ASTM F67 or titanium alloy conforming to ASTM F136. The subject device components are provided non-sterile to the end user.

The provided document is a 510(k) summary for the Medartis AG APTUS® Ankle Trauma System 2.8/3.5. This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. It focuses on the non-clinical performance data (biocompatibility, sterilization, engineering analysis, and mechanical testing) to demonstrate equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical targets. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons of technological characteristics. The "reported device performance" is essentially that it met the requirements of these non-clinical tests and is comparable to predicate devices.

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

The document explicitly states: "Clinical data were not provided in this submission." This means there was no human-patient-based test set. All data presented (biocompatibility, sterilization, mechanical testing, engineering analysis) are non-clinical.

• Sample Size for Test Set: Not applicable, as no clinical test set was used.
• Data Provenance: Non-clinical (laboratory/bench testing, engineering analysis). No country of origin for human data as none was used.

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

Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

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 metallic bone fixation system, not an AI-powered diagnostic or assistive tool.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance evaluation is based on established engineering and materials standards (e.g., ASTM F382, ASTM F543, ASTM F67, ASTM F136), and documented performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable, as no machine learning algorithm requiring a training set was used.

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

Not applicable, as no machine learning algorithm requiring a training set was used.

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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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