(324 days)
Total Hip Arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where is evidence of sufficient sound bone to seat and support the components. The Excera FitRite™ Total Hip Arthroplasty System is indicated for total hip replacement 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
- Certain cases of ankylosis.
The FitRite™ DDH Femoral Stems, Standard Femoral Stems, and Acetabular Cups are intended for cementless application; the FitRite™ Cemented Femoral Stems are intended for cemented application.
The Excera Orthopedics FitMore™ Total Hip Arthroplasty System is intended to be used for primary total hip replacement in skeletally mature individuals. The System's modular design provides a large selection of component sizes.
The System includes three stem designs; a double tapered Femoral Stem (uncemented) with the proximal metaphyseal portion CpTi plasma spray coated, a double-tapered Femoral Stem (un-cemented) with the same essential proximal taper inclusive of a distal stem portion to be inserted in the diaphysis, and the Optimum Femoral Stem (Cemented), a collarless, highly polished double-taper cemented Femoral Stem with design features known to provide reliable performance.
The System's CoCrMo Femoral Heads interlock with the Femoral Stems via a standard taper attachment, providing accurate placement and secure fixation.
There are three different uncemented Acetabular Cup designs allowing for adjunct fixation; two with specifically designed screw hole patterns, and one with protruding "spurs" designed to fixate to the previously prepared acetabular surface. The Ti6Al4V Acetabular Cups are CpTi plasma spray coated on the trabecular surface. The Ti6A14V Acetabular Screws are available in 6 lengths from 15 to 40mm in 5mm increments.
The conventional non-cross-linked UHMWE Acetabular Liners are available in various diameters corresponding to the Femoral Heads and Acetabular Cups, and in 10 degree elevated and standard, non-elevated rim configurations.
This document is a 510(k) premarket notification for the Excera FitRite™ Total Hip Arthroplasty System. It focuses on demonstrating substantial equivalence to predicate devices, rather than proving a device meets specific acceptance criteria through a clinical study or AI performance evaluation. Therefore, most of the requested information regarding acceptance criteria, study details, and AI-specific metrics is not available in this document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical performance or a direct comparison of the subject device's clinical performance against such criteria. Instead, it demonstrates performance through non-clinical mechanical testing:
| Standard | Test Type | Results |
|---|---|---|
| ASTM F2068 | Proximal Fatigue | Pass |
| ISO 7206-4:2010 | Distal Fatigue | Pass |
| ISO 21535:2007 | Range of Motion | Pass |
| ASTM F1875 | Taper Fretting | Pass |
| ASTM F2009 | Femoral Head Distraction | Pass |
| ASTM F1820 | Liner Push out, Lever out & Torque out | Pass |
| ASTM F543 | Screw Insertion Torque & Max Torque | Pass |
The "Pass" result indicates that the device met the requirements of the respective ASTM/ISO standards for mechanical performance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is for a medical device (hip arthroplasty system), not an AI algorithm. The document states:
- "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification."
- The mechanical tests (listed above) were performed in accordance with ASTM/ISO standards. The sample sizes for these specific mechanical tests are not detailed in this summary, nor is the country of origin or whether the data was retrospective or prospective, as these are non-clinical bench tests.
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. This is a physical medical device, not an AI algorithm requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical medical device, not an AI algorithm requiring adjudication of results.
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 medical device, not an AI algorithm that would be used in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance demonstration lies in meeting the specified mechanical requirements of the individual ASTM/ISO standards mentioned (e.g., fatigue strength, range of motion, taper fretting, etc.). These standards define the acceptable performance parameters for hip arthroplasty components.
8. The sample size for the training set
Not applicable. This is a physical medical device; there is no AI training set involved.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device; there is no AI training set involved.
§ 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.