(72 days)
The indications for use of the Zirconia Ceramic Modular Heads include: 1) noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction of functional deformity, and 4) revision of failed hip arthroplasty.
The Biomet ceramic modular head is designed to be the articular surface of an artificial hip joint. The highly polished spherical surface articulates with a polyethylene lined cup. The ball attaches to a metallic femoral stem. These heads are compatible with all of Biomet's hip stems with Type I (4 0' ± 0 2') tapers. The metallic stems are manufactured from either titanium alloy (Ti-6Al-4V) conforming to ASTM F-136 or cobalt alloy (Co-Cr-Mo) conforming to either ASTM F-799. This submission covers 22.22 mm diameter heads with -3 and standard neck offsets.
Biomet Zirconia Ceramic Modular Heads are manufactured from Yttria Stabilized Zirconia. Manufacturing of these ceramic devices will be done entirely outside Biomet by Norton Advanced Ceramics. Mechanical testing was conducted with the final taper design in accordance with the FDA's guideline document. Devices were found to conform to all requirements including compression, pull-off and fatigue strength.
This document is a 510(k) premarket notification for a medical device, the Zirconia 22.22mm Ceramic Modular Head. It does not describe a study involving acceptance criteria and device performance in the context of an AI/algorithm-driven device. Instead, it details the regulatory submission process for a physical hip implant component.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI device. The document primarily focuses on:
- Device Description: A ceramic modular head for hip replacement.
- Intended Use: Noninflammatory degenerative joint disease, rheumatoid arthritis, functional deformity correction, and revision hip arthroplasty.
- Materials: Yttria Stabilized Zirconia, compatible with titanium alloy or cobalt alloy femoral stems.
- Manufacturing: Conducted by Norton Advanced Ceramics.
- Mechanical Testing: Mentioned as being conducted in accordance with FDA guidelines, covering compression, pull-off, and fatigue strength, and devices found to conform to all requirements. This is the closest mention of "acceptance criteria" and "study" but it refers to mechanical engineering tests for the physical product, not a clinical or AI performance study.
- Potential Risks: Standard risks associated with hip replacement surgery (e.g., nerve damage, infection, component loosening).
- Substantial Equivalence: Comparison to existing ceramic heads on the market, specifically mentioning a Zirconia 28mm Ceramic Modular Head by Norton (K964431) as a predicate.
- FDA Clearance: The letter from the FDA granting clearance based on substantial equivalence.
In summary, the provided text does not contain information on:
- A table of acceptance criteria and reported device performance (for an AI/algorithmic device).
- Sample size or data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone performance of an algorithm.
- Type of ground truth used (in the context of an AI device).
- Sample size for a training set.
- How ground truth for a training set was established.
The document describes the regulatory approval of a physical medical implant, not an AI software/device.
§ 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.