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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

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The NBD Cement Restrictor Device is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. The NBD Cement Restrictor is NOT intended for any spinal indications.

The NBD Cement Restrictor Device is a hollow, titanium, rounded rectangular frame with fenestrated surfaces on all sides and 1mm toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.

The provided text describes a medical device, the NBD Cement Restrictor, and its 510(k) submission to the FDA. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, a study proving the device meets those criteria, or details about training and test sets, expert involvement, or comparative effectiveness studies.

The document primarily focuses on:

• Device Description: What the NBD Cement Restrictor is (hollow, titanium, rounded rectangular frame with fenestrated surfaces and spikes).
• Intended Use: As a cement restrictor in orthopedic surgeries like hip stem and total knee replacement, specifically excluding acetabular cup surgeries.
• Performance Data: States "No applicable performance standards have been promulgated," but mentions the material conforms to ISO 5832-3.
• Functional & Safety Testing: A general statement that testing "consisted of examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications. The results were successful and did not raise any issues of safety and effectiveness of the device." This is a qualitative statement, not a detailed study with acceptance criteria.
• Substantial Equivalence: To the RA-BEATM Cement Restrictor Device (K990345), and mentions other predicate devices. This is the primary basis for FDA clearance in this case.
• FDA Communication: The FDA's clearance letter, including a specific warning against spinal indications.

Therefore, many of the requested sections cannot be filled based on the provided text.

Here's a breakdown of what can be inferred or directly stated, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided. The document states "Functional and safety testing... consisted of examination of the function of the device under conditions similar to those found in normal usage" but gives no details on the sample size, specifics of the "conditions," or provenance (e.g., in-vitro, ex-vivo, animal, human, country of origin).

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/Not provided. The device is a physical implant, not an AI or diagnostic device that requires expert-established ground truth for a test set in the conventional sense. The "testing" mentioned is likely engineering/bench testing.

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

• Not applicable/Not provided. This refers to consensus-building among experts, which is not described for the functional/safety testing of this physical device.

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

• No. This is a physical medical device (cement restrictor), not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to its type of evaluation.

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

• No. This is a physical medical device. The concept of "standalone algorithm performance" does not apply.

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

• Not applicable in the typical sense. For a physical device like this, "ground truth" would be established by engineering specifications, material properties, and observed mechanical performance under simulated load or surgical scenarios. The document states "conformance to product specifications" and "successful" function without further detail.

8. The sample size for the training set

• Not applicable/Not provided. This device is not an AI model, so there is no "training set."

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

• Not applicable/Not provided. As there is no AI model, there is no training set or ground truth for it.

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