(95 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 arc intended for implantation with bone cement.
The Avon® Patello-femoral Joint (PFJ) Prosthesis was cleared for marketing in K010100. K020841 and K041160. The current system consists of cobalt-chromium femoral components available in four sizes (extra small, small, medium, and large), and all-polyethylene components available in various sizes (small, medium. and large) and styles. This 510(k) submission is a line extension to the Avon "Patello-femoral Joint Prosthesis to add additional styles of patellar components to the system and update the labeling.
The provided text describes a 510(k) Premarket Notification for the Avon® PFJ Prosthesis, focusing on its substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the format requested.
The document is a summary of safety and effectiveness, and subsequently, the FDA's letter of substantial equivalence. This type of submission relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, largely through comparison of design, materials, indications, and operational principles, often supported by bench testing where relevant. It does not typically involve clinical studies with human subjects that would generate acceptance criteria and performance data in the context of sensitivity, specificity, or similar metrics for diagnostic devices.
Therefore, many of the requested categories concerning acceptance criteria and study details cannot be directly answered from the provided text.
Based on the provided information, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical outcomes or diagnostic accuracy per se. The "performance" assessment is based on the claim of substantial equivalence to a predicate device.
| Acceptance Criteria Category | Reported Device Performance/Rationale | Explanation from Document |
|---|---|---|
| Safety and Effectiveness | Substantially Equivalent | The device is deemed as safe and effective as the predicate device based on comparison of design, materials, indications, and operational principles. |
| Design | Equivalent to predicate | "Avon® Patello-femoral Joint Prosthesis is substantially equivalent to the predicate Avon® PFJ Prosthesis in regards to design..." |
| Materials | Equivalent to predicate | "...materials..." (specifically cobalt-chromium for femoral, all-polyethylene for patellar components). |
| Indications | Equivalent to predicate | "...indications..." (e.g., degenerative arthritis in distal femur and patella, history of patellar dislocation/fracture, failed previous surgery where pain persists). |
| Operational Principles | Equivalent to predicate | "...operational principles." |
| Compatibility | Patellar components are compatible with femoral components. | "Testing demonstrated that the patellar components from the Duracon®, Triathlon® and Scorpio® Knee Systems are compatible with the femoral components in Avon® PFJ Prosthesis." This is a key "performance" aspect cited. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The document describes a 510(k) submission for a medical device (prosthesis), which typically relies on bench testing and comparison to a predicate device, rather than patient-based test sets with a specific sample size. The "testing" mentioned refers to compatibility testing, not a clinical trial or performance study on 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. There is no mention of a ground truth established by experts as this is not a diagnostic device or a study involving human-in-the-loop assessment of images or clinical findings.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set or expert adjudication is described in the context of this device submission.
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 device is a prosthesis, not an AI-powered diagnostic tool, so an MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical implantable device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the sense of a clinical or diagnostic study. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, and the demonstrating that the new device meets the same standards through design, material, and functional equivalence, often supported by bench testing.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable.
§ 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.”