(46 days)
The Prelude™ PF Resurfacing Knee System is intended to be used in cemented patellofemoral arthroplplasty in patients with degenerative arthritis in the distal femur and 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 patella components are to be used with the existing Prelude PF Knee Resurfacing System. The components manufactured from polyethylene (UHMWPE) conforming to ASTM F-648 with a stainless steel x-ray wire and consist of larger sized patella options.
This document is a 510(k) premarket notification for a medical device called "Prelude PF Patellae", a new component for the existing "Prelude PF Knee Resurfacing System". The submission claims substantial equivalence to previously marketed predicate devices.
Here's an analysis of the provided text in relation to your request about acceptance criteria and supporting studies:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of acceptance criteria or quantitative performance metrics for the Prelude PF Patellae. Instead, it relies on demonstrating substantial equivalence based on a comparison to predicate devices across several characteristics.
Acceptance Criteria (Implied) Reported Device Performance Identical Intended Use to predicate devices Met: The proposed Prelude PF Knee Resurfacing System patellae devices have the identical intended use as the predicate. Identical Indications for Use to predicate devices Met: The proposed Prelude PF Knee Resurfacing System patellae devices have identical indications for use as the predicate. Identical Materials to predicate devices Met: The proposed and predicate Prelude PF Knee Resurfacing System patellae devices are manufactured from UHMWPE conforming to ASTM F648. Identical Design Features to predicate devices Met: The proposed and predicate patellae devices incorporate identical design features. (The change is the addition of larger sized patella options, but the fundamental design features are stated as identical). Identical Sterilization Methods to predicate devices Met: The proposed and predicate Prelude PF Knee Resurfacing System patellae devices are provided sterile via identical sterilization methods for single-use. No new risks compared to predicate devices (Engineering Analysis) Met: "Engineering Analysis of the larger patellae demonstrate that the proposed additional sizes to the Prelude PF Knee Resurfacing System patellae do not raise any new risks compared to the predicate Prelude PF Knee Resurfacing System patellae." This is the key performance claim from non-clinical testing. -
Sample sizes used for the test set and data provenance:
- Test Set Sample Size: Not explicitly stated. The "Engineering Analysis" would have likely involved simulations or bench testing, but the number of prototypes or simulations is not mentioned.
- Data Provenance: The study described is an "Engineering Analysis," which implies in-house testing/simulation by Biomet Inc. The country of origin for this data is implicitly USA (where Biomet is located). It is retrospective in the sense that it's comparing a new size to an existing, already-approved design, rather than a de novo clinical trial.
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Number of experts used to establish the ground truth for the test set and their qualifications:
This information is not provided as there wasn't a human-centric study (like a clinical trial or expert review of images) for the "Engineering Analysis." The "ground truth" for this engineering analysis would be the established material properties (ASTM F-648) and biomechanical principles used in the analysis. -
Adjudication method for the test set:
Not applicable, as this was an engineering analysis, not a clinical study requiring expert adjudication. -
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:
No MRMC study was done. This device is a knee joint patellofemoral prosthesis, not an AI-powered diagnostic or assistive tool for human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device (implant), not a standalone algorithm. The "Engineering Analysis" could be considered "standalone" in mechanical terms, as it assesses the physical device's properties. -
The type of ground truth used:
For the non-clinical "Engineering Analysis," the "ground truth" would be based on:- Established material properties (UHMWPE conforming to ASTM F-648).
- Biomechanical principles and engineering standards relevant to prosthetic design.
- Performance characteristics of the legally marketed predicate devices.
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The sample size for the training set:
Not applicable. This is a physical device being compared for substantial equivalence, not a machine learning model requiring a training set. -
How the ground truth for the training set was established:
Not applicable (no training set).
§ 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.”