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510(k) Data Aggregation
(119 days)
The system is indicated for primary or revision surgery in skeletally mature individuals for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
The system is intended for use either with or without bone cement in total hip arthroplasty.
The Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners are neutral and elevated acetabular liners which are intended to mate with either the Continuum or Trilogy IT acetabular shells in total hip arthroplasty.
The Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners are designed for total hip arthroplasty. The acceptance criteria and performance of the device are detailed in a series of non-clinical laboratory tests and animal studies.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Claim | Description of Test/Experiment | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Claim 1: Antioxidant protection prevents oxidation degradation | Tensile (ASTM D638), Izod Impact (ASTM F648, Annex A1), and Oxidation Index (ASTM F2102) samples of Vivacit-E Vitamin E HXPE were tested in non-aged condition and up to 24 weeks of accelerated aging (ASTM F2003: 100% oxygen, 73 psi, 70°C). Additionally, cyclic loading in oxidative environment (0.5 Hz, 10 MPa bending stress at 80°C in air for 5 weeks) was performed. | No significant change in tensile or Izod properties, no detectable oxidation (oxidation indices < 0.01), and no evidence of cracking with negligible oxidation (oxidation indices < 0.05) under cyclic loading. | No statistically significant difference in ultimate tensile strength (p=0.63), elongation (p=0.61), and Izod impact (p=0.47) after 12 times the standard accelerated aging method. Greater than 96% retention of mechanical properties. No detectable oxidation (oxidation indices < 0.01). Under cyclic loading, no evidence of cracking and negligible (~1.5Mc) oxidation (oxidation indices < 0.05). |
| Claim 2: No measurable oxidation during accelerated aging | Vivacit-E Vitamin E HXPE and conventional GUR 1050 gamma sterilized controls were subjected to accelerated aging (ASTM F2003: 70°C, 73 psi, 100% oxygen) for up to 24 weeks. Oxidation index (ASTM F2102) and oxidative induction time (ASTM D3895) were measured. | No detectable oxidation (oxidation indices < 0.01) and oxidative induction times > 8.0 minutes. | Vivacit-E Vitamin E HXPE showed no detectable oxidation (oxidation indices < 0.01) and oxidative induction times > 8.0 minutes after 24 weeks of aging. Conventional GUR 1050 samples showed oxidation indices > 0.5 and OIT < 1.0 min after 2 weeks, and OI > 3 with immeasurable OIT after 4 weeks. |
| Claim 3: Retains mechanical strength after accelerated aging | Vivacit-E Vitamin E HXPE tensile (ASTM D638) and Izod impact (ASTM F648, Annex A1) specimens were tested non-aged and up to 24 weeks of accelerated aging (ASTM F2003: 100% oxygen, 73 psi, 70°C). | No statistically significant difference in mechanical properties, with greater than 96% retention. | No statistically significant difference in ultimate tensile strength (p=0.63), elongation (p=0.61), and Izod impact (p=0.47) after 12 times the standard accelerated aging method. Greater than 96% retention of mechanical properties. |
| Claim 4: Vitamin E does not elute | Exhaustive solvent extractions (boiling hexane, isopropanol) were performed. Vivacit-E Vitamin E HXPE liners were immersed in 40°C de-ionized water for up to 24 weeks. Pressure-induced leaching study (150 N and 1500 N for 1 minute) was conducted. | Residue quantities comparable to non-Vitamin E predicate material; Vitamin E levels in aqueous solution below detectable limits; no change in Vitamin E Index or Oxidation Index; Vitamin E levels under pressure-induced leaching below detection limits. | FTIR analysis showed residues comparable to predicate; UV-Vis showed Vitamin E levels in water below detectable limits; no change in Vitamin E Index or Oxidation Index for liners; fluorescence spectroscopy showed Vitamin E levels under pressure-induced leaching below detection limits. |
| Claim 5: Resists cracking and oxidation under environmental stress | Cyclic loading (0.5 Hz, 10 MPa bending stress at 80°C in air for 5 weeks) in an oxidative environment. | No evidence of cracking and negligible oxidation (oxidation indices < 0.05). | No evidence of cracking and negligible (~1.5Mc) oxidation (oxidation indices < 0.05). |
