(128 days)
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
- Rheumatoid arthritis:
- Correction of functional deformity;
- Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; and
- Revision procedures where other treatment or devices have failed.
The KMTI A400 Hip System is intended for cementless applications unless used with the KMTI Cemented Hip Stem.
The KMTI Porous Coated Acetabular Shell System is intended for cementless applications. In addition, the KMTI Porous Coated Acetabular Shell and Universal liners can be used with:
• The Kyocera Corporation ("KYOCERA") Initia Total Hip System femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or BIOLOX® delta (28-40mm) femoral head.
The Cemented Hip Stem is intended for cemented applications.
The KMTI Tesera Trabecular Technology (T3) Acetabular Shell System is intended for cementless applications. In addition, the KMTI T3 Acetabular Shell and Universal Liners can be used with:
• The KYOCERA Initia femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KMTI femoral stem mated with KYOCERA CoCr (28-40mm) or BIOCERAM AZUL (28-40mm) femoral head.
• The KYOCERA Initia femoral stem mated with KMTI CoCr (28-40mm) or BIOLOX® delta (28-40mm) femoral head.
The Bipolar Head is for use in conjunction with KMTI femoral heads and femoral stems. In addition:
• The KYOCERA 28mm CoCr and 28mm BIOCERAM AZUL femoral heads and Initia femoral stem can be used with the KMTI 28mm ID Bipolar Head.
• The KYOCERA Initia femoral stem can be used with the KMTI 22mm CoCr femoral head and KMTI 22mm ID Bipolar Head.
The Bipolar Head is for uncemented use only.
Bipolar outer heads are not for use with acetabular shells and liners.
The Kyocera Medical Technologies, Inc. ("KMTI") Hip Replacement System includes multiple subsystem offerings, including:
• K132312: Renovis Tesera Trabecular Technologies (T3) Acetabular Shell System
• K141676: Renovis Porous Acetabular Cup System
Renovis Surgical Technologies is now wholly owned by Kyocera International, Inc. (San Diego, CA) as Kyocera Medical Technologies, Inc. ("KMTI"). The subject of this Special 510k Premarket Notification are additional KMTI offerings which include the use of components of the K160895 Kyocera Medical Corporation, Japan Initia Total Hip System (now known as Kyocera Corporation) that may be used with the KMTI K132312 T3 acetabular shell, K141676 porous acetabular shell and KMTI Universal Liners.
This document outlines the substantial equivalence of the KMTI Hip Replacement System to legally marketed predicate devices. The information provided primarily focuses on the physical and mechanical properties of the hip replacement components, rather than the performance of a software or AI-driven medical device. Therefore, many of the requested criteria related to AI/software performance, such as MRMC studies, ground truth establishment for AI training/testing, and expert adjudication, are not applicable to this submission.
However, I can extract information regarding the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text, specifically relating to the mechanical and physical performance of the hip prosthetic components.
1. A table of acceptance criteria and the reported device performance:
The document describes the tests performed but does not explicitly state numerical acceptance criteria or numerical reported device performance in a table format. The evaluation focuses on compliance with established ISO and ASTM standards and comparison to predicate devices. The "acceptance criteria" are implicitly meeting the requirements of these standards for mechanical and physical properties.
Here's a breakdown of the tests conducted and the implied "performance" (successful evaluation and compliance):
| Acceptance Criteria (Implicitly, Compliance with Standards) | Reported Device Performance (Successful Evaluation) |
|---|---|
| Static compression burst test (per applicable standard) | Successfully evaluated under Design Controls. |
| Post-fatigue static compression burst test | Successfully evaluated under Design Controls. |
| Oblique (off-axis) fatigue test | Successfully evaluated under Design Controls. |
| Pull-off tests | Successfully evaluated under Design Controls. |
| Static torsion tests | Successfully evaluated under Design Controls. |
| Stem fatigue test | Successfully evaluated under Design Controls. |
| Head neck fatigue test | Successfully evaluated under Design Controls. |
| ROM (Range of Motion) analysis | Successfully evaluated under Design Controls. |
| Impingement analysis | Successfully evaluated under Design Controls. |
| Fret corrosion risk assessment | Assessed by comparison to K200709 (reference device), femoral head and femoral stem design attribute data analysis and rationale, and literature references. Equivalence demonstrated. |
| Compliance with ISO 7206-4:2010/AMD 1:2016 | Compliance confirmed. |
| Compliance with ISO 7206-6:2013 | Compliance confirmed. |
| Compliance with ISO 7206-10:2018 | Compliance confirmed. |
| Compliance with ISO 7206-13: 2016 | Compliance confirmed. |
| Compliance with ASTM F2009 (2011) | Compliance confirmed. |
| Compliance with ASTM F2345-03(2013) | Compliance confirmed. |
| Compliance with Guidance Document For The Preparation Of Premarket Notification For Ceramic Ball Hip Systems, Draft, January 10, 1995 | Compliance confirmed. |
2. Sample sizes used for the test set and the data provenance:
- Sample size: The document does not specify the exact number of physical samples (e.g., number of hip stems or heads) used for each mechanical test. Standard testing protocols (e.g., ISO, ASTM) typically define minimum sample sizes for such tests.
- Data provenance: The data provenance is from Kyocera Medical Technologies, Inc. (Redlands, CA, USA). The study is described as "successfully evaluated under Design Controls," indicating it's a prospective set of tests conducted for regulatory submission purposes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "ground truth" for this device is based on objective mechanical properties and compliance with engineering standards, not on expert medical opinion or interpretation of images. The tests are physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for mechanical testing. Test results are typically objective measurements, not subject to human adjudication in the same way as, for example, image interpretation by radiologists.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- This is not applicable as this submission is for a physical medical device (hip replacement system), not an AI/software product. Therefore, no MRMC study looking at human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as this is not an algorithm or AI product.
7. The type of ground truth used:
- The "ground truth" for this device is based on established engineering standards and physical test methodologies (e.g., ISO and ASTM guidelines for hip prostheses) that define acceptable mechanical performance, durability, and material properties. It also relies on demonstrated equivalence to predicate devices that have a history of safe and effective use.
8. The sample size for the training set:
- This is not applicable as there is no "training set" in the context of AI/machine learning for this physical device submission.
9. How the ground truth for the training set was established:
- This is not applicable as there is no "training set" for this physical 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.