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The Smith & Nephew TANDEM Unipolar and Bipolar Hip System is intended for partial hip arthroplasty in skeletally mature patients. It is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture.

The TANDEM Unipolar and Bipolar head components are intended to articulate against the natural acetabulum, which requires no use of bone cement.

The TANDEM Hip System is designed to be used for hemiarthroplasty as implantation of these devices replace diseased, affected, or broken femoral head and/or neck with a prosthetic component, while keeping the natural acetabulum, or hip socket, intact. The TANDEM Hip System includes the TANDEM Unipolar Hip System and TANDEM International Bipolar Hip Systems are used for partial hip replacement procedure, in which the unipolar shell are designed to articulate against the host acetabular articular cartilage and replace the femoral head and/or neck during the implantation procedure. The key difference between a unipolar and a bipolar version of the TANDEM Hip System is number of rotational points that are provided – single (unipolar) or two (bipolar) — within the socket.

This document describes a 510(k) premarket notification for the TANDEM Hip System, which focuses on labeling updates to a previously cleared device. Therefore, the information provided does not include typical performance criteria and studies for a novel device. Instead, the submission argues for substantial equivalence based on the device being functionally and technologically identical to its predicates, with only changes to labeling and indications for use.

Due to the nature of this 510(k) submission (labeling updates only), there are no acceptance criteria and associated performance data from a study designed to prove the device meets these criteria in the traditional sense of a new device clearance. The "performance" being assessed here is the continued safety and effectiveness under the updated labeling, which is justified by the equivalence to existing cleared devices.

Here's an breakdown based on the provided text, addressing your points where applicable:

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

   • Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for a new device. The implicit acceptance criterion is that the device, with its updated labeling, remains substantially equivalent to its cleared predicates in terms of safety and effectiveness.
   • Reported Device Performance: Not applicable in the context of a new performance study. The submission asserts that the devices are "identical in function, design features, materials, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared." Therefore, their performance is presumed to be consistent with the performance already established for the predicate devices.

2. 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 was used for performance testing, as per the submission: "Therefore, since there are no changes to the design features, materials, or manufacturing methods of the TANDEM Hip System devices, no performance testing (bench, animal, clinical) was required."
   • The submission mentions that "post market surveillance data" was used to inform the labeling updates, particularly those related to the European Medical Device Regulation 2017/745. However, specific details about the sample size, provenance, or whether it was retrospective or prospective are not provided.

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 new test set required ground truth establishment by external experts for performance evaluation. The justification relies on the existing clearance of the predicate devices.

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

   • Not applicable. No test set for performance evaluation was conducted.

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. This is not an AI-assisted device. No MRMC study was conducted.

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

   • Not applicable. This is not an algorithm-based device.

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

   • For the purpose of this submission (labeling updates), the "ground truth" for the device's safety and effectiveness relies on the previously established substantial equivalence of the predicate devices to which the subject device is identical, and implicitly, the outcomes data and clinical experience gathered since their original clearance. The submission explicitly states "post market surveillance data" informed the labeling changes, which would involve real-world outcomes.

8. The sample size for the training set

   • Not applicable. No new training set was required for performance testing as there were no changes to device design, materials, or manufacturing requiring new performance data.

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

   • Not applicable, as no new training set was used.

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