(124 days)
The EasyStep system is intended for bone fragment and osteotomy fixation of the foot in adult patients. Indications include:
- Bone fragment fixation
- Osteotomy fixation
The Stryker GmbH EasyStep system includes superelastic staples fabricated from Nitinol (Nickel-Titanium alloy) per ASTM F 2063. The staples range in size from 4 mm to 12 mm in 2 mm increments where the staple size refers to the step size associated with each staple. The legs of each staple are barbed to provide anchorage within the bone fragments. All implants within the system are provided sterile.
This document is a 510(k) summary for the EasyStep system, a medical device for bone fixation. It does not describe an AI/ML powered device, therefore, many of the requested categories are not applicable.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Pull-Out Testing (per ASTM F564) | Demonstrated equivalent mechanical performance to the predicate device, Biomedical Enterprises Inc. Memograph Staple System. |
| Four-Point Bending Testing (per ASTM F564) | Demonstrated equivalent mechanical performance to the predicate device, Biomedical Enterprises Inc. Memograph Staple System. |
| Cyclic Potentiodynamic Polarization (Corrosion) Test (per ASTM F2129) | Demonstrated equivalence to the predicate device. |
| Bacterial Endotoxins Test (BET) (per ANSI/AAMI ST72) | Demonstrated equivalence to the predicate device. |
| Magnetically Induced Displacement Force (per ASTM F2052) | Demonstrated compatibility with an MR environment. |
| Magnetically Induced Torque (per ASTM F2213) | Demonstrated compatibility with an MR environment. |
| Heating by RF Fields (per ASTM F2182) | Demonstrated compatibility with an MR environment. |
| Image Artifacts (per ASTM F 2119) | Demonstrated compatibility with an MR environment. |
2. Sample size used for the test set and the data provenance:
- The document states that "Non-clinical laboratory testing was performed on the worst case subject staples." It does not specify the exact sample size for each test.
- The data provenance is from non-clinical laboratory testing performed by the manufacturer, Stryker GmbH. The country of origin of the data is not explicitly stated. It is prospective testing performed for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a hardware implant, not an AI/ML powered device. Therefore, the concept of "ground truth" established by experts for a test set in the context of device performance, as typically understood for AI, is not applicable here. The "ground truth" for the mechanical and material tests is defined by the respective ASTM standards and validated laboratory methodologies.
4. Adjudication method for the test set:
- Not applicable, as this is laboratory testing of a mechanical device, not a performance study involving interpretation by experts.
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 is not an AI/ML powered 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 powered device.
7. The type of ground truth used:
- The "ground truth" for the mechanical and material properties of the device are the physical standards and specifications outlined in the referenced ASTM and ANSI/AAMI documents. For instance, pull-out strength is assessed against a defined standard, not an expert opinion.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML powered device, so there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.