(234 days)
The b-ONE Total Knee System is intended for total knee arthroplasty due to the following conditions:
· Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post -traumatic 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 knee replacement or other procedure.
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· Fracture of the distal femur and/or proximal tibia that cannot be standard fracture- management techniques.
Additional indications for Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+) components: -
· Ligamentous instability requiring implant bearing surface geometries with increased constraint.
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· Absent or nonfunctioning posterior cruciate ligament.
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· Severe anteroposterior instability of the knee joint.
The b-ONE Total Knee System is intended for implantation with bone cement only. b-ONE Total Knee System components are not intended for use with other knee systems.
The b-ONE Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components with optional femoral distal pegs, symmetric cemented tibial baseplate, symmetric tibial inserts with locking wires, symmetric patellar resurfacing button, and reusable surgical instruments. The therapeutic effect is replacement of the diseased joint with artificial components to restore joint function. The system is a posterior stabilized device type and includes two options for posterior stabilization, a PS and a PS+. The PS+ is designed with additional constraint when more stability is required. Compatibility of the system components is only claimed with the b-ONE Total Knee System. There is no allowed interchangeability with systems manufactured by other companies.
The System includes left and right femoral components manufactured from cast cobalt chrome. The system includes 30 sizes. Sizes 1-10 are provided in right and left versions. Sizes 3-7 are provided in both standard and narrow configurations, with the narrow sizes having a relatively smaller aspect ratio of the medial-lateral to anterior-posterior widths when compared to the standard sizes. Optional modular distal pegs are included in the system.
The system includes a Patella Component offered in seven sizes of variable diameter and thicknesses. The bone fixation surface incorporates three fixation pegs. The Patella Components are made from Conventional UHMWPE.
The system includes Tibial Inserts which are offered in 40 sizes, size A/1-4 through HJ/7-10 with 8 thicknesses and 48 sizes for PS+ inserts, size A1-2+ through HJ/7-10+ with 8 thicknesses. The Tibial Inserts are made from Conventional UHMWPE. The Tibial Inserts are pre-assembled with a locking wire which is manufactured from Cobalt Chrome alloy.
The system includes Tibial Baseplates offered in 9 sizes ranging from A-J. Tibial Baseplates are manufactured from forged titanium alloy.
All system components are supplied sterile and are single use devices.
This document is a 510(k) Pre-Market Notification from the FDA for a medical device called the b-ONE Total Knee System. This type of document is used to demonstrate that a new device is "substantially equivalent" to an existing, legally marketed device (predicate device) and therefore does not require a full Pre-Market Approval (PMA).
It is important to understand that a 510(k) summary for a prosthetic joint like a knee replacement does NOT involve clinical studies or "acceptance criteria" related to diagnostic performance as would be found in AI/ML medical devices.
Instead, the "acceptance criteria" for a knee replacement relate to the performance of the physical components (e.g., strength, fatigue life) and their biocompatibility, demonstrating that the new device functions as safely and effectively as the predicate devices. The "study that proves the device meets the acceptance criteria" refers to non-clinical (bench) tests of the device's materials, design, and mechanical properties.
Therefore, the requested information elements related to AI/ML device evaluations (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.
Here's a breakdown of the applicable information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Type of Non-Clinical Test) | Reported Device Performance (Implied by submission) |
|---|---|
| Tibial Baseplate Fatigue | Demonstrated to be equivalent to predicate devices in fatigue resistance. |
| Locking Mechanism Strength | Demonstrated to be equivalent to predicate devices in locking mechanism strength. |
| Tibial Post Fatigue | Demonstrated to be equivalent to predicate devices in tibial post fatigue resistance. |
| Constraint | Demonstrated to have appropriate constraint comparable to predicate devices. |
| Contact Area and Contact Stress | Demonstrated contact area and stress characteristics within acceptable limits and comparable to predicate devices. |
| Tibiofemoral Range of Motion | Demonstrated range of motion comparable to predicate devices. |
| Characterization of UHMWPE Insert Material | Material properties of the Ultra-High Molecular Weight Polyethylene (UHMWPE) inserts were characterized and found to be acceptable and comparable to predicate devices. |
| Bacterial Endotoxin Testing | Met established safety criteria for bacterial endotoxin levels. |
| Shelf Life Studies | Demonstrated appropriate shelf-life for sterility and material integrity. |
| Biocompatibility | Demonstrated to be biocompatible, indicating no harmful biological reactions. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a physical medical device (knee implant), not a diagnostic algorithm. The "test sets" refer to individual device components or representative samples subjected to specific engineering tests, not patient data sets. The data provenance would be laboratory testing results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. "Ground truth" in this context refers to established engineering standards, material specifications, and mechanical performance criteria, not expert consensus on medical images or diagnoses. These tests are conducted by engineers and technicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for subjective interpretations of data, typically in clinical evaluations or AI/ML ground truth establishment. These are objective engineering tests.
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
- No. This is a physical knee implant, not an AI/ML diagnostic or assistive device. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical knee implant, not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is based on established engineering standards, material specifications, mechanical performance criteria, and comparison to the predicate devices' known performance and specifications.
8. The sample size for the training set
- Not Applicable. This is a physical medical device. There is no "training set" in the context of machine learning. The design and manufacturing processes are developed through engineering and materials science principles.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The "ground truth" for the device's design and manufacturing is established through adherence to recognized industry standards, regulatory requirements, and engineering principles.
§ 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.