(87 days)
The DePuy Delta TS Ceramic Femoral Head is intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
The DePuy Delta TS Ceramic Hip Head Prosthesis is indicated for use as the femoral head component in total hip arthroplasty procedures.
Total hip arthroplasty is intended to provide increased patient mobility and 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:
- 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 Delta TS (Taper Sleeve) Ceramic Femoral Heads are designed for use as the femoral head component in total hip arthroplasty procedures. The femoral head is manufactured from an alumina composite ceramic material and includes an internal titanium alloy sleeve to mate with DePuy femoral hip stems with a corresponding taper. The ceramic femoral head mechanically locks with the femoral hip stem via a taper junction, and articulates with a polyethylene acetabular component.
The subject DePuy Delta TS Ceramic Femoral Heads are available in femoral head outer diameters of 28mm, 32mm, 40mm and 44mm. The internal bore of the titanium sleeve is available in a 12/14 option.
This document is a 510(k) summary for the DePuy Delta TS Ceramic Femoral Head. This submission details the substantial equivalence of a new medical device to existing predicate devices, rather than a study proving the device meets specific performance criteria through empirical testing.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The document focuses on demonstrating that the new device has the same intended use, design, materials, manufacturing methods, packaging, and sterilization as already legally marketed predicate devices, making it "substantially equivalent."
Here's why the requested information cannot be extracted from this document:
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Acceptance Criteria and Reported Device Performance: This document does not establish specific performance acceptance criteria (e.g., in terms of mechanical strength, wear rate, bio-compatibility numbers) for the device. Instead, it asserts that the device is substantially equivalent to predicates, implying it meets the same functional performance as those devices. No performance data (such as specific breaking strength, wear measurements, etc.) for the DePuy Delta TS Ceramic Femoral Head is reported to compare against numerical acceptance criteria.
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Sample Size, Data Provenance, Experts, Adjudication Method for Test Set: These points are relevant to studies involving human or animal subjects, or detailed comparative analytical or clinical testing. This 510(k) summary is based on demonstrating equivalence, not on such studies. There is no mention of a "test set" in this context.
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Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: This type of study is typically performed for diagnostic devices or those requiring human interpretation of results (e.g., radiology AI). The DePuy Delta TS Ceramic Femoral Head is a physical implant, not a diagnostic tool, so an MRMC study is not applicable here.
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Standalone (Algorithm Only) Performance: This refers to the performance of an algorithm without human intervention, again typically for AI or diagnostic software. This is not applicable to a physical orthopaedic implant.
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Type of Ground Truth Used: "Ground truth" is established in studies that measure a device's accuracy or effectiveness against a known standard. Since no such performance study is described in this 510(k) summary, there is no mention of ground truth.
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Sample Size for Training Set and How Ground Truth for Training Set Was Established: These pertain to the development and validation of machine learning models. As this document concerns a physical implant, these concepts are not relevant.
In summary, the provided 510(k) Pre-Market Notification focuses on demonstrating substantial equivalence to predicate devices based on similarities in intended use, design, materials, manufacturing, packaging, and sterilization, rather than presenting a performance study against specific acceptance criteria.
§ 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.