(88 days)
The MOST System is intended to replace the proximal, distal and/or total femur, especially in cases that require extensive resection and restoration. The Hex I/M Stem is intended for cemented use only in these situations. Specific diagnostic indications for use of the MOST System include:
- metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) . requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
- patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular . necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement of the proximal and/or distal femur;
- patients suffering from severe arthropathy of the hip and/or knee that does not respond to . any conservative therapy or better alternative surgical treatment;
- . revision cases requiring extensive resection(s) and replacement(s) of the proximal, distal, or total femur.
The MOST System is used for the replacement of the proximal, distal and/or total femur. Unlike primary hip and knee systems, this system is used where the amount of femoral resection and restoration required is extreme (e.g., in oncology cases). A total replacement is possible in those cases where no part of the femur can be salvaged.
The Hex I/M stems are hex shaped and designed to serve as the modular stem portion of either the proximal or distal femoral replacement. A taper feature at the end of the stem allows for connection to the mating modular component. The hex shape allows for rotational stability within the femoral canal once the stem is cemented into place. A ring of CSTi coating around the neck of the CoCr stem (ASTM F1537) allows for tissue attachment.
This 510(k) summary (K973087) submitted by Sulzer Orthopedics Inc. for the MOST Hex Intramedullary (I/M) Stem does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.
The document is a premarket notification (510(k)) which is primarily focused on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than establishing specific performance criteria through new studies.
Therefore, I cannot provide the requested information from the provided text.
Here's why the information is missing:
- 510(k) Premarket Notification: This regulatory pathway is typically used for lower-risk devices and relies on showing that a new device is "substantially equivalent" to a legally marketed predicate device. This often means demonstrating similar technological characteristics and indications for use, without necessarily requiring extensive new clinical or performance studies to define and meet specific acceptance criteria for a novel performance claim.
- Focus on Substantial Equivalence: The document explicitly lists predicate devices and states "Substantial equivalence determination is based on comparison of the MOST Hex I/M Stem to the following legally marketed predicate competitive devices." This comparison is the core of the submission, not a new performance study against defined acceptance criteria.
- Nature of the Device: The MOST Hex I/M Stem is a cemented stem for modular trauma or oncology applications in hip and knee joint replacement. For orthopedic implants like this, substantial equivalence often relies on material biocompatibility, mechanical testing (which might be referenced but isn't detailed as a 'study proving acceptance criteria' in this summary), and design similarity to already approved devices.
To answer your specific questions:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no "test set" in the context of a performance study to establish ground truth.
- Adjudication method for the test set: Not applicable.
- 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, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant.
- 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.
§ 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.