(20 days)
The DePuy Ceramic Femoral Heads are indicated for use as the femoral head component in total hip arthroplasty procedures. Total hip arthroplasty is intended to provide increased patient mobility and to reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions:
- I. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
-
- Avascular necrosis of the femoral head.
-
- Acute traumatic fracture of the femoral head or neck.
-
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
-
- Certain cases of ankylosis.
The DePuy Ceramic Femoral Heads are composed of an alumina composite material and are available in head diameters of 32mm and 36mm sizes with various offset options. The internal bore of the ceramic femoral head, which is designed to interlock with the external taper on the femoral hip stem, is available in two variations (11/13 SROM and 12/14 Articul/eze taper options). The ceramic heads are designed to mate with a corresponding DePuy femoral hip stem and provide the femoral articular surface of a total hip replacement.
This document describes a 510(k) premarket notification for the DePuy Ceramic Femoral Heads. The basis for substantial equivalence is primarily through comparison to a predicate device (DePuy Femoral Heads submitted in K011533), rather than through a study proving specific acceptance criteria related to a device's performance characteristics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies assessing the accuracy or effectiveness of a diagnostic or therapeutic medical device, cannot be found in this document.
This document focuses on regulatory approval based on demonstrating substantial equivalence to a previously cleared device. It asserts similarity in design, material composition, sterilization and packaging methods, intended use/indications for use, and labeling between the new device and its predicate.
To directly answer your request based on the provided text:
-
A table of acceptance criteria and the reported device performance
- Not Applicable. The document does not define specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or mechanical thresholds) for the DePuy Ceramic Femoral Heads with associated reported device performance data from a clinical or technical study. The "performance" is implicitly tied to the previous clearance of the predicate device (K011533).
- Basis of Substantial Equivalence (Implicit "Acceptance Criteria"):
- Similarities in design
- Same material composition
- Same sterilization and packaging methods
- Same intended use/indications for use
- Similar labels
- Reported Device "Performance": The device is considered "substantially equivalent" to K011533 based on meeting the above similarities.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or related data (clinical or in vitro) is described in this document. Substantial equivalence is claimed based on design and material comparison to a predicate device, not through a new performance study with a test set.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. No test set or ground truth establishment process is described. This document is a regulatory submission, not a study report.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a ceramic femoral head (joint component), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study related to human readers and AI assistance is entirely irrelevant and not mentioned.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device (implant), not an algorithm or software. Standalone algorithm performance is not relevant.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. No ground truth is established for the device itself in this submission. The "truth" for regulatory purposes here is the established safety and effectiveness of the predicate device (K011533) to which the new device is compared.
-
The sample size for the training set
- Not Applicable. No training set is mentioned or relevant to this type of regulatory submission for a physical implantable device.
-
How the ground truth for the training set was established
- Not Applicable. No training set or associated ground truth establishment process is described.
§ 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.