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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.

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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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