(28 days)
The ConforMIS metal backed tibial component is intended for use with the ConforMIS Unicondylar Knee Repair System and the ConforMIS BiCompartmental Knee repair Systems, in patients with:
- joint impairment due to osteoarthritis or traumatic arthritis of the knee .
- previous tibial condyle or plateau fracture, creating loss of function .
- . valgus or varus deformity of the knee
The ConforMIS metal backed tibial component is intended only for use with bone cement.
The ConforMIS Metal Backed Tibial Component is to be used with either the ConforMIS Unicondylar Knee Repair System or the BiCompartmental Knee Repair ConforMIS System to provide the surgeon with an alternative tibial component in the event that prefers to use a metal backed he/she component rather than an all polyethylene component. It consists of a cobalt-chrome alloy (CoCrMo) tray and a polyethylene insert. The X/Y dimensions of the device (i.e. the twodimensional shape or "footprint"). are designed to conform to the patient's anatomy as closely as possible based on images (MRI or CT scan) of the patient's knee. It is available with UHMEPE inserts with minimal thickness from 6 to 14 mm.
The provided text is a 510(k) summary for the ConforMIS Metal Backed Tibial Component ("mBT"). It describes a device intended for knee repair and seeks to establish substantial equivalence to predicate devices, rather than proving specific performance against acceptance criteria through a clinical study.
Therefore, many of the requested sections about acceptance criteria, study details, human reader performance, and ground truth establishment cannot be found in this document. This document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to existing devices.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not specify quantitative acceptance criteria or report device performance against such criteria. It states that "Testing completed as part of the design verification procedure for the ConforMIS Metal Backed Tibial Component found this device to be as safe and effective as the predicate devices," implying that it met internal design verification standards, but no specific metrics are given.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document states, "Non-clinical Performance and Conclusions: Testing completed as part of the design verification procedure for the ConforMIS Metal Backed Tibial Component found this device to be as safe and effective as the predicate devices. further confirming substantial equivalence." This refers to non-clinical (likely bench or mechanical) testing, not a clinical test set with patient data. No details on sample size or data provenance for any "test set" are present.
- The document explicitly states, "Clinical Performance: Clinical data and conclusions are not necessary to demonstrate substantial equivalence."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No clinical test set or ground truth establishment by experts is mentioned, as the submission relies on non-clinical performance and equivalence to predicates.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No clinical test set or adjudication method is mentioned.
5. 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
- Cannot be provided. This document describes a medical device (a knee implant component), not an AI algorithm or a diagnostic tool that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This document is for a medical device (implant component), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No clinical ground truth is mentioned, as the submission focuses on non-clinical performance and substantial equivalence.
8. The sample size for the training set
- Cannot be provided. This document is for a physical medical device. It does not mention any "training set" in the context of an algorithm. The device design is customized "based on images (MRI or CT scan) of the patient's knee," but this refers to patient-specific design, not an algorithmic training process.
9. How the ground truth for the training set was established
- Cannot be provided. No training set or ground truth establishment is mentioned.
§ 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.