(80 days)
The Acumed Wrist Spanning Plate is intended for fixation of fractures, osteotomies, and nonunions of the radius.
The Acumed Wrist Spanning Plate is indicated for fixation of fractures, osteotomies, and non-unions of the radius.
The Acumed Wrist Spanning Plate comprises two anatomically designed dorsal fixation plate and is provided in sterile packaging.
The provided text describes a 510(k) summary for the Acumed Wrist Spanning Plate, a medical device for bone fixation. The information available focuses on the device's technical characteristics and its substantial equivalence to a predicate device based on mechanical performance.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Objective | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bending Strength Performance | Statistically equivalent to that of the predicate device (Synthes 3.5mm Locking Compression Plate standard bone plate (K082807)). | "The bending strength performance of the Acumed Wrist Spanning Plate was verified to be statistically equivalent to that of the predicate device." (Section 1) |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not explicitly state the sample size used for the mechanical bending strength performance test. It mentions that "detailed test reports can be found in Section 36," but Section 36 is not included in the provided text.
The data provenance is for a mechanical bench test comparing the new device to a predicate device, not clinical data from patients. Therefore, concepts like country of origin and retrospective/prospective do not apply in the typical sense for this type of study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to the study described. The study is a mechanical bench test comparing the bending strength of two bone plates. There is no "ground truth" established by human experts in this context. The "ground truth" is determined by direct mechanical testing according to established engineering principles.
4. Adjudication Method for the Test Set
This question is not applicable to the study described. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which is not the case for this mechanical bench test.
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 question is not applicable. The study is a mechanical bench test of a bone plate, not a study involving AI, human readers, or medical image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The study is a mechanical bench test of a bone plate, not an algorithm.
7. The Type of Ground Truth Used
For the bending strength performance study, the "ground truth" is established by direct mechanical measurements of the plates' bending strength under controlled experimental conditions, following standardized testing protocols (likely ASTM standards for metallic bone fixation devices). It's an objective physical measurement, not an expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This question is not applicable. The described study is a mechanical validation of a medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as above.
In summary:
The provided text focuses on the mechanical performance of the Acumed Wrist Spanning Plate, demonstrating its substantial equivalence to a legally marketed predicate device through bench testing. The acceptance criteria were met when the bending strength performance of the new device was statistically equivalent to the predicate. The study type is a mechanical performance validation, not a clinical study or an AI performance study.
§ 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.