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Pin Placement Guides: Signature Personalized Patient Care 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 Signature Personalized Patient Care System can be used with the following Biomet® Knee Systems and their respective components: Vanguard™ Complete 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, AGC™ Complete Knee system and Vanguard™ XP Knee system. Cut-Through Guides: 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 M1™ 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, AGC™ Complete Knee system and Vanguard™ XP Knee system. The Signature Personalized Patient Care System is compatible for use with the Oxford® Partial Knee System as approved in P010014/S31. 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 knee replacement components. The Signature guides are patient specific devices that are based on a pre-operative plan which is generated using the Signature Planner software. The Signature guides are produced based on the pre-operative plan and are manufactured to fit a specific patient. The Signature Planner software functions essentially the same as in K102795 and K110415, but is adapted to allow the use of Biomet Vanguard™ XP Knee system (K122160) for total knee arthroplasty procedures. The subject guides are intended for the total knee arthroplasty procedures and represent a combination of design and functionality of those in K102795 and K110415. The Vanguard XP-CR tibial tray will utilize the guides cleared in K102795/K110415 as they have the same profile/bone interface as the predicates. The Vanguard XP-XP tibia guide have similar vertical cut slots as partial tibia guide in K110415. The vertical cut-through slots allow for preliminary cuts of the bone, before final cuts are made and the implant is placed.

Here's a breakdown of the acceptance criteria and the study information for the Signature Personalized Patient Care System, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Two cadaveric trials were used for accuracy performance testing.
   • Data Provenance: The document does not specify the country of origin for the cadaveric trials. It's a non-clinical study, so "retrospective or prospective" designation isn't directly applicable in the same way it would be for patient data.

2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

   • The document does not specify the number of experts or their qualifications for establishing ground truth in the cadaveric trials. Given that the study involves "accuracy performance testing," the ground truth would likely be based on precise physical measurements of instrument placement, rather than expert interpretation of images.

3. Adjudication Method for the Test Set:

   • The document does not describe an adjudication method. For cadaveric accuracy testing, the "ground truth" would be established through direct measurement and comparison to the pre-operative plan, rather than expert consensus on interpretations.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not explicitly mentioned or described. The performance data focuses on non-clinical testing (software validation, cadaveric trials for accuracy, guide deformation, and debris rationale). The submission states "Clinical data: Not applicable."

5. Standalone (Algorithm Only) Performance Study:

   • Yes, a standalone performance study was done for the software compomenent, though not described in detail. The "Signature Planner software has been validated for its intended use" indicates a standalone assessment of the software's capabilities to generate a pre-operative plan. The subsequent cadaveric trials would then integrate this software's output with the physical guides.

6. Type of Ground Truth Used:

   • For the software validation, the ground truth would likely be based on predefined anatomical landmarks and measurements.
   • For the cadaveric trials, the ground truth for accuracy would be based on direct physical measurements (e.g., using a coordinate measuring machine or similar precision tools) to compare the actual placement of the guides/cuts with the pre-operative plan generated by the Signature Planner software.

7. Sample Size for the Training Set:

   • The document does not specify a sample size for a training set. The device is described as inheriting functionality from previously cleared devices (K102795 and K110415) and adapting for new implant systems. Software validation often involves internal testing against specifications rather than a separate "training set" in the machine learning sense, especially for earlier medical device software.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as a distinct training set (in the machine learning context) with established ground truth is not described in the document. Software validation typically involves testing against predefined output specifications and adherence to design requirements, rather than a separate training process for an algorithm that learns from data.

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