| Claim 6: Retains wear properties after extended aging | In-vitro wear test using hip simulator (ISO-14242-1, 5 million cycles) comparing 2-week aged and 6-week aged Vivacit-E Vitamin E HXPE liners (ASTM F2003 aging). | Volumetric wear rates of aged samples not statistically different. | Volumetric wear rates of 2-week aged (1.96±0.34 mm³/Mc) and 6-week aged (1.50±0.32 mm³/Mc) Vivacit-E Vitamin E HXPE liners were not statistically different (p=0.064). |
| Claim 7: Wear properties comparable to Longevity Highly Crosslinked Polyethylene | In-vitro wear test using hip simulator (ISO-14242-1, 5 million cycles) comparing 2-week aged Vivacit-E Vitamin E HXPE and Longevity IT HXPE liners (ASTM F2003 aging). Worst-case articulation size (56mm x 40mm liner with 40mm CoCr femoral head) was used. | Volumetric wear rates not statistically different. | Wear rates for Vivacit-E (1.02±0.39 mm³/Mc) and Longevity (1.56±0.33 mm³/Mc) were not statistically different (p=0.165). |
| Claim 8: 96% reduction in wear over Conventional Polyethylene | In-vitro wear test using hip simulator (ISO-14242-1, 5 million cycles) comparing 2-week aged Vivacit-E Vitamin E HXPE (40mm articulation) and Conventional Polyethylene (32mm articulation). | Significant reduction in wear. | 40mm Vivacit-E Vitamin E Highly Crosslinked Polyethylene liners displayed a 96% reduction in wear compared to 32mm Conventional Polyethylene components. |
| Claim 9: Comparable local and systemic inflammatory responses to wear particles | In-vivo study in rabbits with percutaneous knee injection of Vivacit-E Vitamin E HXPE wear debris, UHMWPE control particles, and vehicle control. Evaluation at 3 and 6 months: blood samples, dissection of knee joint, lymph nodes, spleen, liver. | Local and systemic inflammatory response similar to UHMWPE control; no systemic toxicity; classified as non-irritant. | Local and systemic inflammatory response similar for Vivacit-E HXPE and UHMWPE control; Vivacit-E HXPE did not cause systemic toxicity; microscopically classified as a non-irritant. |
| Claim 10: Classified as a non-irritant in muscle implantation study | Intramuscular implant testing in rabbits (ISO 10993) for 2 and 12 weeks, comparing Vivacit-E Vitamin E HXPE and HDPE sites. Microscopic evaluation of H&E stained tissue. | Macroscopic reaction not significant compared to negative control; irritant ranking score (Test Group Average - Control Group Average) between 0.0 - 2.9. | Average irritant scores for HDPE and Vivacit-E Vitamin E HXPE were 7.0 and 7.0 at 2 weeks, and 3.7 and 3.0 at 12 weeks. Irritant Ranking Scores of 0.0 (2 weeks) and -0.7 (12 weeks), classifying it as a non-irritant. |
| Claim 11: No systemic toxicity in mammalian animal model | Acute systemic toxicity: Vivacit-E Vitamin E HXPE extracts injected into mice. Subchronic systemic toxicity: Vivacit-E Vitamin E HXPE and HDPE reference material surgically implanted subcutaneously in rats for 13 weeks. Chronic systemic toxicity: Vivacit-E Vitamin E HXPE and HDPE reference material surgically implanted subcutaneously in rats for 26 weeks. | No mortality or adverse clinical reactions; no evidence of systemic toxicity; local macroscopic tissue reaction not significant compared to control; classified as non-irritant. | Acute: No mortality or evidence of systemic toxicity. Subchronic: No evidence of systemic toxicity; classified as non-irritant; local macroscopic tissue reaction not significant. Chronic: No evidence of systemic toxicity; macroscopic and microscopic findings found no irritation and tissue response comparable to control; classified as a non-irritant. |
2. Sample Size and Data Provenance
The primary testing presented here consists of non-clinical laboratory tests and animal studies. Therefore, human test sets, countries of origin, or distinctions between retrospective/prospective data are not applicable.
- Mechanical Material Characterization & Oxidation Testing (Claims 1, 2, 3, 5): The document refers to "samples" being tested, indicating multiple specimens per test endpoint and aging interval (e.g., "Vivacit-E Vitamin E HXPE tensle, Izod impact, and oxidation index samples were tested"). Specific numerical sample sizes for each test are not provided in this summary.
