(72 days)
The EIUS® Unicompartmental Knee System is intended for use in unicompartmental kncc arthroplasty. It is intended to be used for patients with moderately disabling joint discase of the knee resulting from painful osteoarthritis or traumatic arthritis; revision of previous unsuccessful unicompartmental knec replacement or other procedure, or as an alternative to tibial osteotomy in patients with unicompartmental ostcoarthritis.
The FIUS® Knee System components are for use in Unicompartmental knee arthroplasty as a result of:
- Moderately disabling joint disease of the knee resulting from painful osteo- or post . traumatic arthritis
- Revision of previous unsuccessful unicompartmental knee replacement or other . procedure
- As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis .
These components are single use only and are intended for implantation with bone cement.
This submission is intended to address a line extension to the EUS® Unicompartmental Knee System. The linc cxtension includes additional tibial components, 8mm, 10mm, and 12mm components without a keel and 6mm components with and without a keel. Also, some changes werc made to the cement recess of the tibial component to ensure adequate thickness under the femoral condyle. Finally, the material will change from the current polycthylene material to the polyethylene material used in the Scorpio Knee System. The new components will be used for resurfacing of either the medial or lateral proximal tibia.
The provided document is a 510(k) Special Summary of Safety and Effectiveness for a line extension to the EIUS® Unicompartmental Knee System. It focuses on device modifications and substantial equivalence to predicate devices, primarily through mechanical testing.
Therefore, the information required to answer many of your questions regarding AI/ML device performance (e.g., acceptance criteria for diagnostic metrics, sample size for test sets/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) is not present in this document. This is because the device described is a physical medical implant (a knee system), not an AI/ML diagnostic or prognostic device.
Here's an attempt to answer the questions based only on the provided text, acknowledging the limitations for an AI/ML context:
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A table of acceptance criteria and the reported device performance
Acceptance Criteria (Implied for medical implants) Reported Device Performance Mechanical Properties: Comparable to predicate devices. "Mechanical testing demonstrated comparable mechanical properties to the predicate devices." Material Equivalence: Material of new components is equivalent to existing, legally marketed components. "The material will change from the current polyethylene material to the polyethylene material used in the Scorpio Knee System." (Scorpio Knee System material was cleared under K962152, implying equivalence). Design Features: New features (cement recess without a keel) are equivalent to existing, legally marketed components. "the cement recess without a keel is equivalent to the UNIX Unicompartmental Knee and the Biomet Repicci Unicompartmental All Polyethylene Tibia component (also available without a keel)." (UNIX cleared under K923011, Biomet under K980665). Intended Use: Same intended use as predicate devices. "The subject components share the same intended use and basic design concept as that of the predicate devices." Also, "The EIUS® Unicompartmental Knee System is intended for use in unicompartmental knee arthroplasty." Safety & Effectiveness: Device is substantially equivalent to predicate devices. Device received 510(k) clearance (K033769) based on substantial equivalence to predicate devices. -
Sample size used for the test set and the data provenance
- Sample Size: Not specified. The study mentioned is "mechanical testing," which typically involves multiple samples of the components under various load conditions, but the exact number isn't reported.
- Data Provenance: Not specified. Mechanical testing is generally conducted in a lab setting rather than from patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. For mechanical testing of a physical implant, "ground truth" is typically established by engineering standards and measurements, not expert human interpretation in the way it is for image analysis or diagnostic tasks.
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Adjudication method for the test set
- Not applicable/Not specified. This concept is typically relevant for subjective human assessments, not objective mechanical testing.
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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
- No. This is irrelevant for a knee implant system. MRMC studies are used for evaluating diagnostic performance with human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is irrelevant for a knee implant system.
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The type of ground truth used
- For the mechanical testing: Engineering specifications, material properties, and comparison to established predicate device performance. The "ground truth" here is the objective, measurable performance characteristics of the device and its compliance with standards relevant to knee implants.
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The sample size for the training set
- Not applicable/Not specified. This concept is for AI/ML models.
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How the ground truth for the training set was established
- Not applicable/Not specified. This concept is for AI/ML models.
§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.