(65 days)
The Pinnacle 100 with Gription Acetabular Cup is indicated for use as part of the acetabular portion of a total hip replacement.
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.
Porous-coated Pinnacle Acetabular Cups are indicated for cementless applications.
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.
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) or high-carbon cobalt chrome (CrCoMo), both of which lock into the outer shell. The liner component articulates with a femoral head of an appropriate diameter. The subject acetabular cup is coated with a proprietary titanium porous coating, Gription.
This document is a 510(k) summary for a medical device called the DePuy Pinnacle® 100 with Gription™ Acetabular Cups. It does not describe a study involving AI or machine learning, nor does it provide acceptance criteria or performance data in the typical sense of algorithm evaluation.
Instead, this document is a regulatory submission demonstrating substantial equivalence to previously approved devices. This means the manufacturer is asserting that their new device is as safe and effective as devices already on the market, based on similarities in intended use, indications for use, material, design, sterilization, packaging, and manufacturing methods.
Therefore, most of the requested information about acceptance criteria, performance, sample sizes, ground truth establishment, and expert involvement for an AI study is not applicable to this document.
Here's an assessment based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable. This document is not a study reporting on the performance of an AI or diagnostic algorithm against specific acceptance criteria. It's a regulatory submission for a physical medical device. The "acceptance criteria" here are implicitly the FDA's requirements for demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. There is no "test set" in the context of an algorithm evaluation. The device itself is the product being reviewed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. There is no "ground truth" established by experts in the context of an algorithm's performance. The safety and effectiveness of the physical device are evaluated based on its design, materials, and comparison to predicate devices, not through expert-labeled data.
4. Adjudication Method for the Test Set:
- Not applicable. No test set or expert adjudication related to algorithm performance.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This document does not mention or describe an MRMC study.
6. Standalone Performance Study (Algorithm Only):
- No. This device is a physical acetabular cup, not a standalone algorithm.
7. Type of Ground Truth Used:
- Not applicable. Ground truth is not a concept pertinent to this type of device submission. The FDA evaluates the device based on its design specifications, materials testing, and comparison to predicate devices.
8. Sample Size for the Training Set:
- Not applicable. There is no training set as this is not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. There is no training set or ground truth in the context of AI/ML.
Summary based on the document:
This document is a 510(k) Pre-market Notification for a medical device (DePuy Pinnacle® 100 with Gription™ Acetabular Cups). The basis of approval is Substantial Equivalence to previously cleared devices (Pinnacle 100 Acetabular Cups with Porocoat K001534 and Pinnacle Cups with Gription K071784). The manufacturer asserts equivalence based on similarities in intended use, indications for use, material, design, sterilization, packaging, and manufacturing method. This type of submission does not involve performance studies of AI algorithms against defined acceptance criteria, nor does it rely on human readers, ground truth datasets, or training sets in the way an AI/ML device would.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.