Search Results

APTUS Hand
Fractures, osteotomies and arthrodesis of the bones of the hand

• Hand System
• fractures of the distal, middle and proximal phalanges
• fractures of the metacarpals
• osteotomies of the hand
• arthrodeses in the hand
• Scaphoid plates
• fractures and non-unions of the scaphoid
  The APTUS Elbow Dorsal Olecranon Plates are indicated for fractures and osteotomies, in particular for the ulna.

The subject device includes the APTUS Hand System, which is used for fractures and arthrodesis of the bones of the hand. APTUS Hand plates are offered in two main system sizes, 1.2/1.5 and 2.0/2.3, depending on the screw size. The subject device plates are to be used with Medartis APTUS TriLock locking screws and SpeedTip screws.

• Non-locking plates 1.2/1.5 use cortical screw sizes of either 1.2 or 1.5 mm, and SpeedTip screw size of 1.5mm
• TriLock locking plates 1.2/1.5 use locking screws sizes of either 1.2 or 1.5 mm, but also accepts cortical screw sizes of 1.2 or 1.5mm as well as SpeedTip screw size of 1.5mm
• TriLock locking plates 2.0/2.3 use locking screws size of 2.0 mm, but also accepts cortical screw sizes of 2.0 or 2.3 mm
  The APTUS Hand plates are anatomically pre-contoured with respect to the anatomy of the specific bone they are designed for. Most plates may be additionally cut and bent intraoperatively for a wide range of applications.
  The subject device screws consist of non-sterile TriLock Screws (locking)and SpeedTip Screws ( non-locking). TriLock Screw heads have spherical three point wedge locking design to create a friction-lock connection through radial bracing of the screw head in the plate, thereby creating uniform distribution of stresses over the screw head and plate. The SpeedTip Screws feature a self-cutting screw tip for insertion without prior drilling.
  The subject device plates are compatible with washers, screws and k-wires previously cleared K102537 (for washers and screws) and K092038 (for k-wires).
  Plate designs are available either non-sterile. Plates provided non-sterile are intended to be sterilized by the end user before use.
  The 510(k) of the subject devices K051567 and K102537 APTUS Hand Group and K234062 APTUS Hand Scaphoid will be grouped in the APTUS Hand System. As a result, the indication will be updated for better clarity. This change does not affect the design, materials, or functionality of the devices.
  APTUS Elbow Dorsal Olecranon Plates
  The purpose of this 510(k) submission is to obtain marketing clearance for the APTUS Elbow Dorsal Olecranon Plates to expand the range of Medartis APTUS fixation devices provided to the end user in a sterile condition. The non-sterile devices were previously cleared under K240613.
  The sterilization process proposed for the APTUS System has also already been cleared under K232144, Sterile Products of the APTUS System, the reference device for this submission.
  The Indication for Use, the Design and the Material are the same as in the previously cleared predicate device K240613 APTUS Elbow Dorsal Olecranon Plates.
  Sterile Products of the APTUS Elbow Dorsal Olecranon screws are made of titanium alloy conforming to ASTM F136 Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Sterile products of the APTUS Elbow Dorsal Olecranon K-wires are made of stainless steel conforming to ASTM F138 Standard Specification for Wrought 18 Chromium -14 Nickel-2.5 Molybdenum Stainless Steel Wire for Surgical Implants (UNS S31673),
  Sterile products of the APTUS Elbow Dorsal Olecranon washers are made of unalloyed titanium, Grade 4, conforming to ASTM F67.

This FDA 510(k) summary does not contain information about acceptance criteria and a study proving a device meets them. Instead, it describes metallic bone fixation appliances and accessories (plates, screws, and washers) for fractures and arthrodesis of the bones of the hand and ulna. The submission argues for substantial equivalence to previously cleared devices based on similar intended use, operating principle, basic design, materials, and sterilization methods.

