(22 days)
DePuy Pinnacle with Gription Acetabular Cups are indicated for total hip replacement in the following conditions:
- A severely painful and/or a severely disabled joint resulting 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 arthoplasty, or other total hip replacement; and
- Certain cases of ankylosis.
Porous-coated Pinnacle Acetabular Cups 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 polyethylene (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. which mates with a compatible DePuy femoral stem. The subject acetabular cups are coated with a proprietary titanium porous coating, Gription™.
This document is a 510(k) summary for the DePuy Pinnacle® with Gription™ Acetabular Cups. It is important to note that a 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical studies with detailed acceptance criteria and performance data like those for novel devices or PMAs.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not contain specific quantitative acceptance criteria (e.g., specific thresholds for wear rates, pull-out strength, etc.) or a quantitative performance report of the device against such criteria. The basis for substantial equivalence is primarily through comparison to previously cleared predicate devices.
The "device performance" described is largely qualitative, focusing on equivalence to predicate devices in terms of:
- Intended use
- Indications for use
- Materials
- Method of manufacturing
- Design
- Sterilization
- Packaging method
The core of this 510(k) states: "The subject Pinnacle with Gription Acetabular Cups are identical to those cleared in K071784. The only change proposed is to add three FDA classifications to the classification cleared in K071784... so that the classifications for all Pinnacle with Gription Cups are the same as those cleared for the Pinnacle 100 with Gription Cups in K090998..."
Therefore, the acceptance criteria implicitly involve demonstrating that the device is identical or substantially equivalent to previously cleared devices in these qualitative aspects, and that the expanded classification does not alter the fundamental safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) is a "Special 510(k)" based on a minor change (adding classification codes) to an already cleared device, and relies on substantial equivalence. It does not present a new study with a "test set" in the context of clinical or performance data for a novel device. The "data provenance" would refer back to the original predicate device clearances (K071784 and K090998), which would have had their own data supporting their clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This document does not describe a study involving a "test set" and expert ground truth establishment for performance evaluation.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Not applicable. This 510(k) is for an orthopedic implant and does not involve AI or image reading, so an MRMC study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This applies to AI/software as a medical device, which is not the case here.
7. Type of Ground Truth Used
Not applicable in the context of a de novo performance study. The "ground truth" for this submission is effectively the established safety and effectiveness of the existing predicate devices (K071784 and K090998) through their prior clearance processes, which would have been based on a combination of engineering testing, materials characterization, and potentially pre-clinical or clinical data if required at the time and for the specific device types.
8. Sample Size for the Training Set
Not applicable. There is no AI component or "training set" described in this submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.