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1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, or traumatic arthritis where one or more compartments are involved.
2. Failure of previous joint replacement procedure.
3. Correction of varus/valgus or post-traumatic deformity.
4. Correction or revision of unsuccessful osteotomy, or arthrodesis.
   . Device designed for use in patients with metal sensitivity.
   Standard surgical and rehabilitative procedures are indicated with this device. .
   . The device is a single-use device intended for use with bone cement.

The Vanguard™ Knee System Titanium Femoral Components have the same design as the predicate Vanguard™ femoral knee components originally cleared as the Maxim® Accel Knee System femoral components. The difference in material offers the opportunity for total knee replacement to those patients with metal sensitivity to the nickel element of the predicate Co-Cr-Mo Cobalt - Chromium alloy femoral knee components.

The provided 510(k) summary for the Biomet Vanguard™ Knee System Titanium Femoral Components does not describe acceptance criteria or a study proving the device meets them in the context of typical AI/software device evaluation metrics (e.g., sensitivity, specificity, AUC).

Instead, this document is a premarket notification for a medical device (a knee implant) that emphasizes "substantial equivalence" to predicate devices. The "testing" mentioned refers to non-clinical laboratory testing to ensure the device is functional for its intended use, rather than a clinical trial or performance study against specific acceptance criteria in the manner of AI/imaging diagnostics.

Here's a breakdown based on the information provided and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing: Specific quantitative performance metrics (e.g., wear rates, mechanical strength thresholds, clinical outcomes) and numerical results demonstrating compliance with those thresholds. The document states "Non-clinical laboratory testing was performed to determine substantial equivalence," but does not detail the specific tests, their acceptance criteria, or the explicit results.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable/Not provided. The document refers to "non-clinical laboratory testing," which would typically involve physical samples of the device undergoing mechanical or material tests, not a "test set" of patient data.
• Data Provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No "ground truth" established by experts in the context of diagnostic performance is mentioned. The assessment is based on non-clinical engineering and material science evaluations.

4. Adjudication method for the test set

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

• No. This type of study is not mentioned as it is typically relevant for diagnostic imaging devices or algorithms where human interpretation is involved.

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

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

7. The type of ground truth used

• The "ground truth" here would be the physical and mechanical properties of the device meeting engineering specifications and biocompatibility requirements. This would be established by standard engineering and material science testing methods (e.g., ASTM standards), not by expert consensus, pathology, or outcomes data in the way typically associated with AI/diagnostic devices.

8. The sample size for the training set

• Not applicable. There is no training set for this type of physical medical device.

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

• Not applicable.

Summary of what the document focuses on instead:

The core of this 510(k) submission is to demonstrate substantial equivalence to already legally marketed predicate devices. This means the manufacturer shows that the new device has the same intended use, indications for use, and technological characteristics, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

• The primary "study" mentioned is non-clinical laboratory testing to ensure the device is functional.
• Clinical testing was explicitly not provided as a basis for substantial equivalence. This is a common aspect of 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data and comparisons to predicate devices.
• The key finding stated is that "The results indicated that the device was functional within its intended use." This is the broad "acceptance criterion" that the non-clinical testing aimed to meet.

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When used with the AGC and Maxim Knee Systems, the indications for use of the Titanium Femoral Component include 1)painful and disabled knee joint resulting from osteoarthritis, rheumatiod arthritis, or traumatic arthritis where one or more compartments are involved, 2)failure of a previous joint replacement procedure. 3)correction of varus, valgus or post traumatic deformity, and 4)correction or revision of unsuccessful osteotomy or arthrodesis.

Device designed for use in patients with metal sensitivity.

Standard surgical and rehabilitative procedures are indicated with this device.

This device is a single use implant for use with bone cement

The femoral components of the AGC and Maxim Knee Systems are identical to their Co-Cr-Mo predecessors with the exception of the material used in manufacturing and a limited component availability. The AGC titanium component is available in primary universal components of five different sizes. The Maxim titanium component is available in five sizes of the primary universal component and five sizes of the revision universal component.
The titanium components are all N ion implanted, to Biomet engineering specification 1.4, in order to reduce the wear of both the titanium femoral component and the ultrahigh molecular weight polyethylene (UHMWPE).

The provided document is a 510(k) summary for a medical device, the Titanium Femoral Component, and does not contain information about acceptance criteria or a study proving the device meets said criteria.

Instead, the document focuses on:

• Substantial Equivalence: It asserts that the Titanium Femoral Component is substantially equivalent to other knee components already on the market from various manufacturers, including:
  • Maxim Knee System (Biomet, Inc.)
  • AGC 2000 Total Knee Prosthesis (Biomet, Inc.)
  • MG II Total Knee (Zimmer, Inc.)
  • Kinemax Plus Total Knee System (Howmedia, Inc.)
  • Genesis Total Knee System (Smith & Nephew Richards, Inc.)
• Device Description: Details the material (titanium, N ion implanted) and available sizes, noting it's similar to predecessors made of Co-Cr-Mo.
• Intended Use: Specifies its use with the AGC and Maxim Knee Systems for conditions like osteoarthritis, rheumatoid arthritis, previous joint replacement failure, and deformity correction, particularly for patients with metal sensitivity and for use with bone cement.
• Potential Risks: Lists general risks associated with joint replacement devices.
• FDA Communication: A letter from the FDA confirming the finding of substantial equivalence, allowing the device to be marketed, with specific limitations regarding its use as a cemented device only.

Therefore, because this is a 510(k) submission based on substantial equivalence to predicate devices rather than a de novo submission requiring clinical performance data against specific acceptance criteria, it does not include the details requested in your prompt. The "acceptance criteria" here are implicitly satisfying the FDA's requirements for substantial equivalence to legally marketed predicate devices.

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