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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 non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
• 5. Revision of previously failed total hip arthroplasty.
• 6. Dislocation risks.

The Active Articulation Hip Bearings and G7 Metal Liners are single-use implants, intended for uncemented applications.

The G7 Dual Mobility system consists of two articulating surfaces in the same joint space. The proposed system includes an UHMWPE Active Articulation Bearing and Cobalt-Chromium Alloy (CoCr) Liner. A femoral head articulates on the inner, concave surface of the Active Articulation Bearing. Once the femoral stem contacts the Active Articulation Bearing, a secondary motion occurs between the Active Articulation Bearing and the CoCr Liner. The G7 Dual Mobility system is designed for both primary and revision surgeries, where all device components associated with the wear couple are removed and replaced.

The proposed CoCr Liners are manufactured from cast Cobalt-Chromium-Molybdenum per ASTM F75. The proposed G7 Active Articulation Bearings are manufactured from E1® (aka E-Poly) or ArComXL highly cross-linked polyethylene per ASTM F648. The proposed Active Articulation Bearings are available in sizes 32 and 36mm with a 22.2mm inner diameter. The proposed CoCr Liners are available in sizes A-J (sizes 32-60mm).

This document, a 510(k) Premarket Notification for the Biomet G7 Dual Mobility System, describes the device and claims substantial equivalence to existing predicate devices. However, it does not include acceptance criteria or a study with performance data against those criteria in the way typically expected for an AI/CADe device.

This document is for a medical device (hip implant components), not a software algorithm or AI device. Therefore, the concept of "acceptance criteria" and "device performance" relating to metrics like sensitivity, specificity, or AUC based on a test set and ground truth is not applicable in this context. The "performance data" referred to in this document relates to mechanical and material properties of the implant.

Here's a breakdown of the requested information based on the provided document, highlighting why many aspects are not present for this type of device:

1. Table of acceptance criteria and the reported device performance

Since this is a physical medical device (hip implant components), the "acceptance criteria" and "reported device performance" are based on mechanical testing and material compatibility, not diagnostic-style metrics.

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

This information is not provided in the document, as it pertains to mechanical testing rather than a clinical or AI performance study. The "test set" would refer to the physical device components tested, but specific sample sizes for each test are not detailed in this summary. Data provenance (country of origin, retrospective/prospective) is not relevant for in-vitro mechanical testing.

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)

This is not applicable for a physical medical device. "Ground truth" in this context would be objective physical and chemical properties measured during mechanical and material testing, performed by laboratory technicians and engineers according to established (ASTM/ISO) standards. Expert consensus for AI model ground truth is not relevant here.

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

This is not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for AI or diagnostic performance studies. For mechanical testing, adherence to established test methods and measurement protocols are the "adjudication."

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

This is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is a hip implant, which does not involve "human readers" in a diagnostic capacity or AI assistance for interpretation.

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

This is not applicable. This describes a physical medical device, not a software algorithm.

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

The "ground truth" for this device's performance is based on objective measurements from standardized mechanical and material testing (e.g., precise force measurements for push-out/lever-out, visual inspection for fretting/corrosion, precise angular measurements for range of motion). It is not based on expert consensus, pathology, or clinical outcomes data in this 510(k) submission summary. The demonstration of substantial equivalence relies on these physical measurements compared to predicate devices or established standards.

8. The sample size for the training set

This is not applicable. This document does not describe an AI/ML algorithm that requires a training set.

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

This is not applicable. This document does not describe an AI/ML algorithm that requires a training set and associated ground truth.

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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.
6. Dislocation risks.
   The ArComXL™ Active Articulation Head is a single-use implant, intended for uncemented applications.

The ArComXL™ Active Articulation belongs to the family of dual mobility acetabular implants: the presence of two articulating surfaces in the same joint device. The ArComXL™ Active Articulation Head fits over a femoral modular head, which articulates within the ArComXL™ Head. The resultant assembly then articulates within the acetabular metal shell. The ArComXL™ Head is designed to be used with several styles of acetabular shells that have been cleared in previous submissions: M²a Magnum™ (K042037), Magnum™ Tri-Spike (K062995), and M²a 38™ Flared Cups and Non-Flared Cups (K011110).
The ArComXL™ Active Articulation Heads are available in sizes 44-66mm (Note: Size 44-66mm references O.D. of mating shell; the actual head sizes are 38-60mm.) and are manufactured from highly cross-linked polyethylene, conforming to ASTM F648. ArComXL™ is not a new material; the material and manufacturing process were cleared in K042051, ArComXL™ Polyethylene Liners, as well as subsequent submissions. The ArComXL™ Active Articulation is designed for both primary and total revision surgeries, where all device components associated with the wear couple are removed and replaced. The system is intended for uncemented applications.

This document describes the Biomet ArComXL™ Active Articulation Head, a hip replacement component. This submission is for a material change from the predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Push-In and Lever-Out: Six samples.
  • Wear Testing: Not explicitly stated, but typically multiple samples are used in ISO 14242 testing. The document states "the ArComXL™ Active Articulation heads were tested".
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Biomet Manufacturing Corp. (the submitter). These are non-clinical tests.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable. The reported studies are non-clinical mechanical tests (Push-In and Lever-Out, Wear Testing), not clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for Test Set

Not applicable. This section relates to clinical studies and expert review, which were not performed for the determination of substantial equivalence for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No clinical studies were conducted, and therefore, no MRMC studies comparing human readers with and without AI assistance were performed. The device is a medical implant, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical implant, not an algorithm or software. The performance studies are non-clinical hardware tests.

7. Type of Ground Truth Used

• Push-In and Lever-Out: Comparison to the performance of a legally marketed predicate device (K991990), establishing functional equivalence.
• Wear Testing: Comparison to the wear rates of a legally marketed predicate device, ArCom™ 36mm liners (K032396), as per ISO 14242 standards.

8. Sample Size for Training Set

Not applicable. This device is a physical implant; there is no "training set" in the context of an algorithm or AI model development.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for this device.

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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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