(219 days)
- Non-inflammatory degenerative joint diseases (NIDJD), e.g., osteoarthritis, avascular necrosis
- Traumatic arthritis
- Previous tibial condyle or plateau fracture with loss of anatomy or function
- Varus deformities
- Revision of the tibial bearing insert of a previously implanted unicompartmental knee system provided that the tibial tray mechanism is not compromised, and femoral and tibial tray components remain well fixed and undamaged.
The BKS Uni is intended for unicompartmental knee arthroplasty procedures. The system is single-use and intended for implantation with bone cement.
The Balanced Knee® System (BKS®) Uni is a single compartment knee replacement. The BKS Uni is indicated for cemented use only.
Cobalt Chromium Femoral Component
The femoral components are cobalt chromium (Co-Cr-Mo). The femoral components are right and left specific and are intended for cemented use only.
Titanium Tibial Trays
The titanium tibial trays (Ti-6Al-4V ELI) are left and right specific and are for cemented use only.
Polyethylene Tibial Insert
The E-Vitalize tibial insert is manufactured from crosslinked Vitamin E Ultra High Molecular Weight Polyethylene. The inserts match the respective size of the tibial tray used.
The provided text describes a 510(k) premarket notification for a medical device called the Balanced Knee® System Uni. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than on a study proving the device meets specific acceptance criteria in the context of AI/ML performance.
Therefore, many of the requested categories (such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) are not applicable to this type of regulatory submission, as it pertains to a physical medical implant (a knee prosthesis) and not an AI/ML diagnostic or prognostic device.
Here's a breakdown of the information that is available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical implant and not an AI/ML device, the "acceptance criteria" are related to mechanical performance, sterilization, shelf life, and biocompatibility, as confirmed through validation against established ISO and CFR standards.
| Acceptance Criteria Category | Specific Standard / Test | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11137-1:2006, Am1:2013 | Complies with standards (gamma radiation & ethylene oxide validated to SAL of 10⁻⁶) |
| ISO 11137-2:2013 | Complies with standards | |
| ISO 11135:2014/Amd.1:2018(E) | Complies with standards | |
| Shelf Life | ISO 11607-1:2006 | Complies with standards |
| ISO 11607-2:2006 | Complies with standards | |
| Biocompatibility | ISO 10993-1:2009 | Complies with standards (contact materials verified) |
| Mechanical Testing | Range of Motion Test | Conducted (results not detailed, but implied to be acceptable for SE claim) |
| Constraint Test | Conducted | |
| Component Interlock Strength Test | Conducted | |
| Tibial Component Fatigue Test | Conducted | |
| Contact Area/Stress Test | Conducted | |
| Femoral Fatigue Test | Conducted | |
| Wear Test Analysis | Conducted |
2. Sample size used for the test set and the data provenance
Not applicable. This is for a physical device, and the "test set" refers to mechanical and material tests, not a dataset for an AI/ML model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for a knee prosthesis is established through mechanical and biocompatibility testing against defined industry standards, not expert evaluation of data.
4. Adjudication method for the test set
Not applicable.
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 not an AI/ML diagnostic or prognostic tool. No MRMC study was performed.
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
The "ground truth" for this medical device is established by validated engineering and biological standards. This includes:
- Sterility Assurance Level (SAL) via ISO standards.
- Packaging integrity and shelf life via ISO standards.
- Biocompatibility via ISO standards.
- Mechanical performance metrics for range of motion, constraint, interlock strength, fatigue, contact area/stress, and wear.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.