Specifically, it states:

• "Non clinical evaluation of the APTUS Hand System plates and screws and the APTUS Elbow Olecranon devices demonstrated that the performance of the subject devices is substantially equivalent to the predicate devices in terms of safety and efficacy."
• "The performance testing of the APTUS Hand Plate System demonstrates the safety and performance of the screws by evaluating torsional properties, driving torque, axial pullout, and self-tapping performance with full insertion in accordance with ASTM F543 as well as the performance of the plates in combination with the screws in a comparison between the worst case devices from the subject and predicate devices."
• "The testing demonstrated that the new APTUS Hand System plates do not represent a new worst case when compared to predicate devices."
• "No new testing of the APTUS Elbow Dorsal Olecranon was conducted as there were no changes to the design, materials, or manufacturing processes in the current submission."
• "Clinical data was not required to establish substantial equivalence of the predicate devices."

Therefore, I cannot provide the requested information.

Ask a specific question about this device

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.

Ask a specific question about this device

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

The subject device sterile screws consist of sterile TriLock screws (locking), Cortical and Cancellous screws (non-locking). The APTUS TriLock Screws, Cortical Screws and Cancellous Screws that are compatible with the subject device plate are manufactured from titanium alloy conforming to ASTM F136. The APTUS K-Wires that are compatible with the subject device plates 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 device-specific instruments (templates) are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700).

The subject device Medartis APTUS Foot System 2.8-3.5 consisting of following plates and systems: 2.8 TriLock Plate Straight, 2.8 TriLock Plate Hole T Extended and 2.8 TriLock TMT-1 Medial Fusion Plates Large, APTUS Mid- and Hindfoot System 2.8/3.5 and Fusion System 3.5. The APTUS Mid- and Hindfoot System 2.8/3.5 includes TriLock 2.8 C Plates, 2.8 TriLock Calcaneus LCL Plates, 3.5 TriLock Calcaneus LCL Plates and 3.5 TriLock Calcaneus Step Plates. The subject device also includes sterile 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 APTUS Fusion System 3.5 includes 3.5 TriLock Wing Plates, 3.5 TriLock Butterfly Plates, 3.5 TriLock TNC Fusion Plates, 3.5 TriLock NCM Fusion Plates, 3.5 TriLock TNCM Fusion Plates, 3.5 TriLock Talonavicular Fusion Plates. Furthermore, 3.5 TriLock Medial Column Fusion Plates, 3.5 TriLock Distal Medial Column Fusion Plates, 3.5 TriLock Proximal Column Fusion Plates. The APTUS Fusion System 3.5 plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The 2.8 TriLock Straight Plates are generic straight plates and used with 2.8 mm screws. The 2.8 TriLock Plate Hole T Extended are generic T plates and used with 2.8 mm screws. The 2.8 TriLock TMT-1 Medial Fusion Plates Large plates have anatomical designs that are appropriate for either the left or the right foot. The subject device plates are manufactured from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNSR50250, UNS R50400, UNS R50550, UNS R50700). The subject device sterile screws consist of sterile TriLock screws (locking), Cortical and Cancellous screws (non-locking).

The provided text describes the regulatory filing for the APTUS Foot System 2.8-3.5 and does not contain information related to a study proving the device meets acceptance criteria for an AI/software-based medical device. Instead, it details the substantial equivalence determination for a physical orthopedic implant system.

Therefore, I cannot extract the information required for acceptance criteria and study data for an AI/software device from this document.

The document states: "The mechanical test results show that the acceptance criteria were met. Clinical data were not provided in this submission." This indicates that mechanical testing was performed for the physical device components, but no clinical data (which might involve an AI component) was submitted.

As such, all the specific points requested (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, ground truth type, training set size, training set ground truth) are not applicable to the provided text.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

The APTUS® Titanium Fixation System is indicated for use in hand and forearm fractures and arthrodeses.
APTUS® Hand group:

• · Management of the fractures of the distal, middle and proximal phalanges and metacarpals
• · Management of all types of transversal fractures, spiral fractures near joints with or without joint
• involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures
• · DIP and PIP arthrodeses
• APTUS® Radius 2.5 group:
• · Management via radio volar approach of extra-aticular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
• Management via dorsal approach of ractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.

