(61 days)
The 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 the Posterior Stabilized (PS) and Posterior Stabilized Plus (PS+):
- · Ligamentous instability requiring implant bearing surface geometries with increased constraint
- · Absent or nonfunctioning posterior cruciate ligament
- · Severe anteroposterior instability of the knee joint
The MOBIO Total Knee System is intended for implantation with bone cement only. 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 trav, 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 condylar stabilizing (CR+) Tibial Insert device type to the system. 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 CR PLUS Tibial Inserts are offered in a total of 50 sizes, size A/1-3 through HJ/8-10, with 10 thicknesses ranging from 9 to 25mm. 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.
All system components are supplied sterile and are single use devices.
Acceptance Criteria and Study Proving Device Meets Criteria: MOBIO Total Knee System (K210483)
Based on the provided FDA 510(k) summary, the device in question is a Total Knee System, not an AI/software medical device. Therefore, the traditional acceptance criteria and study design for AI/software (e.g., MRMC studies, ground truth establishment for images, training/test sets) do not apply to this submission.
The FDA 510(k) process for a physical medical device like a knee replacement focuses on substantial equivalence to a previously cleared predicate device. This is demonstrated through a comparison of technological characteristics and performance data from non-clinical studies (bench testing) rather than clinical studies with human subjects or AI model validation.
Here's a breakdown of the acceptance criteria and study information as it pertains to this orthopedic implant:
1. Table of Acceptance Criteria and Reported Device Performance
For an orthopedic implant seeking 510(k) clearance, the "acceptance criteria" are generally met by demonstrating that the new device's performance is equivalent to, or better than, the predicate device across relevant performance metrics. These metrics are often derived from recognized consensus standards and ensure the device is safe and effective for its intended use.
| Acceptance Criterion (Performance Metric) | Reported Device Performance (as demonstrated by Non-Clinical Studies) |
|---|---|
| Locking Mechanism Strength (Ensuring secure assembly of components) | Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence) |
| Range of Constraint (Characterizing the implant's biomechanical behavior) | Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence) |
| Contact Area and Contact Stress (Evaluating wear and load distribution characteristics of articulating surfaces) | Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence) |
| Tibiofemoral Range of Motion (Assessing the functional movement range of the implant) | Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence) |
| Characterization of UHMWPE Insert Material (Verifying the material properties of the tibial insert) | Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence) |
| Bacterial Endotoxin Testing (Ensuring sterility and absence of harmful endotoxins for single-use, sterile devices) | Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence) |
| Shelf Life Studies (Determining the stability and integrity of the device over its storage period) | Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence) |
| Biocompatibility (Confirming that the device materials are not harmful to biological tissue) | Data provided (details not explicitly stated in this summary, but sufficient for substantial equivalence) |
| Substantial Equivalence to Predicate Device (Overall design features, materials, manufacturing, sterilization methods) | Established; differences do not raise new questions of safety/effectiveness. |
Note: The FDA 510(k) summary typically lists the types of studies performed, but the detailed results and specific numerical acceptance thresholds are part of the full submission, not the public summary. The "Reported Device Performance" here refers to the fact that supporting data was submitted and found acceptable by the FDA to demonstrate equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of human "test sets" as this is a non-clinical (bench) study for a physical device. The "sample size" would refer to the number of devices or components tested for each specific non-clinical study (e.g., how many locking mechanisms were tested for strength). This specific number is not provided in the 510(k) summary.
- Data Provenance: The data is generated from bench testing in a laboratory setting, not from human subjects or clinical data in a specific country. The studies are typically conducted by the manufacturer or a contract research organization following recognized standards (e.g., ISO, ASTM).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This concept is not applicable to a physical medical device bench study. "Ground truth" in this context is established by:
- Engineering specifications and design requirements.
- International and national consensus standards (e.g., ISO 21536 for Knee joint prostheses, ASTM standards for material testing).
- Validated test methods and equipment.
The "experts" involved would be qualified engineers, material scientists, and biomechanical experts who design the device, perform the tests, and interpret the data against established engineering principles and standards. Their qualifications are inherent in their professional roles and adherence to Good Manufacturing Practices (GMP) and quality system regulations (21 CFR 820).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for consensus in subjective human assessments, often in image interpretation. For a physical device, testing involves objective measurements (e.g., force, stress, range of motion) performed according to validated protocols, not subjective interpretation. Any outliers or discrepancies in test results would be investigated through root cause analysis, not adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. MRMC studies are used to assess the impact of AI algorithms on human reader performance, typically in diagnostic imaging. This 510(k) is for a physical orthopedic implant. Clinical studies, if performed, would typically be for PMA (Premarket Approval) applications or for higher-risk devices, not typically for 510(k) clearances that rely on substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is for a physical knee implant, not a software algorithm.
7. The Type of Ground Truth Used
For this physical device, the "ground truth" for performance is defined by:
- Engineering Specifications: The design parameters and expected performance characteristics set by the manufacturer.
- Consensus Standards: Performance criteria defined by recognized standards organizations (e.g., ISO, ASTM) for mechanical properties, material properties, wear, and biocompatibility of orthopedic implants.
- Predicate Device Performance: The demonstrated safe and effective performance of the legally marketed predicate device (MOBIO Total Knee System; K202429, and reference devices K063423, K071071, K180446). The new device must meet or exceed these established benchmarks.
8. The Sample Size for the Training Set
Not applicable. "Training set" refers to data used to train an AI algorithm. For a physical device, the equivalent would be the R&D and design verification process, where prototypes are developed and tested, and design iterations are guided by engineering principles and previous test results. There isn't a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, "ground truth" for a physical device is established through engineering design, recognized standards, and performance of predicate devices. There is no AI model "training" in this 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.