(144 days)
The PBP 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 PBP Total Hip System hip stems and porous structured acetabular shells are intended for cementless or cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.
The PBP Total Hip System HA porous structured acetabular shells are intended for cementless fixation. The HA porous structured surface provides biological fixation.
The PBP Total Hip System is an artificial hip replacement system. The system includes femoral stems, femoral heads, acetabular shells, acetabular liners, acetabular bone screws and dome hole covers (occluders) for the holes in the acetabular shells.
The PBP Femoral Stems are forged titanium alloy and feature a proximal roughened surface (plasma-sprayed CP Titanium), a polished tapered neck, a flat tapered geometry with reduced A/P width (wedge design), and a contoured distal tip and reduced lateral shoulder. The PBP Femoral Stems come in a range of sizes, and are offered in two offset neck options per size.
The PBP Femoral Heads are available in a polished cobalt chromium alloy or a high purity alumina oxide ceramic compound (Biolox® delta). The heads come in a range of diameters and extension options. The variety of head and stem sizes accommodates differences in patient anatomy.
The PBP PST™ (Porous Structured Technology) Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface or an HA porous structured surface. 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 porous structured surface provides biologic fixation.
The PBP Acetabular Liners are manufactured from standard UHMWPE, or from highly crosslinked Vitamin E UHMWPE (XLVE™). The liners are mechanically assembled to the mating shells via engagement of the tightly toleranced liner taper and shell bore. The liners are available in a range of sizes and in neutral, high wall, and offset versions.
Optional components include a threaded acetabular dome hole occluder and acetabular bone screws, all manufactured from titanium alloy.
Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary for the PBP Total Hip System:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like the PBP Total Hip System, acceptance criteria are typically defined by recognized standards (e.g., ISO, ASTM) for safety and performance, and the device's performance is demonstrated by meeting these standards. The acceptance criteria themselves are the limits or thresholds specified within these standards.
| Test Category | Acceptance Criteria (as per referenced standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets ISO 10993 series requirements for various biological effects (Cytotoxicity, Sensitization, Intracutaneous, Acute Systemic Toxicity, Sub-acute/Subchronic Systemic Toxicity, Genotoxicity, Muscle Implantation). | All Biocompatibility tests met the requirements of the respective ISO 10993 standards. (Specific pass/fail for each not detailed but implied by clearance). |
| Wear Testing (highly crosslinked Vitamin E Polyethylene) | In accordance with ISO 14242-1 (standard walking gait cycle) for poly liners; bidirectional pin-on-disc abrasive wear testing to demonstrate reduced wear compared to conventional poly; exhaustive extraction to show no new radiation degradation products vs. predicate. | • Wear tested per ISO 14242 (28mm, 36mm, 40mm liners, EO-sterilized, accelerated aged per ASTM F2003). |
| • Bidirectional pin-on-disc: 35% wear reduction in clean serum (7.7 mg/Mc for standard vs 5 mg/Mc for Vitamin E); 58% wear reduction in abrasive environment (8.3 mg/Mc for standard vs 3.5 mg/Mc for Vitamin E). | ||
| • Wear particle characterization was conducted. | ||
| • Exhaustive extraction (with GCMS and LCMS analysis): Results demonstrated no new radiation degradation products released compared to predicate material. | ||
| Oxidation Analysis (highly crosslinked Vitamin E Polyethylene) | Per ASTM F2102-06, after accelerated aging per ASTM F2003, wear testing, and exhaustive extraction; lower oxidation indices than standard poly. | • Mean surface oxidation index: 0.017 (Vitamin E) vs. 0.097 (standard poly). |
| • Maximum oxidation index: 0.029 (Vitamin E) vs. 0.248 (standard poly). | ||
| • Bulk oxidation index: 0.009 (Vitamin E) vs. 0.036 (standard poly). | ||
| (Demonstrates higher resistance to oxidation). | ||
| Consolidation (highly crosslinked Vitamin E Polyethylene) | Equivalent consolidation to a predicate material after accelerated aging per ASTM F2003 and wear testing, as evaluated by polarized light microscopy and SEM analysis. | Evaluation demonstrated equivalent consolidation to a predicate material. |
| Liner Assembly/Disassembly Testing | Meets force/torque requirements for push-out, lever-out torque, and axial torque for worst-case size liners. | Worst-case size conventional poly liner and highly crosslinked Vitamin E poly acetabular liner were tested for push-out, lever out torque, and axial torque. (Specific values not given, but implied to meet criteria). |
| Hip Stem Fatigue Testing | Per ISO 7206-4:2010 (Endurance Properties and Performance of Stemmed Femoral Components). | Worst-case (smallest) hip stem was tested according to ISO 7206-4:2010. (Implied to meet endurance requirements). |
| Stem Neck Fatigue Testing | Per ISO 7206-6:1992 and ASTM F2068-03 (Standard Specification for Femoral Prostheses - Metallic Implants). | Worst-case size was tested according to ISO 7206-6:1992 and ASTM F2068-03. (Implied to meet fatigue requirements). |
| Femoral Head Pull-off Testing | Meets required pull-off force. | Conducted on metal and ceramic femoral heads. (Implied to meet criteria). |
| Femoral Head Burst Strength Testing | Per ISO 7206-10. | Conducted on Biolox delta Femoral Heads according to ISO 7206-10. (Implied to meet burst strength requirements). |
