(227 days)
The replacement of the patellofemoral joint with the KNEETEC PFJ device is indicated in the case of symptoms and serious signs affecting daily activities involving the joint:
- Serious degenerative arthritis of the patellofemoral joint,
- Failure of conservative procedures (realignment, arthroscopy, transfer of the tibial tuberosity) with the persistence of joint pain or dysfunction,
- Patellofemoral dislocation (dysplastic or other origin),
- Post-traumatic arthritis (patellar fracture),
The KNEETEC PFJ patellofemoral prosthesis is intended for cemented use only.
When used in association with the KNEETEC PFJ prosthesis, the patellar component of the HLS KNEETEC has the above mentioned indications for use.
The Kneetee PFJ is a semiconstrained resecting prosthesis intended for replacement of the patellofemoral joint. The prosthesis consists of two components, both for cemented use only: a femoral implant and a patella. The patella of the knee joint may be resurfaced with the HLS KNEETEC patellar component and a substantially equivalent in K094013) or KNEETEC PFJ patellar implant.
This document is a 510(k) premarket notification for the KNEETEC PFJ and HLS KNEETEC patellar component, which are patellofemoral knee prostheses. A 510(k) submission demonstrates that a new device is substantially equivalent to a legally marketed predicate device. This process does not typically involve clinical studies with human subjects or AI performance evaluations as described in your request. Instead, it relies on demonstrating equivalence through non-clinical (engineering) testing and comparison of technological characteristics.
Therefore, many of the requested categories are not applicable to this type of submission.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrated Equivalence to Predicate Devices) | Reported Device Performance (KNEETEC PFJ) |
|---|---|
| Non-clinical Testing: | |
| Contact area and trajectories of the patella to compare congruence with the trochlea. | No significant difference observed compared to predicate devices. |
| Contact pressure test. | No significant difference observed compared to predicate devices. |
| Measurement of the subluxation force. | No significant difference observed compared to predicate devices. |
| Material Equivalence: | |
| Femoral component material (CoCr alloy). | CoCr alloy (ISO 5832-7 or 5832-12), equivalent to predicate devices. |
| Patellar component material (UHMWPE). | UHMWPE (ISO 5834-2), equivalent to predicate devices. |
| Method of Fixation: | Cemented, equivalent to predicate devices. |
| Intended Use: | Replacement of the patellofemoral joint, similar to predicate devices. |
| Terminal Sterilization: | Gamma, similar to HLS Kneetec (predicate). |
| General Features & Technological Characteristics Equivalence: | Equivalent to predicate devices. |
| Range of Motion Equivalence: | Equivalent to predicate devices. |
| Prosthetic Dimensions Equivalence: | Equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable in the context of a 510(k) for this type of device. The "test set" here refers to the actual physical devices undergoing non-clinical engineering tests (e.g., specific components for contact area, pressure, subluxation force). The document states "The following non-clinical testing has been performed on the smallest components of the ranges (worst case)." This implies a limited number of physical prototypes or manufactured components were tested, focusing on the worst-case scenario (smallest size).
- Data provenance: Not explicitly stated, but these were engineering studies performed by the manufacturer, Tornier (based in France for regulatory affairs contact, and USA for applicant). This is not data from human patients.
- Retrospective or prospective: Not applicable, as this refers to engineering tests, not clinical data collection.
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. Ground truth as typically understood for AI devices (e.g., expert consensus on medical images) is not relevant here. The "truth" in this context is established by engineering standards and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical studies involving human interpretation or diagnoses, not for engineering performance tests.
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 physical knee prosthesis, not an AI or imaging device that would involve human readers or AI assistance in diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (implant), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical testing was based on engineering standards and direct physical measurements. The performance of the KNEETEC PFJ was compared against the measured performance of predicate devices based on parameters like contact area, contact pressure, and subluxation force.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 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.”