(84 days)
The Profix Total Knee System is indicated for:
- Rheumatoid arthritis.
- Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result.
- Failed osteotomies, unicompartmental replacement, or total knee replacement.
- The posterior stabilized knee system is designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
The Profix Total Knee System includes porous coated devices which are indicated for use without bone cement, and are single use devices.
The overall design, components, and materials of the Profix Total Knee System are substantially equivalent to the existing components of the Profix Total Knee System cleared under previous premarket notifications. The main difference between the subject components of the Profix Total Knee System, and the currently marketed components is the intended use of the system without bone cement.
This document is a 510(k) Pre-Market Notification for the Smith & Nephew Profix Total Knee System, seeking clearance for devices indicated for use without bone cement. It is a submission to demonstrate substantial equivalence to previously cleared devices, not a study evaluating new performance criteria or clinical outcomes in the way requested by the prompt.
Therefore, most of the requested information cannot be extracted from the provided text because the submission is not a performance study as described in the prompt. Instead, it is a regulatory filing focused on demonstrating equivalence.
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 submission is for substantial equivalence to existing devices, not a performance study with specific acceptance criteria and outcome metrics for patient care. The "performance" being evaluated here is the substantial equivalence to predicate devices, focusing on design, materials, and intended use.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This document does not describe a clinical performance study with a test set of patients or data provenance. It's a regulatory submission comparing device specifications.
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. There is no "ground truth" derived from expert consensus in this type of submission. The ground truth for regulatory clearance in this context is the FDA's determination of substantial equivalence based on the provided documentation and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or expert adjudication is described.
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 is not an AI or diagnostic imaging device; it's a knee implant. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This is irrelevant to a knee implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" (or basis for approval) for this submission is regulatory in nature. It relies on established predicate devices and the demonstration of "substantial equivalence" in terms of intended use, design, and materials. It's not a clinical performance ground truth based on patient outcomes, pathology, or expert consensus on diagnostic accuracy.
8. The sample size for the training set
- Cannot be provided. This document does not describe a training set for an algorithm.
9. How the ground truth for the training set was established
- Cannot be provided. This document does not describe a training set or its ground truth establishment.
Summary derived from the document:
The provided text describes a 510(k) Pre-Market Notification for the Smith & Nephew Profix Total Knee System. The purpose of this submission is to demonstrate that the expanded use of the system (without bone cement) is "substantially equivalent" to predicate devices already on the market.
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Acceptance Criteria & Device Performance: The primary "acceptance criterion" in a 510(k) is demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" in this context is that the new components (indicated for use without bone cement) are substantially equivalent in terms of their intended use, designs, and materials to the existing Profix Total Knee System and other predicate total knee prostheses.
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Study Type: This is a substantial equivalence submission, not a clinical performance study involving patient data, expert review, or statistical analysis of outcomes for the new "uncemented" feature itself. The study conducted is a comparative technological assessment against predicate devices.
In essence, the document is a regulatory filing for a medical device approval based on equivalence, not a clinical study evaluating the device against specific performance metrics with patient data.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.