(175 days)
The subject DePuy Duraloc Acetabular Cups are intended to be used with DePuy Duraloc polyethylene liners and locking rings to resurface the acetabular socket in cementless total hip replacement.
The subject DePuy Duraloc Acetabular Cups are porous coated Ti-6Al-4V alloy acetabular cups which are available in various sizes, ranging from 38mm in outer diameter. All of the cups have screw holes, either dome or peripheral, for adjunctive fixation. All of the DePuy Duraloc Acetabular Cups are intended to be used with DePuy Duraloc polyethylene liners and locking rings to resurface the acetabular socket in cementless total hip replacement.
This document describes an orthopedic implant (Acetabular Cups) and focuses on demonstrating its substantial equivalence to existing, already cleared devices, rather than establishing acceptance criteria through performance studies with predefined metrics like sensitivity or specificity for a diagnostic device.
Therefore, many of the requested categories (e.g., sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable in this context. The "acceptance criteria" here is primarily based on demonstrating similarity to predicate devices in terms of materials, design, and intended use.
Here's an attempt to address the request based on the provided text, highlighting where information is not relevant to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance / Characteristics |
|---|---|
| Material Composition: Must be Ti-6Al-4V alloy with CP Titanium porous coating. | Manufactured from Ti-6Al-4V alloy with a CP Titanium porous coating. |
| Intended Use: Resurface acetabular socket in cementless total hip replacement, used with Duraloc polyethylene liners and locking rings. | Intended to be used with DePuy Duraloc polyethylene liners and locking rings to resurface the acetabular socket in cementless total hip replacement. |
| General Design Principles: Acetabular cup prosthesis with various sizes and screw holes for fixation. | Porous coated Ti-6Al-4V alloy acetabular cups, available in various sizes (38mm OD and up), with screw holes (dome or peripheral) for adjunctive fixation. |
| Similarity to Predicate Devices: Deemed substantially equivalent to DePuy Duraloc Acetabular 1200 Cups and Modified DePuy Acetabular Cup System. | Explicitly states substantial equivalence to the predicate devices. Differences noted (smaller OD options, number/placement of screw holes, polished inner surface, full 180-degree hemispherical profile) are considered minor and do not alter fundamental safety or effectiveness. |
| Performance (Biocompatibility, Mechanical Strength, etc.): Implicitly demonstrated by similarity to predicate devices which have established safety and effectiveness. | Not explicitly detailed as a separate performance study; reliance on predicate device history. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes a submission for substantial equivalence for a medical implant, not a diagnostic device requiring a "test set" in the conventional sense of clinical performance data for sensitivity/specificity. The demonstration relies on comparative analysis and design validation, not a patient-based test set for performance metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2. Ground truth in this context would likely refer to engineering specifications and clinical consensus on the safety and efficacy of the predicate devices. The document does not describe expert panels for establishing new ground truth for a test set.
4. Adjudication method for the test set
- Not Applicable. See point 2.
5. 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 is an orthopedic implant, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is an orthopedic implant, not a software algorithm.
7. The type of ground truth used
- The "ground truth" for this submission is the established safety and effectiveness of the identified predicate devices (DePuy Duraloc Acetabular 1200 Cups and Modified DePuy Acetabular Cup System), as determined through their prior clearance and clinical use. The new device demonstrates substantial equivalence to these.
8. The sample size for the training set
- Not Applicable. This is an orthopedic implant, not a machine learning model requiring a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.