(164 days)
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)
| Acceptance Criteria Category | Description / Performance Demonstrated |
|---|---|
| Biocompatibility | - Highly crosslinked Vitamin E Polyethylene demonstrated biocompatibility through tests including Cytotoxicity, Maximization/Sensitization, Intracutaneous, Acute Systemic Toxicity, Sub-acute/Subchronic Systemic Toxicity, Genotoxicity, and Muscle Implantation, all in accordance with ISO 10993 series standards. |
- 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:
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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.
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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.
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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.
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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.
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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.
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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).
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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.
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How the ground truth for the training set was established:
- Interpretation: Not applicable as this is not an AI/ML device.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.