(63 days)
The Excia Hip System is intended to replace a hip joint.
The device is intended for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur.
- Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral . ephiphysis
- Patients suffering from disability due to previous fusion ●
- Patients with acute femoral neck fractures .
The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti. With a Ti. Plasma spray.
The Acetabular Cups (Plasmacup® NSC and MSC) are manufactured from Ti. and are offered with a plasmapore® coating. The Plasmacup® is offered in two designs: NSC and MSC (no holes or multiple holes). Both designs are available in sizes ranging from 40mm - 68mm. The new Plasmacup® Acetabular Cups are a line extension to the existing Excia Total Hip System.
The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti. With a Ti. Plasma spray.
This document is a 510(k) Premarket Notification for a line extension of the Excia Total Hip System, specifically for new Acetabular Cups (Plasmacup® NSC and MSC). This submission is for a medical device and thus does not include information about artificial intelligence (AI) performance, study design, or expert review panels typically found in AI/ML medical device submissions.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device meets acceptance criteria as these pertain to AI/ML device performance and are not present in this 510(k) submission.
This submission focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics (material, shape, size) and compliance with relevant orthopedic device testing guidance documents, not on performance criteria measured through clinical studies or AI algorithm evaluation.
Key points from the document indicating a lack of AI/ML information:
- Device Type: The device is a "Total Hip System Line Extension," specifically acetabular cups, which are physical orthopedic implants.
- Performance Data: The "PERFORMANCE DATA" section states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable." It then lists several guidance documents related to testing orthopedic implants, metallic surfaces, modular components, acetabular cup prostheses, femoral stem prostheses, ceramic ball hip systems, and UHMWPE. These are all related to mechanical, material, and biocompatibility testing of physical implants, not AI/ML algorithm performance.
- No mention of AI/ML: There is no mention of software, AI, algorithms, diagnostic performance (e.g., sensitivity, specificity), ground truth, training sets, test sets, or expert review in the context of an AI/ML-driven device.
- Substantial Equivalence: The primary goal of this 510(k) is to demonstrate "Substantial Equivalence" to the predicate device (Plasmacup® SC) based on similar design and materials.
Therefore, all requested sections related to acceptance criteria, study details, sample sizes, ground truth, and expert review directly applicable to AI/ML performance cannot be filled from the provided document.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.