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510(k) Data Aggregation
(59 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 cruciate retaining (CR) device type to the system, including the CR femoral component and corresponding CR Tibial inserts. 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 MOBIO Total Knee System includes left and right femoral components for the Cruciate Retaining (CR) system. These components are manufactured from cast cobalt chrome conforming to ASTM F75. 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. Fixed femoral pegs on the femoral components provide additional medio-lateral fixation.
The CR Tibial Inserts are offered in a total of 50 sizes, size A/1-4 through HJ/7-10, with 10 thicknesses ranging from 9 to 25mm (total thickness with Tibial Baseplate is 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.
The provided text is a 510(k) premarket notification for the MOBIO Total Knee System. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing acceptance criteria or reporting on the performance of an AI/ML powered medical device.
Therefore, the information required to answer your questions about acceptance criteria for an AI/ML device and its study is not present in the provided text. The document describes a traditional medical device (knee replacement system) and addresses its physical properties, materials, manufacturing, and intended use, comparing them to existing devices.
The "Performance Data" section in the document refers to non-clinical studies for the physical knee replacement components (e.g., locking mechanism strength, contact stress, range of motion, material characterization, biocompatibility, shelf life, bacterial endotoxin testing). These are for the mechanical device itself, not for an AI/ML algorithm's performance.
To answer your request, I would need a document detailing the performance evaluation of an AI/ML medical device, which would typically involve clinical validation studies, metrics like sensitivity, specificity, AUC, and details on ground truth establishment and expert adjudication.
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(76 days)
General Total Knee Arthroplasty (TKR) Indications:
- . Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), theumatoid 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 stabilized by standard ● fracture -management techniques.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.
The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.
The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
- Ligamentous instability requiring implant bearing surface geometries with increased ● constraint.
- Absent or non-functioning posterior cruciate ligament. ●
- Severe anteroposterior instability of the knee joint. ●
Additional Indications for Total Stabilizer (TS) Components:
- Severe instability of the knee secondary to compromised collateral ligament integrity or function.
Indications for Bone Augments:
- Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
- Salvage of previous unsuccessful total knee replacement or other surgical procedure, ● accompanied by bone loss.
Additional Indications for Cone Augments:
- Severe degeneration or trauma requiring extensive resection and replacement ●
- Femoral and Tibial bone voids
- Metaphyseal reconstruction
The Triathlon TS Cone Augments are intended for cemented or cementless use.
The subject Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components are a modified version of the predicate Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components. The device designs are identical to the predicate devices which are available in the posterior stabilized (PS), cruciate retaining (CR), condylar stabilizing (CS) and total stabilizing (TS) designs for the tibial inserts, and the symmetric and asymmetric designs for the patellar components. The subject inserts and patellar components will have a different method of terminal sterilization (ethylene oxide) and will be formed by consolidating Type 1 (GUR1020) resin via conventional methods which meet the specifications of ASTM F648. Like the predicate devices, the subject Triathlon® X3® CR, CS, PS and TS+ tibial inserts will contain a Cobalt Chromium locking wire as per ASTM F90, and the Triathlon TS+ tibial insert will also additionally contain a Cobalt Chromium tibial support pin as per ASTM F1537.
The provided text does not contain information about the acceptance criteria or a study that proves a device meets specific acceptance criteria in the context of an AI/ML medical device. Instead, the document is a 510(k) premarket notification for Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components, which are orthopedic implants (knee joint replacement components).
The document details the substantial equivalence of this device to previously cleared predicate devices based on material, design, intended use, and non-clinical performance testing. It explicitly states: "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence."
Therefore, I cannot provide the requested information, including:
- Table of acceptance criteria and reported device performance: This document does not specify performance metrics or acceptance criteria for an AI/ML driven device.
- Sample size, data provenance: Not applicable as no clinical study for an AI/ML device is discussed.
- Number of experts, qualifications: Not applicable.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study, effect size: Not applicable.
- Standalone performance: Not applicable.
- Type of ground truth: Not applicable.
- Training set sample size: Not applicable.
- Ground truth for training set: Not applicable.
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(96 days)
General Total Knee Arthroplasty (TKR) Indications:
- 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 stabilized by standard fracture -management techniques.
