(88 days)
The Ortho Development Balanced Knee™ System is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis. primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, pseudo-gout, or complications from a previous prosthesis. This device is intended for cemented use only.
The Balanced Knee™ System is intended for single use in primary total knee replacement only. Indications include:
- Loss of joint configuration and joint function: ●
- Osteoarthritis of the knee joint;
- Rheumatoid arthritis of the knee joint; .
- Post-traumatic arthritis of the knee joint; .
- . Moderate valgus, varus, or flexion deformities.
The Ortho Development Balanced Knee™ System is a semi-constrained total knee replacement system, consisting of femoral, tibial and patellar components.
- The devices are manufactured from CoCr alloy (cast or Wrought), Ti-6Al-4V alloy Materials: and Ultra High Molecular Weight Polyethylene (UHMWPE) per ASTM standards,
- The system functions to provide restoration of function as a replacement for Function: diseased and arthritic knees.
This document is a 510(k) premarket notification for the Ortho Development Balanced Knee™ System. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a de novo study with acceptance criteria and test results. Therefore, much of the requested information about device performance against acceptance criteria and study details is not present in this document.
Here's an analysis of the provided text in relation to your questions:
1. Table of acceptance criteria and the reported device performance:
This document does not report specific acceptance criteria or quantitative device performance metrics. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use, technological characteristics, and performs as safely and effectively as the predicate. It does not typically involve setting novel performance acceptance criteria or conducting de novo clinical studies to prove these. Instead, it relies on comparison to existing devices.
2. Sample size used for the test set and the data provenance:
Not applicable. This document does not describe a "test set" in the context of performance testing with human subjects or a dataset for AI. It's a regulatory submission for a medical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This document does not pertain to establishing ground truth for a test set, as no such test set (in the AI/clinical study sense) is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication method 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:
Not applicable. This document describes a knee replacement system, not an AI or imaging diagnostic device that would typically undergo MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth is established in this document, as it is a regulatory submission for substantial equivalence.
8. The sample size for the training set:
Not applicable. This document does not describe an AI device or a training set for an algorithm.
9. How the ground truth for the training set was established:
Not applicable. As above, no training set is described.
Summary of Relevant Information from the Document:
- Device Type: Ortho Development Balanced Knee™ System (semi-constrained total knee replacement system).
- Purpose of Submission: 510(k) premarket notification to demonstrate substantial equivalence to legally marketed predicate devices.
- Predicate Devices: Performance Total Knee System (Kirschner), NexGen Total Knee System (Zimmer), PCA Modular Total Knee System (Howmedica), Natural Knee System (Intermedics), AGC Modular Total Knee System (Biomet), Foundation Total Knee System (Encore).
- Basis of Equivalence: The document states, "There are no significant differences between the Ortho Development Balanced Knee™ System and the systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use." This comparison of design, function, materials, and intended use is the "testing" or "proof" presented in a 510(k) submission, rather than de novo performance metrics.
- Intended Use/Indications: For patients suffering from severe knee pain and disability, including various forms of arthritis and complications from previous prostheses. Intended for cemented use only and for single use in primary total knee replacement.
- Materials: CoCr alloy (cast or Wrought), Ti-6Al-4V alloy, and Ultra High Molecular Weight Polyethylene (UHMWPE) per ASTM standards.
In conclusion, this document is a regulatory submission focused on demonstrating substantial equivalence, not a study reporting specific performance data against a set of acceptance criteria. Therefore, most of your questions, which are geared towards performance studies and AI evaluation, do not directly apply to the content provided.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.