(26 days)
The DePuy Pinnacle Acetabular System is intended to resurface the acetabular socket in cemented or cementless total hip arthroplasty.
The Pinnacle Acetabular System is indicated for total hip replacement in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, theumatoid 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.
All Pinnacle porous-coated acetabular shells are indicated for cementless application.
The Pinnacle Acetabular System is part of a modular system for use in total hip replacement. The acetabular component is provided as two separate units, a porous coated hemispherical outer shell manufactured from titanium alloy (Ti-6Al-4V) and a liner manufactured from ultra high molecular weight polyetheylene (UHMWPE), which locks into the outer shell. The liner component articulates with a femoral head of an appropriate diameter.
This document, K001534, is a 510(k) premarket notification for the Pinnacle Acetabular System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for a novel AI/software device.
Therefore, much of the requested information regarding acceptance criteria, study methodologies, ground truth establishment, sample sizes, and expert involvement is not present in this document because it outlines a regulatory submission for a medical device (an acetabular cup prosthesis) and not an AI or diagnostic software. The "basis of substantial equivalence" is the key here, not a performance study against acceptance criteria.
However, based on the provided text, I can infer and state what is available and what is explicitly not available.
Acceptance Criteria and Study for K001534: Pinnacle Acetabular System
This 510(k) submission (K001534) for the DePuy Orthopaedics Pinnacle Acetabular System is primarily focused on demonstrating substantial equivalence to a predicate device (K000306), rather than presenting a performance study against a predefined set of quantitative acceptance criteria in the context of an AI or diagnostic device.
The "acceptance criteria" in this context refer to the characteristics and performance aspects that allowed the device to be considered substantially equivalent to a legally marketed predicate device. The "study" proving this largely relies on comparisons of design, materials, manufacturing, and intended use as described below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance (as stated in submission) |
|---|---|
| Intended Use: For total hip replacement, similar indications. | The Pinnacle Acetabular System has the "same intended use" as the acetabular cup liners cleared in K000306, including indications for osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, traumatic fracture, failed previous hip surgery, and ankylosis. |
| Material: Same material composition. | The Pinnacle Acetabular System uses the "same material" (titanium alloy Ti-6Al-4V for the shell, UHMWPE for the liner) as the predicate device. |
| Method of Manufacture: Similar manufacturing processes. | The Pinnacle Acetabular System uses the "same method of manufacture" as the predicate device. |
| Design: Similar design principles/features. | The Pinnacle Acetabular System has the "same design" (modular system with porous coated hemispherical outer shell and UHMWPE liner) as the predicate device. |
| Sterilization & Packaging: Similar methods. | The Pinnacle Acetabular System uses the "same sterilization and packaging methods" as the predicate device. |
| Overall Performance & Safety: Adequate performance. | The Pinnacle Acetabular System "demonstrated adequate performance in design control activities." |
The following information is NOT available in the provided document:
2. Sample size used for the test set and the data provenance: Not applicable. This is a submission for an implantable device, not an AI/software. There is no "test set" of data in the sense of patient images or specific clinical outcomes data analyzed in this document for algorithm performance. The "test" here refers to demonstrating physical characteristics and equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/diagnostic software is not relevant here. The ground truth for the device's physical properties and performance would be established through engineering testing and material science, not clinical expert consensus on diagnostic data.
4. Adjudication method for the test set: Not applicable for the reasons stated above.
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 device is an orthopedic implant, not an AI / diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an orthopedic implant, not an algorithm.
7. The type of ground truth used: For this device, the "ground truth" would relate to the physical and chemical properties of the materials, the mechanical performance (e.g., wear, fatigue, pull-out strength), and biocompatibility, as evaluated through engineering design controls and established predicate device performance. It is not expert consensus, pathology, or outcomes data in the context of diagnostics.
8. The sample size for the training set: Not applicable. This device is an orthopedic implant; there is no "training set" in the machine learning sense.
9. How the ground truth for the training set was established: Not applicable for the reasons stated above.
§ 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.