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• Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
• Correction of varus, valgus, or posttraumatic deformity.
• Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
  The device is a single use implant intended for use with bone cement.

Vanguard™ Removable Molded Polyethylene Tibia is intended to replace the tibial articulating surface in a joint replacement along with femoral components that were cleared in K023546. There are three parts to the Vanguard™ Removable Molded Polyethylene Tibia component: the tibial tray, tibial bearing, and an insert.

The I-beam profile of the tibial tray is identical to that of the Maxim® tibial tray cleared in the following submissions K984623 and K991753. The articulating surface is identical to the surface cleared in K023546.

The provided document is a 510(k) summary for a medical device called the "Vanguard™ Removable Molded Polyethylene Tibia (Pop-Top)". This type of document is for premarket notification of a medical device and aims to demonstrate substantial equivalence to a predicate device already on the market. It does not typically include detailed studies with acceptance criteria, sample sizes, expert-established ground truth, or multi-reader multi-case studies as would be found in a clinical trial report for AI/CAD devices.

Based on the provided text, here's what can be extracted and what is explicitly stated as not applicable:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or a direct performance table as would be expected for an AI/CAD device. Instead, the "acceptance" is based on demonstrating substantial equivalence through non-clinical testing.

Study Details

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

   • No test set for clinical performance is mentioned. The assessment was based on non-clinical laboratory testing.

2. 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 from experts for a device performance test set.

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

   • Not applicable. No clinical test set or adjudication process is described.

4. 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. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This type of study is not relevant for this device's submission.

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

   • Not applicable. This is a physical implantable device, not an algorithm.

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

   • For the non-clinical testing, the "ground truth" would be established by engineering standards and specifications for material properties, mechanical performance, and design adherence to the predicate device. The document does not detail the specific ground truth methods for these non-clinical tests, but implies they were sufficient for substantial equivalence.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI/ML device that requires a training set.

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