(215 days)
The Initia Total Hip System is a single use total hip system for use in cementless hip arthroplasty procedures for the following indications:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results,
The Initia Total Hip System femoral stems are intended for cementless press-fit use. The Initia Total Hip System acetabular shells are intended for cementless use with biological fixation.
The BIOCERAM AZUL HEAD is a single use modular femoral head component for use in hip arthroplasty procedures for the following indications:
- Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis,
- Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure,
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
The Initia Total Hip System is comprised of femoral stems, Co-Cr femoral heads, acetabular shells, an apical hole plug, bone screws and crosslinked polyethylene acetabular liners.
The BIOCERAM AZUL® ceramic heads are zirconia toughened alumina (ZTA) ceramic femoral heads compatible with the femoral stems, acetabular shells and acetabular liners of the Initia Total Hip System.
The femoral stem is a monoblock wedge tapered design. It is manufactured from forged titanium alloy complying with ASTM F136 and ASTM F620 and is coated with a plasma spray of commercially pure titanium complying with ASTM F1580. The stem is offered in 19 stem sizes which include both standard and high offset neck options, for a total of 38 offerings.
The Co-Cr femoral head is manufactured from wrought Co-Cr complying with ASTM F1537. The head has a 12/14 taper bore and is available in outer diameters of 22, 26, 28, 32, 36, 40 and 44 mm. Each head diameter is available in multiple offset options.
The acetabular shell is also made from titanium alloy complying with ASTM F136. The acetabular shell is available in outer diameters ranging from 40 mm to 74 mm in 2 mm increments. The outer surface of the shell is coated with a plasma spray of commercially pure titanium complying with ASTM F1580. The acetabular shell is offered in 0 hole, 3 hole, and multi-hole configurations. Self-tapping acetabular bone screws can be used for initial shell fixation. The screws are made from titanium alloy complying with ASTM F136. Bone screws are available in a 6.5 mm diameter and lengths from 15 to 60 mm in 5 mm increments. An apical hole plug, manufactured from titanium alloy complying with ASTM F136, is available to close the apical hole on the acetabular shell.
The acetabular liner is made from crosslinked ultra high molecular weight polyethylene (UHMWPE) complying with ASTM F648 and ASTM F2565. The polyethylene liner is offered in inner diameters of 22, 26, 28, 32, 36, 40 and 44 mm with outer diameters to fit the 40 - 74 mm acetabular shells. The liner is offered in 4 configurations: standard (STD), standard with offset (STD HO), elevated rim (MX), and elevated rim with offset (MX HO). The liner mates with the shell using a circumferential locking feature that is integrated into the liner to prevent disassociation. The locking feature mates with a circular groove machined into the shell. The liner also possesses anti-rotation tabs that mate with scallops in the shell.
The BIOCERAM AZUL® ceramic head is manufactured from high purity alumina matrix with zirconia reinforcement, which complies with ISO 6474-2. The head has a 12/14 taper bore and is available in outer diameters of 28, 32, 36, 40 and 44 mm. There are 3 offsets (-3.5, +0, +3.5 mm) for the 28 mm size. There are 4 offsets (-3.5, +0, +3.5, +7 mm) for the 32 to 44 mm sizes.
The provided text describes a 510(k) premarket notification for the "Initia Total Hip System & BIOCERAM AZUL® HEAD." This document focuses on the substantial equivalence of the new device to existing predicate devices, primarily through mechanical testing and material characterization, rather than studies involving human or expert evaluation of performance in a diagnostic or clinical decision-making context.
Therefore, many of the requested categories related to expert-based ground truth, multi-reader multi-case studies, and human performance improvement are not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the devices met "pre-determined acceptance criteria" for various mechanical tests. Specific numerical acceptance criteria values are not provided in this summary. The reported performance is generally stated as "met pre-determined acceptance criteria."
