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510(k) Data Aggregation
(268 days)
Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatic arthritis.
Post-traumatic loss of knee joint configuration and function.
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Revision of previous unsuccessful uni-knee replacement or other procedure.
The system components are intended for cemented use only.
The XN Knee Prosthesis System is a knee implant developed by Beijing Chunlizhengda Medical Instruments Co. Ltd. The subject system includes femoral condyle, tibial tray, tibial insert and patella. The fixation method of the system is bone cement fixation. It is mainly used in total knee replacement to repair the diseased or injured knee joint, improve the range of motion of the knee joint and reduce the pain of the patient. The XN Knee Prosthesis System is a Posterior Stabilized (PS) total knee replacement system.
This document is a 510(k) clearance letter from the FDA for a medical device (XN Knee Prosthesis System). It confirms that the device is substantially equivalent to a previously marketed predicate device. For devices seeking 510(k) clearance based on substantial equivalence, the "study that proves the device meets the acceptance criteria" is typically a series of non-clinical performance tests and engineering analyses that demonstrate the new device performs as safely and effectively as a legally marketed predicate device.
It's important to understand that a 510(k) submission generally does not involve large-scale clinical trials or studies akin to those for drug approvals. Instead, the focus is on demonstrating equivalence through comparison to an existing device, primarily via bench testing, material characterization, and engineering simulations.
Based on the provided text, here's a breakdown of the "acceptance criteria" and the "study" (non-clinical testing) that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "Testing and engineering analyses showed that the subject components met the pre-determined acceptance criteria identified in the Bench Testing Summary, demonstrating that the subject components are substantially equivalent compared to the predicate components."
While explicit numerical acceptance criteria for each test are not detailed in this summary (they would be in the full submission, which is not provided), the document lists the types of performance tests conducted. The "reported device performance" is implicitly that the device passed these tests and was found substantially equivalent.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Sufficient Component Interlocking Strength | Met acceptance criteria (demonstrated acceptable mechanical performance) |
| Acceptable Fatigue Performance Under High Flexion | Met acceptance criteria (demonstrated acceptable mechanical performance) |
| Acceptable Tibial Insert Constraint | Met acceptance criteria (demonstrated acceptable mechanical performance) |
| Acceptable Surface Roughness | Met acceptance criteria (demonstrated acceptable mechanical performance) |
| Acceptable Patella Contact Pressure | Met acceptance criteria (demonstrated acceptable mechanical performance) |
| Acceptable Patella Constraint | Met acceptance criteria (demonstrated acceptable mechanical performance) |
| Acceptable Static Contact Stress | Met acceptance criteria (demonstrated acceptable mechanical performance) |
| Acceptable Dynamic Fatigue | Met acceptance criteria (demonstrated acceptable mechanical performance) |
| Acceptable Wear Performance | Met acceptance criteria (demonstrated acceptable mechanical performance) |
| Acceptable UHMWPE Characterization | Met acceptance criteria (demonstrated acceptable mechanical performance) |
| Mechanical performance for intended use | Acceptable mechanical performance demonstrated for intended use |
| Equivalence to predicate device in intended use, materials, and fundamental technology | Substantially equivalent to predicate device |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each test. For non-clinical bench testing, sample sizes are typically determined by relevant ASTM or ISO standards for testing medical devices (e.g., often N=3 or N=5 for certain mechanical tests, depending on variability and statistical power needs). This information would be in the detailed test protocols within the full 510(k) submission.
- Data Provenance: The testing was non-clinical (bench testing and engineering analysis) and performed by the manufacturer, Beijing Chunlizhengda Medical Instruments Co. LTD. The location of primary testing would likely be China, where the manufacturer is based. It is retrospective in the sense that the data was collected and analyzed for this specific submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This question is not applicable in the context of a 510(k) non-clinical bench testing submission. "Ground truth" for these tests is established by engineering specifications, accepted industry standards (e.g., ISO, ASTM), and comparison to the predicate device's known performance characteristics. There are no human "experts" establishing a "ground truth" for each individual test sample in the way a clinical trial might use radiologists for image interpretation. The expertise lies in the engineers performing and reviewing the tests, and the FDA reviewers assessing the data against regulatory standards.
4. Adjudication Method for the Test Set
- This question is not applicable as the "test set" consists of physical devices undergoing mechanical and material property testing, not subjective human assessments that would require adjudication.
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
- This question is not applicable. The XN Knee Prosthesis System is a mechanical orthopedic implant, not an AI/software device used for diagnostic imaging or a human-in-the-loop system. The clearance is based on substantial equivalence to a predicate device through non-clinical performance data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable. As stated, this is a mechanical implant, not an algorithm.
7. The Type of Ground Truth Used
- For this device, the "ground truth" for substantial equivalence is primarily established through:
- Engineering specifications and design requirements: The device must meet predefined mechanical and material properties that ensure safety and efficacy.
- Comparison to the predicate device: The new device's performance is measured against the known and accepted performance of the legally marketed predicate device (Stryker Triathlon® Total Knee System). The standard is "substantially equivalent," meaning it performs as safely and effectively as the predicate.
- Relevant industry standards (e.g., ISO, ASTM): These standards often define the specific tests and acceptable ranges for performance for orthopedic implants.
8. The Sample Size for the Training Set
- This question is not applicable. This is a mechanical device, not a machine learning or AI model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the same reason as point 8.
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(81 days)
The Klassic® Revision System is intended for prosthetic replacement in treatment of the following:
- · Patient conditions of non-inflammatory degenerative joint disease (NIDID): avascular necrosis and osteoarthritis
- Patient conditions of inflammatory joint disease (IJD): rheumatoid arthritis
- · Patients with failed previous surgery where pain, deformity, or dysfunction persists
- · Correctable varus-valgus deformity and moderate flexion contracture
- · Revision of a previously failed knee arthroplasty
- · Patients who require a total knee replacement
The Klassic® Revision System is indicated for cemented use only, except for the Klassic® Femur, with Cobalt 3D®, the Klassic® Tibial Baseplate with Ti-Coat® and the Universal Cones™ with Ti-Coat®, which are also indicated for cementless use.
The Klassic® Revision System is being introduced as a line extension for use with the Klassic® Knee System during total knee arthroplasty. The Klassic® Revision System includes the following implants and implant materials: Klassic® Stem Extension, Femoral, Cemented (Ti6Al4V), Klassic® Stem Adapter, Femoral (Ti6A14V), Klassic® Posterior Femoral Augment (Ti6A14V), Klassic® Distal Femoral Augment (Ti6Al4V), Klassic® Tibial Augment (Ti6Al4V, UHMWPE), Posterior Femoral Augment Set Screw (Ti6A14V), Distal Femoral Augment Set Screw (Ti6Al4V), Universal Cone™ with Ti-Coat (Ti6A14V and unalloyed Ti powder).
The provided text is an FDA 510(k) clearance letter for the Klassic® Revision System, a knee replacement system. It details the device's indications for use, description, predicate devices, and a summary of non-clinical testing.
However, this document does not contain information on an AI/ML-driven medical device, nor does it provide details about acceptance criteria, study methodologies (like sample sizes, expert involvement, ground truth establishment, MRMC studies, or training set details) related to the performance of such a device.
The "Discussion of Non-Clinical Testing/Performance Data" section solely refers to mechanical and material testing (fatigue, torque disassembly, fretting corrosion, augment fixation, porous coating characterization) relevant to the physical components of the knee replacement system. This type of device does not involve AI/ML components that would require a study proving its diagnostic or predictive performance, nor does it refer to human readers or human-in-the-loop performance.
Therefore, I cannot provide the requested information based on the given text.
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