(26 days)
The DePuy Global CAP™ HA Resurfacing Shoulder Humcral Heads are intended as a hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation.
The DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, noninflammatory degenerative joint disease (i.e. ostcoarthritis and avascular necrosis). deformity and/or limited motion, fractures of the humeral head and traumatic arthritis.
The DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads are intended for cementless use only.
The DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads are composed of a cobalt chrome molybdenum alloy (ASTM F-75), and are available in a variety of diameters. This device will be available in curvatures of 40, 44, 48, 52 and 56mm, all available with head heights of 15mm (short), 18mm (medium) or 21mm (large) (Exhibit 1). This proposed range of sizes is designed to fit the natural range of the humeral head anatomy. This range and combination of head diameters and head heights have been cleared in the Global Advantage Humeral Head Premarket Notification (K031971). The stem is a tapered cruciate design intended to provide maximum fixation and stability when impacted in the humerus.
The humeral head is a onc-piece shell with 2mm thick wall. The stem has a cobalt chrome porous coating proximally and is grit blasted distally. The distal stem has a cruciate design and tapers down to the distal tip. The distal tip has a 58° radius. A thin layer of plasma sprayed hydroxyapatite (HA) has been applied to the humeral heads.
This submission is for a medical device (DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads), not an AI/ML powered device. As such, the concept of "acceptance criteria," "device performance" in terms of algorithmic metrics, "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set" as typically applied to AI/ML devices, is not applicable here.
Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device based on design, materials, manufacturing processes, and intended use. The device performance is assessed through comparisons of its characteristics to a known, previously cleared device.
Therefore, I cannot fill out the requested table and information as it pertains to AI/ML device evaluation. The provided 510(k) summary (K033516) for the DePuy Global CAP™ HA Resurfacing Shoulder Humeral Heads does not contain information related to AI/ML performance testing. It is a traditional medical device submission for an orthopedic implant.
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.