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For wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability, post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; turnor resection; and spastic deformities. Single use device for cementless use only.

Device Description

These anatomically contoured plates are offered in two lengths (standard or short), manufactured from either titanium (ASTM F-136) or stainless steel (ASTM F-138 or ASTM F-2229). The plate contains a single row of screw holes (2.4mm, 2.7mm and 3.2mm in diameter) down its length. The locking screws are 2.4mm in diameter and vary in length from 6mm to 14mm. The 2.7mm and 3.2mm screws were previously cleared. In addition to the screws, the device utilizes a press fit intramedullary fixation for the proximal stem.

AI/ML Overview

This is not an AI/ML device. This is a 510(k) premarket notification for a medical device called "Wrist Fusion Plate". The document does not contain information about acceptance criteria or a study proving the device meets them because it is a traditional medical device, not an AI/ML product. Therefore, it is unable to answer the question as it pertains to AI/ML device testing and evaluation.

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K Number

K021321

Device Name

WRIST FUSION PLATE

Manufacturer

ACUMED, INC.

Date Cleared

2002-07-17

(83 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K991873,K012655

Predicate For

K030881,K050681,K103243

Intended Use

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.

Device Description

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.

AI/ML Overview

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: