(78 days)
The Exactech AuRA Calcar Replacement Femoral Stem is indicated for use in skeletally mature patients in whom the calcar region is missing due to a failed previous total hip replacement as a result of osteoarthritis, osteonecrosis , rheumatoid arthritis or congenital hip dysplasia. It is also potentially indicated for use in post-traumatic degenerative problems. FOR CEMENTED USE ONLY
The collar of the calcar replacement stem differentiates itself from all other cemented femoral components in that it provides a horizontal and vertical collar type platform for the best load transfer in a compromised femoral situation. A cemented primary or long stem device typically has a collar designed at some angle to the femoral centerline whereby a bone loading platform can be established at the optimum resection location. In many instances, this ideal position has been compromised and an implant surface that is horizontally perpendicular to and vertically parallel to the femoral centerline is preferred for optimal axial load transfer to the bone and appropriate trochanteric fixation can be achieved. The surface finish is dominated by an overall satin, glass bead blast everywhere except on the taper. A secondary grit blast is performed on portions of the proximal region of the implant. A complete instrumentation and trial system is available to assist in accurate implantation of the AuRATM Calcar Replacement Femoral Stem.
The provided text describes a medical device, the AuRA™ Hip System Calcar Replacement Femoral Stem, and its regulatory submission (K962002). However, it does not contain information regarding an acceptance criteria table, device performance data, or a study specifically designed to compare against acceptance criteria.
The document focuses on demonstrating substantial equivalence to pre-amendment devices and other legally marketed devices, primarily through:
- Device Description and Design Rationale: Highlighting features like material, surface finish, and collar design.
- Similarities/Dissimilarities to a Predicate Device (Howmedica hnr Hip System): Comparing material, design elements, and sizes.
- Material Specifications: Referring to ASTM standards for forged cobalt chrome.
- Mechanical Testing: Stating that forged cobalt chromium exhibits specific mechanical properties and that "fatigue testing results have been favorable for this type of device."
- Biocompatibility: Citing ASTM F799-95 for evaluation of biocompatibility and corrosion resistance.
- Sterilization: Describing the sterilization method (gamma irradiation) and adherence to AAMI guidelines.
- Utilization of Implantation, Indications, and Contraindications.
Therefore, I cannot fulfill your request for: "A table of acceptance criteria and the reported device performance," nor can I provide details about the specific study that proves the device meets those criteria, as this information is not present in the provided text.
The document's intent is to establish substantial equivalence based on material, design, and general mechanical properties, rather than present a study with specific performance metrics against defined acceptance criteria for a new, novel AI or diagnostic device.
To directly answer your specific numbered questions based on the lack of this information in the provided text:
- A table of acceptance criteria and the reported device performance: Not provided in the text.
- Sample size used for the test set and the data provenance: Not applicable, as no such test set or study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or study is described.
- Adjudication method for the test set: Not applicable, as no such test set or study is described.
- 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 document is about a hip implant, not an AI or diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about a hip implant, not an AI or diagnostic device.
- The type of ground truth used: Not applicable, as no such test is described. The "ground truth" for a hip implant's equivalence relies on material properties, design comparison, and clinical history of similar devices.
- The sample size for the training set: Not applicable, as no "training set" in the context of an AI/diagnostic algorithm is relevant to this device submission.
- How the ground truth for the training set was established: Not applicable, as no "training set" or "ground truth" in the context of an AI/diagnostic algorithm is relevant to this device submission.
{0}------------------------------------------------
SUMMARY OF THE SAFETY AND EFFECTIVENESS INFORMATION FOR THE PREMARKET NOTIFICATION FOR THE AuRA TM Hip System CALCAR REPLACEMENT FEMORAL STEM
Exactech®, Inc.
Establishment Registration Number 1038671
The AuRATM Calcar Replacement Femoral Stems are made of similar materials and are of similar design to prostheses that were on the market before May 28, 1976. Additionally, the calcar stems are of similar design to other cemented femoral components on the market that have been determined to be equivalent to devices on the market prior to May 28, 1976. These predicates include, but are not limited to: Howmedica hnr Head/Neck Replacement System.
Exactech, Inc. has supplied advertisements, brochures and/or catalog information from the company to the FDA as evidence of equivalency. This literature is in the public domain. In addition, Exactech has provided the FDA design drawings, material specifications and dimensional images of the AuRATM stems.
This device is appropriately placed in FDA classification: Prosthesis, Hip, Femoral Component, Cemented, Metal. Number 87JDG, Class II device, under 21 CFR 888.3360.
