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The NEO Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, undergoing surgery for total knee replacement due to:

• · Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
• . Failed osteotomies, failed partial knee replacement, or failed total knee replacement whose age, weight and activity level are compatible with an adequate long-term result.
• . Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities. .
  The Neo Total Knee System components are indicated for use only with cement and are single use devices.

The NEO Total Knee System was cleared for marketing in April 2012, under 510(k) #K120313. The predicate knee system includes a cruciate retaining (CR) femoral component design, tibial trays, CR tibial inserts for use with intact posterior cruciate ligament(PCL), and patellar components. The subject 510(k) adds ultra congruent (UC) tibial inserts for use when the PCL is sacrificed. There are no changes to materials or to system component size offering.
The Neo Knee System CR femoral components, when used with the mating Neo Knee System CR and UC articular surfaces, are designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

The provided document is a 510(k) summary for the NEO Total Knee System - Line Extension. This document does not describe a study involving an AI/CADeX device. Instead, it describes a medical device (a knee implant) and its performance through mechanical and material testing, not a clinical or comparative effectiveness study involving human readers or AI.

Therefore, many of the requested categories in the prompt do not apply to this document. I will answer the questions that can be addressed based on the provided text, and explicitly state when a question is not applicable.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to legally marketed predicate devices. This is achieved by showing that the new components (ultra congruent tibial inserts) perform comparably to or within acceptable limits for a total knee replacement system. The performance criteria are related to the mechanical and material integrity of the implant components.

Study Proving Device Meets Acceptance Criteria:

The study referenced is a series of "Performance Testing" and a comparison of "Technological Characteristics" to predicate devices. This is a non-clinical, benchtop, and analytical comparison study as typically used for 510(k) submissions for medical devices like implants.

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

   • Sample Size: Not specified in the document. For benchtop mechanical testing, typical sample sizes might be N=5 or N=10 per test condition, but this is not mentioned.
   • Data Provenance: Not specified, but likely from laboratory testing conducted by the manufacturer or a contracted lab. The terms "retrospective" or "prospectively" do not apply to this type of mechanical testing.

2. 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 submission describes the mechanical and material performance of an orthopedic implant, not a diagnostic device that requires expert interpretation for a ground truth. The "ground truth" here is the physical measurement of performance against established standards or predicate device performance.

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

   • Not applicable. As above, this does not involve human interpretation or adjudication for a diagnostic task.

4. 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. No MRMC or AI study was performed. This is a 510(k) for a physical implant, not an AI/CADeX device.

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

   • Not applicable. No algorithm or AI device is described.

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

   • The "ground truth" for this type of device is based on engineering and material science principles, established mechanical testing standards (e.g., ISO or ASTM for implants), and performance data from legally marketed predicate devices. The goal is to demonstrate that the new component (UC tibial inserts) performs equivalently or acceptably within the established parameters for total knee systems.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

   • Not applicable. As there is no training set mentioned, this question does not apply.

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PIPELINE Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia:
• Acute traumatic fracture of the femoral head or neck;
• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The PIPELINE Tapered Femoral Stem and PIPELINE PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

The PIPELINE PST™ Acetabular Shell with HA is intended for cementless fixation. The porous structured surface with HA provides biological fixation.

The predicate Pipeline Total Hip System (K112802) and PBP Total Hip System (K122802) are artificial hip replacement systems that include femoral stems (titanium alloy and CP titanium), femoral heads (cobalt chromium or alumina ceramic), acetabular shells (titanium alloy, porous structured technology (PST™)), acetabular liners (ultrahigh molecular weight polyethylene, standard and highly crosslinked Vitamin E), acetabular bone screws (titanium alloy) and dome hole covers (titanium alloy) for the holes in the acetabular shells. This subject 510k adds the following components to the existing hip systems:

• A smaller, size 1 femoral stem; .
• The option of hip stems (all sizes) with 3 tantalum beads, to allow the surgeon to . perform radiostereometric analysis(RSA) to measure implant migration; and
• . The option of acetabular screw hole occluders provided either separately (for assembly by the surgeon), or pre-assembled to the acetabular shells.

