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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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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) Rheumatoid arthritis, 3) Correction of functional deformity 4) Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) Revision of previously failed total hip arthroplasty. Intended for cemented and uncemented applications

The ArComXLTM polyethylene liners are manufactured from highly cross-linked polyethylene conforming to ASTM F648 that was previously cleared in K042051. ArComXLTM is available in three designs: MaxRom, Hi-Wall, and 10o. Biolox® delta Ceramic Heads (K042091) are composed of Transition-Toughened-Platelet-Alumina (TTPA). The highly polished spherical surface articulates with the ArComXLTM polyethylene liner acetabular component. The modular head attaches to a metallic femoral stem with a Biomet Type I taper.

This document describes the 510(k) premarket notification for the ArComXL™ Acetabular Liners and Biolox® delta Ceramic Heads. However, it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.

Instead, this document is a regulatory submission for a traditional medical device (hip joint prostheses) that relies on demonstrating substantial equivalence to previously cleared predicate devices. The "study" mentioned, "Volumetric wear testing," is a non-clinical test performed to support this substantial equivalence.

Therefore, many of the requested fields related to AI/ML device studies, ground truth, and expert evaluation cannot be filled from the provided text.

Here is an attempt to answer the questions based only on the provided text, with many fields noted as "Not applicable" or "Not provided" due to the nature of the document:

1. Table of acceptance criteria and the reported device performance

Explanation: For traditional medical devices like this, acceptance criteria typically involve demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through non-clinical testing and comparison of design and materials rather than explicit quantitative clinical performance metrics against pre-defined acceptance thresholds in the way an AI/ML study would. The key acceptance is the FDA's finding of "substantial equivalence."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable in the context of an AI/ML study. For the volumetric wear testing, the sample size of liners/heads tested is not specified.
• Data Provenance: Not applicable for an AI/ML study. The wear testing is a laboratory-based non-clinical study. Country of origin of the data is not specified (though Biomet is based in the US). Retrospective or prospective does not apply to a pre-clinical bench test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This device is a physical implant, not an AI/ML diagnostic or prognostic tool requiring expert-established ground truth from patient data. The "ground truth" for wear testing is the measured volumetric wear.

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

• Not applicable. This is not a study requiring adjudication of expert interpretations.

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

• No. An MRMC study was not done as this is not an AI/ML device impacting human reader performance.
• Effect size: Not applicable.

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

• Not applicable, as this is not an AI/ML algorithm.

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

• For the non-clinical volumetric wear testing, the "ground truth" is derived from physical measurements of material loss post-wear simulation. This is a physical measurement-based ground truth.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it's not an AI/ML algorithm.

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

• Not applicable. This device does not involve a training set.

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