(135 days)
The Zimmer Patient Specific Instruments System is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intra-operatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN CR fixed bearing, Zimmer NEXGEN LPS-FLEX fixed bearing, Zimmer NEXGEN LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses families only.
The Zimmer Patient Specific Instruments are intended for single use only.
The Zimmer Patient Specific Instruments System consists of a software component, Zimmer Patient Specific Instruments Planner and a hardware component, Zimmer Patient Specific Instruments and is designed to assist the surgeon in the placement of total knee replacement components for Zimmer NEXGEN CR-FLEX fixed bearing, Zimmer NEXGEN CR fixed bearing, Zimmer NEXGEN LPS-FLEX fixed bearing, Zimmer NEXGEN LPS fixed bearing and Zimmer Gender Solutions Natural - Knee Flex fixed bearing prostheses.
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It generally states that "Non-clinical tests were performed to assess the safety and effectiveness of the device. Testing verified that the accuracy and performance of the system is adequate to perform as intended." and "Clinical cases performed confirmed the safety and effectiveness of the device."
2. Sample Size and Data Provenance for Test Set
The document mentions "Non-clinical tests" and "Clinical cases," but does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number and Qualifications of Experts for Ground Truth
The document does not provide information on the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for Test Set
The document does not describe any adjudication method used for either non-clinical or clinical tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it quantify any effect size of human readers improving with AI vs. without AI assistance. The device is a surgical instrument system (software and hardware components) to assist surgeons, not strictly an AI diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance
The document describes the "Zimmer Patient Specific Instruments Planner" (software component) and "Zimmer Patient Specific Instruments" (hardware component) as parts of a system "designed to assist the surgeon." The software generates a pre-surgical plan which is then "inspected, fine-tuned and approved by a qualified surgeon." This indicates a human-in-the-loop process, and no standalone algorithm-only performance is described.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance evaluation (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for Training Set
The document does not provide information on the sample size used for any training set.
9. How Ground Truth for Training Set Was Established
The document does not provide information on how ground truth was established for any training set.
§ 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.