The provided text describes a 510(k) summary for a hip replacement system, which details its components, intended use, and substantial equivalence to predicate devices, but does not contain information related to a "device" in the context of an AI/ML algorithm or medical imaging diagnostic device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because the provided document is for a mechanical orthopedic implant, not a diagnostic or AI-powered device.

The questions in the prompt (e.g., "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance") are specific to the evaluation of AI/ML or diagnostic imaging devices, which are not relevant to the Pipeline Total Hip System.

The "Performance Testing" section in the document refers to:

• Hip Stem Fatigue Testing: Conducted according to ISO 7206-4:2010 to determine endurance properties.
• Stem Neck Fatigue Testing: Conducted according to ISO 7206-6:1992 and ASTM F2068-03.
  These are mechanical engineering tests to ensure the structural integrity and durability of the implant under physical stress, not a study to prove diagnostic accuracy or AI performance.

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The Pipeline Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia.
• Acute traumatic fracture of the femoral head or neck.
• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.
  The Tapered Hip Stem and PST™ Acetabular Shell are intended for cementless or cemented fixation. The porous structured (PST™) surface provides biological fixation when used in a cementless application.
  The Pipeline Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.

This 510(k) addresses the addition of the following components (already cleared under 510(k) #K122158) to the Pipeline Total Hip System:

• . HA-coated Acetabular Shells feature a thin HA coating applied over the porous structured (PST) shells in a range of sizes,
• . Biolox® delta Ceramic Femoral Heads available in a range of diameters and extension options,
• . 40mm CoCr Femoral Heads, and
• . 40mm inner diameter Highly Crosslinked Vitamin E UHMWPE Acetabular Liners.
  These components are compatible with the total hip system determined substantially equivalent as the Pipeline Total Hip System in 510(k) #K112802 and as the PBP Total Hip System in 510(k) #K122158.

The provided text describes a Special 510(k) Premarket Application for a line extension to the "Pipeline Total Hip System." This type of submission claims substantial equivalence to previously cleared devices. Therefore, the "acceptance criteria" and "study" described are not for a de novo device, but rather the justification for substantial equivalence.

Here's how the information aligns with your request:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for this 510(k) is substantial equivalence to predicate devices. The reported "performance" is that the new components are identical to those already cleared.

2. Sample Size Used for the Test Set and Data Provenance

This submission does not involve a "test set" in the traditional sense of clinical or performance data for a new device. Instead, the "test" is a comparison to existing, cleared devices on the market. The submission asserts that the components are identical to those previously cleared. Therefore, there's no independent sample size or data provenance to report for a specific "test set." The "provenance" for the predicate devices would be based on the information provided in their respective 510(k) submissions (K112802 and K122158), which is not detailed here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a claim of identicality to cleared devices, not a study requiring expert-established ground truth for a new device's performance. The "ground truth" here is the prior FDA clearance of the identical components.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" requiring adjudication in this type of submission.

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 device is a mechanical hip replacement system, not an AI-assisted diagnostic or imaging tool.

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

Not applicable. This device is a mechanical hip replacement system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the prior FDA clearance and determination of substantial equivalence for the identical components under 510(k) #K122158. The submission argues that since the new components are identical to those previously cleared, their safety and effectiveness are established by the predicate's clearance.

8. The Sample Size for the Training Set

Not applicable, as this is a mechanical device, not a machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable, as this is a mechanical device, not a machine learning algorithm.

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The Pipeline Knee System is indicated for skeletally mature patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis,
• . Collagen disorders, and/or avascular necrosis of the femoral condyle,
• . Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy,
• . Moderate valgus, varus, or flexion deformities,
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot otherwise be obtained at the time of surgery..

Pipeline Knee System components are indicated for use only with cement, and are single use devices.

