(27 days)
The subject Avon™ Patellar Component is intended to be used with the Avon™ Patello-femoral Joint Replacement in replacement of the patello-femoral joint. The subject Avon™ patellar component is a modification of the Kinemax® All Polyethylene Patellar Component. The Avon" Patellar Component has been modified to include the addition of a blend radius on the medial aspect of the patella. This blend is designed to reduce the contact stress of the patella on the patello-femoral component. The rest of the design features of the Avon patellar component are identical to that of the previous released Kinemax® All Polyethylene Patellar Component.
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.
The Avon™ Patellar Component and the Avon™ Patello-femoral Joint Prosthesis are intended for use with bone cement.
It is the intention of Howmedica Osteonics Corp. to modify the Kinemax® Plus All Polyethylene Patellar Component. The modified device will be marketed as the Avon Patellar Component. This all polyethylene patellar component will be used to articulate with the cobalt-chromium alloy femoral component of the Avon™ Patello-femoral Joint Replacement.
The subject Avon™ Patellar Component is identical in design features with the exception of the following: a blend radius has been added on the articular surface of the patella in order to reduce the potential for impingement of the patellar component on the bone.
No other changes have been made to the design of the patellar component. The Avon™ Patellar Component will be available for use with bone cement in patello-femoral replacement surgery.
This looks like a 510(k) premarket notification for a medical device modification, specifically the Avon™ Patellar Component, which is a modification of the Kinemax® Patellar Component.
Based on the provided text, there is no acceptance criteria or study that proves the device meets specific performance criteria in terms of AI/algorithm performance.
The document describes a design modification to an existing medical device, not a new device incorporating AI or an algorithm. The "testing presented to address these risks" mentioned in the document refers to traditional medical device testing to demonstrate substantial equivalence to a predicate device, likely mechanical testing, biocompatibility, etc., for the modified patellar component, rather than performance metrics related to an algorithm's output.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/algorithmic device because this document does not pertain to such a device.
To answer your specific points:
- A table of acceptance criteria and the reported device performance: Not applicable. This document does not describe performance of an AI/algorithmic device.
- Sample size used for the test set and the data provenance: Not applicable. This document does not describe an AI/algorithmic device test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is primarily concerned with establishing substantial equivalence of a modified physical medical device (a patellar component) to a predicate device, as required for a 510(k) submission to the FDA.
§ 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.”