(650 days)
Gas Plasma Sterilization is intended to be used for terminal sterilization of all Zimmer Ultra-High Molecular-Weight Polyethylene (UHMWPE) products as follows:
- Trilogy® Acctabular System (acctabular liners) .
- t Nex Gento Complete Knee Solution (articular surfaces and patellas)
Sterrad 100 Sterilization System
The provided document describes the summary of safety and effectiveness for "Gas Plasma Sterilization" for Zimmer Ultra-High Molecular-Weight Polyethylene (UHMWPE) products.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Achievement of a sterility assurance level (SAL) of 10⁻⁶ (implied by typical sterilization standards) | A sterility assurance level (SAL) of 10⁻⁶ was achieved. (Stated as "a sterility assurance level (SAL) of 10⁻⁶") |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set of the sterilization validation. It broadly mentions "Performance Testing/Sterilization Validation." It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective). Sterilization validations typically involve controlled laboratory experiments rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts or the establishment of "ground truth" in the context of a test set for this sterilization validation. Sterilization validations typically rely on established microbiological testing methods rather than expert consensus on subjective interpretations.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are usually relevant for studies involving human interpretation or subjective assessment, which is not the case for a sterilization validation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study is not applicable as this is a sterilization validation, not a study evaluating human readers' performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, in principle. A sterilization validation is inherently a standalone performance assessment of the sterilization process itself, without human intervention in the sterilization efficacy. The "device" in this context is the sterilization process.
7. Type of Ground Truth Used
The ground truth used for a sterilization validation is based on microbiological testing, specifically demonstrating the inactivation of a predefined number of highly resistant microorganisms (biological indicators) to achieve the specified Sterility Assurance Level (SAL). This is an objective, quantitative measure.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable to a sterilization validation. Sterilization validations are based on established scientific principles and experimental protocols, not machine learning models that require training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a sterilization validation.
§ 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.