The Pipeline Knee System is a patellofemorotibial polymer/metal/polymer semiconstrained cemented knee joint prosthesis. The system includes femoral components, tibial trays, biomimetic cruciate retaining (CR) tibial inserts, patellar components, and associated instrumentation. The tibial trays are manufactured from highly crosslinked vitamin E polyethylene. The patellar components are manufactured from vitamin E polyethylene. The CR inserts are designed for use when the posterior cruciate ligament is intact.

The Pipeline Total Knee System femoral component, when used with the Pipeline Knee System articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

The document is a 510(k) summary for the Pipeline Knee System, which is a knee joint prosthesis. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria for device performance.

Therefore, the provided text does not contain acceptance criteria for device performance in the way one would expect for a diagnostic or AI-driven decision support system (e.g., sensitivity, specificity, accuracy thresholds). Similarly, it doesn't describe a study that "proves" the device meets such criteria through statistical analysis of clinical outcomes.

Instead, the document details non-clinical performance testing to support the substantial equivalence of the new Pipeline Knee System to existing predicate devices.

Given this context, I will address the requested information based on what is available in the provided text, while also noting what is not present due to the nature of this type of submission.

Acceptance Criteria and Device Performance

• Tibial tray fatigue strength
• Insert locking mechanism strength
• Femorotibial range of motion
• Femorotibial range of constraint
• Patellofemoral range of constraint
• Femorotibial contact areas/contact stress
• Patellofemoral contact area and contact stress
• Wear simulation. |
  | Material Properties: Highly crosslinked Vitamin E polyethylene material properties are comparable to legally marketed devices, ensuring safety and performance. (Implicit within the submission's goal of demonstrating substantial equivalence to legally marketed devices for the same indications for use and material/design characteristics.) | Testing provided to support the substantial equivalence of the highly cross-linked Vitamin E polyethylene for the following properties:
• Tensile strength
• Yield strength
• Elongation
• Density
• Crystallinity
• Wear resistance and particle size characterization
• Free radical concentration
• Thermal properties
• Impact strength
• Small punch strength
• Oxidation resistance
• Trans vinylene index
• Biocompatibility testing. |
  | Indications for Use: The device is suitable for the stated indications and is comparable to predicate devices in this regard. | The Pipeline Knee System's indications for use are similar to legally marketed predicate devices, for skeletally mature patients with severe knee pain and disability due to various conditions (e.g., rheumatoid arthritis, osteoarthritis, traumatic arthritis, collagen disorders, avascular necrosis, post-traumatic loss of joint configuration, deformities, salvage of failed attempts). |

Additional Requested Information:

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

• Not Applicable. This document describes non-clinical performance testing of a physical medical device (knee prosthesis), not a software device or AI algorithm with a 'test set' of data. The testing involves mechanical and material property assessments on device components or prototypes. There is no mention of patient data or clinical data utilized as a 'test set'.

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. As this is non-clinical testing of a physical device, there is no 'ground truth' established by medical experts in the context of imaging or clinical diagnoses. The "truth" for mechanical and material properties is determined by engineering standards and measurement techniques.

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

• Not Applicable. There is no 'test set' or adjudication process involving human experts for establishing ground truth in this non-clinical testing context.

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 a 510(k) submission for a physical knee prosthesis, not an AI or imaging diagnostic device. Therefore, no MRMC study or AI-assisted performance evaluation was conducted or is relevant.

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

• Not Applicable. This filing pertains to a physical orthopedic implant. There is no algorithm involved.

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

• Not Applicable. For the non-clinical performance data, the 'ground truth' is based on established engineering and material science principles, standardized test methods (likely ASTM or ISO standards), and physical measurements of the device's mechanical and material properties. It is not an expert consensus on clinical cases, pathology, or outcomes data, as these are not relevant for demonstrating substantial equivalence of a device's physical and material characteristics.

8. The sample size for the training set

• Not Applicable. This is not a machine learning or AI algorithm; therefore, there is no concept of a 'training set'.

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

• Not Applicable. As there is no training set, this question is not applicable.

