(155 days)
The Balanced Knee® System High Flex Vitamin E PS tibial insert and patella are intended for use in cemented total knee arthroplasty procedures with the following.indications:
- Loss of knee joint configuration and joint function.
- Osteoarthritis of the knee joint.
- Rheumatoid arthritis of the knee joint.
- Post-traumatic arthritis of the knee joint.
- Valgus, varus, or flexion deformities of the knee joint.
- Revision procedures where other treatments or devices have failed.
The Balanced Knee® System High Flex Vitamin E (High Flex Vit E) PS tibial insert and patella are machined from extensively crosslinked, compression molded, Vitamin E UHMWPE. Both components are single use only. The High Flex Vit E PS tibial insert must be used in conjunction with the High Flex PS femoral component (K123457). Used together, these components are designed to accommodate increased range of motion up to 150° of flexion. The High Flex Vit E patella may be used in conjunction with the Balanced Knee® System (BKS) femoral components (K994370), the BKS modular femoral components (K060569), or the High Flex PS femoral components (K123457). Both the High Flex Vit E PS tibial insert and patella may be used in conjunction with the BKS standard and modular tibial trays, tibial augments, and stems to complete the semi-constrained modular knee prosthesis. The tibial trays, tibial augments, and stems were approved under K994370 and K031201.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Balanced Knee® System High Flex Vitamin E PS Tibial Insert and Patella:
The provided document is a 510(k) summary for a medical device seeking substantial equivalence to existing predicate devices. It focuses on the technological characteristics and performance data to demonstrate this equivalence, rather than a clinical study with human patients. This is common for devices that are modifications of already approved devices.
1. Table of Acceptance Criteria and Reported Device Performance
The "Performance Data" section (page 2) lists various properties tested. Since this is a 510(k) summary demonstrating substantial equivalence, the "acceptance criteria" are implicitly that the device's performance is "Substantially Equivalent" or "Substantially equivalent or better than" the predicate device(s).
| Property | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Range of Motion | Substantially Equivalent to predicate device, BKS High Flex | Up to 150° flexion; Substantially Equivalent to predicate device, BKS High Flex |
| Femorotibial Constraint | Substantially Equivalent to predicate device, BKS High Flex | Substantially Equivalent to predicate device, BKS High Flex |
| Femorotibial Contact Area | Substantially Equivalent to predicate device, BKS High Flex | Substantially Equivalent to predicate device, BKS High Flex |
| Patellofemoral Constraint | Substantially Equivalent to predicate device, BKS High Flex | Substantially Equivalent to predicate device, BKS High Flex |
| Patellofemoral Contact Area | Substantially Equivalent to predicate device, BKS High Flex | Substantially Equivalent to predicate device, BKS High Flex |
| PS Spine Fatigue | Substantially Equivalent to predicate device, BKS High Flex | Substantially Equivalent |
| Insert Assembly/Disassembly | Substantially Equivalent to predicate device, BKS High Flex | Substantially Equivalent |
| Crosslinking Characterization of High Flex Vit E | Substantially equivalent or better than BKS | Substantially equivalent or better than BKS |
| Vitamin E Characterization of High Flex Vit E | Substantially equivalent or better than BKS | Substantially equivalent or better than BKS |
| High Flex Knee Wear | Not explicitly stated as "equivalent," but improvement is implicit | Decrease in wear over BKS |
Note: The last item, "High Flex Knee Wear," is reported as a "Decrease in wear over BKS," which suggests an improvement rather than just equivalence. This would still be considered meeting an implicit acceptance criterion of being at least as good as the predicate (or better).
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes in terms of number of patients or clinical cases because the studies described are non-clinical (benchtop) tests. The "test set" here refers to the physical samples of the device and predicate devices used in the mechanical and material characterization tests. The provenance of this data is from the manufacturer's internal testing. There is no information about country of origin for data or whether it's retrospective/prospective, as these terms apply to clinical studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document describes non-clinical (benchtop) testing rather than studies that require expert-established ground truth from medical imaging or clinical observations. Therefore, there were no medical experts (e.g., radiologists) involved in establishing ground truth for the test set in the way this question implies. Ground truth for these types of tests is established by engineering and material science standards and measurements.
4. Adjudication Method for the Test Set
Not applicable. As this is non-clinical benchtop testing, there is no "adjudication method" involving human experts in the context of clinical studies (e.g., 2+1, 3+1). The results are based on objective physical measurements and comparisons to predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, as this device is not an AI-assisted diagnostic tool. No effect size of human readers improving with AI vs. without AI assistance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a medical implant (total knee replacement components), not a software algorithm or AI device. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Objective mechanical and material property measurements: Standards for flexion, constraint, contact area, fatigue, crosslinking, and Vitamin E content.
- Comparison to predicate devices: The "ground truth" for substantial equivalence is the established performance characteristics and safety profile of the legally marketed predicate devices. The new device must meet or exceed these established benchmarks.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for it.
§ 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.