Search Results

Artisan Bone Plug: These bone plugs are intended to be placed in the femoral canal prior to the introduction of bone cement in a cemented hip procedure. The plug is placed distally to the femoral stem to help allow cement pressurization and to help prevent cement migration further down the femoral canal.
Universal Cement Restrictor: For cement spacers, mid-shaft restrictors and Cement Plugs: In cemented hip arthroplasty, when the cement spacer, restrictor and/or plug is thought to be advantageous.

The Artisan Bone Plug and Universal Cement Restrictor are commercially available devices that have been determined substantially equivalent in previous 510(k) premarket notifications. The purpose of this submission is to modify the labeling of these devices to add MR Conditional labeling and make other minor labeling updates.

Based on the provided text, the document is a 510(k) summary for a medical device (Artisan Bone Plug and Universal Cement Restrictor). It describes a labeling update for these devices, specifically adding "MR Conditional" labeling.

Crucially, the text explicitly states:

• "Clinical Testing: Clinical testing was not required as a basis for substantial equivalence."
• "There have been no changes to the technological characteristics of the subject devices as a result of the revision to the labeling. The subject devices have the same design and are manufactured from the same materials as the predicate devices."

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets performance criteria in the context of clinical or AI-based performance. Instead, it relies on non-clinical testing for MR compatibility and the substantial equivalence to previously cleared predicate devices.

Here's why the requested information cannot be provided from the given text:

1. AI/Algorithm Performance: The device (Bone Plug/Cement Restrictor) is a physical implant, not an AI or software-based medical device. The concepts of "device performance" in terms of AI metrics (like sensitivity, specificity, accuracy), test sets, expert ground truth, adjudication, MRMC studies, or standalone algorithm performance are not applicable to the information provided.
2. Clinical Performance Study: The document explicitly states that clinical testing was not required for the substantial equivalence determination for this labeling update. The non-clinical testing mentioned is solely for MR compatibility (displacement, torque, image artifact, heating).
3. Acceptance Criteria Table: Since there are no clinical performance studies or AI-based performance metrics discussed, there are no acceptance criteria for such metrics. The "acceptance criteria" here would relate to regulatory compliance and the results of the non-clinical MR testing, which are described in a qualitative manner ("do not create a new worst case").

Summary of what can be extracted related to "study" and "criteria":

• Study type: Non-clinical testing for MR compatibility.
• Tests performed:
  • Magnetically Induced Displacement Force (ASTM F2052-15)
  • Magnetically Induced Torque (ASTM F2213-17)
  • Image Artifact (ASTM F2119-07, Reapproved 2013)
  • Heating by RF Fields (ASTM F2182-19)
  • Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2019 for pyrogenicity.
• "Proves device meets acceptance criteria": An engineering analysis was conducted which determined that the subject devices "do not create a new worst case" compared to devices previously tested for MR compatibility (K153345). For BET, the acceptance criterion was an "endotoxin limit of

Ask a specific question about this device