(90 days)
The subject devices are sterile, single use devices. They are intended for mechanical fixation to their mating hip stems, and can be used in cementless hip arthroplasty procedures. They can be used with all Howmedica Osteonics C-Taper® and V-40® hip stems made from Titanium or CoCr alloys. When used as a total hip replacement, they are intended for use only with Howmedica Osteonics polyethylene inserts.
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results,
- Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.
The LFIT Cobalt Chrome femoral head product line will now be available with large diameter femoral heads and acetabular components that accommodate the larger diameters. The LFIT femoral heads will be offered in 36mm, 40mm, and 44mm diameters. The larger diameter femoral heads are compatible with Howmedica Osteonics V-40® and C-taper® hip stems.
The Trident® acetabular system will offer polyethylene liners able to accommodate 40mm and 44mm diameter femoral heads. The polyethylene liners are compatible with the Trident® line of acetabular shells.
The provided text is a 510(k) summary for the Trident® Hip System. This document outlines the regulatory submission for a medical device (hip prosthesis) and focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a study with specific acceptance criteria, device performance metrics, or details about a training/test set, expert ground truth, or MRMC studies.
Therefore, most of the information requested in your prompt cannot be extracted from this document as it does not contain details of an AI/algorithm performance study.
However, I can provide what information is available:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the context of an algorithm's performance, nor does it report device performance in terms of metrics like sensitivity, specificity, accuracy, etc., which would be typical for an AI-enabled device. The "acceptance" in this context refers to regulatory acceptance based on substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes a medical device (hip prosthesis), not an AI algorithm evaluated with a test set of data.
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. Ground truth for an AI algorithm is not established in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
§ 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.