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The NEO™ PS Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with excised posterior cruciate ligament, undergoing surgery for total knee replacement due to:
. Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
. Failed osteotomies, partial knee replacement, or failed prior total knee replacement whose age, weight and activity level are compatible with an adequate long-term result.
. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
. Moderate valgus, varus, or flexion deformities.
NEO™ PS Total Knee System components are indicated for use only with cement and are single use devices.

The NEO PS Knee System includes components designed for total knee replacement. The system includes femoral components, tibial inserts, tibial trays, patellar components and surgical instrumentation:
The Neo PS Knee System femoral component, when used with the Neo PS articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

The provided text describes a medical device, the NEO PS Knee System, and its clearance process through the FDA's 510(k) pathway. This pathway establishes substantial equivalence to predicate devices rather than proving safety and effectiveness through clinical trials with defined acceptance criteria. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood in the context of diagnostic accuracy or performance, is not directly applicable to this submission.

However, based on the provided document, we can infer the "acceptance criteria" and "study" in the context of a 510(k) submission as demonstrating substantial equivalence to predicate devices through various performance tests.

Here's an analysis of the information that can be extracted or reasonably inferred from the document:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission for a knee implant, the "acceptance criteria" are not reported as specific statistical thresholds for diagnostic accuracy (e.g., sensitivity, specificity). Instead, they are implied to be achieving comparable or acceptable performance in mechanical and functional tests as benchmarked against predicate devices and relevant industry standards.

• Tibial tray fatigue strength
• Insert locking mechanism strength
• PS post strength |
  | Functional Range of Motion (comparable to predicate devices and patient needs) | Evaluated for:
• Femorotibial range of motion
• Femorotibial range of constraint
• Patellofemoral range of constraint |
  | Contact Mechanics (comparable to predicate devices to minimize wear and stress) | Evaluated for:
• Femorotibial contact areas/contact stress
• Patellofemoral contact area and contact stress |
  | Material Compliance (meeting established biomedical standards) | "The metals and standard UHMWPE material from which the components are manufactured are the same materials used in the predicate knee systems and comply with applicable implantable materials standards." |
  | Overall Substantial Equivalence | "All evaluations determined that the NEO PS Knee System is substantially equivalent to the predicate devices." |

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

• Sample Size for Test Set: Not applicable in the context of a clinical test set for diagnostic performance. The "test set" here refers to the physical devices undergoing various mechanical and material tests. The specific number of physical samples tested for each mechanical test is not disclosed in this summary.
• Data Provenance: The tests are likely conducted in a controlled laboratory environment by the manufacturer (Pipeline Orthopedics) or a contract testing laboratory. The country of origin for these tests is not specified but is presumably the US, where the company is based. The data would be considered prospective in the sense that the tests are designed and performed to evaluate the new device's characteristics.

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

This information is not applicable to this type of submission. "Ground truth" in the context of a 510(k) for a medical implant refers to established engineering principles, material standards, and the performance characteristics of legally marketed predicate devices. The "experts" involved are likely biomechanical engineers, material scientists, and regulatory experts who interpret test results against these standards and predicate device data. The document does not specify the number or detailed qualifications of such experts involved in the testing or the substantial equivalence determination beyond the general regulatory process.

4. Adjudication method for the test set:

This concept is not applicable here. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies in expert interpretations of medical data (e.g., image readings). For a medical implant's mechanical testing, the "adjudication" is inherent in the test protocols themselves, the calculation of results, and the comparison against predefined acceptance criteria or predicate device performance. Any discrepancies would relate to test execution or interpretation which would be resolved through standard engineering and quality control procedures.

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 diagnostic devices (e.g., imaging software) where human interpretation is involved and improved with AI assistance. The NEO PS Knee System is a joint implant, not a diagnostic tool.

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

This is not applicable. This question pertains to AI/algorithm performance. The NEO PS Knee System is a physical knee implant.

