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The Mallory/ Head Smooth femoral component is indicated for:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Revision procedures where other treatment or devices have failed
5. Treatment of nonunions, which are femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
   This device is for use with bone cement.

The Mallory/Head Smooth femoral components are composed of Co-Cr-Mo alloy conforming to ASTM F-799 standards. The Mallory/Head Smooth is to be used with bone cement. A progressive increase in cross-sectional dimensions and overall length is seen throughout the range of sizes (size 1 -- 5). The straight stem design eliminates the need for left and right configurations.
The most defining feature of this series is the surface geometry and finish of the stem body. The finish is sisal buff in one direction (proximal to distal) around the entire stem with a roughness (Ra) value not less than 24 microinches. The surface is void of ledges, grooves, and collars. This smooth design will allow minute amounts of subsidence over an extended period of time. The smooth stem is used with the centralizer/sinker set so that the stem continues to remain tightly wedged in place rather than loosening progressively over time.
The centralizer/sinker set consists of two polymethylmethacrylate (PMMA) pieces. The sinker fits on the distal tip of the stem and creates a 2-3 mm (in length) void in the cement mantle. Without this void, distal to the tip of the stem, small amounts of subsidence would cause undesirable point loads in the cement. The centralizer is designed to fit on the central one-third of the stem and to provide a cement mantle of uniform thickness around the stem.
The Mallory/Head Smooth Femoral Component can be used with any Biomet modular head with a Type 1 taper, such as: Cobalt Chrome modular heads, Zirconia modular heads or an endoprosthesis head. Zirconia ceramic heads have been previously cleared in 510(k)'s: K905687, K913420, K925345, K943586. K964431. K991708. For metallic heads the surface of the bore of the head was measured to have a roughness (Rg) value of 34 microinches. The articulating surface roughness (Ra) value was found to be 5.6. The ceramic heads have a surface roughness of Rg

The provided text describes a 510(k) premarket notification for the Mallory/Head Smooth Femoral Stem, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with predefined acceptance criteria.

Therefore, the document does not contain information about acceptance criteria, a study proving device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as typically sought for AI/diagnostic devices.

The submission is for a hip femoral component prosthesis, which is a physical implant, not a diagnostic or AI-driven device. As such, the FDA's clearance is based on a review of the device's design, materials, and intended use, and its substantial equivalence to previously cleared predicate devices.

Here's what can be extracted from the text in relation to your request, with the understanding that it won't fulfill all aspects due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific "acceptance criteria" such as sensitivity, specificity, or accuracy are provided, nor is there a performance study reporting these metrics. The performance is assessed through demonstration of "substantial equivalence" to predicate devices, focusing on design, materials, and intended use.

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Biomet's APF Porous Coated Line Extension Prosthesis is intended for use in reconstruction of the hip joint due to damage caused by trauma or degenerative disease and in cases where a previous hip replacement component has failed. The device is intended for cemented application for general use and non-cemented application in skeletally mature individuals undergoing primary surgery for rehabilitating hip joints damaged as a result of non-inflammatory degenerative joint disease or any of its composite diagnosis. The device is a single use implant.

The device is composed of a metallic femoral stem (forged titanium) which is designed to articulate with a commercially available acetabular component. The APF Porous Coated Line Extension stem geometry is designed for proximal, as well as, distal stability and gradual offloading into the bone along the canal. The proximal portion of the stem incorporates a bi-planar taper to encourage proximal offloading, thus reducing stress shielding. This broad proximal geometry fills a greater portion of the metaphysis, thus providing improved rotational stability. In a cemented application, the increased proximal stress transfer of titanium helps preserve the calcar bone and maintain the integrity of the proximal cement mantle. The stem has a porous coated collar which is incorporated to provide the component stability and stress transfer. Only the underside of the collar is porous coated to help ensure collar-calcar contact and stress distribution. This also provides additional rotational stability and load transfer. Distally the stem is cylindrical with an anterior bow for left and right configurations. The distal anterior bow more closely matches the anatomic femur to provide rotational stability. This cylindrical design will also enhance implant stability by providing a potential area of biological fixation in situations of proximal bone deficiencies. The lower modulus of elasticity of a titanium stem will also produce less distal stress offloading and is less likely to fracture the cement mantle. The APF Porous Coated Line Extension stems will be 75%-100% porous coated to provide maximum proximal and distal fixation through tissue ingrowth in non-cemented applications or cement adherence in cemented applications. This circumferential closedpore porous coating potentially seals the the femur from debris migration. Porous coating on the underside of the collar along with extended proximal to distal porous coating, provide areas of potential tissue ingrowth in crucial regions of cortical bone. The roughened surface of the porous coating will also enhance the hip stem/cement bonding, thus improving the chances of long term success. The portion of the stem that is not porous coated (on the 75% and 80% porous coated components) has a 30 grit corse blast finish or (on the 100% porous coated components) the distal tip of the component has a bead blast finish. The femoral component utilizes a modular head which is taper-fit onto the stem at the time of surgery (Exhibit I). The modular heads are manufactured from wrought cobalt-chromium-molybdenum conforming to ASTM F-1537. The use of mixed metals in surgery is also addressed in MAF-153 (7/10/92 amendment, pg. 54-105). The stem trunions are identical to Biomet's Type I tapers for the Zirconia Ceramic Heads cleared in 510(k) K905687, K913420, and K925345. There is a 4 degree included angle on the trunion. Refer to Exhibit I for a complete listing of modular heads to be used with this stem. For more information on these modular heads, refer to MAF-442.

The provided text is a 510(k) summary for a medical device (APF Porous Coated Line Extension) seeking substantial equivalence to existing devices. It focuses on device description, intended use, and comparison to predicate devices, rather than presenting a study with specific acceptance criteria and performance data in the format requested.

Therefore, the information required to populate the table and answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth is not available in the provided text.

The document discusses:

• Device Description: The physical characteristics and materials of the hip prosthesis.
• Intended Use: The medical conditions and patient populations for which the device is designed.
• Potential Risks: General risks associated with hip replacement surgery.
• Substantial Equivalence: A comparison of the device to other legally marketed hip stems (predicate devices). This is the primary method for demonstrating safety and effectiveness in a 510(k) submission, rather than presenting a de novo clinical study with specific acceptance criteria.

Based on the provided text, I cannot complete the requested tables and answer the questions. A 510(k) summary typically does not include the detailed study design, acceptance criteria, and performance metrics as would be found in a clinical study report or a different type of regulatory submission.

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