(265 days)
The Kyocera TRIBRID® Unicompartmental Knee System is indicated for use in patients with the following:
- Painful and disabled knee joint resulting from osteoarthritis, or idiopathic osteonecrosis, of . either the medial or lateral compartments.
- Correction of varus, valgus, or posttraumatic deformity. .
- As an alternative to tibial osteotomy in patients with unicompartmental NIDJD disease. .
- Revision procedures where other treatments or devices have failed. ●
This device is intended for cemented use only.
KMTI's TRIBRID® Unicompartmental Knee System is a partial knee replacement prostheses intended for application with bone cement. Partial knee replacement components include femoral and tibial components. Femoral baseplates are CoCrMo Alloy while the Tibial implants are Ti6Al4V Alloy. The Tibial bearing inserts are made from Ultra-High Molecular Weight Polyethylene (UHMWPE) variations. Components are available in a variety of designs and size ranges intended for both primary and revision applications.
This document is a 510(k) summary for the Kyocera TRIBRID® Unicompartmental Knee System, a medical device. It focuses on mechanical, non-clinical performance data rather than AI/software performance. Therefore, many of the requested criteria related to AI device performance are not applicable.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating that its mechanical performance is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. The document does not provide specific quantitative pass/fail values as acceptance criteria; rather, it lists the types of tests performed and concludes that the results support substantial equivalence.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category (Implicit from tests) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Strength & Durability | |
| Baseplate Fatigue (per ASTM F3140-17) | Results show sufficient strength for intended use. |
| Femoral Component Durability (per ASTM F3210-22) | Results show sufficient strength for intended use. |
| Intrinsic Stability Characteristics | Not specified quantitatively, but contributes to overall conclusion of substantial equivalence. |
| Modular Disassembly Characteristics (per ASTM F1814 and ASTM F2083) | Not specified quantitatively, but contributes to overall conclusion of substantial equivalence. |
| Range of Motion Assessment (per ASTM F2083) | Not specified quantitatively, but contributes to overall conclusion of substantial equivalence. |
| Simulated Wear (per ISO 14243-3) | Not specified quantitatively, but contributes to overall conclusion of substantial equivalence. |
| Overall Comparison to Predicate Devices | The overall technology characteristics and mechanical performance data lead to the conclusion that the TRIBRID® Unicompartmental Knee System is substantially equivalent to the predicate device. |
Study Details (based on the provided document)
Since the document describes a mechanical device and its non-clinical performance testing rather than an AI/software device, many of the typical questions for AI acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts, MRMC studies, standalone performance) are not applicable.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in this summary. Mechanical tests typically use a small number of samples (e.g., 3-6 or more, depending on the standard) to demonstrate compliance with a standard or to compare to predicate devices.
- Data Provenance: Not applicable. This is in vitro mechanical testing, not human 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. Ground truth for mechanical testing is established by engineering specifications, material properties, and industry standards (e.g., ASTM, ISO), not by expert consensus on clinical data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is for mechanical testing, not interpretation of clinical imagery or data by experts. Test results are typically compared directly to standard requirements or predicate device performance.
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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:
- Not applicable. This is a knee implant, not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Mechanical Testing Standards: The "ground truth" for this type of device is compliance with industrial standards (e.g., ASTM, ISO) for mechanical properties, durability, and wear, and demonstrating substantial equivalence to predicate devices that have established safety and effectiveness through their historical use.
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The sample size for the training set:
- Not applicable. This is non-clinical mechanical testing, not a machine learning model.
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How the ground truth for the training set was established:
- Not applicable. As above, this is mechanical engineering testing.
§ 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.