7. The type of ground truth used:

The "ground truth" for this 510(k) submission is primarily established through:

• Predicate Device Performance: Benchmarking against the mechanical and functional characteristics of the legally marketed predicate devices (NEO CR Knee System, NexGen® LPS-Flex Knee System, Triathlon PS Knee System).
• Industry Standards: Compliance with "applicable implantable materials standards" (e.g., ASTM, ISO standards for biocompatibility, mechanical properties, etc., though not explicitly named).
• Engineering Principles: The tests conducted (fatigue, strength, ROM, contact stress) are based on established biomechanical and engineering principles to ensure the device can withstand anticipated physiological conditions.

8. The sample size for the training set:

This is not applicable. A "training set" refers to data used to train an AI algorithm. The NEO PS Knee System is a physical implant.

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

This is not applicable for the same reason as point 8.

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The NEO CR Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing surgery for total knee replacement due to:

• Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
• Failed osteotomies, failed partial knee replacement, or failed total knee replacement whose age, weight and activity level are compatible with an adequate long-term result.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
  Neo CR Knee System components are indicated for use only with cement and are single use devices.

The NEO CR Knee System includes components designed for total knee replacement. The system includes femoral components, tibial trays, patellar components and surgical instrumentation. The Neo CR Knee System femoral component, when used with the Neo CR articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

The provided text describes a 510(k) summary for the NEO CR Knee System, a total knee replacement device. It establishes substantial equivalence to predicate devices based on design and performance testing. However, the document does not contain the specific information required to answer your questions regarding acceptance criteria and a study proving the device meets those criteria in the context of AI device performance.

Specifically, the document focuses on regulatory clearance for a physical medical device (a knee implant) and not an AI medical device. The criteria listed are for the mechanical and material performance of the knee implant itself, and the "performance testing" mentioned refers to engineering tests, not studies of AI algorithm efficacy or diagnostic accuracy.

Therefore, I cannot provide the requested information from the given text.

Here's why the required information is missing:

• Acceptance Criteria for AI/Performance: The document discusses performance testing for the knee implant's mechanical properties (fatigue strength, locking mechanism, range of motion, contact stress), not diagnostic accuracy, sensitivity, specificity, or other metrics typically used for AI device acceptance.
• Study Proving Acceptance Criteria: The document mentions "performance testing" was done, but it does not detail specific studies, sample sizes, ground truth establishment, or expert evaluation methods relevant to AI performance.
• Sample Size (Test Set/Training Set) and Data Provenance: This information is not present as the "device" in question is a physical implant, not an AI algorithm.
• Number of Experts/Qualifications/Adjudication Method: These are relevant for establishing ground truth in AI diagnostic studies, which is not applicable here.
• MRMC Comparative Effectiveness Study: Such studies are conducted to evaluate the human-AI interaction or impact of AI assistance on human readers. This is not mentioned.
• Standalone Performance: This refers to the AI algorithm's performance without human interaction. Not applicable here.
• Type of Ground Truth: For AI, this would be pathology, expert consensus on images, clinical outcomes, etc. For a mechanical implant, ground truth relates to engineering specifications and physical measurements.
• Ground Truth for Training Set: This is specific to AI model training, which is not relevant to a physical knee implant.

In summary, the provided 510(k) summary is for a traditional medical device (knee implant) and thus does not contain the details pertaining to acceptance criteria and studies for an AI-powered medical device.

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The Pipeline CR Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, with an intact posterior cruciate ligament, undergoing total knee replacement due to:

• . Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
• Failed osteotomies, failed partial knee replacement, or failed prior total knee . replacement whose age, weight and activity level are compatible with an adequate long-term result.
• . Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities. .
  Pipeline CR Total Knee System components are indicated for use only with cement and are single use devices.

The Pipeline Primary CR Knee System includes components designed for total knee replacement. The system includes femoral components, tibial inserts, tibial trays, patellar components and surgical instrumentation.
The Pipeline CR Total Knee System femoral component, when used with the Pipeline CR articular surfaces, is designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

The provided text is a 510(k) Summary for the Pipeline Primary CR Knee System, which is a medical device (total knee system). It does not contain information about acceptance criteria or a study proving the device meets those criteria, as such studies are not typically required or described in a 510(k) summary for this type of device.

