(147 days)
Joint replacement is indicated for patients suffering from disability due to:
- · noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
- rheumatoid arthritis:
- · correction of functional deformity;
- · femoral fracture.
This device may also be indicated in the salvage of previously failed surgical attempts.
This device is indicated for cementless use.
The DJO Acetabular System allows for the total replacement of the acetabulum. The system consists of porous coated titanium acetabular cups, bone screws for use with the cups, and acetabular liners manufactured from highly crossed linked polyethylene with Vitamin E. It is designed for compatibility with currently cleared DJO stems and femoral heads.
This looks like a 510(k) summary for a medical device that does not involve AI. Therefore, most of the questions about acceptance criteria, study design, ground truth, and expert involvement are not applicable in the context of AI/ML devices.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The provided document describes a traditional medical device (hip implant) and does not specify quantitative acceptance criteria in the way you would expect for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly that the device performs equivalently to the predicates in non-clinical mechanical testing.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Ability to perform under expected conditions consistent with predicates in: | Device demonstrated ability to perform under expected conditions. |
| All testing determined that the device is substantially equivalent to the predicate devices. | |
| - Range of Motion Analysis | (Passed - Implicitly equivalent to predicates) |
| - Impingement Testing | (Passed - Implicitly equivalent to predicates) |
| - Push Out, Lever Out, and Torsional Strength | (Passed - Implicitly equivalent to predicates) |
| Pyrogen limit specifications met via Kinetic Chromogenic method | Pyrogen limit specifications are met via the Kinetic Chromogenic method for bacterial endotoxin testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This device clearance did not involve clinical testing as stated: "Clinical Testing: Clinical testing was not required". Therefore, there is no "test set" of patient data in the context of an AI/ML study. The "testing" referred to is mechanical testing of the physical device components. The document does not specify sample sizes for these mechanical tests, nor is data provenance (country, retrospective/prospective) relevant here.
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, as no clinical testing or AI/ML ground truth was established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing or AI/ML ground truth was established.
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 a physical hip implant device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For mechanical testing, the "ground truth" is typically defined by engineering specifications, material properties, and comparison to predicate device performance under controlled laboratory conditions, rather than clinical outcomes or expert consensus on a diagnosis.
8. The sample size for the training set
Not applicable. There is no AI/ML model to train.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model to train.
§ 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.