(76 days)
intended for prosthetic replacement of the proximal portion of the femur in a hip replacement.
The APR® Fully Textured Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in a hip replacement. This device is a nonporous. anatomic femoral component that comes in a variety of sizes in both left and right configurations. This stem is manufactured from wrought Ti-6A1-4V alloy (ASTM F 136) and features surface texturing along the full length of the stem (with the exception of the neck area) for enhanced fixation in cemented or press-fit applications. In addition, the APR® Fully Textured Hip Stem:
- incorporates an anterior anguiation in the proximal body to match the normal anterior angulation of the natural femur;
- . features a double wedge shaped proximal body to maximize filling of the proximal femur;
- has a 12/14 Morse taper making it compatible with modular femoral heads:
- . has a distal stem with a circular cross section allowing for ease in canal preparation and prosthesis insertion; and;
- incorporates a cylindrical hole in the distal stem of the larger sizes to increase distal stem flexibility.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving device performance as typically understood in the context of medical AI/software devices.
The document describes a 510(k) Summary for a physical medical device: the Intermedics Orthopedics, Inc. APR® Fully Textured Hip Stem. It details:
- Product Description: A hip stem for prosthetic replacement of the proximal femur.
- Materials: Wrought Ti-6A1-4V alloy.
- Design features: Surface texturing, anterior angulation, double wedge shape, Morse taper, circular distal stem, cylindrical hole in larger sizes.
- Intended Use: Cemented or press-fit applications.
- Substantial Equivalence: To other existing hip stems (Bi-Metric Primary Interlok Hip Stem and Alloclassic Zweymüller Cementless Stem).
The concepts of "acceptance criteria," "sample size for test set," "ground truth," "expert adjudication," "MRMC study," or "standalone performance" are relevant to artificial intelligence/machine learning (AI/ML) based medical devices or diagnostic software, which analyze data (e.g., images, physiological signals) to provide insights or diagnoses.
This document pertains to a physical orthopedic implant, where "acceptance criteria" and "proof of performance" would typically refer to:
- Mechanical Testing: Fatigue strength, static strength, wear characteristics, torsional stability.
- Biocompatibility Testing: Material safety.
- Clinical Outcomes (Post-market): Long-term implant survival, aseptic loosening rates, patient function, pain relief (often from post-market surveillance or registries, not pre-market studies for 510(k)).
- Manufacturing Quality Control: Adherence to design specifications.
Since the request is specifically for information related to AI/software device evaluation metrics, and the provided document describes a physical hip stem, I cannot extract the requested information.
§ 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.