(161 days)
The Foundation® Porous Acetabular System is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion. The intended use is press-fit.
The indications for use of the total hip replacement prosthesis include: degenerative joint disease including osteoarthritis and nonimianmatory - organisatoid arthritis; correction of functional deformity; avasodial nocroors, where other treatments where devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the treatinent of their with head involvement, which is unmanageable using other techniques.
The Foundation® Porous Acetabular System Cups are fabricated from wrought/forged or cast Ti-6AI-4V that conforms to ASTM F136 or F1108, respectively. The outside surfaces are coated with commercially pure titanium beads (ASTM F67) for the purpose of providing a porous surface for enhanced press-fit fixation.
The hemispherical and flared shells are available with and without screw holes. The geometry of the screw holes is such that a 12° angulation of the screws is possible.
The poly liners are manufactured from ultra high molecular weight polyethylene and are available in a neutral, 10°, and 20° hooded design. The hooded design is intended for those patients prone to subluxation because of soft tissue laxity.
The provided text describes a medical device submission (K973119) for the Foundation® Porous Acetabular System, a hip replacement component. However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to its performance in a clinical or diagnostic context.
The document is a "Summary of Safety and Effectiveness" which is a declaration that the device is substantially equivalent to a predicate device. It briefly mentions "Test Results" for the attachment strength of liners to the shell, stating that "All results are sufficient for in-vivo loading." This is a very high-level statement and does not provide specific acceptance criteria or detailed study information.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in detail. The document broadly states that "All results are sufficient for in-vivo loading" for liner attachment strength. This is an outcome statement, not a specific criterion. | "All results are sufficient for in-vivo loading" for the attachment strength of liners to the shell. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not specified. The document does not provide any details about the sample size for any tests, nor the origin or type 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. This information is typically relevant for studies involving subjective interpretation or diagnostic performance, which is not the focus of the engineering tests mentioned (e.g., attachment strength). The document does not describe any such expert-driven ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is mentioned as there's no mention of subjective interpretations needing consensus.
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 device is a physical hip implant component, not an AI or diagnostic imaging device. Therefore, an MRMC study comparing human reader performance with or without AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant. "Standalone" performance generally refers to an algorithm operating without human intervention for diagnostic tasks, which is not relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the "attachment strength of liners to shell," the ground truth would likely be a quantitative engineering measurement against a predefined specification or standard (e.g., maximum load bearing before failure). However, the specific type of ground truth and the standards are not detailed in the document beyond a general statement of "sufficiency for in-vivo loading."
8. The sample size for the training set
Not applicable. Training sets are typically associated with machine learning or AI models. This document describes a physical medical device.
9. How the ground truth for the training set was established
Not applicable. As above, training sets are not relevant to this device description.
§ 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.