(28 days)
The KMTI Hip Replacement System is indicated for patients suffering from:
- 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 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.
Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and study details.
Important Note: The provided document is a 510(k) Premarket Notification Summary for a medical device. This type of submission often focuses on demonstrating "substantial equivalence" to a previously cleared predicate device, rather than proving performance against specific clinical acceptance criteria in standalone clinical trials. Therefore, much of the requested information regarding "device performance," "sample size," "ground truth," and "MRMC comparative effectiveness studies" is not typically found in this type of regulatory document, as these are more common for novel devices or those undergoing PMA approval. The studies mentioned here are primarily mechanical and material tests to ensure the new device components are equivalent to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Test / Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Implied acceptance is successful completion of tests without failure and demonstration of comparable or equivalent performance to predicate device components and industry standards. The document explicitly states, "All changes were assessed for risk and successfully evaluated under Design Controls. The following were successfully conducted:" followed by a list of tests. It also notes, "Equivalence of the use of KYOCERA components and use of KMTI components has been demonstrated." and "The performance...is substantially equivalent to and expected to have equivalent performance to the KMTI femoral head/femoral stem or KCJ femoral head/femoral stem used with the KMTI T3 acetabular shell and Porous acetabular cup and Universal Liner." | Successfully conducted: |
- Static compression burst tests
- Post-fatigue static compression burst tests
- Oblique (off-axis) fatigue test
- Pull-off tests
- Static torsion tests
Compliance with Standards:
- ISO 7206-10:2018 Implants for surgery Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads
- ASTM F2345-03(2013) Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads
- ISO 7206-13:2016 Implants for surgery Partial and total hip joint prostheses - Part 13: Determination of resistance to torque of head fixation of stemmed femoral components
- Guidance Document For The Preparation Of Premarket Notification For Ceramic o Ball Hip Systems, Draft, January 10, 1995 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the document. The studies conducted are mechanical tests of components, not clinical studies involving patient data. Therefore, the concept of a "test set" in the context of clinical data or AI systems with patient samples does not apply here.
- Data Provenance: Not applicable. The "data" comes from in vitro mechanical testing, not patient-derived data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. For mechanical tests, the "ground truth" is determined by the physical properties and performance measured according to established engineering standards (e.g., ISO, ASTM). Expert opinion is typically involved in designing the tests and interpreting the results against those standards, but not in establishing a "ground truth" for individual test items in the way it would be for an AI diagnostic system.
- Qualifications of Experts: Not applicable for establishing ground truth in this context. While engineers and material scientists would be involved in conducting and evaluating these tests, their role is not to establish "ground truth" via consensus for a test set.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in studies involving human interpretation (e.g., radiologists reviewing images). Mechanical tests rely on objective physical measurements against predefined criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This document describes a medical device (hip replacement system) that is not an AI diagnostic tool and does not involve human readers interpreting cases. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This device is a physical hip replacement system, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the mechanical tests performed, the "ground truth" is defined by established engineering standards, material properties, and mechanical performance limits (e.g., fatigue strength specified by ASTM, static load resistance specified by ISO). The tests aim to demonstrate that the device components meet these objective engineering benchmarks and are equivalent to predicate devices.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI system that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for a 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.