(133 days)
The 4Web Osteotomy Bone Wedge is intended to be used for internal bone fixation on osteotomies in the foot, such as:
- Opening wedge osteotomies of Hallux Valgus
- Cotton opening wedge osteotomies
- Evans lengthening osteotomies
These devices are intended to be used with autograft bone and ancillary fixation. The 4Web Osteotomy Bone Wedge is not intended for use in the spine.
The 4Web Osteotomy Bone Wedge is a titanium alloy implant used for correction of small bones in the foot. It is offered in two shapes and multiple sizes for each shape with varying widths and thicknesses to accommodate a variety of small bone applications. Each device uses the 4-Web truss system of architecture. Implants are made from medical grade titanium allow (6Al4V-ELI) per ASTM F-136/ISO 5832-3.
This document describes a 510(k) premarket notification for the 4Web Osteotomy Bone Wedge. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against specific acceptance criteria for a new, innovative device technology (like AI/ML).
Therefore, many of the requested sections regarding AI/ML-specific performance studies are not applicable or cannot be extracted from the provided text.
Here is the information that can be extracted from the provided documents:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from predicate device standards) | Reported Device Performance (4Web Osteotomy Bone Wedge) |
|---|---|
| Static Compression Testing (per ASTM F2077-11) | Indicated substantial equivalence to predicate device and adequacy for intended use. |
| Dynamic Compression Testing (per ASTM F2077-11) | Indicated substantial equivalence to predicate device and adequacy for intended use. |
| Expulsion Testing | Indicated substantial equivalence to predicate device and adequacy for intended use. |
Explanation: The acceptance criteria are implicitly defined by the performance of the predicate device (Biofoam Bone Wedge from Wright Medical, K073535) and the standards applied to that class of device (ASTM F2077-11). The 4Web Osteotomy Bone Wedge aims to meet or exceed these established performance levels to demonstrate substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "pre-clinical testing" but does not detail sample sizes for the mechanical tests, nor does it refer to patient data.
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)
This information is not applicable/provided. This device is undergoing a 510(k) submission based on substantial equivalence through mechanical testing, not a clinical study involving expert interpretation of data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. As above, this is a mechanical device submission, not a clinical study requiring adjudication of expert interpretations.
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
This information is not applicable/provided. The document does not describe an AI/ML device, nor a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The document does not describe an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" is defined by the established performance standards (ASTM F2077-11) and the performance characteristics of the predicate device. There is no biological or clinical "ground truth" mentioned as these are pre-clinical mechanical tests.
8. The sample size for the training set
This information is not applicable/provided. There is no mention of a training set as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no mention of a training set or its ground truth establishment.
§ 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.