(83 days)
The Acumed Wrist Fusion Plate, an addition to the Acumed Congruent Bone Plate System, is designed specifically for fusion of the small bones of the hand including: hamate, capitate, lunate, triqueteral and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis.
The Acumed Wrist Fusion Plate is spherical in shape. Holes or slots offer multiple screw placement options. The plate also has holes that may be utilized for provisional tacking or positioning with Kirschner wires to the bones prior to screw installation. A threaded hole in the center of the plate allows for optional accessories to be attached to the plate.
In this 510(k) submission for the Acumed Wrist Fusion Plate (K021321), no specific performance data or studies proving the device meets acceptance criteria are provided. The submission states that "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable."
The basis for clearance is substantial equivalence to predicate devices (KMI Wrist Fusion System (K991873) and Acumed Congruent Bone Plate System (K012655)), rather than direct performance testing of the device itself.
Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted from the provided document. The sections on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details are not applicable as these types of studies were explicitly stated to not have been performed or required for this submission.
Summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable, as no performance study was conducted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no performance study was conducted.
4. Adjudication Method for the Test Set:
Not applicable, as no performance study was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done.
6. Standalone Performance Study:
No, a standalone performance study was not done.
7. Type of Ground Truth Used:
Not applicable, as no performance study was conducted.
8. Sample Size for the Training Set:
Not applicable, as no performance study was conducted.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no performance study was conducted.
§ 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.