1. Device Description/ Design Rationale
The collar of the calcar replacement stem differentiates itself from all other cemented femoral components in that it provides a horizontal and vertical collar type platform for the best load transfer in a compromised femoral situation. A cemented primary or long stem device typically has a collar designed at some angle to the femoral centerline whereby a bone loading platform can be established at the optimum resection location. In many instances, this ideal position has been compromised and an implant surface that is horizontally perpendicular to and vertically parallel to the femoral centerline is preferred for optimal axial load transfer to the bone and appropriate trochanteric fixation can be achieved.
The surface finish is dominated by an overall satin, glass bead blast everywhere except on the taper. A secondary grit blast is performed on portions of the proximal region of the implant.
A complete instrumentation and trial system is available to assist in accurate implantation of the AuRATM Calcar Replacement Femoral Stem.
{1}------------------------------------------------
Similarities/Dissimilarities to the Howmedica hnr Hip System:
The Exactech AuRA™ Calcar Replacement Femoral Stem is similar to the Howmedica hnr Femoral Stem in the type of finish used: both have a dual grit blast. Both prosthesis feature derotation keels and calcar slots. Both offer distal centralization. Both the Exactech AuRA™ and the Howmedica hnr use modular femoral heads.
The Exactech AuRA™ Calcar Replacement Femoral Stem is dissimilar to the Howmedica hnr in the material used: the Exactech Femoral Stem is manufactured from forged cobalt chrome as apposed to the cast cobalt chrome used in the Howmedica hnr Femoral Stem. The Exactech stem has a straight body: the Howmedica stém is available with both a straight and curved body. The Hip Systems differ in the sizes offered: the smallest calcar flange length offered by Exactech is a 44mm, while the Howmedica system has a 33mm. The shortest body length offered by the Exactech system is 146mm, while the Howmedica system has a body length of 135mm. The Exactech Calcar Replacement Femoral Stem design has no longitudinal distal flutes featured in the Howmedica prosthesis. The Exactech stem features both slots and holes for wire fixation: the Howmedica femoral stem has only slots
2. Material Specifications
The AuRATM Calcar Replacement Femoral Stem is made from forged cobalt chrome which meets ASTM specification F799-95 . Fr
3. Mechanical Testing
The forged cobalt chromium alloy exhibits mechanical properties in excess of 170,000 psi ultimate tensile strength, 120,000 psi vield strength, 12% elongation, and 12% reduction of area and a minimum of 35 hardness. Rc.
In addition, fatigue testing results have been favorable for this type of device.
Range of Motion and Constraint 4.
The AuRATM Calcar Replacement Femoral Stem is designed to mate with the appropriate femoral stem size dictated by the patient's anatomy. Likewise, the patient's range of motion and constraint is limited by the anatomy.
5. Biocompatibility
According to ASTM F799-95, the material in this specification has been evaluated for biocompatibility and corrosion resistance and has been found comparable to material conforming to specification F75. The results of these studies and the clinical history indicate a well-characterized level of local biological response.
{2}------------------------------------------------
Sterilization 6.
The AuRATM Calcar Replacement Femoral Stem will be supplied sterile. The components will be sterilized in the final, sealed packages by gamma irradiation at a contract sterilization facility. The sterilization protocol will be based on the Guidelines for Radiation Sterilization of Medical Devices, issued by the Association for Advancement of Medical Instrumentation Process Control. The devices are not claimed to be pyrogen free.
008
7. Utilization of Implantation
Selection of the component is made by the surgeon in relationship to the requirements of the patient. The surgeon should become thoroughly familiar with the technique of implantation of the prosthesis by: 1) appropriate reading of the literature and 2) training in the operative skills and techniques required for hip arthroplasty surgeries.
8. Indications
The Exactech AuRA Calcar Replacement Femoral Stem is indicated for use in skeletally mature patients in whom the calcar region is missing due to a failed previous total hip replacement as a result of osteoarthritis, osteonecrosis , rheumatoid arthritis or congenital hip dysplasia. It is also potentially indicated for use in post-traumatic degenerative problems.
ﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬﻬ
FOR CEMENTED USE ONLY
9. Contraindications
Use of the AuRA™ Calcar Replacement Femoral Stem is contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, in patients with neuromuscular disorders that do not allow control of the hip joint, and in patients whose weight, age or activity level would cause the surgeon to expect early failure of the system.
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.