(115 days)
The G2 Total Hip System Femoral Stems (11/13 Taper) are indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatiod arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of this prosthesis is also indicated for patients with congenial hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques.
The G2 Polished Femoral Stem (11/13 taper) is indicated for use only with PMMA bone cement.
The G2 Microtextured Femoral Stem (11/13 taper) is not indicated for use with PMMA bone cement.
G2 Cementless Femoral Stem: The cementless G2 femoral stems are made of the titanium alloy which is microtextured/roughened and available in 12 sizes with both a standard neck length and an offset neck length. These stems are designed with a series of anterior and posterior fins on the proximal portion of the press fit stem and a proximal to distal taper. The design features of the press fit stem allow for axial load transfer to the bone while minimizing shear loads at the stem and bone interface. The design also features initial torsional stability, enhancement of load transfer and the minimizing of micromotion.
G2 Cemented Femoral Stem: The cemented G2 stems are forged cobalt chromium with a polished surface and are available in 6 sizes, with both standard and offset neck lengths. They have a double taper collarless geometry with a proximal lateral flange, as well as mid shaft PMMA cement spacers to allow for centralization of the stem in the cement. The design features of the polished stem allow for proper seating of stem in cement, reduction of torsional stesses in the proximal section of the cement mantle, and potentially minimize cement debris at the stem interface during micromotion.
The provided text describes a 510(k) submission for a medical device, the G2 Total Hip System Femoral Stem. It does not describe an AI/ML device or a study with acceptance criteria related to AI/ML performance.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types as these are not present in the provided document.
The document primarily focuses on:
- Device Description: Physical characteristics of the cementless and cemented femoral stems.
- Indications for Use: Medical conditions for which the device is intended.
- Summary of Testing: States that the device was evaluated following ISO standard 7206-4 for conformance to FDA's Draft Guidance Document for Femoral Stem Prosthesis, and that test results demonstrated conformity.
- Substantial Equivalence: Lists predicate devices to which the G2 System is considered substantially equivalent.
- FDA Clearance Letter: Confirms that the device is substantially equivalent to legally marketed devices and can be marketed.
In summary, there is no information in the provided text to answer the specific questions about the acceptance criteria and study data as it pertains to AI/ML device performance. The document describes a traditional medical device's regulatory clearance based on substantial equivalence and mechanical performance testing against an ISO standard.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.