(132 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 technique
The Renovis Bipolar Hip System includes a bipolar head and 22 mm femoral heads. The Renovis Bipolar heads are offered in a range of inner and outer dimensions from 39 to 65 mm to fit either 22 or 28 mm femoral heads. Renovis already has FDA clearance for a 28 mm femoral head (K112897). The bipolar head is a sub-component of a hip replacement construct where it assumes the function of the natural femoral head and is combined with a femoral head and hip stem. It consists of a highly polished CoCr alloy outer shell and a polyethylene insert. The ultra-highmolecular weight polyethylene (UHMWPE) insert is comprised of an inner liner and a locking ring. The bipolar head has two articulation surfaces: the outer CoCr head articulates with the patient's natural acetabular cartilage and the inner UHMWPE liner articulates with the femoral head assembled to the femoral stem. The modular CoCr alloy femoral head, is held in place within the bipolar head by a retaining ring that is pre-assembled into the polyethylene insert. The bipolar heads and femoral heads are gamma sterilized. The system is offered with the full instrumentation required for the procedure.
Here's a breakdown of the acceptance criteria and study information for the Renovis Bipolar Hip System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the acceptance criteria in terms of compliance with specific ASTM and ISO standards for material properties, testing methods, and sterilization. It does not provide specific numerical acceptance criteria (e.g., minimum force for disassembly) or corresponding numerical performance values from the testing. Instead, it makes a general statement of successful compliance.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ASTM F1820-13 (Determining Forces for Disassembly of Modular Acetabular Devices, with deviations specific for bipolar head testing) | Successfully undergone ASTM performance testing in compliance with ASTM F1820-13, but with deviations specific for testing of a bipolar head. The results "indicate that the device performs as expected." |
| ISO 5832-4:1996 (Metallic materials - Cobalt-chromium-molybdenum casting alloy) | Complies |
| ISO 5834-2:2011 (Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 2: Moulded forms) | Complies |
| ASTM F1537-8 (Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants) | Complies |
| ASTM F983-86 (Reapproved 2009) (Standard Practice for Permanent Marking of Orthopaedic Implant Components) | Complies |
| ASTM F 565-04 (Reapproved 2009)el (Standard Practice for Care and Handling of Orthopedic Implants and Instruments) | Complies |
| ASTM F2033-12 (Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials) | Complies |
| ISO 11137-2:2006 (Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose) | Complies |
| ISO 17665-1:2006 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices) | Complies |
2. Sample Size Used for the Test Set and Data Provenance
The document only states that the device "successfully undergone ASTM performance testing." It does not specify the sample size used for the mechanical testing (e.g., number of bipolar heads tested for disassembly force). The data provenance is not explicitly mentioned but implies laboratory testing, not clinical data, and therefore, country of origin is not relevant in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as the evaluation is based on in-vitro performance testing against engineering standards, not on clinical interpretation requiring expert consensus.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation is based on in-vitro performance testing against engineering standards, not on clinical interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This document describes the premarket notification for a medical device (hip prosthesis) based on substantial equivalence, which primarily relies on engineering performance testing and comparison to predicate devices, not clinical effectiveness studies of human readers with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to this medical device submission. The "device" in this context is a physical hip prosthesis, not an algorithm or AI system. The performance testing described is mechanical, in-vitro testing.
7. Type of Ground Truth Used
The "ground truth" for this submission is established by engineering standards and specifications (ASTM and ISO). The device's components and overall system are tested against the requirements outlined in these standards.
8. Sample Size for the Training Set
There is no training set for this device submission as it is a physical medical device (hip prosthesis) and not an AI/algorithm-based product.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set mentioned or implied for this physical medical device.
§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.