(86 days)
The Foundation® Unipolar femoral head is intended for treatment of patients who are candidates for hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis of femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the srugeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with any stem that has the appropriate size head. This submission includes the unipolar femoral head with a modular neck length sleeve.
The Foundation® Unipolar headis fabricated from cast CoCrMo that conforms to ASTM F795. The modular neck length sleeve is fabricated from Ti-6A1-4V that conforms to ASTM F136.
This device is assembled by the surgeon at the time of implantation. The sleeve is placed on the taper of the femoral component and impacted into place. Next the unipolar head is placed on the taper and using the impactor is locked into place.
The unipolar head may be used with any stem that has the appropriate Morse Taper.
The provided text is a 510(k) summary for a medical device called the Foundation® Unipolar Femoral Head with Modular Neck Length Sleeve. It describes the device, its intended use, and states that testing was performed. However, it does not contain acceptance criteria for the device's performance, nor does it detail a study that proves the device meets specific acceptance criteria.
The document states: "Testing on this device included fatigue testing on the unipolar head and the modular neck length sleeve. As well as, axial pull off and torque strength of the modular neck length sleeves." This confirms that some testing was done, but no results or performance metrics are provided.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, ground truth establishment, or human-in-the-loop performance, as this information is not present in the provided text.
The closest information available is related to comparable features to predicate devices, which notes: "The Foundation® Unipolar head has the same geomety, is manufactured from the same material, and has the same indications as the predicate devices." This implies that the acceptance for the device heavily relies on its substantial equivalence to existing, legally marketed devices.
If this were a typical AI/ML device submission, the provided information would be insufficient to describe the acceptance criteria and the study proving it. For hardware like this, the "acceptance criteria" are usually linked to industry standards for mechanical performance and bio-compatibility, and the "study" would be a series of engineering tests. The text only vaguely mentions the types of tests performed, not the results or the thresholds for acceptance.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.