(206 days)
The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
The subject device plates are provided in a variety of anatomical designs, in various lengths, widths and thicknesses. The plate thickness varies from 1.6 mm to 2.0 mm depending on the design. The screw holes of the subject device plates are designed to accommodate appropriately sized subject device screws, or screws presently marketed as part of the APTUS System and previously cleared under K091479. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are used with TriLock locking screws and cortical (nonlocking) screws. All subject device screws are self-tapping and self-drilling and provided in diameters of 2.0, 2.8 and 3.5 mm, and in various lengths from 8 to 45 mm.
The subject device plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The subject device screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
This document is a 510(k) Premarket Notification from Medartis AG for their APTUS® Foot System. It aims to demonstrate substantial equivalence to previously marketed devices. While it describes performance data, it does not explicitly define acceptance criteria as a standalone statement with pass/fail thresholds. Instead, the "performance data" section outlines the types of testing conducted to support substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
Since explicit acceptance criteria are not provided, I will infer them based on the types of tests conducted and the general objective of demonstrating substantial equivalence to predicate devices regarding safety and effectiveness. The reported device performance is based on the information provided in the "PERFORMANCE DATA" section.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Dimensional Analysis: Conformity to specified dimensions for plates and screws. | Conducted to demonstrate substantial equivalence; implies conformity. |
| Engineering Analysis: Structural integrity and design parameters. | Conducted to demonstrate substantial equivalence; implies acceptable engineering. |
| Finite Element Analysis (FEA): Simulation of stress, strain, and deformation under load. | Conducted to demonstrate substantial equivalence; implies acceptable mechanical behavior. |
| Mechanical Testing: | |
| * ASTM F543 - Metallic Bone Screws Test Methods: | |
| * Insertion Torque: Acceptable torque for screw insertion. | Tested (subject and predicate screws). |
| * Maximum Torque: Acceptable maximum torque before failure. | Tested (subject and predicate screws). |
| * Pull-Out Testing: Sufficient resistance to pull-out forces. | Tested (subject and predicate screws). |
| * Dynamic Mechanical Testing: Acceptable fatigue strength and durability for plate designs. | Tested (subject and predicate plate designs). |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for any of the tests. The document only mentions "subject device screws were tested" and "Dynamic mechanical testing of the subject and predicate plate designs also was performed."
- Data Provenance: Not explicitly stated. The tests were performed to support a 510(k) submission for a device manufactured by Medartis AG, located in Basel, Switzerland. The data would have been generated as part of their product development and regulatory submission process. It is generally retrospective for the purpose of a 510(k) submission, meaning the tests were conducted on pre-market devices to gather data for equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This submission does not involve a clinical study or a judgmental process requiring expert consensus on a test set (e.g., image interpretation). The "ground truth" for the mechanical and engineering performance data is established by the results of the standardized tests (e.g., ASTM F543) themselves and the comparative analysis against predicate devices.
4. Adjudication Method for the Test Set:
- Not Applicable. No human adjudication method was described as the performance data consisted of dimensional, engineering, finite element analysis, and mechanical testing, not clinical outcomes requiring expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC comparative effectiveness study was not done. This submission focuses on the mechanical and design equivalence of a bone fixation system, not on an algorithm or imaging device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This device is a bone fixation system, not a software algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is based on engineering standards, material specifications, and objective mechanical test results. For example:
8. The Sample Size for the Training Set:
- Not Applicable. This submission is for a physical medical device (bone fixation system), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for it does not apply here.
§ 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.