(149 days)
The Kinematic® II Replacement Tibial Inserts are intended to be used in the revision of an existing Kinematic® II tibial component assembly. These inserts are intended to be used when the Vitallium baseplate portion of the tibial assembly is well fixed by cement, but the polyethylene bearing portion of the tibial assembly needs revision due to wear or ligament laxity.
Not Found
This submission describes a medical device, the Kinematic® II Replacement Tibial Inserts, and its equivalence to existing legally marketed devices. However, the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/software device evaluation (e.g., diagnostic performance, accuracy, sensitivity, specificity).
The acceptance criteria described here pertain to engineering performance and material equivalence for a physical implant, not to the performance of a software algorithm or diagnostic tool.
Therefore, I cannot directly answer your prompt's specific questions regarding acceptance criteria and study details as they are typically applied to AI/software performance evaluations. The information provided is for a traditional medical device (joint implant).
However, I can extract the relevant information regarding the type of testing performed:
1. A table of acceptance criteria and the reported device performance:
Since the provided text does not define specific numerical acceptance criteria (e.g., "flexural strength must be > X MPa"), I can only infer the types of performance evaluated for equivalence. No specific reported values are given for these tests in this summary.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (as stated in the summary) |
|---|---|
| Contact Area Characteristics | "Testing was presented which characterized the contact area... for the subject devices." Specific values or comparison results are not provided in this summary. |
| Range of Constraint | "Testing was presented which characterized the... range of constraint for the subject devices." Specific values or comparison results are not provided in this summary. |
| Attachment Strength | "Testing was presented which characterized the... attachment strength of the inserts to the baseplates." Specific values or comparison results are not provided in this summary. |
| Material Equivalence | "This equivalence is based upon similarities in... material... to the legally marketed devices." No specific material properties or tests are enumerated. |
| Design Equivalence | "This equivalence is based upon similarities in... design... to the legally marketed devices." No specific design parameters or tests are enumerated. |
| Intended Use Equivalence | "This equivalence is based upon similarities in intended use... to the legally marketed devices." This is a descriptive criteria, not a performance metric. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify sample sizes (e.g., number of inserts tested).
- The data provenance (country of origin, retrospective/prospective) is not mentioned. These are typical engineering tests, not clinical studies in the AI sense.
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):
- This question is not applicable to the type of device and testing described. "Ground truth" in this context would refer to objective engineering measurements, not expert consensus on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This question is not applicable. Adjudication methods are used for human interpretation discrepancies, not for objective engineering measurements.
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 MRMC study was mentioned.
- This device is a physical knee implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. There is no AI algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the tests mentioned (contact area, range of constraint, attachment strength) would be objective engineering measurements obtained from mechanical testing equipment following established standards (e.g., ASTM, ISO).
8. The sample size for the training set:
- This question is not applicable. There is no training set as it's not an AI/machine learning device.
9. How the ground truth for the training set was established:
- This question is not applicable. There is no training set.
Summary of Device and Equivalence:
The Kinematic® II Replacement Tibial Inserts are mechanical orthopedic implants used for knee revision surgery. The submission focuses on demonstrating substantially equivalence to predicate devices based on:
- Intended Use: Revision of existing Kinematic® II tibial components.
- Material: Implicitly similar to predicate devices.
- Design: Implicitly similar to predicate devices.
- Performance Testing:
- Characterization of contact area.
- Characterization of range of constraint.
- Measurement of attachment strength of inserts to baseplates.
The "study" referenced is a series of engineering tests designed to show that the new inserts perform equivalently to the predicate devices in these physical properties. The summary indicates that "Comparisons were made to legally marketed devices," implying that the results of these tests demonstrated similar performance characteristics.
§ 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.