(65 days)
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The Modular Oncology System Technology (MOST) will be used for the replacement of the proximal, distal or total femur. Replacement of the distal femur would also include replacement of the proximal tibia and the possible resurfacing of the patella, if necessary. Unlike primary hip and knee systems, this system will be used where the amount of femoral resection and restoration required is extreme (e.g., in oncology cases). The modularity of this system allows for the resection of varying amounts of the femur (and the proximal tibia and patella, if necessary) before implantation. The components of the MOST include:
- a proximal femoral replacement available with or without Cancellous-Structured Titanium" (CSTi ).
- suture holes on the Proximal Femur provide for soft tissue attachment, if necessary,
- intramedullary stems with CSTi and femoral segments which will be used in conjunction with the proximal and distal replacements,
- the distal femoral replacement which mates with a tibial component via a hinge-type mechanism, and
- an all-poly patella.
This document is a 510(k) summary for a medical device (Modular Oncology System Technology - MOST) and describes its substantial equivalence to existing devices. It does not contain information about acceptance criteria, device performance, or studies in the way typically expected for an AI/software assessment. The product description is for a physical orthopedic implant system, not a software or AI device.
Therefore, I cannot extract the requested information like sample sizes for test/training sets, expert qualifications, or details about comparative effectiveness studies, as these concepts are not applicable to the provided text.
Based on the provided text, there is no information available regarding:
- A table of acceptance criteria and the reported device performance: The document describes a physical medical device and its components, not performance metrics against acceptance criteria.
- Sample size used for the test set and the data provenance: Not applicable as this is a physical implant, not a software or AI device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
- If a standalone performance study was done: The document describes substantial equivalence to existing orthopedic implants, but doesn't detail standalone performance studies in the context of software/AI.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document focuses on establishing "substantial equivalence" of the MOST system to other legally marketed orthopedic implants (Wright Medical Technology, Inc., Waldermar Link, Joint Medical Products Corporation, and Howmedica, Inc.) based on its modular design and components for oncology cases. This is a regulatory pathway for physical medical devices, not a performance evaluation in the context of AI or software.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.