(178 days)
The IntraBlock™ BioBall™ Hip System (IBS) is intended for use in total hip arthroplasty.
The IBS is indicated for:
- Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis,
- Avascular necrosis of the femoral head, -
- = Correction of functional deformity,
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques,
- -Revision procedures where other treatment or devices have failed.
The IBS is indicated for cementless use only.
The IntraBlock™ BioBall™ Hip System (IBS) is composed of femoral stems, heads, taper adapter sleeves and acetabulum cups. The System is designed for uncemented use for either primary or revision hip arthroplasty.
The Ceramic Head is made of Biolox® delta (Alumina Matrix Composite ISO 6474-2) and available in diameters 28, 32 and 36 mm.
The cementless MultiCup Locking PressFit is manufactured from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F-136 with a titanium plasma spray (TPS) coating on the outer surface. It is used with a UHMWPE Inlay sized for Ø28, 32 and 36 mm heads. 5 holes with threaded plugs give the option for an additional fixation with locking screws. The MultiCup is available in 9 different sizes ranged from 46 mm, 48 mm up to 62 mm outer diameter.
The provided document is a 510(k) premarket notification decision letter and summary for a medical device: the IntraBlock™ BioBall™ Hip System (IBS). It focuses on establishing substantial equivalence to previously marketed devices based on non-clinical performance data (mechanical testing and analysis).
Therefore, this document does not contain information about acceptance criteria for a study proving device performance on human subjects, nor does it describe such a study. It describes a regulatory submission for a medical device (a hip replacement system) primarily based on non-clinical (laboratory) testing for mechanical properties and material characteristics to demonstrate substantial equivalence to predicate devices.
Specifically, the document states:
- Non-Clinical Performance Data: "Non-clinical testing and analysis were provided to support substantial equivalence. Mechanical testing included testing of the modular connection, wear testing and mechanical testing of the coating as well as coating characterization. Range of Motion analysis also was performed. The modular connection analysis included fretting and corrosion as well as static compression testing (burst testing and post-fatigue burst testing) consistent with the "Guidance document for the preparation of premarket notifications for ceramic ball hip systems". Furthermore the connections between the stem, the adapter and the head, as well as the liner locking mechanism were tested in pull-off, rotation testing and cup/liner disassembly testing."
This clearly indicates a focus on laboratory or bench testing rather than clinical studies involving human subjects or expert assessment of clinical data.
Therefore, I cannot provide the requested information regarding acceptance criteria for a device performance study involving human subjects or expert ground truth, as that information is not present in the provided text.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.