(427 days)
Total hip replacement is indicated in the following conditions:
- A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
- Avascular necrosis of the femoral head.
- Acute traumatic fracture of the femoral head or neck.
- Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The subject devices are a line extension to the existing range of Articul/Eze 36mm Femoral Heads and represent additional taper sizes and offsets to allow surgeons more flexibility in the choice of femoral hip stem. Specifically, the tapers include 12/14 Articul/Eze taper with +15.5mm offset, 11/13 S-ROM taper with -3mm, 0mm, +3mm, +6mm, +9mm and 12mm offsets, and 14/16 taper with 0mm, +3mm, +5mm, +8mm and +11mm offsets. The tapers are designed to mate with femoral hip stems which have matching neck taper sizes. The offsets vary to allow the surgeon flexibility in lateralization of the hip joint.
There is no information in the provided text about acceptance criteria or a study proving that a device (in the context of AI or diagnostic algorithms) meets such criteria. The document is a 510(k) summary for DePuy M-Spec 36mm Femoral Heads, which are medical devices used in total hip arthroplasty (hip replacement), not a "device" in the sense of an AI/ML algorithm.
The document states that a dimensional analysis was conducted to demonstrate substantial equivalence to predicate devices, but this is a characteristic of the physical product, not a performance metric that would typically have "acceptance criteria" in the way an AI algorithm does (e.g., sensitivity, specificity thresholds).
Here's an analysis based on the provided text, highlighting what is and is not present:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. The document describes a physical medical device (femoral heads) and its substantial equivalence to previously cleared devices. It does not contain acceptance criteria or performance metrics (like sensitivity, specificity, or AUC) typically associated with diagnostic AI or similar software devices. The "performance data" section only mentions "dimensional analysis" to show substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. There is no "test set" in the context of an AI/ML device. The "dimensional analysis" would involve measuring the physical characteristics of the femoral heads. Information on the number of units measured or their origin is not provided.
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)
- Not Applicable. There is no "ground truth" establishment by experts because this is not an AI/ML device requiring such validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is described as it's not relevant for this type of device submission.
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 is not an AI-assisted device, so no MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth, as typically defined for AI/ML devices, was used. The demonstration of substantial equivalence relied on a "dimensional analysis" comparing the new device's physical dimensions to those of predicate devices.
8. The sample size for the training set
- Not Applicable. There is no training set for a physical medical device like this.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set or ground truth for this type of device.
In summary: The provided text is a 510(k) summary for a physical medical device (femoral heads) and does not relate to an AI/ML device or software. Therefore, most of the requested information about acceptance criteria for AI performance studies is not present or applicable. The submission focused on demonstrating "substantial equivalence" through dimensional analysis rather than performance metrics typically associated with AI/ML algorithms.
§ 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.