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The Vanguard™ Patella is intended use is for replacement of part of the knee joint in conjunction with a femoral and tibial component. Specifically:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valqus or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

Features of the Vanguard™ Patella Components are as follows:

• 1", true dome shape .
• Grooves on the under surface ●
• Single or 3-peg design
• Available with or without an x-ray wire .
• ArCom polvethvlene .

The provided document is a 510(k) summary for the Vanguard™ Patella Components, a knee joint patellar component. It explicitly states:

"Clinical Testing: None provided"

This means that the submission does not include any clinical studies to demonstrate the device meets acceptance criteria. Therefore, most of the information requested in your prompt (such as acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) cannot be extracted from this document.

The basis for this device's acceptance is its substantial equivalence to legally marketed predicate devices (AGC® LP Patellar Button - K912245 and K921182) through non-clinical testing (engineering analysis).

Here's what can be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics. The underlying acceptance criterion for 510(k) clearance is "substantial equivalence" to a predicate device, which was demonstrated via engineering analysis.
• Reported Device Performance: Not reported in clinical terms as no clinical testing was performed. The device's performance is assumed to be equivalent to the predicate devices based on non-clinical engineering analysis.

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

• Not applicable. No clinical test set was used.

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 ground truth was established as no clinical testing was performed.

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. No clinical studies, including MRMC studies, were performed. This device is a medical implant, not an AI diagnostic tool.

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

• Not applicable. This device is a medical implant, not an algorithm. No standalone performance testing in this context was performed.

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

• Not applicable. No clinical ground truth was established as no clinical testing was performed. The "ground truth" for 510(k) clearance in this case was the established performance and safety of the predicate devices, against which the new device's engineering characteristics were compared.

8. The sample size for the training set

• Not applicable. No training set was used as no clinical study or machine learning algorithm development was performed.

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

• Not applicable. No training set was used.

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