(88 days)
The Duracon® Constrained Posterior Stabilizer (PS) Tibial Inserts are intended to be used with legally marketed Duracon® tibial baseplates and wedges, Duracon® PS and TS femoral components, and patellar components as part of a total knee system in primary or revision cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments may or may not be present. More specific indications/contraindications are listed below:
Indications
- Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis,
- Rheumatoid arthritis,
- Correction of functional deformity,
- Revision procedures where other treatments or devices have failed,
- Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,
- Irreparable fracture of the knee
The Duracon® Constrained PS tibial inserts share critical design features as the predicate Duracon® TS tibial inserts. Both designs incorporate an intercondylar post which fits into the intercondylar cavity of the Duracon® TS or PS femoral component. Both designs have a metallic support bracket imbedded into the tibial insert at the time of manufacture. This bracket has two metallic feet which engage the posterior tabs of the baseplate during assembly. The insert-baseplate locking mechanism is augmented by a hex head locking screw in both designs.
The provided text describes a 510(k) summary for the Duracon® Constrained PS Tibial Inserts. However, it does not contain the specific information required to complete the table and answer all questions regarding acceptance criteria and a study demonstrating device performance. The document focuses on regulatory approval based on "substantial equivalence" to a predicate device, rather than detailed performance studies with acceptance criteria.
The "Performance Data" section merely states: "Mechanical testing has been performed to demonstrate the substantial equivalence of the subject inserts to the predicate inserts." It does not provide any specifics about the type of tests, the acceptance criteria, or the results.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's a breakdown of what can and cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | Mechanical testing was performed to demonstrate substantial equivalence to the predicate device. Specific results and parameters are not provided. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified (e.g., retrospective or prospective. It's mechanical testing, not a clinical study on patients, so concepts like country of origin for data aren't directly applicable in the same way).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the studies mentioned are mechanical testing, not a clinical assessment requiring expert ground truth.
4. Adjudication method for the test set
- Not applicable for mechanical testing.
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, an MRMC comparative effectiveness study was not done. This device is a knee prosthesis, not an AI diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used
- For mechanical testing, the "ground truth" would typically be established engineering standards or performance characteristics of the predicate device. However, the document doesn't specify these.
8. The sample size for the training set
- Not applicable. This is not a machine learning model, so there's no "training set."
9. How the ground truth for the training set was established
- Not applicable.
Summary of available information from the document:
- Device Name: Duracon® Constrained PS Tibial Inserts
- Predicate Device: Duracon® TS tibial inserts (K973164)
- Performance Data: Mechanical testing confirmed "substantial equivalence" to the predicate device. No details of the tests, criteria, or results are provided in this summary.
- Intended Use & Indications: Clearly defined, similar to the predicate device, for total knee arthroplasty in specific conditions where cruciate ligaments are inadequate or absent and stability is impaired.
- Contraindications: Clearly defined absolute and relative contraindications.
§ 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.