(106 days)
The Columbus (CR) Total Knee System is indicated for use in reconstruction of the diseased knee joint caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, the need to revise failed arthroplasties or osteotomies where pain, deformity or dysfunction persist, and for patients suffering from correctable valgus or varus deformity and moderate flexion contracture. The Columbus Knee is designed for use with bone cement.
The Columbus MIOS CR/PS tibial tray is a sterile, single-use device that is intended to be used with the previously cleared femoral component, insert, patella, and attachned to mechanism of the Columbus (CR) Total Knee System or with the femoral component and insert of the Columbus (PS) Total Knee System.
The Columbus Total Knee System MIOS CR/PS Tibial Tray is a medical device. The provided text refers to a 510(k) Premarket Notification to the FDA, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with human subjects.
Therefore, many of the requested details about acceptance criteria, detailed study design, sample sizes, expert ground truth, and MRMC studies are not applicable or explicitly stated in this type of regulatory submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not directly available. For 510(k) submissions for orthopedic implants, the "acceptance criteria" are typically demonstrating that the new device has similar technological characteristics and performs at least as safely and effectively as a legally marketed predicate device. This is primarily done through mechanical testing to ensure the device meets established industry standards or recognized guidance documents.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance: Meet relevant industry standards and guidance for orthopedic implants. | Testing per Guidance Documents: |
- "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements"
- "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement"
- "Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements"
- "Guidance Document for Testing Non-articulating, "Mechanically Locked" Modular Implant Components"
- "Data Requirements for Ultrahigh Molecular Weight Polyethylene (UHMPE) Used in Orthopedic Devices"
(The text states "All required testing... were done where applicable" and lists these specific guidance documents. This implies that the device met the criteria outlined in these documents, as it received clearance.) |
| Material Compatibility: Use materials commonly used in medical devices and similar to predicate. | Materials Used: Base material for the Aesculap Implant Systems device is the same as predicate devices. PMMA Nano-Bond surface pretreatment uses materials commonly used on other medical devices. |
| Dimensional & Design Similarity: Similar shapes and sizes to predicate devices. | Similar Characteristics: "The MIOS CR/PS tibial tray is offered in similar shapes and sizes as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of a 510(k) submission for this type of device based on the provided text. The "test set" here refers to mechanical testing of the device itself (e.g., fatigue, wear, strength), not a clinical study on human subjects. Sample sizes for such engineering tests are specified within the listed guidance documents, but not explicitly detailed in this summary. Data provenance would be from laboratory testing conducted by the manufacturer or a contracted lab. There's no mention of country of origin for such mechanical test data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For mechanical testing, the "ground truth" is defined by the engineering specifications and performance standards outlined in the guidance documents. Expert consensus in a clinical sense is not used for this type of testing.
4. Adjudication Method for the Test Set
Not applicable. Mechanical tests have pass/fail criteria based on objective measurements against engineering standards, not through adjudication by human experts.
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 device is an orthopedic implant, not an AI-powered diagnostic tool requiring MRMC studies for human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used
For mechanical testing, the "ground truth" is the established engineering standard or performance requirement outlined in the various FDA guidance documents and recognized consensus standards (e.g., ISO, ASTM) that are referenced. It relies on objective, repeatable measurements.
8. The Sample Size for the Training Set
Not applicable. This device does not use a "training set" in the machine learning sense. The "development" or "design" process for an implant involves engineering principles, material science, and prior knowledge from predicate devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" for an algorithm, there's no ground truth established in this context. The design of the implant is based on established biomechanical principles, material properties, and the performance history of predicate devices.
§ 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.