(219 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength (Axial and Lever Arm Disassembly) | Axial and lever arm disassembling (ASTM F 1820) testing results showed that there is enough safety regarding the lever arm disassembling force which is double as high as the load of an average human bending. Load values reported: Diameter 48 mm: 1156 N, Diameter 64 mm: 1460 N. |
| Fatigue Life (Hip Stem Compatibility) | Fatigue testing - using the MRS-Titan while testing hip stems - according to ISO 7206-4 has demonstrated that the device survived 5 x 10^6 cycles without failure while loaded according to ISO 7206. (This criteria applies to the system with a compatible hip head, not solely the MRS-Titan). |
| Biocompatibility of Materials | Approved medical-grade materials: Ti6Al4V (accord. to ASTM F 136), Ti1 CP Titanium (accord. to ASTM F 67), UHMWPE. The statement implicitly accepts these materials as suitable for implantation. |
| Sterilization Efficacy | The MRS-Titan system metal and Polyethylene will be shipped in sterile package by Gamma-Radiation > 25 kGy. (Acceptance criteria implicitly met by using a validated sterilization method). |
| Substantial Equivalence (Overall Function & Safety) | "MRS-Titan functions in a similar manner as predicted commercially available devices and are equivalent to systems cited in this application... MRS-Titan is substantially equivalent to other acetabular devices on the market in our design and intended function." (This is the primary acceptance criteria for a 510(k) submission, not a performance metric per se, but an overarching regulatory finding based on comparison to predicate devices and supporting data like mechanical testing). |
| Absence of Substantial Adverse Effects in Prior Literature | "We have reviewed all prior literature on this type of implant device and can not find a substantial body of information on the adverse effects with this device." (This is a statement regarding the review of existing knowledge, implying that no known adverse effects contradict its safety for market introduction, rather than a direct performance metric). |
| Potential Risks (Identified and Managed) | Potential risks associated with hip replacement devices are acknowledged and listed (e.g., reaction to bone cement, fracture, loosening, infection, etc.). The implication is that these risks are similar to predicate devices and are deemed acceptable given the benefits and design. |
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.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.