(36 days)
The Avon Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patella, patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.
These components are single use only and are intended for implantation with bone cement.
This submission covers the Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis. The femoral components are manufactured from Cobalt Chrome (CoCr) and the patellar components are manufactured from Ultra-high Molecular Weight Polyethylene (UHMWPE) materials.
The purpose of this submission is to add Magnetic Resonance (MR) Conditional labeling to the labeling of the Avon femoral and patellar components of the Avon Patello-femoral Joint Prosthesis. Additionally, minor labeling and packaging updates, as detailed in the respective sections, are also included in this submission.
The provided text is a 510(k) Summary for a medical device (Avon Patello-femoral Joint Prosthesis) seeking clearance for minor labeling and packaging updates, specifically to add Magnetic Resonance (MR) Conditional labeling. This submission does not describe a study to prove the device meets acceptance criteria related to its clinical effectiveness or performance in a patient.
Instead, it describes non-clinical testing to demonstrate that the device is "MR Conditional" as per relevant ASTM standards. Therefore, many of the requested categories are not applicable to the information provided.
Here's the breakdown of what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Magnetically Induced Displacement Force: | It was concluded that the subject Avon femoral and patellar components... do not present a new worst case with respect to magnetically induced displacement force... Therefore, the Avon components are qualified to be "MR Conditional" for MR-induced displacement. |
| ASTM F2052-15: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment | |
| Magnetically Induced Torque: | It was concluded that the subject Avon femoral and patellar components... do not present a new worst case with respect to... torque... Therefore, the Avon components are qualified to be "MR Conditional" for... torque. |
| ASTM F2213-17: Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment | |
| Image Artifact: | It was concluded that the subject Avon femoral and patellar components... do not present a new worst case with respect to... MR image artifacts... Therefore, the Avon components are qualified to be "MR Conditional" for... image artifacts. |
| ASTM F2119-07 (Reapproved 2013): Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants | |
| Heating by RF Fields: | It was concluded that the subject Avon femoral and patellar components... do not present a new worst case with respect to... RF-induced heating. Therefore, the Avon components are qualified to be "MR Conditional" for... RF-induced heating. The labeling has been modified to include the MR Conditional symbol and to provide the parameters for safe scanning. |
| ASTM F2182-19: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. The testing was non-clinical (laboratory testing of the device components), not involving human subjects or patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The ground truth for the MR Conditional testing is established by the ASTM standards themselves, which define methodologies and criteria for measurement. No human experts were involved in establishing "ground truth" for this non-clinical testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This was non-clinical, objective testing against predefined engineering standards.
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 document is not about AI or diagnostic imaging interpretation. It is for a joint prosthesis and its MR compatibility.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This document is not about an algorithm, but a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical testing was defined by adherence to published ASTM standards for MR compatibility. These are objective engineering and physics standards.
8. The sample size for the training set
Not applicable. This was non-clinical testing, not a machine learning study.
9. How the ground truth for the training set was established
Not applicable. This was non-clinical testing, not a machine learning study.
§ 888.3540 Knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemoral polymer/metal semi-constrained cemented prosthesis is a two-part device intended to be implanted to replace part of a knee joint in the treatment of primary patellofemoral arthritis or chondromalacia. 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 includes a component made of alloys, such as cobalt-chromium-molybdenum or austenitic steel, for resurfacing the intercondylar groove (femoral sulcus) on the anterior aspect of the distal femur, and a patellar component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those devices intended for use with bone cement (§ 888.3027). The patellar component is designed to be implanted only with its femoral component.(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Applications for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,” and
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 7207-2:1998 “Implants for Surgery—Components for Partial and Total Knee Joint Prostheses—Part 2: Articulating Surfaces Made of Metal, Ceramic and Plastic Materials,” and
(viii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants,” and
(viii) F 1672-95 “Specification for Resurfacing Patellar Prosthesis.”