APTUS® 2.0/2.3 Four Corner Fusion Plate
The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand.

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

APTUS® 1.5 TriLock
The APTUS® 1.5 TriLock is indicated for use in hand and forearm fractures, osteotomies and arthrodeses.
APTUS® Hand group:

• · Management of the fractures of the distal, middle and proximal phalanges and metacarpals
• · Management of all types of transversal fractures, fractures near joints with or without joint
• involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures
• DIP and PIP arthrodeses
• APTUS® Radius 2.5 group:
• · Management via radio volar approach of extra-aticular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
• Management via dorsal approach of ractures that cannot be adequately reduced via volar approach.

procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.

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

APTUS® Wrist 2.5 System
APTUS® Wrist 2.5 System is indicated for use in hand and forearm fractures and arthrodeses.

APTUS® Wrist Arthrodesis Plates APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.

APTUS® Forearm Shaft Plates
APTUS® Forearm Shaft Plates are indicated for management of fractures and osteotomies of the radius and ulna shaft.

The Sterile Products of the APTUS System is a plating, screw, and K-wire system for internal fixation of the hand, wrist, and/ or forearm. All plates have anatomical designs that are appropriate to their intended use. The subject device plates includes crew holes designed to accommodate appropriately sized bone screws.

Sterile Products of the APTUS System plate, screw, and K-wire system are the previously cleared predicate and additional predicate devices. The overal dimens of the subject device plates have the same lengths, widths, and thicknesses as the previously cleared predicate and additional predicate device screws have the same design as the previously cleared Medartis APTUS Screws under K051567, K103332, and K142906. These include both locking (cortical) screws. The subject device K-wires have design as the previously cleared APTUS K-Wires System under K092038. The K-wires are provided with a diameter of 1.2, 1.6, or 1.8 mm. All have a length of 150 mm. Single-ended trocar points are provided in 1.2 mm and 1.6 mm diameters, and single-ended bayonet (lancet) points are provided at all 3 diameters.

This submission includes all plates screws, and K-wires that have been previously cleared under the predicate devices by Medartis AG, however, they will be provided in a sterile condition.

All subject device plates are manufactured from unalloyed titanium conforming to ASTM F67.

All subject device screws are manufactured from titanium alloy conforming to ASTM F136.

All subject device K-wires are manufactured from stainless steel conforming to ASTM F138.

All subject devices are associated with the predicate device and/or an additional predicate device mentioned in the predicates and product list sections.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called "Sterile Products of the APTUS System." It describes the device, its intended use, a comparison to previously cleared predicate devices, and a summary of non-clinical testing.

However, this document does NOT contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML medical device. The product is a bone fixation system (plates, screws, and K-wires), and the 510(k) submission is primarily focused on demonstrating substantial equivalence to already marketed devices, especially regarding the sterilization process and packaging of these physical implants.

The questions you've asked (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are highly relevant to the validation of AI/ML-enabled medical devices that perform tasks like image analysis, diagnosis, or prediction. This document describes a physical implantable device, not an AI/ML algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them in the context of AI/ML, as this information is not present in the provided text. The document is about hardware (bone fixation systems) and its sterilization, not software or AI performance validation.

Ask a specific question about this device

The APTUS 3.5 TriLock Straight Plates are intended for the fixation of fractures, osteotomies and non-unions of the scapula, olecranon, radius, ulna, foot, distal tibia and fibula.

The subject device APTUS 3.5 TriLock Straight Plates are available in eleven (11) designs with 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, or 16 screw holes. The plates have an overall length ranging from 32 mm to 200 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 K193633, K110908, and K092038. The subject device plates are manufactured from titanium alloy conforming to ASTM F136, and are provided non-sterile or sterile to the end user.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific aspects like training set, ground truth, expert adjudication, MRMC studies, and standalone performance are not applicable.

The submission focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices, primarily through non-clinical performance data and comparison of technological characteristics.

