(189 days)
The Materialise PKA Guide System is intended to be used as a surgical instrument to assist in the positioning of Partial Knee Replacement components intra-operatively and in guiding the marking of bone before cutting and to guide cutting of the bone.
The Materialise PKA Guide System is to be used with ZUK UNI, JOURNEY™ UNI, JOURNEY II UNI, JZ (Hybrid) UNI knee systems. Vanguard™ M Unicompartmental Knee System and Oxford® Partial Knee System prostheses families only.
The Zimmer Biomet Patient Specific Instruments are compatible for use with the Oxford® Partial Knee System as approved in P010014.
The Materialise PKA Guides are intended for single use only.
Materialise PKA Guides are patient-specific medical devices that are designed to implant partial knee prosthesis.
The Materialise PKA Guides must only be used in conjunction with the 510(k) cleared, legally marketed prosthesis. Consult the prosthesis labeling and instructions for specific patient indications, contraindications, associated risks, information for use, warnings and precautions. Moterialise PKA Guides is an instrument set containing a femur and/or tibia template(s) and bone models.
This document describes a 510(k) premarket notification for the Materialise PKA Guide System. It is a surgical instrument intended to assist in the positioning of Partial Knee Replacement components.
Based on the provided text, the device itself is not a diagnostic AI/ML algorithm. Instead, it seems to be software that assists in pre-surgical planning (Materialise PKA Planner) which then informs the design of patient-specific surgical guides (Materialise PKA Guides) created for physical use during surgery. The "Performance Data" section explicitly states, "No new testing of the Materialise PKA Guides was done in support of this pre-market notification." and "New software validation/verification testing of the Materialise PKA Planner was done in support of this pre-market notification in the form of usability evaluations."
Therefore, the document does not contain information about acceptance criteria or a study that proves an AI/ML device meets certain performance metrics, especially not in the context of diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI assistance. It focuses on demonstrating substantial equivalence to predicate devices for a surgical guide system.
In particular, the request asks for:
- A table of acceptance criteria and the reported device performance: Not present for an AI/ML diagnostic. The document refers to "usability evaluations" for the software.
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML diagnostic test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not done and not applicable to this device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The "Materialise PKA Planner" software requires a surgeon to "inspect, fine-tune and approve the pre-surgical plan."
- The type of ground truth used: Not applicable for an AI/ML diagnostic. The "ground truth" for the surgical guides is based on the pre-surgical plan approved by the surgeon and the intended anatomical alignment during surgery.
- The sample size for the training set: Not applicable, as this is not an ML algorithm in the sense of being "trained" on a large dataset for diagnosis.
- How the ground truth for the training set was established: Not applicable.
The document discusses "Performance Data" but this refers to non-clinical testing for biocompatibility, sterility, cleaning, debris, dimensional stability, and the applicability of previous cadaver testing for guidance stability. For the software component, it mentions "usability evaluations."
Conclusion: The provided document is for a medical device (surgical guide system and its planning software) and does not contain the information requested about the acceptance criteria and study proving an AI/ML diagnostic device's performance. The device is not an AI/ML diagnostic.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.