(29 days)
Indications for use of the proposed devices will not change from the indications for use as described in their respective predicate device 510(k)s; only a change in packaging is being proposed.
All standard UHMWPE components of the following legacy Centerpulse trade names: Apollo® Knee System, APR® Hip System, Bipolar Prosthesis, Epsilon™ Acetabular System, MOST® System, Natural-Knee® System, Natural-Knee® II System. The packaging for the legacy Centerpulse standard UHMWPE devices will be changed from the current packaging to the packaging used for legacy Zimmer, Inc. UHMWPE device in order to standardize packaging within Zimmer, Inc.
This document describes an "Oxygenless Packaging Conversion of Legacy Centerpulse Standard Polyethylene Devices" for various joint replacement systems. The study focuses on comparing a new packaging configuration to existing ones rather than the performance of the medical device itself. As such, many of the typical acceptance criteria and study data points for a traditional medical device (e.g., accuracy, sensitivity, specificity, clinical outcomes, multi-reader studies) are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Packaging) | Reported Device Performance (for Packaging) |
|---|---|
| Residual Oxygen Levels: The new package configuration should maintain acceptable levels of residual oxygen. | The legacy Zimmer Inc. nitrogen-flushed package (the new proposed packaging for legacy Centerpulse devices) outperformed the legacy Centerpulse package containing an oxygen absorber in terms of residual oxygen. |
| Surface Oxidation Index: The new package configuration should prevent or minimize surface oxidation on the polyethylene components. | Surface oxidation was not detected on any of the samples, regardless of the package configuration (both legacy Zimmer and legacy Centerpulse packages). |
| Sufficiency for Legacy Centerpulse Polyethylene Inserts: The new package must be deemed sufficient for the legacy Centerpulse standard polyethylene inserts. | The legacy Zimmer Inc. nitrogen-flushed package for standard polyethylene devices is sufficient for use for packaging of legacy Centerpulse standard polyethylene inserts. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the numerical sample size. It refers to "samples" being tested.
- Data Provenance: The study was non-clinical performance testing. The origin of the data (country) is not specified, but the submitter is Zimmer, Inc., P.O. Box 708, Warsaw, IN 46581-0708, USA, implying the testing likely occurred within the USA or was overseen by a US-based entity. The study is retrospective in the sense that it compares existing packaging configurations (legacy Zimmer and legacy Centerpulse) and their performance after "long-term shelf-life aging."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The study is a non-clinical performance test of packaging, not a clinical study requiring expert interpretation of medical data or ground truth establishment in a clinical context. The "ground truth" here is the objective measurement of residual oxygen and surface oxidation.
4. Adjudication Method for the Test Set
This information is not applicable. There was no need for adjudication as the study involved objective measurements of chemical properties (residual oxygen, surface oxidation) rather than subjective interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in interpreting medical images or data. This submission focuses on the performance of device packaging, not AI.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This information is not applicable. This is not an AI or algorithm-based device. The study evaluates the performance of physical packaging.
7. Type of Ground Truth Used
The "ground truth" for this non-clinical study was based on objective measurements of:
- Residual oxygen levels within the package.
- Surface oxidation index on the Ultra High Molecular Weight Polyethylene (UHMWPE) components after long-term shelf-life aging.
8. Sample Size for the Training Set
This information is not applicable. This is a non-clinical performance study of packaging, not a machine learning or AI-based device that would require training data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of non-clinical packaging study.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.