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Femoral Stem Neck Fatigue | Pre-determined | Met acceptance criteria |
| Femoral Stem Fatigue | Pre-determined | Met acceptance criteria |
| Co-Cr Femoral Head / Femoral Stem Taper Axial Pull-Off | Pre-determined | Met acceptance criteria |
| Fretting Corrosion (Co-Cr femoral head) | Pre-determined | Met acceptance criteria |
| Acetabular Shell / Acetabular Liner Push-Out | Pre-determined | Met acceptance criteria |
| Acetabular Shell / Acetabular Liner Lever-Out | Pre-determined | Met acceptance criteria |
| Acetabular Shell / Acetabular Liner Torque-Out | Pre-determined | Met acceptance criteria |
| Hip Simulator Wear (Co-Cr femoral head) | Pre-determined | Met acceptance criteria |
| Mode 3 (w/ roughened femoral head) Hip Simulator Wear | Pre-determined | Met acceptance criteria |
| Wear Particle Analyses (Co-Cr femoral head) | Pre-determined | Met acceptance criteria |
| Impingement | Pre-determined | Met acceptance criteria |
| Bone Screw Torsional Strength | Pre-determined | Met acceptance criteria |
| Bone Screw Insertion and Removal Torque | Pre-determined | Met acceptance criteria |
| Bone Screw Pull-Out | Pre-determined | Met acceptance criteria |
| Total Hip Range of Motion | Pre-determined | Met acceptance criteria |
| Femoral Stem Coating Characterization & Performance (Static Shear, Static Tensile, Shear Fatigue, Abrasion Resistance) | Pre-determined | Met acceptance criteria |
| Acetabular Shell Coating Characterization & Performance (Static Shear, Static Tensile, Shear Fatigue, Abrasion Resistance) | Pre-determined | Met acceptance criteria |
| Crosslinked UHMWPE liner material characterization (aged/unaged vs. predicate) | Pre-determined | Met acceptance criteria |
| Bacterial Endotoxin Testing | 20 EU/device | Met endotoxin limit |
| BIOCERAM AZUL® Ceramic Heads: Static Burst Strength | Pre-determined | Met acceptance criteria |
| BIOCERAM AZUL® Ceramic Heads: Fatigue | Pre-determined | Met acceptance criteria |
| BIOCERAM AZUL® Ceramic Heads: Post-Fatigue Burst Strength | Pre-determined | Met acceptance criteria |
| BIOCERAM AZUL® Ceramic Heads: Axial Pull-Off | Pre-determined | Met acceptance criteria |
| BIOCERAM AZUL® Ceramic Heads: Fretting Corrosion | Pre-determined | Met acceptance criteria |
| BIOCERAM AZUL® Ceramic Heads: Hip Simulator Wear | Pre-determined | Met acceptance criteria |
| BIOCERAM AZUL® Ceramic Heads: Mode 3 (w/ roughened ceramic head) Hip Simulator Wear | Pre-determined | Met acceptance criteria |
| BIOCERAM AZUL® Ceramic Heads: Wear Particle Analyses | Pre-determined | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide specific sample sizes for the mechanical tests. The data provenance is implied to be laboratory testing conducted by the manufacturer, KYOCERA Medical Corporation. There is no mention of country of origin of the data explicitly, nor whether it was retrospective or prospective in the context of clinical data, as this was not a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not Applicable. This submission is based on mechanical and material engineering testing, not on expert clinical judgment for a diagnostic or AI-based performance evaluation.
4. Adjudication Method for the Test Set:
Not Applicable. As there was no expert review or clinical assessment, no adjudication method was used.
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 submission does not involve an AI device or human-in-the-loop performance evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not Applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth for this device's performance is established by engineering standards and pre-determined mechanical and material acceptance criteria. For example, the Bacterial Endotoxin Testing had a specific limit of 20EU/device. For other tests, the "pre-determined acceptance criteria" serve as the ground truth against which the device performance was measured.
8. The Sample Size for the Training Set:
Not Applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not Applicable. Not an AI model.
In summary, this regulatory submission primarily relies on non-clinical performance data (mechanical, material, and biocompatibility testing) to demonstrate substantial equivalence to predicate devices, without involving clinical studies or AI algorithm evaluations.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.