(107 days)
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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.