(116 days)
The Medacta® Endo Head is intended for use in combination with Medacta® Hip Prosthesis System for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
· Femoral neck and trochanteric fractures of the proximal femur;
· Osteonecrosis of the femoral head;
· Revision procedures where other devices or treatments for these indications have failed.
The Medacta Endo Head is a unipolar prosthesis that consists of a monobloc prosthetic femoral head made of Cobalt Chromium Molybdenum (CoCrMo ISO 5832-12) designed to articulate directly in the patient's acetabulum. It is designed to be assembled with all the Medacta stems. Three sizes (S, M and L) are available for a 12/14 Morse taper with an outer diameter varying from 40 to 56 mm with 1 mm increments between sizes.
The provided text is a 510(k) Summary for a medical device called "Endo Head" by Medacta International. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria for device performance. Therefore, the information required to populate the fields of your request (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the document.
The document primarily provides:
- Device Information: Trade name, common name, classification, product codes.
- Predicate Devices: A list of previously cleared devices to which the Endo Head is compared.
- Product Description: Material (CoCrMo), design (unipolar prosthesis, monobloc), and sizes.
- Indications for Use: Conditions for which the device is intended (femoral neck/trochanteric fractures, osteonecrosis, revision procedures).
- Comparison to Predicate Devices: Claims of substantial equivalence based on intended use, material, neck lengths, external diameter, sterilization, biocompatibility, and coupling with Medacta stems.
- Regulatory Conclusion: Affirmation of substantial equivalence by the FDA.
No study proving the device meets acceptance criteria, as per your request, is described in this 510(k) summary. The 510(k) process for this type of device (a hip prosthes is component) typically relies on demonstrating equivalence to existing legally marketed devices, often through mechanical testing (e.g., fatigue, wear) and material characterization, rather than clinical efficacy studies with human subjects that would involve ground truth establishment and expert adjudication in the manner you described.
Therefore, I cannot fill out the requested table and details based on the provided text.
§ 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.