510(k) summaries, like this one, primarily focus on demonstrating substantial equivalence to legally marketed predicate devices. This involves comparing the new device's indications for use and technological characteristics (e.g., materials, design features) to those of the predicate devices. Performance testing mentioned in such summaries is usually related to ensuring the device is capable of withstanding anticipated physiological conditions, rather than a clinical study with specific performance metrics against acceptance criteria that would include human-AI interaction or expert review.

Therefore, I cannot fulfill the request to provide acceptance criteria and a study proving the device meets them based solely on the provided input. The prompt's requirements (sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) are typical for AI/ML-driven medical device submissions and are not applicable to the Pipeline Primary CR Knee System, which is a physical implant.

In summary, the provided document does not contain the information required to answer the prompt.

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Pipeline Total Hip System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

• A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
• Acute traumatic fracture of the femoral head or neck; -
• Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.
  The Pipeline Total Hip System is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

The Pipeline Total Hip System is an artificial hip replacement system comprised of femoral stems and mating metal heads; acetabular shells and mating acetabular liners; optional acetabular bone screws; and optional acetabular dome hole occluders.
The Pipeline Femoral Stems are forged titanium alloy, feature a proximal roughened surface (plasma-sprayed CP Titanium), come in a range of sizes, and are offered in two offset neck options per size. The Pipeline Femoral Heads are polished cobalt chromium alloy and come in a range of diameters and extension options.
The Pipeline Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface (titanium alloy). The shells feature a dome hole, are available with or without a cluster screw hole pattern for supplemental bone screw fixation, and come in a range of outer diameter sizes. The Pipeline Acetabular Liners are manufactured from ultrahigh molecular weight polyethylene (standard UHMWPE or highly crosslinked Vitamin E UHMWPE). The liners are mechanically assembled to the mating shells via engagement of the liner taper with the shell bore. Locking is achieved through engagement of interrupted poly rib at the taper to sphere transition of the liner with a mating groove on the shell. Poly tabs of the liner mate with scallops on the face of the shell to prohibit rotation of the liner. The liners are available in a range of sizes, and are available in neutral, high wall, +4mm offset, +4mm offset/10° elevated, and +4mm offset/high wall options.
Optional components include a threaded acetabular dome hole occluder and acetabular bone screws, all manufactured from titanium alloy.

This 510(k) summary describes a medical device, the Pipeline Total Hip System, rather than an AI/ML product. Therefore, the traditional acceptance criteria and study design elements typically associated with AI/ML device evaluations (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable here.

The document primarily focuses on demonstrating the substantial equivalence of the Pipeline Total Hip System to legally marketed predicate hip systems. This is a regulatory pathway for medical devices that relies on showing that the new device is as safe and effective as devices already on the market.

Instead of AI/ML performance metrics, the acceptance criteria and supporting studies for this device relate to its physical properties, biocompatibility, and mechanical performance.

Below is a reinterpretation of your requested categories to fit the context of this medical device submission:

Acceptance Criteria and Device Performance (Adapted for Medical Device)