The Triathlon® Tritanium® Tibial Baseplate and Tritaium® Metal-Backed Patella components are indicated for both uncemented and cemented use.
The Triathion® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.
The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
- Ligamentous instability requiring implant bearing surface geometries with increased constraint.
- Absent or non-functioning posterior cruciate ligament.
- Severe anteroposterior instability of the knee joint.
Additional Indications for Total Stabilizer (TS) Components:
- Severe instability of the knee secondary to compromised collateral ligament integrity or function.
Indications for Bone Augments:
- Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
- Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
The Triathlon® Tritanium® Metal-Backed Patella is an extension of the Triathlon® Total Knee System product line for use in primary and revision Total Knee Arthroplasty. It is a sterile, single-use, non-modular metal-backed patella that is manufactured from UHMWPE (ASTM F648) and commercially pure titanium (ASTM F1580). The device is offered in symmetric and asymmetric designs that are available in multiple sizes. The metalbacking features a porous-coated posterior surface and three porous-coated pegs to provide cemented or cementless fixation to bone.
This document, a 510(k) Summary for the Triathlon® Tritanium® Metal-Backed Patella, focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of a device meeting specific acceptance criteria through performance data. Therefore, many of the requested elements for describing an acceptance criteria study are not present in this submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria with corresponding device performance metrics in the typical sense of a clinical or analytical performance study. Instead, it lists non-clinical laboratory tests performed to demonstrate substantial equivalence to predicate devices. The "reported device performance" in this context is the successful completion of these tests, implying that the new device performs comparably to the predicates.
| Acceptance Criteria (Implied by Test Type) | Reported Device Performance |
|---|---|
| Material Properties: | |
| Elemental Composition (ASTM E1941, E1447, E1409) | Tested and found comparable to predicates |
| Metallurgical & Morphological Properties (ASTM E112, F1854) | Tested and found comparable to predicates |
| Mechanical Properties (ASTM F1147, F1044, F1160, E8) | Tested and found comparable to predicates |
| Plastic Deformation of Porosity (ASTM F1854) | Tested and found comparable to predicates |
| Mechanical Performance: | |
| Static Tensile Bond Strength of UHMWPE/Metal Interface | Tested and found comparable to predicates |
| Static Peg Shear Strength | Tested and found comparable to predicates |
| Patello-Femoral Contact Stress/Contact Area | Tested and found comparable to predicates |
| Malaligned Endurance Testing | Tested and found comparable to predicates |
| Patellar Subluxation Testing | Tested and found comparable to predicates |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. For non-clinical laboratory testing, the sample size typically refers to the number of test articles (patellar components) subjected to each specific test. This tends to be much smaller than clinical study sample sizes and is dependent on the specific ASTM standard or internal protocol used.
- Data Provenance: The tests are non-clinical laboratory tests, likely conducted by the manufacturer (Stryker Orthopaedics) or a contract laboratory. The "country of origin of the data" would typically be the location of the testing facility, which is not specified but presumed to be a regulated environment. The data is retrospective in the sense that these are engineering and material characterization tests performed on manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as this submission is for a medical device and relies on engineering and material testing standards (ASTM) to demonstrate substantial equivalence, not on expert ground truth for an AI or diagnostic device.
4. Adjudication Method for the Test Set
This is not applicable. The "test set" here refers to physical components undergoing laboratory testing, not, for example, medical images requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is used for diagnostic or AI-assisted devices to assess human reader performance. This submission is for a physical orthopedic implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This concept applies to AI/software as a medical device, which this orthopedic implant is not.
7. The Type of Ground Truth Used
The "ground truth" for this submission are the established engineering and material specifications, as well as the performance characteristics of the predicate devices. The new device is tested against these benchmarks (often defined by ASTM standards) to show that its properties are within acceptable ranges and comparable to the predicates.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of an orthopedic implant submission based on substantial equivalence through non-clinical testing. This term is relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8.
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(70 days)
The Triathlon® CS (Condylar Stabilizing) Lipped Insert is intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. The Triathlon® CS (Condylar Stabilizing) Lipped Inserts will be provided sterile and are for single use only.
