(20 days)
EXULT Knee Replacement System is indicated for the treatment of diseases as follows:
· Painful, disabling joint disease of the knee resulting from non-inflammatory degenerative joint disease (including osteoarthritis traumatic arthritis or avascular necrosis) or rheumatoid 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.
· Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous arthroplasty procedure.
EXULT Knee Replacement System is intended for cemented application only.
The purpose of the submission is a line extension of the EXULT Tibial Insert (UC-type) to the EXULT Knee Replacement System (K192507). The UC-type Tibial Inserts are designed based on the design of the other Tibial Inserts of the EXULT Knee Replacement System (PS-type and CR-type). The UC-type, which is ultra-congruent, has high conformity and increased anterior/posterior edge height, which limits anterior/posterior motion instead of a post structure, like the PS-type. The UC-type Tibial Insert matches Femoral Components of one-size up and down. The UC-type Tibial Insert is symmetrical and used in both the right and left knee. It is only used in combination with the Femoral component/Tibial baseplate of the predicate device (K192507).
Here's an analysis of the provided text regarding acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Wear Testing as per ISO 14242-1&2, ASTM F2003-02 | Evaluated to demonstrate substantial equivalence to predicate devices. |
| Constraint test as per ASTM F1223 | Evaluated to demonstrate substantial equivalence to predicate devices. |
| Contact pressure as per ASTM F2083, ASTM F1672 | Evaluated to demonstrate substantial equivalence to predicate devices. |
| Range of Motion as per ISO 21536 | Evaluated to demonstrate substantial equivalence to predicate devices. |
Important Note: The document does not provide specific numerical acceptance criteria or numerical reported device performance values for any of these tests. It only states that the device was "evaluated to demonstrate substantial equivalence to the predicate devices" based on these tests.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text mentions "non-clinical testing" but does not specify sample sizes for materials tested, nor does it refer to patient data (retrospective or prospective) or countries of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable and therefore not provided in the document. The device is a knee replacement system (implant), not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis. The tests described are mechanical and material performance tests.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. As noted above, this is a mechanical device, not an AI/software device involving human reader interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and therefore not provided in the document. This is a medical device (knee implant), not an AI-assisted diagnostic or treatment planning software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and therefore not provided in the document. This is a medical device (knee implant), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing of this knee implant system would be the physical and mechanical properties of the device and its predicate, measured according to established international and ASTM standards. For instance, in wear testing, the "ground truth" is the actual material loss measured. In contact pressure testing, it's the measured pressure distribution.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided in the document. This is a medical device (knee implant), not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided in the document. As this is not an AI/ML device, there is no training set or ground truth in that context.
§ 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.