• The Vitamin E raw material blend in the polyethylene is the same as the predicate highly crosslinked Vitamin E polyethylene.
• Exhaustive extraction testing (GCMS and LCMS) showed no new radiation degradation products compared to a predicate material. |
  | Wear Resistance | - Wear testing conducted on 36mm inner diameter highly crosslinked Vitamin E poly liners (EO-sterilized, accelerated aged per ASTM F2003, tested per ISO 14242 using standard walking gait cycle).
• Bidirectional pin-on-disc abrasive wear testing compared wear rates of highly-crosslinked Vitamin E poly to conventional gamma-sterilized poly under abrasive conditions.
• Wear particle characterization was conducted.
• Oxidation analysis (ASTM F2102-06 after ASTM F2003 accelerated aging and wear testing) showed favorable results compared to gamma-sterilized GUR 1020. |
  | Mechanical Integrity / Strength | - Liner Assembly/Disassembly Testing: Worst-case size highly crosslinked Vitamin E poly and conventional poly acetabular liners tested for push-out, lever-out torque, and axial torque.
• Hip Stem Fatigue Testing: Worst-case (smallest) hip stem tested according to ISO 7206-4:2010.
• Stem Neck Fatigue Testing: Worst-case size stem tested according to ISO 7206-6:1992 and ASTM F2068-03.
• Head/Taper Strength: Average pull-off force demonstrated for worst-case sizes.
• Bone Screw Testing: Worst-case diameter bone screws tested for torsion (torque to failure) and screw pull-out (pull-out to failure) per ASTM F543-07. |
  | Range of Motion (ROM) | - Analysis conducted on typical and worst-case ranges of motion permitted by various liner size/style, head size/style, and stem size/style combinations. ROM reported for flexion/extension, abduction/adduction, and internal/external rotation per ISO 21535. |
  | Coating Characterization & Biological Fixation (Porous Surfaces) | - Characterization of Hip Stem (Plasma-Spray Titanium Coating) and Acetabular Shell (Porous Structured Surface) according to "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement."
• Porous structured surface evaluated in a transcortical canine model to assess biological response (histological and mechanical evaluations) up to 12 weeks. This demonstrates suitability for biological fixation in cementless applications. |
  | Substantial Equivalence to Predicates | - The materials (metals, standard UHMWPE, highly crosslinked Vitamin E UHMWPE) comply with applicable implantable material standards and are equivalent to those used in predicate devices.
• Design features are comparable to predicate hip systems.
• The device is capable of withstanding anticipated physiological conditions.
• The Pipeline Hip System shares the same indications for use as predicate hip systems. Overall, the device meets the criteria for substantial equivalence, implying it is as safe and effective as the predicate devices. |

Non-Applicable/Re-interpreted AI/ML Specific Questions:

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

   • Interpretation: For this physical device, "test sets" refer to the samples and methods used in the various engineering, materials, and biological tests.
   • Details:
     • Wear testing: 36mm inner diameter highly crosslinked Vitamin E poly liners (number not specified).
     • Liner Assembly/Disassembly: "worst case size" liners (number not specified).
     • Hip Stem Fatigue: "worst case (smallest)" hip stem (number not specified).
     • Stem Neck Fatigue: "worst-case size" (number not specified).
     • Head/Taper Strength: "worst-case sizes" (number not specified).
     • Bone Screw Testing: "worst-case diameter" for torsion and pull-out (number not specified).
     • Porous Surface Biological Response: Transcortical canine model (number of animals not specified, but this would be a prospective animal study).
   • Provenance: All tests were conducted in a laboratory setting (in-vitro, ex-vivo, or animal model) to established international standards (ISO, ASTM). This is not human data and therefore "country of origin" or "retrospective/prospective" in the clinical sense are not directly applicable.

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

   • Interpretation: This is not applicable. For a physical medical device, "ground truth" is established by direct measurement, observation, and adherence to validated testing standards (ISO, ASTM). The "experts" are the engineers, materials scientists, and biologists performing and interpreting these standardized tests.

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

   • Interpretation: Not applicable. Testing results are based on objective measurements against pass/fail criteria defined by relevant standards, not subjective human assessment needing adjudication.

4. 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:

   • Interpretation: Not applicable as this is not an AI/ML device.

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

   • Interpretation: Not applicable as this is not an AI/ML device.

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

   • Interpretation: For this device, the "ground truth" is defined by adherence to established engineering and material science standards (e.g., ISO 10993 for biocompatibility, ISO 14242 for wear, ISO 7206 for fatigue, ASTM F543 for screws), and pre-clinical biological observations (canine model for osseointegration).

7. The sample size for the training set:

   • Interpretation: Not applicable as this is not an AI/ML device that requires a "training set." The design and manufacturing processes are likely informed by years of historical engineering data and predicate device performance, but not in the context of an AI training set.

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

   • Interpretation: Not applicable as this is not an AI/ML device.

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