(258 days)
The Prelude™ PF Resurfacing Knee System is intended to be used in cemented patella-femoral 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 Prelude™ Patellofemoral (PF) Resurfacing Knee System is a patellofemoral resurfacing prosthesis incorporating a distal femoral trochlear surface articular component and a patella component. The cast femoral component is manufactured from CoCrMo (ASTM F-75) and the MIM femoral component is manufactured from CoCrMo (ASTM F-2886) both with a porous undersurface coating of titanium from polyethylene (UHMWPE) conforming to ASTM F-648 with a stainless steel x-ray wire. The implant system is intended to be implanted with bone cement.
The provided document is a 510(k) Summary for the Biomet Manufacturing Corp. "Prelude™ PF Resurfacing Knee System." This document describes a medical device submission seeking clearance for a new knee implant, and as such, it does not contain information about clinical studies involving AI, human readers, or performance metrics like accuracy, sensitivity, or specificity for diagnostic purposes.
Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) through non-clinical testing and shared technological characteristics.
Therefore, most of the requested information regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be extracted from this document, as it is not relevant to this type of device submission.
Here's what can be extracted based on the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document does not present quantitative acceptance criteria or device performance in terms of diagnostic accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices, meaning the device should perform "within the intended use" and "not raise any new safety and efficacy issues" as determined by non-clinical tests.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices (Technological Characteristics) | Design - Femoral: Variation in curvature of articulating surface, central keel (compared to K060127/K071413) |
| Design - Patella: Single-peg and Three-peg (identical to K040770) | |
| Material: Co-Cr-Mo (shared with K060127/K071413, K080029/K082088) | |
| Material: UHMWPE (shared with K040770) | |
| Principle of operation: Replace articulating surfaces of knee (shared with K060127/K071413, K080029/K082088) | |
| Dimensions - Femoral: 9 options: 1-6 and 6W, 7W, and 8W (compared to K060127/K071413) | |
| Dimensions - Patella: 25mm x 8mm, 28mm x 8mm, 31mm x 8mm, 25mm x 6.2mm, 28 x 6.2mm, and 31mm x 6.2mm (compared to K040770) | |
| Safety and Effectiveness (Demonstrated via Non-Clinical Tests) | Preclinical performance tests/rationales were provided to address the subject construct's: |
- Contact Area
- Fatigue Strength
- Surface Finish
- Magnetic Resonance rationale
Results indicate that the subject construct is substantially equivalent to legally marketed devices, performs within the intended use, and does not raise any new safety and efficacy issues. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device submission did not involve clinical studies with human subjects or data sets in the context of diagnostic performance. The "tests" mentioned are non-clinical (mechanical, material, etc.).
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 was no "ground truth" establishment by experts for a test set in the context of diagnostic performance as described in the prompt. The device is a knee implant, and its equivalence is based on engineering and material characteristics, not diagnostic interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication methods were mentioned as there were no clinical or diagnostic test sets involving expert evaluation.
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
No. An MRMC comparative effectiveness study was not done. This device is a knee implant, not an AI diagnostic tool. No AI assistance or human reader involvement is part of this submission's evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. A standalone algorithm performance study was not done. This device is a physical knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of diagnostic performance. The "truth" for this device's evaluation is primarily based on established engineering standards, material specifications, and comparative analyses with predicate device designs and performance under non-clinical conditions.
8. The sample size for the training set
Not applicable. There was no "training set" for an algorithm involved in this submission.
9. How the ground truth for the training set was established
Not applicable. There was no "training set" for an algorithm involved in this submission.
§ 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.”