| Range of Motion (ROM) Analysis | Meets physiological ROM requirements per ISO 21535 (flexion/extension, abduction/adduction, internal/external rotation). | Analysis was conducted to determine typical and worst-case ranges of motion for various liner/head/stem combinations. ROM was reported for flexion/extension, abduction/adduction, and internal/external rotation per ISO 21535. (Implied to meet criteria). |
| Bone Screw Testing | Per ASTM F543-07 (Metallic Medical Bone Screws) for torsion (torque to failure) and screw pull-out (pull-out to failure). | Conducted for torsion (torque to failure) and screw pull-out (pull-out to failure) according to ASTM F543-07. (Implied to meet criteria). |
| Porous Structured Surface Characterization | Meets relevant aspects of "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement." | Characterization completed for Acetabular Shell – PST Surface, Acetabular Shell – HA PST Surface, and Hip Stem - Plasma-Spray Titanium Coating. |
| Ceramic Head Characterization | Meets relevant aspects of "Guidance Document for the Preparation of Premarket Notifications for Ceramic Ball HIP Systems." | Characterization completed for the ceramic femoral heads. |
| Biologic Response (Porous Structured Surface) | Demonstrates favorable biological response (e.g., bone ingrowth, lack of adverse reaction) in a transcortical canine model. | Evaluated in a transcortical canine model at intervals up to 12 weeks, using histological and mechanical evaluations (implied to demonstrate acceptable biological response). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Wear Testing: 28mm, 36mm, and 40mm inner diameter highly crosslinked Vitamin E poly liners were tested (number of units per size not specified).
- Liner Assembly/Disassembly Testing: "worst case size Pipeline Hip System highly crosslinked Vitamin E poly acetabular liner and worst case size conventional poly liner" (number of units not specified).
- Hip Stem Fatigue Testing: "worst case (smallest) hip stem" (number of units not specified, but typically multiple samples are tested to establish a statistical confidence).
- Stem Neck Fatigue Testing: "worst-case size" (number of units not specified).
- Porous Structured Surface Biologic Response: "a transcortical canine model" (number of canines not specified, but generally a small, controlled animal study).
- Other tests (biocompatibility, oxidation, consolidation, pull-off, burst strength, bone screw, characterization) would also have specific sample sizes, but these are not explicitly detailed in the summary beyond "testing was conducted" or "analysis was conducted." The phrase "worst case" implies a focus on challenging conditions relevant to product safety.
- Data Provenance: The document does not specify the country of origin for the data, but it is a submission to the US FDA, implying that the data was generated or compiled for US regulatory review. The studies are pre-clinical/pre-market performance evaluations conducted in a laboratory or animal setting, not human clinical trials. Thus, the data provenance is from controlled laboratory/animal studies. The studies are prospective in nature, as they were designed and executed to gather specific performance data for the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (experts for ground truth) is not applicable to this 510(k) submission. The PBP Total Hip System is a mechanical orthopedic implant, and its performance is evaluated against engineering and biological standards using objective measurements in laboratory and animal models. "Ground truth" established by human experts (like radiologists for image analysis) is typically relevant for diagnostic devices or AI algorithms that interpret complex human data.
4. Adjudication Method for the Test Set
This is not applicable to this type of device and study. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers or experts, which is not the methodology for evaluating the mechanical and biological performance of an orthopedic implant.
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 to this device. An MRMC study is designed for evaluating diagnostic devices or AI algorithms that assist human interpretation of medical images or data. The PBP Total Hip System is a physical implant, not a diagnostic or AI-assisted device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable to this device. This concept relates to the performance of an AI algorithm independently, which is not relevant for a hip implant.
7. The Type of Ground Truth Used
For this device, the "ground truth" is defined by:
- Engineering Standards: Specific values, thresholds, and methodologies outlined in international (e.g., ISO) and national (e.g., ASTM) standards for material properties, mechanical strength, fatigue life, wear rates, and range of motion.
- Predicate Device Comparison: The performance of the predicate devices implicitly sets a "ground truth" for acceptable performance for substantial equivalence. For instance, the oxidation resistance and wear rates are compared directly to predicate/standard materials.
- Biological Response: Histological and mechanical evaluations in the canine model serve as the "ground truth" for assessing the biological fixation and response of the porous surface.
8. The Sample Size for the Training Set
This is not applicable to this device. "Training set" refers to data used to train machine learning models. This 510(k) describes performance testing for a physical orthopedic implant, not an AI or software device.
9. How the Ground Truth for the Training Set was Established
This is not applicable to this device, as there is no "training set."
§ 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.