(184 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 Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses families only.
The Zimmer Patient Specific Instruments are intended for single use only.
The subject device Zimmer Patient Specific Instruments System 5.0 is a modification to the predicate device Zimmer Patient Specific Instruments System 2.5 (K111492) to accommodate the new compatible implant system Zimmer Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses cleared via 510(k) K113369. It is designed to assist a surgeon in the placement of total knee replacement components for Zimmer Persona CR fixed bearing and Zimmer Persona PS fixed bearing prostheses. The system consists of a software device, branded as Zimmer Patient Specific Instruments Planner (ZPSIP) and a hardware component, branded as Zimmer Patient Specific Instruments (ZPSI).
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not explicitly detail specific quantitative acceptance criteria. Instead, it states that "the accuracy and performance of the system is adequate to perform as intended" based on non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adequate accuracy for pre-surgical planning | "accuracy...is adequate to perform as intended" |
| Adequate performance for assisting in component positioning | "performance...is adequate to perform as intended" |
| Safe and effective for intended use | "Results of software verification testing demonstrated the device can be used safe and effective as intended" |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of a specific number of cases or patients. The testing was conducted using "cadaveric specimens and saw bones."
- Data Provenance: The testing was non-clinical. The "cadaveric specimens and saw bones" represent simulated rather than real patient data. There is no information on the country of origin, and it is inherently a prospective test on these simulated models.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The ground truth for the non-clinical tests on cadaveric specimens and saw bones would likely be established through precise measurements and physical verification, not expert consensus. There is no mention of experts being involved in establishing the ground truth for this testing.
4. Adjudication Method for the Test Set:
Not applicable. As the testing was non-clinical using cadaveric specimens and saw bones, and ground truth was likely established through physical measurements, there would be no need for an adjudication method among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The document focuses on the device's standalone performance and its substantial equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance evaluation of the algorithm (referred to as the "system") was done. The "Performance Data" section states: "Non-clinical tests using cadaveric specimens and saw bones have been performed to assess the safety and effectiveness of the subject device. Testing verified that the accuracy and performance of the system is adequate to perform as intended. Results of software verification testing demonstrated the device can be used safe and effective as intended." This indicates that the device's functional performance was evaluated independently.
7. Type of Ground Truth Used:
The ground truth used for the non-clinical tests would have been based on physical measurements and known anatomical features/target positions on the cadaveric specimens and saw bones. This is a form of objective, empirical ground truth rather than expert consensus, pathology, or outcomes data, which are typically associated with clinical studies.
8. Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size. The focus is on the testing of the final device, not on its development or training phase.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no information on a training set is 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.