Here's a breakdown of the relevant information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of explicit acceptance criteria with corresponding performance metrics in the way one might see for an AI/ML diagnostic device with sensitivity/specificity targets. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence through:

• Biocompatibility: Referenced from predicate device K193633. (No specific numerical performance reported for the subject device beyond equivalence).
• Sterilization: Referenced from predicate device K193633 (moist heat for non-sterile, X-ray beam for sterile components). (No specific numerical performance reported for the subject device beyond equivalence).
• Packaging and Sterile Barrier Shelf Life: Referenced from predicate device K193633. (No specific numerical performance reported for the subject device beyond equivalence).
• Mechanical Testing: Performed according to ASTM F382. This standard specifies requirements for metallic bone plates. The document states that mechanical testing was done "according to ASTM F382," implying that the device met the requirements of this standard. No specific numerical performance results (e.g., fatigue life, stiffness) are provided in this summary, but the reference to the standard confirms compliance.

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

• Sample Size for Test Set: Not applicable for this type of device submission. Mechanical testing per ASTM F382 would involve a specific number of samples, but the exact number is not detailed in this summary.
• Data Provenance: The data is "non-clinical testing data," meaning it's from laboratory tests, not human subjects. It does not involve patient data or geographical provenance. It is entirely retrospective in the sense that the testing and its results underpin the submission for marketing clearance.

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

• Not applicable. This is a medical device for bone fixation, not an AI/ML diagnostic system requiring expert interpretation of images or patient data to establish ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. (See answer to #3).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used:

For the non-clinical performance data, the "ground truth" refers to the established standards and accepted scientific methods:

• Mechanical Testing: The "ground truth" is adherence to the requirements and test methods outlined in ASTM F382.
• Biocompatibility: Adherence to established ISO standards for biocompatibility (referenced implicitly by reliance on the predicate device's clearance).
• Sterilization: Adherence to recognized standards for sterilization methods (e.g., Moist Heat, X-ray beam).

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

Ask a specific question about this device

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.

Ask a specific question about this device

APTUS® Cannulated Compression Screws and headed Cannulated Compression Screws are intended for the treatment of fractures, osteotomies and arthrodesis of bones with the appropriate screw size.

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

The subject device includes APTUS Cannulated Compression Screws in thread diameters 1.7 mm, 2.2 mm, 3.0 mm, 5.0 mm, and APTUS headed Cannulated Compression Screws in diameters 2.2 mm, 3.0 mm, 5.0 mm, and 7.0 mm. APTUS Cannulated Compression Screws are headless screws that incorporate threads with different pitch on the head and tip of the screws; this difference in pitch provides compression as the screw is inserted. APTUS headed Cannulated Compression Screws have conventional bone screw heads that apply compression between the threads and the head. Both types of screws provide compression of the bone segments upon insertion of the screw. Additionally, all subject device screws have a triangular SpeedTip® shape designed to improve cutting and insertion torque and an internal hexalobular instrument face.

The APTUS Cannulated Compression Screws and APTUS headed Cannulated Compression Screws come in partially threaded and fully threaded designs. The 1.7 mm diameter screws are provided in overall lengths ranging from 8 mm to 20 mm. The 2.2 mm diameter screw are provided in overall lengths ranging from 10 mm to 40 mm. The 3.0 mm diameter screws are provided in overall lengths ranging from 10 mm to 40 mm. The 4.0 mm diameter screws are provided in overall lengths ranging from 16 mm to 60 mm. The 5.0 mm diameter screws are provided in overall lengths ranging from 24 mm to 70 mm. The 7.0 mm diameter screws are provided in overall lengths ranging from 30 mm to 140 mm.

The subject device 1.7 mm, 2.2 mm, 4.0 mm, 5.0 mm, and 7.0 mm thread diameter APTUS Cannulated Compression Screws and APTUS headed Cannulated Compression screws are used with the corresponding subject device K-wires (0.6, 0.8, 1.1, 1.25, 1.6, and 2.2 mm, respectively). The subject device screws also are compatible with the Medartis K-wires cleared under K092038. Similarly, the subject device K-wires are compatible with the APTUS Cannulated Compression Screws cleared under K133460 and K110658.

