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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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Biomet's Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem is intended to be implanted to replace a damaged hip joint having large defects in the calcar region as a result of trauma or degenerative disease and in cases where a previous hip replacement component has failed.

This device is a single use implant intended for cemented application.

Biomet's 150mm CoCr BiMetric Head/Neck Replacement Hip Stem – Color Buff Finish Prosthesis is indicated for use in noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; theumatoid arthritis; correction of functional deformity; treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

This device is a single use implant intended for cemented application only.

The device is composed of a metallic femoral stem which is designed to articulate with a commercially available acetabular component. The device limits translation and rotation via the geometry of the articulating surface. There is no linkage across the joint.

Proximally, the stem is designed to replace the proximal portion of the femur in cases of severe bone loss. The medial portion is built up to compensate for bone deficiencies. It is further enhanced by a keel, which allows transfer of the proximal load to the calcar region, and resists torsional forces.

There are suture holes in the lateral flange of the proximal platform for reattaching and securing the greater trochanter in cases where a trochanter osteotomy has been performed.

The platform inside the collar is bead blasted; the stem outside the collar distally has a highly polished surface with a mirror-like appearance (according to Biomet's Color Buff Finish spec Q00999). This surface finish allows for some subsidence of the stem within the cement mantle and decrease the incidence of stem loosening.

A proximal to distal taper of the femoral stem parallels the shape of the femur to follow the natural contours of the canal. The tapered geometry loads the cement mantle in compression and promotes evenly distributed stress off-loading. The employment of a PMMA distal stem positioner centralizes the stem within the canal.

The femoral component utilizes a modular head which is taper-fit onto the stem at the time of surgery. The modular heads are manufactured from wrought cobalt-chromemolybdenum conforming to ASTM F-1537. The stem trunions are identical to Biomet's Type I Tapers for the Zirconia Ceramic Heads cleared in 510(k) K905687. There is a 4 degree included angle on the trunion.

The provided text is a 510(k) summary for a medical device (Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem), which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical trial acceptance criteria and performance data for a novel device. As such, the document does NOT contain the detailed information necessary to fully answer all aspects of your request.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

• Cannot be provided. The document does not describe specific acceptance criteria (e.g., specific thresholds for wear rates, fatigue life, or clinical outcomes) or quantitative performance metrics from a study in the format typically used for medical device approval based on novel data. The 510(k) process relies on demonstrating equivalence to an already approved device.

2. Sample size used for the test set and the data provenance:

• Cannot be provided. This document is not a clinical study report. It does not mention any test set, sample sizes for human subjects, or data provenance (country of origin, retrospective/prospective) for a study proving acceptance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Cannot be provided. This information pertains to a study's methodology for establishing ground truth, which is not present in this 510(k) submission.

4. Adjudication method for the test set:

• Cannot be provided. Adjudication methods are relevant to clinical studies, which are not detailed here.

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:

• Cannot be provided. An MRMC study is completely irrelevant here. This is a hip implant, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Cannot be provided. This question is also irrelevant as the device is a physical hip implant and not an algorithm.

7. The type of ground truth used:

• Cannot be fully provided in the context of a "study proving acceptance criteria." For mechanical aspects, the "ground truth" would be engineering specifications and testing (e.g., fatigue testing, wear testing against standards), but specific data or thresholds are not in this summary. For clinical outcomes, the "ground truth" for the 510(k) is the established performance and safety of the predicate devices to which it is deemed substantially equivalent, as there's no new clinical trial data presented to establish independent ground truth for this specific device.

8. The sample size for the training set:

• Cannot be provided. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Cannot be provided. As above, no training set.

What the document DOES tell us about "acceptance criteria" in the context of a 510(k):

In a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. This means the new device shares the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness compared to a legally marketed predicate device.

The document states:

• Intended Use: Biomet's Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem is intended to be implanted to replace a damaged hip joint having large defects in the calcar region as a result of trauma or degenerative disease and in cases where a previous hip replacement component has failed.
• Substantial Equivalence: "In function and overall design Biomet's Bi-Metric CoCr Head/Neck Color Buff Replacement Hip Stem Prosthesis is equivalent to other commercially available hip prosthesis currently on the market." (Specifically listing HNR, Solution, Modular Calcar, and Biomet's own Grit Blast Finish model).
• Technological Characteristics: The document describes the materials (CoCr, Stainless Steel, UHMWPE), design features (collar, keel, polished surface, tapered geometry, modular head, specific taper angle), and manufacturing processes that are comparable to existing devices.
• Potential Risks: The document explicitly states, "The potential risks associated with this device are the same as with any joint replacement device." This implies that the device does not introduce new or unmanageable risks beyond what is already accepted for hip replacements.

Therefore, the "study that proves the device meets the acceptance criteria" in this context is the 510(k) submission itself, which primarily relies on comparison to predicate devices and adherence to established engineering and material standards for such implants, rather than a novel clinical trial with specific performance metrics for this particular device. The FDA's letter (K983710) confirms that based on the submission, the device is considered "substantially equivalent" and therefore meets the regulatory "acceptance criteria" for market entry.

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