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510(k) Data Aggregation
(56 days)
b-ONER MOBIO Total Knee System
The b-ONE™ MOBIO™ 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 · 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. - · Absent or nonfunctioning posterior cruciate ligament. - · Severe anteroposterior instability of the knee joint The b-ONE™ MOBIO™ Total Knee System is intended for implantation with bone cement only. b-ONE™ MOBIO™ Total Knee System components are not intended for use with other knee systems.
The MOBIO Total Knee System is a modular artificial knee replacement system comprised of symmetric cemented femoral components, symmetric cemented tibial tray, 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. This submission is to add a Stemmed Baseplate with modular Stem Extension options. Compatibility of the system components is only claimed with the b-ONE Total Knee System components. There is no allowed interchangeability with systems manufactured by other companies. The b-ONE MOBIO Total Knee System Stemmed Tibial Baseplates are manufactured from forged titanium alloy. The baseplates are offered in 9 sizes with medial lateral dimensional range from 58-85mm and anterior posterior dimensional range from 58-85mm and anterior posterior dimensional range from 38-59mm. The baseplate is intended for cemented fixation. The Stemmed Baseplates mate with stem extensions through a threaded junction. The Tibial Stems are manufactured from forged titanium alloy. The Tibial Stems are offered in 3 diameters (12, 14, and 16mm) with various lengths ranging from 20-120mm. The stems are intended for cemented fixation. All system components are supplied sterile and are single use devices.
The provided text describes a 510(k) premarket notification for a medical device, the MOBIO Total Knee System. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria or reporting results from a study proving the device meets those criteria in the way one might expect for an AI algorithm or a diagnostic tool.
The "acceptance criteria" in this context refer to the requirements for demonstrating substantial equivalence for a new or modified medical device. The "study" proving the device meets these criteria is the collection of non-clinical tests and comparisons presented in the 510(k) submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't present a table with explicit "acceptance criteria" and "reported device performance" in the quantitative sense typical for a diagnostic or AI device. Instead, the acceptance criteria are implicitly met by demonstrating that the new device's performance, materials, and design are substantially equivalent to those of legally marketed predicate devices.
The "reported device performance" is essentially that the MOBIO Total Knee System is as safe and effective as the predicate devices based on the non-clinical tests performed.
| Category | Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Materials | Materials of construction are substantially equivalent to predicate devices. | Subject device uses forged titanium alloy for baseplates and stems, the same material class as commonly used in predicate knee systems. |
| Manufacturing | Manufacturing processes are substantially equivalent to predicate devices. | Standard manufacturing processes for medical implants are used, similar to predicate devices. |
| Sizes Offered | Sizes offered are comparable to predicate devices. | Tibial Baseplates offered in 9 sizes (medial-lateral: 58-85mm, anterior-posterior: 38-59mm). Tibial Stems offered in 3 diameters (12, 14, 16mm) with lengths from 20-120mm. These ranges are typical for total knee systems. |
| Product Design | Product design (shape, macrostructures) is substantially equivalent to predicate devices. | Design features are comparable to predicate devices, with minor differences not raising new safety/effectiveness questions. This submission focused on adding a Stemmed Baseplate with modular Stem Extension options to an existing cleared system. |
| Sterilization | Sterilization methods are substantially equivalent to predicate devices. | All system components are supplied sterile and are single-use devices, consistent with standard practice for surgically implanted devices. |
| Mechanical Performance | The device performs mechanically comparably to predicate devices for its intended use, as demonstrated by non-clinical tests. | Non-clinical studies included: Tibial Baseplate Fatigue, Torque Testing, Locking Mechanism Strength, Constraint, Contact Area and Contact Stress, Tibiofemoral Range of Motion. The results are implied to be acceptable as they support substantial equivalence. |
| Biocompatibility | The device materials are biocompatible, similar to predicate devices. | Biocompatibility testing was performed. The results are implied to be acceptable as they support substantial equivalence. |
| Shelf Life | The device maintains its safety and effectiveness over its stated shelf life. | Shelf Life Studies were performed. The results are implied to be acceptable as they support substantial equivalence. |
| Bacterial Endotoxin | The device is free from bacterial endotoxin within acceptable limits. | Bacterial Endotoxin Testing was performed. The results are implied to be acceptable as they support substantial equivalence. |
| Safety & Effectiveness | The device is as safe and effective as the legally marketed predicate devices. Differences in design/technology do not raise new safety/effectiveness questions. | "The information provided above supports that the MOBIO Total Knee System Stemmed Baseplate and Stem Extension components are as safe and effective as the predicate devices with the same intended use. Some minor differences in design and technology exist between the subject and predicate devices, however applicable reference devices have been cited to support the conclusion that these differences do not raise any new questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and the Data Provenance
For a medical implant like a total knee system, studies are typically non-clinical (bench testing, mechanical testing) rather than involving patient test data sets in the way an AI algorithm would.
- Sample Size: Not explicitly stated in terms of "test set" size. The "samples" would be the individual components or assemblies tested for fatigue, torque, etc. The document does not specify the number of units tested for each non-clinical study.
- Data Provenance: The studies are non-clinical (bench testing), so there's no patient data involved in this 510(k) summary. These tests would have been conducted in a laboratory setting by the manufacturer or a contract research organization.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable in the context of this 510(k) submission.
- Ground Truth for Non-Clinical Tests: For mechanical and material tests, the "ground truth" is established by adherence to recognized standards (e.g., ISO, ASTM) and engineering principles, not by expert consensus on clinical images or diagnoses. The "experts" would be the engineers and scientists performing and interpreting these tests.
- The document implies that the internal experts of b-ONE ORTHO, Corp. and potentially external labs were involved in conducting and evaluating these non-clinical tests, following established regulatory and scientific guidelines.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic studies, not for non-clinical mechanical testing of medical devices.
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. This 510(k) is for a total knee replacement system, which is a physical implant, not an AI-assisted diagnostic tool or an imaging modality. There are no "human readers" or "AI assistance" involved in its direct function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The MOBIO Total Knee System is a physical medical device (an implant), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As this is a non-clinical 510(k) submission for a physical implant, the "ground truth" for the performance studies refers to:
- Adherence to validated test methods and standards: For example, fatigue testing would be evaluated against established standards for implant longevity.
- Material specifications: Conformance to established material properties for the titanium alloy.
- Design specifications: Proof that the device meets its design intent, often through dimensional verification and mechanical simulation/testing.
- Biocompatibility standards: Compliance with ISO 10993 series for biological evaluation of medical devices.
8. The sample size for the training set
This question is not applicable. As this device is a physical implant and not an AI algorithm, there is no "training set" in the machine learning sense. The "training" for such a device comes from engineering design, material science, and prior knowledge from predicate devices.
9. How the ground truth for the training set was established
This question is not applicable, as there is no "training set" for this type of medical device submission.
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