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The MRS-Titan system is intended to be used as the acetabular part of a hip arthroplasty. The indications for use of the MRS-Titan system are revision operations and fractures of primary hip operated patients, especially with large bone defects in the acetabulum, as well as tumour situations at the acetabulum.

Painful, disabling joint diseases of the hip resulting from degeneration, arthritis, rheumatoid arthritis, post traumatic arthritis.
Revision of previous unsuccessfull femoral head replacement, cup arthroplasty or other procedure.
Clinical management problem solve arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated deficiencies of the acetabulum.

The patientmatched modular revision acetabular system MRS-Titan was developed to achieve best fixation of the cup in the acetabulum by using a cementless bone fixation technique. Depending on the needed diameter the surgeon is able to decide the size between Ø 48 mm and Ø 64 mm in 4 mm steps. All diameters are able to be used either with a caudal hook and a strap, two straps or only with two straps. In general the caudal hook is designed to fix the original center of rotation because generally the use of MRS-Titan is intended after the second, third or fourth revision operation at the natural acetabulum. Typically this condition shows a very bad boney situation. So this device allows the surgeon to create a good remodelling of the acetabular bone as well as a good mechanical stabilisation of the cup. In comparison to other systems having received the SEletter the straps are not fixed in one angle, rotation allows to adapt the straps in best angle situation the patient needs. The MRS components are single-use devices.

The provided text describes the ROTEC MEDIZINTECHNIK GmbH MRS-Titan System, an acetabular revision system. However, it does not contain specific acceptance criteria or a study designed to prove the device meets such criteria in a way that would allow for the detailed answers requested. Instead, the document is a summary of safety and effectiveness information for a 510(k) application, focusing on substantial equivalence to predicate devices and mechanical testing within established standards.

Therefore, many of the requested fields cannot be answered directly from the provided text.

Here's an attempt to answer based on the available information, noting where details are missing:

1. Table of acceptance criteria and the 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)

• Sample Size for Test Set: Not specified for any specific clinical test set. The mechanical tests (ASTM F 1820 and ISO 7206-4) would have involved a sample of the manufactured devices, but the exact number of units tested is not stated. These are laboratory tests, not clinical data.
• Data Provenance: Not specified. The company is based in Germany, so it's plausible the testing was conducted there or by affiliated labs. The data is from in vitro mechanical testing, not human clinical trials (retrospective or prospective).

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)

• This question is not applicable. The device's performance was evaluated through in vitro mechanical testing against established standards (ASTM F 1820, ISO 7206). There was no "ground truth" derived from expert consensus on clinical cases. The "experts" involved would be engineers and material scientists conducting the tests and interpreting the results against the standards. Their qualifications are not mentioned.

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

• Not applicable. This concept pertains to human review of clinical data, often involving multiple readers and a consensus or adjudication process. The provided document concerns in vitro mechanical testing and a regulatory submission based on substantial equivalence.

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 device is a physical implant (acetabular revision system), not an AI diagnostic or assistance tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not applicable. This device is a physical implant, not an algorithm or AI system.

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

• The "ground truth" for the device's mechanical performance was adherence to recognized international standards for orthopedic implants (ASTM F 1820 for disassembling forces and ISO 7206-4 for fatigue testing) and the use of biocompatible materials. The core of the 510(k) submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices rather than proving novel clinical efficacy through outcomes data.

8. The sample size for the training set

• Not applicable. This device is a physical implant, not a machine learning model. There is no concept of a "training set" in this context. The manufacturing process of such devices involves extensive quality control and verification, but not "training data."

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

• Not applicable, as there is no training set for this type of device.

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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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