- Elution and Extraction (Claim 4): "Several exhaustive solvent extractions" were conducted. For the aqueous environment test, "liners" were removed at 6 time intervals (1, 2, 4, 8, 12, 24 weeks), implying multiple liners or samples were used. For the pressure-induced leaching, "thin films (100 micron thick)" were cut, and "the transfer film" was analyzed, likely indicating multiple films assessed.
- Wear Testing (Claims 6, 7, 8): For the hip simulator tests, the study mentions "12-station AMTI" hip simulators and refers to "All samples."
- Claim 6: Compares "2 week aged" and "6 week aged" Vivacit-E samples; specific number of samples per group is not given.
- Claim 7: Compares Vivacit-E and Longevity IT HXPE liners; specific number of samples per group is not given, but uses "the largest articulation size... as it constitutes the worst case size for wear."
- Claim 8: Compares Vivacit-E Vitamin E HXPE and Conventional Polyethylene; specific number of samples per group is not given.
- Inflammatory Response (Claim 9): "Healthy white rabbits." The study describes "each of the four article suspensions (UHMWPE control, vehicle control, high dose Vivacit-E HXPE, and low dose Vivacit-E HXPE were injected into the lateral-anterior aspect of the right and left hind knee joint of rabbits." This indicates multiple rabbits were used, with injections into both knees. Specific number of rabbits is not provided.
- Muscle Implantation (Claim 10): "Healthy white rabbits." "Four Vivacit-E Vitamin E HXPE sites and four HDPE sites were implanted for each rabbit at each time interval," referring to 2-week and 12-week intervals. This implies multiple rabbits were used. Specific number of rabbits is not provided.
- Systemic Toxicity (Claim 11):
- Acute: "Healthy adult mice." "A single dose... injected into each animal." Specific number of mice not provided.
- Subchronic: "Healthy adult male and female rats." Vivacit-E and HDPE reference material implanted. Specific number of rats not provided.
- Chronic: "Healthy adult male and female rats." Vivacit-E and HDPE reference material implanted. Specific number of rats not provided.
3. Number of Experts and Qualifications (Not Applicable)
The studies described are non-clinical (in-vitro lab tests and in-vivo animal studies). The ground truth for these tests is established through quantitative measurements, chemical analyses, and histopathological evaluations by trained professionals (e.g., veterinary pathologist for animal studies), not by human clinical experts in the context of diagnostic imaging or similar scenarios where expert consensus is typically required.
4. Adjudication Method (None)
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human readers and complex interpretations (e.g., radiology reads). These methods are not applicable to the non-clinical laboratory and animal studies described for this device. The results are based on objective measurements and established scientific protocols.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Not Applicable)
The device is an orthopedic implant component, not a diagnostic or assistive technology for human readers. Therefore, an MRMC study to compare the effect of AI assistance on human reader performance is not relevant or applicable.
6. Standalone (Algorithm Only) Performance (Not Applicable)
This is a physical medical device (hip liner), not an AI algorithm. Therefore, "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The device's performance is intrinsically linked to its physical characteristics and interaction with the biological system.
7. Type of Ground Truth Used
The ground truth for these studies is established through:
- Quantitative measurements: For mechanical properties (tensile strength, elongation, Izod impact), oxidation indices, oxidative induction times, Vitamin E levels, and wear rates, the ground truth is derived from the direct and objective measurements obtained using standardized ASTM and ISO test methods and analytical techniques (e.g., FTIR, UV-Vis, GC-MS, LC-MS, fluorescence spectroscopy, gravimetric analysis).
- Histopathology/Pathological findings: For animal studies (inflammatory response, muscle implantation, systemic toxicity), the ground truth is established by macroscopic and microscopic evaluation of tissues and organs by qualified professionals (e.g., veterinary pathologist). This includes assessing irritation, inflammation, and cellular responses.
- Clinical observations/Biological response: In animal studies, observations of clinical signs, body weights, and hematology/clinical chemistry analyses contribute to establishing the ground truth for systemic toxicity.
8. Sample Size for the Training Set (Not Applicable)
This is a physical device being evaluated through non-clinical and animal studies. There is no concept of a "training set" in the context of developing and validating the device's material properties or biological interactions, unlike machine learning-based devices.
9. How the Ground Truth for the Training Set Was Established (Not Applicable)
As there is no training set for a physical device, this question is not applicable. The device's formulation and manufacturing processes are developed based on extensive materials science, engineering principles, and prior knowledge of biocompatible materials, rather than through data-driven training of an algorithm.
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