(138 days)
The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis. traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.
The Univation® Unicompartmental Knee System is a prosthesis that replaces only one compartment of the knee condyle which consists of a femoral, tibial and meniscal components that are available in a wide range of sizes. The Univation® Unicompartmental Knee System components are medial unicondylar knee replacements for either the right or left knee. The femoral and tibial components are manufactured from CoCrMo, the meniscal components are manufactured from UHMWPE. The femoral and tibial components are available with either a PMMA (polymethylmethacrylate) or ZrN (zirconium nitride) coating. All components are sterile and for single use only.
The provided document is a 510(k) summary for the UNIVATION® Unicompartmental Knee System, which is a medical device. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the detailed information necessary to answer all sections of the request regarding acceptance criteria and a study proving device performance in the context of an AI/algorithm-driven device.
Specifically, it describes performance data from physical testing based on general guidance documents for orthopedic devices, not from a study involving an algorithm or AI.
Therefore, I can only provide information where it aligns with the data found in the document.
Based on the provided text, here is what can be extracted and what cannot:
Acceptance Criteria and Study for UNIVATION® Unicompartmental Knee System
The UNIVATION® Unicompartmental Knee System is a mechanical prosthetic device, not an AI or algorithm-driven device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical performance and safety evaluations as per FDA guidance for orthopedic implants, rather than performance metrics for an algorithm.
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria with corresponding reported device performance results in numerical form. Instead, it states that "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable." It also references specific guidance documents for cemented total knee prostheses, PMMA bone cement, and porous-coated uncemented prostheses.
This implies that the acceptance criteria are adherence to the mechanical, material, and biocompatibility standards outlined in these FDA guidance documents. The "reported device performance" is implicitly that the device met all these required tests, which allowed it to receive 510(k) clearance based on substantial equivalence.
Summary of "Performance Data" from the document:
| Criteria/Type of Testing | Performance Statement |
|---|---|
| Adherence to FDA Guidance Documents | "All required testing per 'Draft Guidance... for Orthopedic Devices - The Basic Elements' were done where applicable." |
| "Testing per the 'Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses'" | |
| "'Guidance Document for Polymethylmethacrylate (PMMA) Bone Cement'" | |
| "'Class II Special Controls Guidance Document for Knee Joint Patellofemorotibial & Femorotibial Metal/Polyer Porous-Coated Uncemented Prostheses'" |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For mechanical devices, testing typically involves a specific number of samples (e.g., components) subjected to various mechanical load tests (fatigue, wear, static strength) in a laboratory setting, rather than a clinical "test set" as understood for AI/diagnostic algorithms. The provenance of such mechanical test data would be the testing laboratory.
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)
This concept of "experts establishing ground truth for a test set" is not applicable to the mechanical testing required for this type of medical device clearance. Ground truth in this context refers to established engineering standards and material properties, validated through laboratory tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable to the mechanical performance testing of an orthopedic implant.
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
This is not applicable as the UNIVATION® Unicompartmental Knee System is a physical orthopedic implant, not an AI or algorithm for diagnostic interpretation or human reader assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the UNIVATION® Unicompartmental Knee System is a physical orthopedic implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for its performance is established through adherence to recognized industry standards (e.g., ISO, ASTM) and FDA guidance documents for mechanical and material properties (e.g., fatigue strength, wear resistance of materials, bone cement interface strength). This is typically determined through laboratory testing and material characterization, not clinical expert consensus, pathology, or outcomes data at the premarket application stage (though post-market surveillance would gather outcomes data).
8. The sample size for the training set
This is not applicable, as there is no "training set" for a mechanical device in the way there is for an AI algorithm.
9. How the ground truth for the training set was established
This is not applicable, as there is no "training set."
In summary: The provided document is a regulatory submission for a physical medical device. The questions posed are primarily structured for evaluating an AI/algorithm-driven device. Therefore, most of the specific details requested regarding "acceptance criteria" and "study" are not present in the document because they pertain to a different type of medical technology. The "studies" for this device were mechanical and material tests conducted according to established engineering standards and FDA guidance, demonstrating substantial equivalence to predicate devices, rather than clinical studies with human readers or AI performance metrics.
§ 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.