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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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This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
3. Correction of function deformity;
4. Revision procedures where other treatments or devices have failed;
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.

This device is a single use implant and intended for cementless use only except cemented stem which is designed for cemented use only.

There are two purposes in current submission, the fist one is to expand the Indications for Use of two cleared products: U2 Hip System (K111546) and Femoral Heads, +2.5 & +7.5 mm Offset (K122504), which have been expanded to a population with similar demographic, diagnosis and prognosis as the original. The second purpose of this submission is to reword the statement of Indications for Use of six cleared "UNITED" hip products including U1 Hip System (K994078), U2 Hip Stem, Ti porous coated (K003237), U2 Acetabular Cup and Femoral Head (K022520), U2 Acetabular Component (K050262), U2 Hip Stem and Ti Plasma Spray (K062978) and U2 Acetabular Cup, Plasma Spray (K121777). Through this submission, the Indications for Use of above listed devices are unified as one version, and the components, materials, design, processing methods, sterilization methods, biocompatibility, safety and effectiveness of above listed devices are unchanged by this submission.

The provided text describes a 510(k) summary for the "U2 Hip System, Expanded Indications for Use". This document focuses on establishing substantial equivalence to previously cleared predicate devices for the indications for use of a hip implant system, rather than proving the performance of a newly designed device through explicit acceptance criteria and a detailed study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established is not applicable in this context.

Here's why and what the document does provide:

• Type of Device: This is a hip prosthesis (total hip replacement system).
• Regulatory Pathway: This is a 510(k) premarket notification. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics (design, materials, packaging, sterilization) and intended use, rather than conducting new clinical performance studies against specific acceptance criteria for a novel device.
• Purpose of the Submission:
  1. Expand Indications for Use: For two existing products (U2 Hip System K111546 and Femoral Heads K122504) to include a similar patient demographic, diagnosis, and prognosis.
  2. Reword/Unify Indications for Use: For six other cleared "UNITED" hip products to a single, unified version.
• Basis for Substantial Equivalence: The submission states that the components, design, materials, packaging, and sterilization method of the "U2 Hip System - Expanded Indications for Use" are identical to cleared predicate devices. The only difference is the integration of indications for use.
• Non-Clinical and Clinical Testing: The document explicitly states:
  • "Non-clinical laboratory testing is not provided as a basis for substantial equivalence."
  • "Clinical Testing None provided as a basis for substantial equivalence."

Conclusion:

This submission does not contain information about a study designed to prove the device meets specific acceptance criteria in the manner requested because it relies on demonstrating substantial equivalence to pre-existing, legally marketed devices. The performance and safety of the device are implicitly linked to the predicate devices it is compared against, not to new performance data generated for this specific submission.

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The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acefabular components have been considered. The R3 Constrained Liner is intended for single use only.

The R3 Constrained Liner and Shell Construct is a multi-piece acetabular component made up of an R3 Shell and the Constrained Liner Constrained Liner Construct includes a bipolar bearing which articulates with a captured outer polyethylene liner, locking ring and outer poly support ring.

The R3 Constrained Liner may be used with previously implanted femoral stems, femoral heads and acetabular shells as in a revision case, or it may be used in primary cases and implanted along with a shell, head and stem. The R3 Constrained liner was designed to be used with existing Smith & Nephew hip components. The R3 Constrained Liner should not be used with ceramic femoral heads or skirted femoral heads of any material.

The provided document is a 510(k) summary for the Smith & Nephew R3 Constrained Liners. This document details the regulatory clearance process for a medical device and relies on showing "substantial equivalence" to a predicate device, rather than explicit acceptance criteria and performance studies for the new device.

Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

Instead, the document states:

• D. Summary of Technological comparison: "The intended use, design, and materials of the R3 Constrained Liners are substantially equivalent to the previously cleared Osteonics Constrained Liners (P960047). Design Control Activities have been completed and the results indicated that the subject device is safe and effective."

This indicates that the safety and effectiveness of the R3 Constrained Liners were established through design control activities and a comparison to a predicate device, rather than through a performance study against predefined acceptance criteria for the new device as would be typical for software or AI medical devices.

To answer your request, if this were a software/AI device, I would need a different type of submission document that would detail performance studies.

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