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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 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.

This 510(k) addresses the addition of the following components (already cleared under 510(k) #K130353) to the subject hip system:

• A size 1 femoral stem;
• Hip stems (all sizes, 1-12) with the option of 3 tantalum beads, to allow the surgeon to perform radiostereometric analysis(RSA) to measure implant migration; and
• Optional acetabular screw hole occluders provided either separately (for assembly by the surgeon), or pre-assembled to the acetabular shells.

These components are compatible with the total hip system determined substantially equivalent as the Pipeline Total Hip System in 510(k) #K12802 and K131237 and as the PBP Total Hip System in 510(k) #K122158.

The provided text is a 510(k) summary for a medical device (Pipeline Total Hip System - Line Extension) and a subsequent FDA clearance letter. It does not describe acceptance criteria or a study that proves the device meets specific performance criteria in the way typically seen for AI/software devices.

Instead, this submission is a Special 510(k) for a line extension, where the key argument for substantial equivalence is that the new components are identical to previously cleared components under a different subsidiary name of the same parent company (Pipeline Biomedical Holdings).

Therefore, many of the requested points regarding AI/software performance studies are not applicable to this type of device clearance. Below is an attempt to answer the questions based on the provided text, while acknowledging the inherent mismatch due to the nature of this 510(k) submission.

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

This information is not provided in the document as it's a line extension based on identity to a predicate, not a new device requiring performance testing against specific criteria. The "performance" is implicitly deemed to be identical to the predicate device.

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. No new performance testing was conducted for this submission. The device's "performance" is considered identical to a previously cleared device (K130353).

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. No test set or ground truth establishment relevant to AI/software performance.

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

Not applicable. No test set for 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

Not applicable. This device is a total hip replacement system, not an AI/software device intended to assist human readers.

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

Not applicable. This device is a total hip replacement system, not an algorithm.

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

Not applicable. No new performance validation studies were conducted as the components are stated to be identical to previously cleared predicate devices. The "ground truth" for this submission is the identity of the components to the legally marketed predicate.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/software requiring a training set.

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

Not applicable. As above, no training set.

Summary of the 510(k) Submission (K132626) based on the provided text:

This 510(k) is a Special 510(k) for a line extension to the Pipeline Total Hip System. The purpose is to add specific components (a size 1 femoral stem, hip stems with tantalum beads for RSA, and acetabular screw hole occluders) to the existing system.

The core argument for substantial equivalence is that these added components are identical to components already cleared by the FDA under 510(k) #K130353, which were marketed by a different subsidiary (Pipeline Orthopedics) of the same parent company (Pipeline Biomedical Holdings).

Because the components are claimed to be identical in "intended use, materials, design features, component sizing, or manufacturing methods," no additional nonclinical or clinical testing was conducted or deemed necessary for this particular submission (K132626). The "acceptance criteria" and "performance" are therefore assumed to be met by virtue of their identity to the predicate device cleared under K130353.

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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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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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