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The Cross-Over Acetabular Shell and Liner are intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip Arthroplasty.
   The Cross-Over Acetabular Shell and Liner are used as part of the Provident Hip Systems. The components of this hip system are intended for cementless fixation.

The Cross-Over Acetabular Shell and Liner will be used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty.
The Cross-Over Acetabular Shell is made of titanium alloy with a commercially pure titanium plasma spray coating. The Cross-Over Liner is made of polyethylene blended with Vitamin E. The liner is available in both non-hooded and hooded options.

This K122773 submission for the Cross-Over Acetabular Shell and Liner is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study or a standalone algorithm performance study.

Therefore, many of the requested categories in the prompt (e.g., acceptance criteria, reported device performance, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, ground truth for training set) are not applicable to this type of submission.

Here's a breakdown of what is available and what is not applicable based on the provided text:

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

• Not Applicable. This submission is for a medical device (hip implant components). The "acceptance criteria" here relate to the mechanical and material properties necessary to demonstrate substantial equivalence to existing devices, not a performance metric like accuracy or sensitivity for a diagnostic algorithm. The document states "Non-clinical testing was performed on the Cross-Over Acetabular Shell and Liner to assess the interconnection mechanism between the shell and liner (i.e., disassembly force, lever-out torque, and rotational failure torque). The results of the performed tests demonstrate that the Cross-Over Acetabular Shell and Liner are substantially equivalent to legally marketed predicate devices." However, specific quantitative acceptance criteria and the numerical results against those criteria are not provided in this summary.

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

• Not Applicable. This is a physical device, and the testing described is non-clinical (mechanical/bench testing), not performance measured on a test dataset of patient data.

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. Ground truth, in the context of expert review, is not relevant for this type of mechanical device testing.

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

• Not Applicable.

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 a physical hip implant component, not an AI or diagnostic imaging device.

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

• Not Applicable. This is a physical hip implant component.

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

• Not Applicable. For mechanical testing, the "ground truth" would be the measured physical properties according to established engineering standards, rather than expert consensus on medical findings.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable.

Summary of the Study and Substantial Equivalence Claim:

The study described for the Cross-Over Acetabular Shell and Liner is a preclinical (non-clinical) testing program.

• Objective: To assess the interconnection mechanism between the shell and liner.
• Specific Tests Conducted: Disassembly force, lever-out torque, and rotational failure torque.
• Purpose: To demonstrate substantial equivalence to legally marketed predicate devices. This means the device met the expected performance characteristics in these non-clinical tests, and these results were deemed comparable to those of the predicate devices.
• Predicate Devices:
  • Acetabular Shells in the Stelkast Provident Hip System (K001745)
  • EXp Acetabular Liner (K094035)
• Basis for Substantial Equivalence: The predicate devices have the same intended use, general design, similar size range, and are made of the same materials. The non-clinical testing confirmed similar performance characteristics for the interconnection mechanism.

In essence, this submission focuses on demonstrating that the new device is as safe and effective as already legally marketed devices, based on comparative design, materials, indications for use, and a limited set of non-clinical mechanical tests, rather than establishing performance against de novo acceptance criteria through clinical or algorithmic studies.

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