Search Results

The EVOLUTION® BIOFOAM® Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
   The EVOLUTION® BIOFOAM® Tibial System is for use without bone cement.

The ADVANCE® BIOFOAM® Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis;
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
   The ADVANCE® BIOFOAM® Tibial System is for use without bone cement and is intended for use with EVOLUTION® and ADVANCE® modular keels.

The EVOLUTION® BIOFOAM® Tibial System is a line extension of the EVOLUTION® MP Total Knee System product line. The device is an asymmetrical tibial base with a BIOFOAM® coating on the distal surface. The design features are summarized below:
. Manufactured from titanium alloy conforming to ASTM F620/F136 (forged/wrought)
. Available in 11 sizes, left and right
Tibial base is available with and without holes for bone screws ●
. System includes 3 options of modular keels consisting of a two fin bullet-tip, a four fin bullet-tip and a four fin stem-accepting keel
Compatible with 510(k) cleared EVOLUTION® Tibial Inserts, ADVANCE® . Keels and ADVANTIM® Stems

The keel compatibility for the ADVANCE® BIOFOAM® Tibia is being expanded to include all keels subject to this 510(k). The subject design and indications remain identical according to K063128.

The provided text is a 510(k) Summary of Safety and Effectiveness for the EVOLUTION® BIOFOAM® Tibial System and ADVANCE® BIOFOAM® Tibial System. This document focuses on demonstrating substantial equivalence to existing predicate devices, not on providing the results of a primary study proving a device meets specific acceptance criteria in a clinical context.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it states:

• Clinical Testing: "Clinical data was not provided for the subject devices."
• Acceptance Criteria/Performance: The document discusses non-clinical testing for fatigue strength against a predicate device, but this is not presented as "acceptance criteria" with reported "device performance" in the clinical sense you've outlined.

The non-clinical testing section (D) does mention.

• Nonclinical Testing: "The subject EVOLUTION® BIOFOAM® Tibial System was evaluated for fatigue strength per ASTM F1800 and 3-point stem fatigue. Results concluded that the subject tibial base is expected to perform as well or better than the predicate device in fatigue loading."

While this indicates some engineering performance evaluation, it does not fulfill the requirements of your prompt for clinical acceptance criteria and related study details.

To answer your prompt directly based on the provided text:

1. A table of acceptance criteria and the reported device performance

   • Not available. The document states "Clinical data was not provided for the subject devices." Non-clinical testing for fatigue strength was performed, concluding "the subject tibial base is expected to perform as well or better than the predicate device in fatigue loading," but specific acceptance criteria and detailed performance metrics are not given for this non-clinical test.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Not available. No clinical test set information is provided. For the non-clinical fatigue testing, the sample size is not mentioned, and given it's a mechanical test, country of origin or retrospective/prospective status is not applicable in the human data 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)

   • Not applicable. No clinical test set was used, therefore no experts were used to establish clinical ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • Not applicable. No clinical test set 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 knee implant, not an AI diagnostic tool. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. Not an algorithm/AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Not applicable for clinical ground truth. For the non-clinical fatigue testing, the "ground truth" would be engineering standards (ASTM F1800) and mechanical measurements.

8. The sample size for the training set

   • Not applicable. This device is a physical implant, not an AI model requiring a training set.

9. How the ground truth for the training set was established

   • Not applicable. Not an AI model.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device (knee implant), not an AI/diagnostic device. Consequently, it does not contain the information you requested about clinical acceptance criteria and associated studies.

Ask a specific question about this device