(109 days)
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Painful and disabled knee joint resulting from osteoarthritis, and/or 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 biological fixation application. Non-coated (Interlok) devices and all-polyethylene patellar components are indicated for cemented application only.
Regenerex components are intended only for uncemented biologic fixation application.
The tibial bearings are intended for use with Biomet cemented or uncemented tibial trays.
All-polyethylene patellar components are indicated for cemented use only.
The subject devices are intended for use in total knee arthroplasty.
This document is a 510(k) premarket notification for Biomet Knee Joint Replacement Prostheses, primarily focusing on its MR Labeling. It establishes substantial equivalence to previously cleared predicate devices. The document highlights MR safety testing as the basis for this equivalence. There is no study provided that establishes acceptance criteria for clinical performance or any AI/algorithm-related performance. The document is a regulatory submission for a medical device (knee prostheses), not an AI/ML-driven device, and thus the requested information regarding AI performance will not be found.
However, based on the provided text, I can extract information related to the device's MR safety and the context of the submission.
Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not applicable or not present:
1. A table of acceptance criteria and the reported device performance
Since this is a submission related to MR Labeling for a physical knee implant, and not a disease detection algorithm, typical performance metrics like sensitivity, specificity, or AUC are not applicable here. The "performance" in this context relates to MR safety.
| Acceptance Criteria (Implied for MR Conditional Labeling) | Reported Device Performance (Summary of MR Testing) |
|---|---|
| Device is MR Conditional per ASTM F2503-13 | MR Conditional label established. |
| RF heating within acceptable limits (ASTM F2182-11a) | Testing performed; no specific values provided, but implied to be within limits to gain MR Conditional status. |
| Image distortion within acceptable limits (ASTM F2119-07) | Testing performed; no specific values provided, but implied to be within limits to gain MR Conditional status. |
| Magnetically Induced Displacement Force within acceptable limits (ASTM 2052-14) | Testing performed; no specific values provided, but implied to be within limits to gain MR Conditional status. |
| No specific pyrogenicity reported for individual tests | Products determined to be nonpyrogenic. |
| CEM43 analysis performed | Testing performed; no specific details, but supports MR Conditional status. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of this document. The "tests" refer to non-clinical laboratory MR safety tests on the implants themselves, not a clinical study on patients.
- Data Provenance: Not specified, but likely laboratory testing conducted by or for the manufacturer (Biomet, Inc., located in Warsaw, Indiana, USA). These are non-clinical, in-vitro tests, not patient data.
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)
Not applicable. Ground truth in this context would be adherence to ASTM standards for MR safety testing. The "experts" would be the engineers and technicians performing and interpreting the results of the physical MR tests. Their qualifications are not specified but would be implicit in their roles as testers and regulatory affairs personnel.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation of data requiring adjudication. The assessment is based on physical measurements against established technical standards (ASTM).
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. This document does not describe an AI/ML-driven device or an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This document does not describe an AI/ML-driven device. It concerns physical knee joint prostheses and their MR safety labeling.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is defined by established engineering and medical device standards, specifically ASTM standards (F2503-13, F2182-11a, F2119-07, ASTM 2052-14) for MR safety and principles of nonpyrogenicity. It is a technical, objective ground truth based on physical measurements and compliance with industry standards.
8. The sample size for the training set
Not applicable. This document is not describing an AI/ML model for which a training set would be required.
9. How the ground truth for the training set was established
Not applicable. No AI/ML model or training set is involved.
§ 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.