This submission also includes the corresponding washers for APTUS headed Cannulated Compression Screws.

The subject device cannulated compression screws and washers are manufactured from titanium allov conforming to ASTM F136 Standard Specification for Wrought Titanium-61 anadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). 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).

All subject devices are provided non-sterile to the end user. The subject devices are single-use only.

This document describes a 510(k) premarket notification for Medartis AG's APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, and APTUS K-Wire System. This is a submission for medical devices that are typically evaluated based on substantial equivalence to predicate devices, rather than strict performance against predefined acceptance criteria for a new clinical indication. Therefore, the information you've requested regarding acceptance criteria and a study proving those criteria are met is not directly applicable in the context of this 510(k) submission as it would be for a novel diagnostic AI device.

Instead, the submission focuses on demonstrating that the new devices are "substantially equivalent" to already legally marketed predicate devices. This is typically done through comparisons of:

• Intended Use/Indications for Use: Ensuring the new device is used for the same purpose and in similar patient populations as the predicate.
• Technological Characteristics: Comparing materials, design, operating principles, and performance.
• Performance Data: This is usually non-clinical testing (e.g., mechanical, biocompatibility, sterilization) to show that any differences in technological characteristics do not raise new questions of safety or effectiveness. Clinical data are often not required for 510(k) submissions unless deemed necessary to address a specific safety or effectiveness concern.

Given this context, I will address your points based on the information provided in the document, interpreting "acceptance criteria" through the lens of "substantial equivalence" as demonstrated by the non-clinical performance data.

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

Since this is a 510(k) submission for substantial equivalence rather than a device with a novel performance claim requiring specific clinical acceptance criteria, the document does not present a table of acceptance criteria in the manner you might expect for a diagnostic AI device. Instead, "acceptance criteria" are implicitly met by demonstrating that the device performs equivalently to the predicates in specific engineering tests.

The document states that performance data relied upon "include: biocompatibility referenced from K133460, K110658, K092038, and K193633; moist heat sterilization (to be performed by the end user) also referenced from K133460, K110658, and K193633; X-ray beam sterilization, packaging, and sterile barrier shelf life referenced from K191848 and K 193633; and mechanical testing according to ASTM F543 Standard Specification and Test Methods for Metallic Medical Bone Screws."

This implies that the "acceptance criteria" are compliance with recognized standards and demonstrated equivalence to predicate devices.

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

The document primarily refers to non-clinical testing (biocompatibility, sterilization, mechanical testing). For such tests, the "sample size" is typically defined by the requirements of the specific ASTM standards or other test protocols. The document does not specify the exact number of devices tested for each non-clinical performance test (e.g., how many screws were subjected to ASTM F543).

• Data Provenance: The document does not specify the country of origin for the non-clinical test data. Given Medartis AG is based in Switzerland and their consultant PaxMed International, LLC is in the USA, it's likely the testing was conducted in ISO-accredited labs in one of these regions or globally. The data would be considered prospective in the sense that the tests were conducted specifically for this submission to demonstrate the device's characteristics against a standard or predicate.
• Clinical data: The document explicitly states: "Clinical data were not provided in this submission." Therefore, there is no "test set" of patient data for clinical evaluation.

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. Since no clinical data was provided and the evaluation relies on non-clinical testing and substantial equivalence to predicates, there was no "ground truth" to be established by clinical experts in the context of this 510(k) submission.

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

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

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 fastener and K-wire system, not an AI or diagnostic imaging device.

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

Not applicable. This is not an algorithm or AI device.

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

For the non-clinical performance data, the "ground truth" or reference is established by recognized industry standards (e.g., ASTM F543) and the established safety and effectiveness profile of the predicate devices. The mechanical properties are compared against benchmark values or the performance of the predicate. Biocompatibility relies on the known properties of the materials used in accordance with established standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Ask a specific question about this device

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.

Ask a specific question about this device