(80 days)
The Duracon® Extra-Small Stabilizer Tibial Insert and Baseplate are intended to be used with previously released Duracon femoral and patellar components as a total knee system in primary or revision cemented total knee arthroplasty. These components are specifically intended to be used in situations where the posterior cruciate ligament is not intact, not present, or cannot be repaired. The collateral ligaments should be intact, or repaired so that adequate mediolateral stability is present. These components are intended to be implanted using bone cement in small boned, skeletally mature individuals.
The Duracon® Extra-Small Stabilizer Tibial Insert and Baseplate are intended to be used with previously released Duracon® femoral and patellar components as a total knee system in primary or revision cemented total knee arthroplasty. These components are specifically intended to be used in situations where the posterior cruciate ligament is not intact, not present, or cannot be repaired. The collateral ligaments should be intact, or repaired so that adequate mediolateral stability is present. These components are intended to be implanted using bone cement in small boned. skeletally mature individuals.
The provided text is a 510(k) summary for the Duracon® Extra-Small Stabilizer Tibial Insert and Baseplate. It describes the intended use and states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain acceptance criteria or detailed results from a study that would prove the device meets specific performance metrics. Instead, it refers to testing being "presented in accordance with the FDA Draft Guidance on Testing Semi-Constrained Total Knee Replacements," but it does not present the results of that testing or any specific acceptance criteria.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not mentioned. The document only states that "testing... was presented."
- Number of experts used to establish the ground truth... and qualifications: Not applicable, as no ground truth creation for test sets is described.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned.
- Standalone performance study: Not mentioned. The document focuses on substantial equivalence to predicate devices, not specific performance metrics against a defined standard.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable, as this is not a study involving AI or machine learning.
- How the ground truth for the training set was established: Not applicable.
Summary of available information related to performance/equivalence:
- Device: Duracon® Extra-Small Stabilizer Tibial Insert and Baseplate
- Intended Use: Used with previously released Duracon® femoral and patellar components as a total knee system in primary or revision cemented total knee arthroplasty, specifically when the posterior cruciate ligament is not intact/present/repairable, and collateral ligaments are intact or repaired for mediolateral stability. Intended for use in small boned, skeletally mature individuals with bone cement.
- Basis for Equivalence: Substantially equivalent to:
- Equivalence Attributes: Similarities in intended use, design, materials, and surgical placement.
- Testing Mentioned: "Testing of these extra-small components was presented in accordance with the FDA Draft Guidance on Testing Semi-Constrained Total Knee Replacements." (No results or specific criteria are provided).
- Specific Limitations/Conditions from FDA Letter:
- Thinnest tibial insert available is the nominal "9mm" size, with a minimum polyethylene thickness under the condyles of 6.0mm.
- May not be labeled or promoted for non-cemented use.
- All labeling must prominently state intended for cemented use only.
- Non-cemented fixation is considered investigational (significant risk device) and requires IDE approval.
The document is a regulatory submission focused on demonstrating substantial equivalence to pre-existing devices, not a detailed scientific study outlining performance against predefined acceptance criteria.
§ 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.