(67 days)
The Overture Orthopaedics Patellofemoral System is intended to be used in cemented arthroplasty in patients with osteoarthritis limited to the distal patello-femoral joint, patients with a history of patellar fracture, and those patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release, etc.) where pain, deformity or dysfunction persists.
The Overture Orthopaedics Patellofemoral System is comprised of trochlear implants, and a set of ancillary instruments. The trochlear implants are titanium and feature a polished articulating surface with a titanium nitride (TiN) coating. The patellar implants are cross-linked ultra high molecular weight polyethylene (UHMWPE) and feature a titanium pin for X-ray visualization. The trochlear and patellar implants utilize cemented pegs for immediate fixation. The trochlear implants also feature porous titanium bone-contacting surfaces.
The implants are provided in a variety of configurations and sizes to accommodate various patient anatomy. The trochlear implants are offered in long and round geometries. The long implants are offered in lengths ranging 25-40mm and widths ranging 20-35mm. The round trochlear implants are offered in diameters ranging 20-35mm. The patellar implants are offered in a domed geometry in diameters of 25mm and 30mm.
The implants are provided gamma sterilized and individually packaged. The ancillary instruments are provided non-sterile and are to be sterilized by the end user.
This document is a 510(k) summary for the Overture Orthopaedics Patellofemoral System. It describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence.
Based on the provided text, the device in question is a medical implant, specifically a patellofemoral system for knee joint arthroplasty. The acceptance criteria and the study that proves the device meets them are described in terms of performance testing for mechanical characteristics, not in terms of diagnostic accuracy or reader performance as the format of the request assumes.
Here's a breakdown of the requested information based on the provided document:
-
A table of acceptance criteria and the reported device performance
The document does not explicitly list acceptance criteria in a quantitative table with corresponding reported performance for each criterion. Instead, it lists the types of performance testing conducted to demonstrate substantial equivalence. The document states:
"In summary, rationales and mechanical testing of the Overture Orthopaedics Patellofemoral System indicated there are no new risks and demonstrated substantial equivalence in performance compared to a legally marketed predicate."
This implies that the acceptance criterion for each test was likely "demonstrates substantial equivalence to the predicate device" or "meets established rationales without new risks." The reported device performance is summarized as having met this overall criterion.
Acceptance Criteria (Implied) Reported Device Performance Demonstrate substantial equivalence to predicate device in terms of: - Patellofemoral Contact Area and Contact Stress Testing indicated no new risks and substantial equivalence. - Patellofemoral Constraint Testing indicated no new risks and substantial equivalence. - Range of Motion Testing indicated no new risks and substantial equivalence. - Fatigue Strength Rationale adopted, indicating substantial equivalence. - Wear Rationale adopted, indicating substantial equivalence. - Additive Manufacturing Characteristics Rationale adopted, indicating substantial equivalence. - Characterization of UHMWPE Rationale adopted, indicating substantial equivalence. - Characterization of Porous Coating Rationale adopted, indicating substantial equivalence. - Modified Metallic Surfaces Rationale adopted, indicating substantial equivalence. Absence of new risks No new risks indicated. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "bench testing" and "cadaveric validation lab." It does not specify sample sizes for these tests (e.g., how many implants were tested for fatigue, how many cadavers were used). It also does not mention country of origin or whether the data was retrospective or prospective, as these terms are generally not applicable to bench and cadaveric testing of medical implants.
-
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)
This question is not applicable to the type of device and testing described. The "ground truth" for mechanical performance tests is typically measured physical properties, not expert consensus on medical images or diagnoses.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies involving interpretation (e.g., by radiologists), not for bench testing of medical implants.
-
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
This question is not applicable. An MRMC study with human readers and AI assistance is relevant for diagnostic AI devices. The Overture Orthopaedics Patellofemoral System is a surgical implant undergoing mechanical and material testing, not an AI diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical implant, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing mentioned (e.g., contact area, stress, constraint, fatigue), the "ground truth" would be physical measurements and engineering data obtained from standardized mechanical tests or cadaveric studies. The basis for comparison is the performance of the legally marketed predicate device.
-
The sample size for the training set
This question is not applicable. There is no concept of a "training set" for a physical medical implant device in the context of its mechanical performance testing.
-
How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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.”