(20 days)
The Fixed Bearing Uni Component is indicated for use for 1) Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; 2) Correction of varus, valgus, or posttraumatic deformity; and 3) Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is intended to be used with bone cement.
The tibial component consists of polyethylene plateau molded over a one-piece Co-Cr-Mo base and central keel. The molded tibial components are anatomical in geometry with right and left medical/lateral allocations. The overall form of the implant is tear-shaped. The Fixed Bearing Uni Components will be used in conjunction with the Oxford Unicompartmental Knee Femoral Component (K011138) and the Repicci IITM Unicondylar Knee (K971938).
The provided text is a 510(k) premarket notification for a medical device called the "Fixed Bearing Uni Component." It describes the device, its indications for use, and the basis for its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in the traditional sense of a performance study (e.g., accuracy, sensitivity, specificity thresholds). Instead, the acceptance was based on demonstrating substantial equivalence to a legally marketed predicate device (Repicci IITM Unicondylar Knee, K971938).
The "performance" of the device is implied by its similarity to the predicate.
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Material Equivalence | The Fixed Bearing Uni Components - the materials, design, sizing, and indications are similar or identical to the predicate devices. | The materials of the new device are stated to be similar or identical to the predicate device. |
| Design Equivalence | The Fixed Bearing Uni Components - the materials, design, sizing, and indications are similar or identical to the predicate devices. | The design of the new device is stated to be similar or identical to the predicate device. |
| Sizing Equivalence | The Fixed Bearing Uni Components - the materials, design, sizing, and indications are similar or identical to the predicate devices. | The sizing of the new device is stated to be similar or identical to the predicate device. |
| Indications for Use Equivalence | The Fixed Bearing Uni Components - the materials, design, sizing, and indications are similar or identical to the predicate devices. | The indications for use of the new device are stated to be similar or identical to the predicate device. |
| Safety Equivalence | Non-Clinical Testing: Engineering Justifications, Mechanical Testing, and a Finite Element Analysis (FEA) determined that the Fixed Bearing Uni Components presented no new risks and was, therefore, substantially equivalent to the predicate device. | Engineering justifications, mechanical testing, and FEA were used to demonstrate no new risks compared to the predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No clinical testing was conducted or provided. The basis for substantial equivalence relied solely on non-clinical testing (engineering justifications, mechanical testing, and Finite Element Analysis). Therefore, there is no "test set" in the context of clinical data, no sample size, and no data provenance from human subjects.
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. Since no clinical testing was performed, there was no test set requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As there was no clinical test set, no adjudication method was used.
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
Not applicable. This device is a physical knee implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical knee implant, not an algorithm or software. Its performance is evaluated through mechanical and engineering means as an implantable medical device, not as a standalone AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing:
- Mechanical Testing: Ground truth would be defined by established engineering standards, material properties, and biomechanical parameters.
- Finite Element Analysis (FEA): Ground truth is based on physical laws, material science, and computational models that predict mechanical behavior.
- Engineering Justifications: Ground truth is based on established engineering principles and comparison to the known performance of the predicate device.
8. The sample size for the training set
Not applicable. There was no "training set" in the context of machine learning. The design and validation of the device relied on engineering principles and comparison to a predicate device. If one were to interpret "training set" very broadly as the data used for the design and analysis, it would include things like material property data, CAD models, and results from previous mechanical tests on similar devices (including the predicate). However, this is not a "training set" in the typical AI/ML sense.
9. How the ground truth for the training set was established
Not applicable. As explained above, there was no training set in the context of AI/ML. The "ground truth" for the engineering design and non-clinical assessment was based on established engineering standards, material specifications, and the historical performance and regulatory approval of the predicate device.
§ 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.