Search Results
Found 1 results
510(k) Data Aggregation
(458 days)
KeYi Total Knee System
The KeYi Total Knee System indications for use are:
· 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 KeYi Total Knee System is indicated for cemented use only.
The KeYi Total Knee System is a fixed-bearing, posterior stabilized (PS) arthroplasty device. It is a patellofemorotibial, polymer, semi-constrained, cemented knee prosthesis that consists of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component, ultra-highmolecular-weight polyethylene (UHMWPE) tibial insert, titanium (Ti) alloy tibial baseplate and UHMWPE patellar component. The device has tibial inserts with posts and femoral components with cams that interact with the posts to help stabilize the knee after the posterior cruciate ligament is removed. The femoral component articulates with the tibial insert component. The underside of the tibial insert component is flat and "snaps" into the tibial baseplate component.
The provided text describes the 510(k) summary for the KeYi Total Knee System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through performance data from mechanical and material testing, rather than clinical study data from an AI/imaging device.
Therefore, the requested information regarding acceptance criteria and a study proving device performance for an AI/imaging device (which would involve concepts like sensitivity, specificity, expert readers, ground truth, etc.) is not applicable to this document.
The document discusses mechanical and material performance data for the knee implant, which are proven through engineering tests against established ASTM and ISO standards for orthopedic implants.
Here's a breakdown of what is present in the document related to "acceptance criteria" and "proof of meeting criteria," reinterpreted for a physical medical device:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table in the exact format requested for AI, but it lists the types of mechanical tests performed, implying that the device met the corresponding acceptance criteria defined by the relevant ASTM and ISO standards.
| Acceptance Criteria (Implied by standard) | Reported Device Performance (Implied by submission) |
|---|---|
| Meeting requirements of ASTM F3334 for Tibial Baseplate Fatigue (FEA Simulation) | Test performed, results support substantial equivalence. |
| Meeting requirements of ASTM F1800 for Tibial Baseplate Fatigue (Mechanical) | Test performed, results support substantial equivalence. |
| Meeting requirements of ASTM F3161 for Femoral Component (FEA Simulation) | Test performed, results support substantial equivalence. |
| Meeting requirements of ASTM F1223 for Constraint Testing (Tibia/Femoral & Patella/Femoral Components) | Tests performed, results support substantial equivalence. |
| Meeting requirements for Contact Area and Stress Testing (Tibia/Femoral & Patella/Femoral Components) | Tests performed, results support substantial equivalence. |
| Meeting requirements for Static Shear and Shear Fatigue Test of Tibial Post | Test performed, results support substantial equivalence. |
| Meeting requirements for Tibial Liner Locking Mechanism Test | Test performed, results support substantial equivalence. |
| Meeting requirements for Surface Roughness Analysis for Femoral and Tibial Inserts | Analysis performed, results support substantial equivalence. |
| Meeting requirements of ISO 14243 for Wear Testing | Test performed, results support substantial equivalence. |
| Meeting requirements for Range of Motion Analysis | Analysis performed, results support substantial equivalence. |
| Meeting requirements for Material properties characterization of non-crosslinked UHMWPE | Characterization performed, results support substantial equivalence. |
| Meeting requirements for Pyrogen test of sterile packaged implants | Test performed, results support substantial equivalence. |
The following points (2-9) are not applicable in the context of this device submission (a knee implant) and its associated performance testing (mechanical). They are relevant for AI/imaging device studies.
2. Sample size used for the test set and the data provenance: Not applicable. For mechanical tests, the "sample size" refers to the number of physical samples of the implant components tested. The provenance is internal lab testing.
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 for mechanical properties is established by engineering specifications and physical measurements, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth is derived from engineering design specifications and established material/mechanical properties standards.
8. The sample size for the training set: Not applicable. This concept mainly applies to machine learning models.
9. How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
Page 1 of 1