(84 days)
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial opening wedge osteotomies.
The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System which consists of tapered plates, screws (cancellous and cortical design), and spacer blocks in various sizes. The plate in this system accepts 6 mm cancellous screws proximally and 4.5 mm cortical screw distally. The Aesculap Implant Systems High Tibial Osteotomy (HTO) Plating System is manufactured from Titanium/Titanium Alloy and will be provided sterile.
This looks like a 510(k) summary for a medical device (HTO Plating System), which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance as would be seen for AI/ML devices. Therefore, much of the requested information (like effect size for MRMC studies, ground truth establishment, training set details) is not applicable or unavailable in this type of document.
However, I will extract what is available regarding performance and equivalence.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence: Similar performance to previously cleared high tibial osteotomy systems with similar indications. | Met: Biomechanical testing of the subject device (HTO Maxi Plate and screws) found it to be similar in performance to previously cleared high tibial osteotomy systems with similar indications. Fatigue testing was performed to support this. |
2. Sample Size Used for the Test Set and Data Provenance:
This document describes a biomechanical test, not a clinical study involving a "test set" of patient data. Therefore, this information is not applicable.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
Not applicable. Ground truth, in the context of device performance for this type of submission, refers to the physical properties and mechanical behavior of the device itself, usually measured in a lab setting by engineers or technicians, not by medical experts establishing diagnostic ground truth from patient data.
4. Adjudication Method for the Test Set:
Not applicable. As described above, this was a biomechanical test, not a clinical study with adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of clinical data, not for an orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an AI/ML algorithm or diagnostic device.
7. The Type of Ground Truth Used:
For this type of device, the "ground truth" would be established through objective engineering measurements in a lab setting, such as:
- Material properties (e.g., tensile strength, yield strength, fatigue limit)
- Dimensional accuracy
- Biomechanical performance determined by standardized tests (e.g., fatigue testing, static loading)
The document specifically mentions "Fatigue testing" as the performance data.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that undergoes training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of the Study:
The study referenced in the document is a biomechanical performance study, specifically fatigue testing, of the new HTO Maxi Plate. The purpose of this testing was to demonstrate that the new components (HTO Maxi Plate and screws) are substantially equivalent in performance to the predicate device and other legally marketed high tibial osteotomy systems. The document states that the testing "found [the device] to be similar in performance" to these predicates. This type of testing is standard for orthopedic implants to ensure mechanical integrity and durability.
Key takeaway: This 510(k) submission is for an orthopedic implant, where the focus is on mechanical and material performance to prove substantial equivalence, rather than a diagnostic AI/ML device where clinical efficacy and reader performance are assessed through complex clinical studies.
§ 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.