(29 days)
Intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.
The additional components that are the subject of this Special 510(k) submission are the tibial inserts and baseplates. These components are to be used with the femoral components of the Uni Knee cleared in K020741.
The tibial inserts of this submission are the similar the tibial components in K020741 with the addition of a snap feature on the non-articulating side. This snap feature is meant to be used with the tibial baseplate. The tibial inserts are manufactured from UHMWPE that conforms to ASTM F648 and are available in 5 sizes (35-45 mm) and 3 thicknesses (6-8 mm).
The tibial baseplates are manufactured from CoCr alloy that conforms to ASTM F75 and are available in 5 sizes (35-45 mm) and 2 configurations (left medial/right lateral and right medial/left lateral).
The provided text describes a submission for "Uni Knee Additional Components" to the FDA, but it does not contain any information regarding acceptance criteria, device performance metrics, or the details of a study that proves the device meets specific criteria.
The 510(k) summary focuses on:
- Device identification: Submitter, device name (Uni Knee Additional Components), common name, classification, and predicate devices.
- Device description: Details the tibial inserts (UHMWPE, snap feature, 5 sizes, 3 thicknesses) and tibial baseplates (CoCr alloy, 5 sizes, 2 configurations).
- Intended use: Partial replacement of articulating knee surfaces for specific conditions, for single use with bone cement.
- Basis for Substantial Equivalence: States similarity in design, materials, and indications to a previously cleared device (K020741).
The FDA's response letter (K022437) confirms that the device is substantially equivalent to legally marketed predicate devices. This indicates that the FDA found the device to be as safe and effective as existing devices, based on the information provided in the 510(k) submission.
Therefore, I cannot provide the requested information about acceptance criteria or a study proving device performance because it is not present in the provided document. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.
To address the specific points you requested, if such information were available, here's how it would typically be presented:
Hypothetical Response (if the information were available in the provided text):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Mechanical Strength, Wear Rate, Biocompatibility) | Reported Device Performance (e.g., "X MPa ultimate tensile strength," "Y mm^3/million cycles wear," "Meets ISO 10993 standards") |
|---|---|
| [Specific criteria would be listed here] | [Corresponding performance data would be listed here] |
| ... | ... |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): [e.g., N=10 implants for fatigue testing, N=5 animal models for biocompatibility]
- Data Provenance: [e.g., In-vitro lab testing conducted in the USA, Retrospective clinical data from European clinics, Prospective animal study conducted in Canada]
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: [e.g., 3 orthopedic surgeons]
- Qualifications: [e.g., Each with over 15 years of experience in knee arthroplasty, Board-certified and affiliated with major academic medical centers]
4. Adjudication Method for the Test Set
- Adjudication Method: [e.g., 2+1 (two experts agree, or a third expert resolves disagreement), Consensus panel, Majority rule, None (if ground truth is objective, like pathology reports)]
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Conducted?: [Yes/No]
- Effect Size (Human Readers with AI vs. Without AI): *[e.g., "Human readers demonstrated a 15% improvement in diagnostic accuracy with AI assistance (p
§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.