(91 days)
Signature™ Personalized Patient Care System is intended to be used as a surgical instrument to assist in the positioning of total and partial knee replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
The Signature™ Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete Knee System, Vanguard™ M Unicompartmental Knee System, Vanguard™ SSK 360, Vanguard™ SSK Revision Knee System, Regenerex™ Primary Tibial System, Offset & Microplasty Tibial Systems, Maxim™ Complete Knee System, Ascent™ Total Knee System, and AGC™ Complete Knee system.
The Signature™ guides are intended for single use only.
The Signature™ Personalized Patient Care System consists of a software component, Signature™ Planner and a hardware component, Signature™ guides and is designed to assist the surgeon in the placement of Biomet total and partial knee replacement components.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Software Accuracy | "The Signature™ Planner software has been validated for its intended use..." and "...verified that the accuracy and performance of the system is adequate to perform as intended." |
| Accuracy of Surgical Guidance | "...accuracy performance testing by means of cadaveric trials...verified that the accuracy and performance of the system is adequate to perform as intended." |
| Guide Deformation after Sterilization | "...guide deformation verification after sterilization was performed...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
The provided text does not explicitly state the sample size for the test set. It mentions "cadaveric trials" for accuracy performance testing.
The data provenance is from cadaveric trials, which implies a pre-clinical, non-human source. The country of origin is not specified. It is a retrospective study in the sense that cadavers are used for testing, but given the nature of the device (surgical planning and guidance), it implies a pre-clinical evaluation phase.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The provided text does not specify the number of experts used to establish ground truth or their qualifications for the test set.
4. Adjudication Method for the Test Set
The provided text does not specify an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance data focuses on the device's standalone accuracy and performance, not on its impact on human reader performance.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was done for the algorithm. The text states: "The Signature™ Planner software has been validated for its intended use to determine substantial equivalence to the predicate devices." and "...accuracy performance testing by means of cadaveric trials...was performed to determine substantial equivalence. Testing verified that the accuracy and performance of the system is adequate to perform as intended." This indicates the software and guides were tested for their inherent accuracy and performance.
7. Type of Ground Truth Used
The ground truth for the in-vitro performance was established through cadaveric trials for the surgical guidance accuracy. For the software validation, it's implicitly against established engineering and computational standards for accuracy, though the exact method isn't detailed.
8. Sample Size for the Training Set
The provided text does not specify the sample size for the training set. The device description points to it being a software that generates plans based on MRI imaging data, implying an underlying algorithm that would likely have been trained, but no details are given.
9. How the Ground Truth for the Training Set Was Established
The provided text does not describe how the ground truth for the training set was established.
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.