(75 days)
Biomet Tibial Trays are modular components that are part of a total knee implant system intended to replace the damaged or diseased knee joint during total knee arthroplasty.
Indications for use are as follows:
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- Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
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- Correction of varus, valgus, or posttraumatic deformity.
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- Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The Regenerex femoral augments are indicated for use with the Vanguard Total Knee System.
The Regenerex tibial augments are indicated for use with standard and offset Biomet Tibial Trays.
Femoral components and tibial tray components with porous coatings are indicated for cemented and uncemented biological fixation application. Non-coated (Interlok) devices and allpolyethylene patellar components are indicated for cemented application only.
Regenerex components are intended only for uncemented biologic fixation application.
The subject Biomet Tibial Trays are available in four design configurations – Interlok, porous, stemmed, and offset. The trays, as a system construct, are compatible with existing, legally marketed Biomet femoral components, tibial bearings, patella components, stems, and various auxiliary components, including augment blocks and wedges.
This submission includes a modification to remove the shot peen operation from the manufacturing process of the subject Biomet Tibial Trays. In addition, a new cementing technique option is being introduced for the Interlok tibial trays. The technique is executed via use of new implant-specific instrumentation referred to as CementON Tibial Molds.
This document is a 510(k) premarket notification for Biomet Tibial Trays. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a device performance study with specific acceptance criteria in the context of clinical AI/software performance.
Therefore, many of the requested categories related to clinical study design, AI performance, ground truth, and expert evaluation cannot be answered from the provided text.
However, I can extract information regarding the non-clinical performance tests that were conducted.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tibial Tray Cyclic Fatigue Testing | Not explicitly stated, but implied to be sufficient for demonstrating substantial equivalence and safety. | Data collected supported substantial equivalence (details not provided in this summary). |
| I-beam Implant Pullout Force from a Cement Mantle after CementON or Manual Cement Application | Not explicitly stated, but implied to be sufficient for demonstrating substantial equivalence and safety. | Data collected supported substantial equivalence (details not provided in this summary). |
| Finned Implant Pullout Force from a Cement Mantle after CementON or Manual Cement Application | Not explicitly stated, but implied to be sufficient for demonstrating substantial equivalence and safety. | Data collected supported substantial equivalence (details not provided in this summary). |
2. Sample size used for the test set and the data provenance
This information is not provided in the document for the non-clinical tests. The document states "Clinical data was not required to establish substantial equivalence".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical ground truth was established from experts for this submission. The tests were non-clinical mechanical or material tests.
4. Adjudication method for the test set
Not applicable. No human adjudication method was described as these were non-clinical tests.
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
No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (tibial trays) which is a physical implant, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is for a physical medical device, not an algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" would be the engineering specifications and performance standards relevant to tibial trays, but these specific criteria are not detailed in this summary.
8. The sample size for the training set
Not applicable. This submission is for a physical medical device, not an AI/ML algorithm that would typically have a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace 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 have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.