(166 days)
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
- Revision of previously failed total hip arthroplasty.
The Medallion Modular Hip System is a complete system of femoral stem implants. The implants have a proximal female dovetail groove attachment site that is utilized for attaching various modular trunnions. The modular trunnions have a distal male semi-dovetail projection that engages the female dovetail groove on one side in such a way that a keyway is defined between the two components. The implants also include a key that is to be wedged in the keyway to lock the three components together and prevent relative sliding.
The provided text is a 510(k) summary for the Medallion Modular Hip System. This document describes a medical device, and the information requested pertains to the acceptance criteria and detailed study information typically found for diagnostic devices or AI/ML-driven devices.
Based on the provided text, the Medallion Modular Hip System is an orthopedic implant (a total hip femoral component). For such devices, "acceptance criteria" usually refer to mechanical performance standards (e.g., strength, fatigue life, wear resistance) rather than diagnostic accuracy metrics.
Therefore, many of the requested categories are not applicable to this type of device and the information is not present in the provided 510(k) summary. I will answer what can be gleaned from the text.
Acceptance Criteria and Reported Device Performance
For an orthopedic implant like the Medallion Modular Hip System, acceptance criteria are typically related to mechanical strength and durability. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sufficient strength for intended use | "Testing demonstrates that the design has sufficient strength for the intended use" |
| Not present additional safety or efficacy issues compared to predicates | "The differences between the Medallion Modular Hip System and the predicates are not significant and have shown not to present additional safety or efficacy issues." |
| Substantial equivalence to predicate devices | "The information presented demonstrates that the Medallion Modular Hip System is substantially equivalent to currently marketed predicate devices." |
Study Details (Based on provided text)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any specific test set.
- Data Provenance: Not specified. It is implied that typical non-clinical bench testing was performed, likely in a laboratory setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not specified. Ground truth in the context of diagnostic accuracy for expert consensus is not relevant for an orthopedic implant's mechanical testing.
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Adjudication method for the test set:
- Not applicable / Not specified. Adjudication methods like 2+1 or 3+1 are used for reconciling expert opinions in diagnostic studies, which is not relevant here.
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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:
- No. This is not an AI/ML-driven diagnostic device. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm-driven device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For mechanical testing, the "ground truth" would be the measured mechanical properties of the device components compared to engineering specifications and performance of predicate devices.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of AI/ML or diagnostic models.
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How the ground truth for the training set was established:
- Not applicable.
Summary of what the document explicitly states regarding studies:
- Non-Clinical Testing: "The information presented demonstrates that the Medallion Modular Hip System is substantially equivalent to currently marketed predicate devices. The differences between the Medallion Modular Hip System and the predicates are not significant and have shown not to present additional safety or efficacy issues." This implies mechanical bench testing was performed.
- Clinical Testing: "No clinical testing was conducted for this design." This is a key statement, indicating that the device's substantial equivalence was based solely on non-clinical data and comparison to predicate devices.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.