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The Porous Titanium Acetabular Shells are indicated for cemented or non-cemented use in total hip replacement in cases of:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.

Specific indications for compatible components (femorals, heads, liners, and screws) that can be used with the Regenerex™ Hip Products include:
Freedom® Constrained Liners (K030047): The Biomet Freedom® Constrained liner is indicated for use as a component of a total hip prosthesis in primary and/or revision patients at hip dislocation due to history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.
Tri-Polar System (K991990): Indication #5 (Revision of previously failed total hip arthroplasty) is further specified to include recurrent dislocation.
OSS/Salvage Systems/Total Femur (K974558, K002757, K021380, K033871): Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, tumor resection, trauma and revision of unsuccessful osteotomy or arthrodesis.
Interlocking Stems (K990830, K042774): Interlocking hip stems are indicated for non-cemented application in cases of revision, trauma, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
HA PMI Hip Femoral Stems (K030048): Non-cemented use for skeletally mature patients undergoing primary hip replacement surgery as a result of non-inflammatory degenerative joint disease.
Gross Hip Femoral (K001580) and Bohn Hip Femoral (K000262): These femoral components are also indicated for treatment in conjunction with tumor resection and trauma.
Taper 2 ™ Porous Femoral (K050441) and Balance Microplasty (K050251): Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. These stems are indicated for the revision of previously failed femoral head resurfacing component.
Color Buffed Femoral (K992903), CB DDH Femoral (K012019), Bi-Metric Hip (K992058), CB Answer Femoral (K991987), Reach Femoral (K982367): Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. The statement should read, "Revisions of hip replacement components".
150mm Bi-Metric Hip Stem (K983710): Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. They are not indicated for revision procedures.
Zirconia Ceramic Heads (K964431 and K991708): Indication #4 (Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques) is not applicable to these Zirconia Ceramic Heads.
Biolox® delta Ceramic Heads (K042091), Rx90™ Standard/Lateralized Femoral (K023085), Portrait Femoral (K010560), MalloryHead Smooth Femoral (K994007), Generation 4 Polished Femoral (K031734), Modular Reach Femoral (K994038), Indication #5 (Revision of previously failed total hip arthroplasty) is not applicable for these components. The statement should read, "Revision procedures where other treatment or devices have failed".
Medallion Modular Hip System (K041850): Same list of five indications but cleared for uncemented use only.

Porous Titanium Acetabular Shells are Intended for use in reconstruction of the hip joint due to disease, deformly, or trauma. The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery. The device is a single use implant. This submission includes acetabular shells for use as reconstructive components. The acetabular shells range In size (OD) from 52mm to 80mm in 2mm Increments. The shell is constructed of a porous titanlum allov (Ti-6Al-4V) and has been designed for cemented or non-cemented use with the option of using screws for added fixation to the native bone. The wall of the shell is composed entirely of the porous material. The rim of the implant is solld titanlum for reinforcement and provides the mating geometry necessary to mate with the instrumentation. The acetabular shells are designed for use with commercially available all polyethylene acetabular liners. These polyethylene ilners are to be cemented into the acetabular shells.

The provided text is a 510(k) Summary for a medical device (Porous Titanium Acetabular Shells) seeking substantial equivalence to predicate devices. It does not present any acceptance criteria or a study proving that the device meets those criteria from an AI/algorithm performance perspective.

Instead, it focuses on demonstrating substantially equivalent technological characteristics and intended use compared to existing devices already on the market.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the context of AI/algorithm performance. The document only states the following regarding testing:

• Non-Clinical Testing: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its Intended use."
• Clinical Testing: "None provided as a basis for substantial equivalence."

This indicates that the FDA clearance for this device was based on engineering and material testing (non-clinical) to show it performed similarly to existing devices, not on a study evaluating an AI's diagnostic or predictive performance.

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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 < 0.2 microns on the articulating surface and 0.4 - 0.8 microns in the head bore. Any commercially available acetabular component may be used with the Mallory/ Head Smooth femoral component.

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.

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

• Sample Size: Not applicable/Not provided. The 510(k) submission describes the device characteristics and compares them to predicate devices. It does not involve a "test set" in the context of clinical performance evaluation for diagnostic devices.
• Data Provenance: Not applicable. The information provided is design and material specification data, along with a list of predicate devices.

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

• Not applicable. "Ground truth" in the context of expert consensus is not relevant to this type of device submission. The FDA reviews the technical documentation and comparison to predicates.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. There is no test set in the diagnostic sense, and therefore no adjudication method.

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:

• Not applicable. This is not an AI-assisted diagnostic device, so MRMC studies are irrelevant.

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

• Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable. The "ground truth" for this device's clearance is its adherence to material standards, design specifications, and successful demonstration of substantial equivalence to existing, legally marketed predicate devices, which implies a history of safe and effective use.

8. The sample size for the training set:

• Not applicable. This is not an AI device, so there is no training set.

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

• Not applicable.

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