(28 days)
Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures.
Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.
Like its predicate, the VerSys Fiber Metal MidCoat Low Head Center Hip Prosthesis is a cementless, straight, modular femoral stem. The proposed and predicate devices are designed with trapezoidal geometry and feature 12/14 Morse-type proximal neck tapers to mate with the corresponding 12/14 bore of a femoral head component. Both devices feature 125-degree neck angles and distal, longitudinal splines. The modified device is manufactured from Tivanium Alloy and has circumferential, commercially-pure titanium fiber metal pads for biological fixation.
The provided text describes a Special 510(k) submission for a device modification, not a study proving a device meets acceptance criteria for an AI/ML-driven medical device. Therefore, much of the requested information regarding AI/ML device performance, ground truth, expert opinions, and training/test sets is not applicable to this document.
The document discusses the VerSys® Fiber Metal MidCoat Low Head Center Hip Prosthesis, a total hip prosthesis. The submission is for a modification to an existing cleared device (K042776).
Here's an analysis based on the provided text, highlighting what is and isn't available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Non-clinical performance testing demonstrated that the device is equivalent to the predicate." However, it does not provide a table of acceptance criteria or specific performance metrics. The "acceptance criteria" in this context would likely be related to mechanical properties, biocompatibility, and sterilization effectiveness – all of which are implicitly met through equivalence to the predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (Likely mechanical strength, fatigue, material properties, biocompatibility, sterilization effectiveness) | Non-clinical performance testing demonstrated equivalence to the predicate device (VerSys Beaded MidCoat Low Head Center Hip Prosthesis, K042776). |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable as this is a non-clinical device modification submission, not a study involving a test set of data (e.g., medical images). The "test set" in this context would refer to material samples or test specimens. The document doesn't specify the sample sizes for the non-clinical performance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable. "Ground truth" in this context would typically refer to expert consensus on medical findings for AI/ML evaluation. For a hip prosthesis, ground truth would be established through specific engineering standards, physical testing, and material science analysis rather than expert medical interpretation of images. The document does not mention any experts in this capacity.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple experts reviewing medical data, which is not relevant to this device modification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic or prognostic devices to assess the impact of AI on human reader performance. This submission is for a physical medical device (hip prosthesis).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone performance evaluation (in the context of an algorithm) was not done. This is a hardware device.
7. The Type of Ground Truth Used:
For this device, the "ground truth" would be established by:
- Engineering standards and specifications: Defining the required mechanical properties, material composition, wear resistance, etc.
- Physical and mechanical testing: Including fatigue testing, static strength testing, and material characterization (e.g., tensile strength, hardness, surface roughness).
- Biocompatibility testing: As per ISO standards.
- Sterilization validation: Ensuring the device can be consistently sterilized.
The document states "Non-clinical performance testing demonstrated that the device is equivalent to the predicate," implying that these types of engineering and laboratory tests were performed and validated against established benchmarks for the predicate.
8. The Sample Size for the Training Set:
This information is not applicable as there is no "training set" in the context of an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" in the context of an AI/ML algorithm.
In summary, this document is a regulatory submission for a physical medical device modification, where "performance data" refers to non-clinical engineering and material equivalence testing, rather than a clinical study or AI/ML performance evaluation.
§ 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.