(203 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 intraoperatively and in guiding the marking of bone before cutting. The Zimmer Patient Specific Instruments System is to be used with Zimmer NEXGEN CR-FLEX fixed bearing and Zimmer NEXGEN LPS-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 and Zimmer NEXGEN LPS-FLEX fixed bearing prostheses families.
Here's a breakdown of the acceptance criteria and study information for the Zimmer Patient Specific Instruments System (K091263):
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria in a quantitative or tabular format for the device's performance. Instead, it makes a general statement about the non-clinical tests.
| Acceptance Criteria (Not explicitly stated in the document) | Reported Device Performance |
|---|---|
| (Presumed: Sufficient accuracy and performance for intended use) | "Testing verified that the accuracy and performance of the system is adequate to perform as intended." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document as a "test set" and "ground truth" for the non-clinical tests are not detailed in this submission summary.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no clinical data or MRMC study was performed or reported in this summary.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document mentions "The Zimmer Patient Specific Instruments Planner (software component)" which generates a pre-surgical plan. This plan is "then used pre-operatively by a qualified surgeon to inspect, fine-tune and approve the pre-surgical plan." This indicates that the system is designed with a human-in-the-loop for approval, so a purely standalone (algorithm-only) performance without human review is not explicitly stated or implied as the basis for evaluation.
7. Type of Ground Truth Used
The document states "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."
Given the nature of the device (surgical planning and instrumentation), the ground truth for these non-clinical tests would likely involve:
- Benchtop measurements: Comparing the planned cuts/drilling locations to actual surgical guide dimensions and accuracy.
- Engineering specifications/tolerances: Conformance to predefined precision and accuracy requirements for the guides.
- Simulated surgical scenarios: While not a clinical study, these might involve phantom models or cadavers where known anatomical landmarks could serve as a "truth."
However, the specific "type of ground truth" (e.g., expert consensus, pathology, outcomes data) is not detailed in the provided 510(k) summary for the non-clinical tests.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This type of detail is often associated with machine learning or AI algorithm development, which is not extensively detailed for this device in this submission.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided, how its ground truth was established is also not applicable/not provided.
§ 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.