Indications For Use:
- Painful, disabling joint disease of the knee resulting from: noninflammatory . degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis), or rheumatoid 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 stabilized by standard . fracture management techniques
The Triathlon® CS (Condylar Stabilizing) Lipped Insert is compatible with the standard Triathlon® CR (Cruciate Retaining) and Triathlon® PS (Posterior Stabilizing) femoral components as well as the Triathlon® Primary Cemented, Triathlon® Beaded Baseplates, the Triathlon® Universal Baseplate and the Triathlon® Low-Profile Baseplate. The Triathlon® CS Lipped Insert features a similar anterior constraint to the Triathlon® CR insert which allows the surgeon to retain or sacrifice the Posterior Cruciate Ligament (PCL).
The provided document is a 510(k) Summary for a medical device called the Triathlon® CS (Condylar Stabilizing) Lipped Insert. This document is related to a knee implant component, not an AI/ML-driven diagnostic or prognostic device. Therefore, much of the information requested in your prompt regarding AI/ML study design (such as sample sizes for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) is not applicable.
The document focuses on establishing substantial equivalence to existing legally marketed predicate devices, which is the regulatory pathway for this type of medical device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific device (a knee implant component), the "acceptance criteria" are demonstrated through substantial equivalence to predicate devices, focusing on design, materials, and operational principles, rather than performance metrics typically seen in AI/ML studies (like sensitivity, specificity, or AUC). The reported "performance" relates to its physical characteristics and how they compare to established implants.
| Acceptance Criterion (Demonstrates Substantial Equivalence to Predicates) | Reported Device Performance (Comparison) |
|---|---|
| Intended Use (Primary and revision total knee arthroplasty to alleviate pain and restore function) | States intended use is "substantially equivalent to other modular tibial inserts" |
| Design (Lipped insert compatible with specific femoral and baseplate components, similar anterior constraint to Triathlon® CR insert allowing PCL retention/sacrifice) | Compared to Duracon® CS Lipped Tibial Insert, Triathlon® CR Tibial insert, and Triathlon® PS insert. "Range of Constraint and Contact Area/Peak Stress was presented to compare to other tibial inserts on the market." |
| Materials (Polymer) | States materials are "substantially equivalent to other modular tibial inserts" |
| Operational Principles (Mechanism of action within the knee joint) | States operational principles are "substantially equivalent to other modular tibial inserts" |
| Biomechanical Performance (Range of Constraint, Contact Area/Peak Stress) | "The results demonstrate that the subject components are substantially equivalent to the predicate components." (Specific values are not provided in this summary) |
2. Sample Size for Test Set and Data Provenance
Not applicable for this type of submission. This is a medical device (implant) and its equivalence isn't typically demonstrated through a "test set" of patient data in the way an AI/ML algorithm would be. The "test" for this device involves engineering analysis, material testing, and potentially bench testing, not clinical data sets for performance evaluation against a ground truth.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. There is no "ground truth" establishment in the context of clinical images or data for this engineering-focused substantial equivalence. The "experts" involved would be engineers, materials scientists, and regulatory specialists evaluating the design and testing of the implant.
4. Adjudication Method for the Test Set
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML device that assists human readers.
6. Standalone Performance Study
While the device undergoes extensive standalone engineering and material testing (e.g., fatigue testing, wear testing, range of motion, contact stress analysis), these are not presented as "standalone performance" in the context of an algorithm's output. The summary explicitly states: "Range of Constraint and Contact Area/Peak Stress was presented to compare to other tibial inserts on the market." This indicates engineering performance testing was conducted, but specific details or test results are not provided in this regulatory summary.
7. Type of Ground Truth Used
The "ground truth" in this context is the established performance and safety of the predicate devices and fundamental engineering and biomechanical principles for knee implants. Compliance with these established standards and the demonstrated equivalence to existing safe and effective devices serve as the basis for regulatory acceptance.
8. Sample Size for the Training Set
Not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary Conclusion for this Specific Device:
This 510(k) summary demonstrates the substantial equivalence of the Triathlon® CS (Condylar Stabilizing) Lipped Insert to predicate devices, thereby establishing its safety and effectiveness without needing extensive new clinical trials or AI-specific performance metrics. The "study" here refers to the comparative analysis of its design, materials, and biomechanical properties against legally marketed knee implant components, conforming to engineering standards and principles rather than statistical performance on patient data.
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