Search Results

The A3 Total Knee System indications for use is:

• Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis) or rheumatoid arthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint configuration and function.
• Moderate valgus, varus, or flexion deformity.
• . Knee fractures untreatable by other methods.

The A3 Total Knee System is indicated for cemented use only.

The subject device and both predicate devices are total knee replacement systems consisting of five components:

• 1. Femoral Condyle
• 2. Tibial Tray
• 3. Tibial Insert
• 4. Patellar Component
• 5. Locking Mechanism

The subject device and both predicates have femoral condyle and tibial tray components manufactured from cast cobalt chromium molybdenum (Co-Cr-Mo) alloy. The femoral components of all devices are available in both left and right configurations.

The tibial inserts of the subject device and primary predicate device are manufactured from conventional ultra-high molecular weight polyethylene (UHMWPE), while the reference predicate is manufactured using a combination of UHMWPE and cobalt-chromium (Co-Cr). The range of available sizes of the tibial trays and inserts varies for the subject and predicate devices.

The subject device and primary predicate have a patellar component manufactured from UHMWPE, while the material of construct of the patella of the reference predicate is unknown. The subject and both predicate devices have a locking mechanism, although the configurations and method of operation are slightly different. The locking clip for the subject device is manufactured from titanium, the reference predicate locking wire is manufactured from Co-Cr and the material of the primary predicate is unknown. The subject and primary predicate devices have the same maximum degree of flexion (145°), while the maximum flexion of the reference predicate is slightly less (110°).

All devices are of a posterior stabilized design and none are cruciate ligament retaining devices. The subject and both predicates are shipped sterile.

This document is a 510(k) premarket notification for a medical device and therefore does not contain the detailed information about acceptance criteria or a study that would be typically found in a clinical trial report or a performance evaluation report. The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance against them in a "study" in the traditional sense of a clinical trial.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is absent:

1. A table of acceptance criteria and the reported device performance

• Absent. The document does not provide a table of acceptance criteria with corresponding performance results. It lists several mechanical tests performed (e.g., Tibial Tray Fatigue Testing, Wear Mechanical Performance Testing), but it does not specify the quantitative acceptance criteria for these tests nor does it present the numerical results obtained. The conclusion states that the "performance testing... as well as the same indications for use and materials demonstrate that the A3 Total Knee System is as safe and effective as its predicate devices," implying that the device passed these internal tests, but specifics are not given.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Absent. This document describes mechanical/bench testing of the device itself, not a study involving human subjects or data derived from them. Therefore, there is no "test set" in the context of patient data, nor is there information on data provenance (country of origin, retrospective/prospective). The tests listed are laboratory-based mechanical evaluations of the device components.

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)

• Absent. As this is a mechanical performance evaluation of a knee implant, the concept of "ground truth" as established by medical experts for diagnostic or prognostic purposes does not apply here. The "ground truth" for mechanical testing would be the accepted engineering standards and specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Absent. Adjudication methods are relevant in studies involving human interpretation or clinical endpoints. This document describes bench testing, which does not involve adjudication.

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

• Absent. This is a premarket notification for a knee implant, which is a physical medical device. It is not an AI-powered diagnostic or interpretive device, so an MRMC study or evaluation of AI assistance is entirely irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Absent. Similar to the point above, this is not an algorithm-based device. Therefore, standalone algorithm performance is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Engineering Standards and Predicate Device Performance: For the mechanical tests listed, the "ground truth" or reference points would be the established international standards for knee implants (e.g., ISO, ASTM standards) and the known performance characteristics of the predicate devices. The document implies that the device met these standards and performed comparably to the predicates but does not explicitly state the specific "ground truth" used for each test.

8. The sample size for the training set

• Absent. This concept pertains to machine learning and AI, which are not relevant to this device submission.

9. How the ground truth for the training set was established

• Absent. This concept pertains to machine learning and AI, which are not relevant to this device submission.

Summary of what is present:

The document describes the type of device (A3 Total Knee System), its intended use and indications for use, and its technological characteristics in comparison to predicate devices. It lists the mechanical performance tests conducted to demonstrate substantial equivalence:

• The Tibial Tray Fatigue Testing.
• The Wear Mechanical Performance Testing.
• The Constraint Testing.
• The Contact Pressure Testing.
• The Shear Fatigue Testing of the Tibial Post.
• Surface Roughness Analysis.
• Physiological Loads Testing on Interlocking Mechanisms.
• The Shear Fatigue Testing on the Patellar Component.
• Patella Constraint Testing
• Patella Contact Testing
• Static Shear Testing of the Patellar Component

The "study" referred to in the prompt's context is the mechanical/bench testing performed on the A3 Total Knee System. The document concludes that these tests, along with material and indications for use, demonstrate that the device is "as safe and effective as its predicate devices."

To answer your request completely in the format requested, much of the information is not provided within this specific regulatory document. The nature of a 510(k) submission is to demonstrate equivalence to legally marketed predicate devices, primarily through comparison of design, materials, indications for use, and a battery of standard mechanical tests, rather than a clinical study with detailed acceptance criteria and expert-adjudicated ground truth.

Ask a specific question about this device