(126 days)
Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The devices covered in this 510(k) are intended to be used with Repicci Femoral component. The device is intended to be used with bone cement.
The Repicci II® Metal Back Inlay Unicompartmental Tibial component comprised of ultra-high molecular polyethylene (UHMWPE), with a thin corrugated metal plate molded into the inferior surface of the device. The tibial components are available in six profiles and two thicknesses and is intended for cemented fixation.
The provided text describes a 510(k) submission for the Biomet Repicci II® Metal Back Inlay Unicompartmental Tibial Bearing Component. This is a medical device, specifically a knee implant component, and its approval process relies on demonstrating "substantial equivalence" to already legally marketed devices.
Crucially, the submission explicitly states "Clinical Testing: None provided as a basis for substantial equivalence." This means that traditional clinical studies, as understood in terms of evaluating performance against acceptance criteria using patient data, were not performed for this device's approval.
Therefore, many of the questions regarding acceptance criteria, study design, ground truth, and human reader performance are not applicable to this specific submission. The "study" that proves the device meets acceptance criteria here is a non-clinical, bench testing study comparing the new device to its predicates.
Here's a breakdown of what can be extracted based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional within intended use | The results indicated that the device was functional within its intended use. (Demonstrated through Non-Clinical Testing) |
| Substantially Equivalent to predicate devices (Repicci II® Unicondylar Knee K971938 and Repicci III® Unicondylar Knee All Poly Tibial Components K980665) | The technological characteristics (material, design, sizing, and indications) of the Repicci II® Metal Back Inlay Unicompartmental Tibial Bearing Component are similar or identical to the predicate devices. |
Study Details (Based on Non-Clinical Testing)
Since no clinical study was performed, the following points are addressed in the context of non-clinical testing, which is the basis for substantial equivalence in this case.
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. Non-clinical testing typically involves a set number of physical devices or models.
- Data Provenance: Not human data. This would be laboratory data generated from mechanical testing, material analysis, and design comparisons.
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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 in the human reader/clinical context. For non-clinical testing, "ground truth" would be established by engineering specifications, material standards, and biomechanical principles, evaluated by qualified engineers and scientists. The document does not specify the number or qualifications of these individuals.
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Adjudication method for the test set:
- Not applicable. Adjudication typically refers to resolving discrepancies in human expert opinions, which did not occur here. Testing results would be analyzed against predetermined engineering specifications and standards.
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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 such study was done. This device is a physical implant, not an AI-assisted diagnostic tool or an imaging device.
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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:
- For the non-clinical testing, the "ground truth" would be established by:
- Engineering specifications: Design parameters, material properties, and manufacturing tolerances.
- Biomechanical performance standards: Requirements for strength, wear, and fatigue.
- Comparison to predicate devices: The established performance and safety profiles of the legally marketed predicate devices.
- For the non-clinical testing, the "ground truth" would be established by:
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of non-clinical testing for a physical implant device. The concept of training data is relevant for AI/machine learning models.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
In summary, the approval for the Biomet Repicci II® Metal Back Inlay Unicompartmental Tibial Bearing Component was based on non-clinical testing demonstrating its functional performance and substantial equivalence in "material, design, sizing, and indications" to its predicate devices, rather than clinical trials with patient data.
§ 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.