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The MRP-Titan system is intended to be used as the proximal part of a hip stem arthoplasty. The indications for use of the MRP-Titan system are revision operations and femur fractures of primary hip operated patients as well as tumour situations at the femur.

Primary and revision arthroplasty: Revision of primary hip stem prostheses
Fractures of the proximal femur
Tumor situation of the proximal femur
Reconstructions of the upper area of the proximal femur after both primary hip operation or traumafracture
Recovery of leg-lengthening
Improving antetorsion after failed primary hip stem operation

The patientmatched modular revision hip system MRP-Titan was developed to achieve best fixation of the stem in the femur canal by using a star-shaped design. Depending on the needed length the surgeon is able to decide using the sleeve or not. All necks are available in three sizes to achieve the total length needed. The use of the instruments and the single step to assemble the system is shown very clearly in the enclosed pictures.

The MRP-Titan components are single-use devices.

Here's an analysis of the provided text regarding the ROTEC MEDIZINTECHNIK GmbH MRP-Titan System, focusing on acceptance criteria and study data.

It's important to note that the provided documentation is a 510(k) summary for a medical device (hip prosthesis components). This type of submission focuses on demonstrating "Substantial Equivalence" to previously marketed devices, rather than comprehensive performance studies as might be seen for novel technologies or AI/software. Therefore, many of the typical AI/software performance study elements requested will not be present.

Based on the provided text, the device itself is a mechanical implant, not an AI/software device. The "acceptance criteria" here refer to the mechanical performance and biocompatibility of the implant, not the accuracy of an algorithm.

Acceptance Criteria and Device Performance (for a Mechanical Implant)

Study Information (as applicable for a mechanical implant 510(k))

Since this is a 510(k) for a medical device (hip prosthesis components) and not an AI/software device, many of the requested AI-specific study details are not applicable or not present in this type of regulatory submission. The studies described are engineering/biomechanical tests.

1. Sample size used for the test set and the data provenance:

   • Test Set (for Fatigue Testing): The document indicates "the device with 12/14 taper" was tested. It does not specify the exact number of physical samples tested, but usually, multiple samples would be subjected to fatigue testing to establish reliability.
   • Data Provenance: The fatigue testing refers to ISO standards (ISO 7206-4, -8), implying these tests were conducted in a controlled laboratory environment, likely in Germany where the manufacturer is located, or by a certified testing facility adhering to these international standards. The data is prospective, as it's generated specifically for regulatory submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. For mechanical fatigue testing, "ground truth" is not established by human experts in the same way as medical image interpretation. The "ground truth" is defined by the physical properties of the material and the engineering standards (ISO 7206 series) that specify failure criteria and loading conditions. The experts involved would be materials scientists, mechanical engineers, and quality assurance personnel overseeing the testing. Their qualifications would involve expertise in biomechanics, material science, and ISO standards.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert interpretations (e.g., diagnosing a condition from an image). For mechanical testing, the failure criteria are objective (e.g., "without any failure" as reported). The lab conducting the test ensures adherence to the ISO standard.

4. 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 device is a passive mechanical implant and does not involve AI or human readers for diagnostic interpretation.

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

   • Not applicable. This device is a passive mechanical implant and does not involve an algorithm.

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

   • For the fatigue testing, the "ground truth" for success is defined by the implant (specifically the 12/14 taper) surviving more than 5 x 10^6 cycles without any failure when loaded according to the specifications of ISO 7206 standards. This is a predetermined, objective engineering standard rather than an expert consensus or pathology.

7. The sample size for the training set:

   • Not applicable. This device is a physical implant, not a machine learning model. There is no "training set."

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

   • Not applicable. As there is no training set for a machine learning model, there is no ground truth to establish for it.

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