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This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. Inflammatory degenerative joint disease such as rheumatoid arthritis;
3. Correction of function deformity;
4. Revision procedures where other treatments or devices have failed;
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that is unmanageable using other techniques.

This device is a single use implant and intended for cementless use only except cemented stem which is designed for cemented use only.

There are two purposes in current submission, the fist one is to expand the Indications for Use of two cleared products: U2 Hip System (K111546) and Femoral Heads, +2.5 & +7.5 mm Offset (K122504), which have been expanded to a population with similar demographic, diagnosis and prognosis as the original. The second purpose of this submission is to reword the statement of Indications for Use of six cleared "UNITED" hip products including U1 Hip System (K994078), U2 Hip Stem, Ti porous coated (K003237), U2 Acetabular Cup and Femoral Head (K022520), U2 Acetabular Component (K050262), U2 Hip Stem and Ti Plasma Spray (K062978) and U2 Acetabular Cup, Plasma Spray (K121777). Through this submission, the Indications for Use of above listed devices are unified as one version, and the components, materials, design, processing methods, sterilization methods, biocompatibility, safety and effectiveness of above listed devices are unchanged by this submission.

The provided text describes a 510(k) summary for the "U2 Hip System, Expanded Indications for Use". This document focuses on establishing substantial equivalence to previously cleared predicate devices for the indications for use of a hip implant system, rather than proving the performance of a newly designed device through explicit acceptance criteria and a detailed study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and how ground truth was established is not applicable in this context.

Here's why and what the document does provide:

• Type of Device: This is a hip prosthesis (total hip replacement system).
• Regulatory Pathway: This is a 510(k) premarket notification. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics (design, materials, packaging, sterilization) and intended use, rather than conducting new clinical performance studies against specific acceptance criteria for a novel device.
• Purpose of the Submission:
  1. Expand Indications for Use: For two existing products (U2 Hip System K111546 and Femoral Heads K122504) to include a similar patient demographic, diagnosis, and prognosis.
  2. Reword/Unify Indications for Use: For six other cleared "UNITED" hip products to a single, unified version.
• Basis for Substantial Equivalence: The submission states that the components, design, materials, packaging, and sterilization method of the "U2 Hip System - Expanded Indications for Use" are identical to cleared predicate devices. The only difference is the integration of indications for use.
• Non-Clinical and Clinical Testing: The document explicitly states:
  • "Non-clinical laboratory testing is not provided as a basis for substantial equivalence."
  • "Clinical Testing None provided as a basis for substantial equivalence."

Conclusion:

This submission does not contain information about a study designed to prove the device meets specific acceptance criteria in the manner requested because it relies on demonstrating substantial equivalence to pre-existing, legally marketed devices. The performance and safety of the device are implicitly linked to the predicate devices it is compared against, not to new performance data generated for this specific submission.

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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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