(28 days)
in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
- Inflammatory degenerative joint disease such as rheumatoid arthritis;
- Correction of function deformity:
- Revision procedures where other treatments or devices have failed; and
- Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
The INFINTY® Titanium Anodized Distal Femoral Component is a product line addition to the INFINTY® Hip System. This modular system consists of a distal femoral component and a trochanteric module which are assembled by the surgeon at the time of surgery to yield a collared or collarless femoral hip prosthesis. The INFINTY® Hip System is designed for use with cobalt chrome or ceramic femoral heads. The INFINTY® Titanium Anodized Distal Femoral Components are available in standard and microtaper designs. Indications, design features, and functional requirements remain the same. The INFINTY® Titanium Anodized Distal Femoral Components are intended to be used in cemented or uncemented applications. The stems are manufactured from titanium alloy in conformance with ASTM F 136, and are anodized in an additional step to improve resistance to fretting corrosion and improve fatigue characteristics.
The provided text describes the INFINTY® Titanium Anodized Distal Femoral Component, a hip prosthesis. The information focuses on its design, intended use, and a summary of its testing.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Adequate fatigue strength | "Fatigue testing resulted in runout of all test specimens, demonstrating adequate fatigue strength of the INFINTY® Titanium Anodized Distal Femoral Component coupled with an INFINTY® trochanteric module." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "all test specimens" were used for fatigue testing. However, it does not specify the exact number of specimens or the data provenance. This type of testing is typically prospective, conducted in a laboratory setting. The country of origin for the testing data is not mentioned, but given the submission to the FDA, it is likely that the testing was conducted in the USA or by a globally recognized testing facility.
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)
This device is a physical medical implant, not a diagnostic or interpretative system. Therefore, the "ground truth" for its performance (fatigue strength) is established through standardized engineering testing rather than expert consensus on medical images or patient data. No human experts are used to establish "ground truth" for the fatigue test results themselves, as it's a quantitative measurement based on physical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this involves physical testing of a medical device, not an assessment requiring adjudication by experts. The results of fatigue testing are typically quantitative and objective measurements against predefined engineering standards.
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-powered diagnostic tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the physical medical device alone through fatigue testing, without human "in-the-loop" for interpretation. In this context, the fatigue testing is a standalone assessment of the device's mechanical properties.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on engineering standards and physical testing results (specifically, fatigue testing runout). The device's ability to resist fatigue is objectively measured against a predefined standard for "adequate fatigue strength."
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in the evaluation of its mechanical properties.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a physical device, there is no ground truth established for it in this context.
§ 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.