(190 days)
The DePuy AMK 3 Peg Patella is intended for use with the DePuy AMK Total Knee System for cemented, tricompartmental total knee arthroplasty, utilizing the AMK system's existing femoral components, tibial trays, and tibial inserts. The AMK system is intended to replace severely disabled or painful joints resulting from osteoarthritis or post-traumatic arthritis, joints with correctable varus or valgus deformity and joints with failed previous surgeries where pain, deformity or dysfunction persist.
The DePuy AMK 3 Peg Patella is an all polyethylene patella component with a domed articular surface and a 3 peg fixation surface. It is intended for use with the DePuy AMK Total Knee System for cemented, tricompartmental total knee arthroplasty, utilizing the AMK system's existing femoral components, tibial trays, and tibial inserts.
This document describes the DePuy AMK 3 Peg Patella, an all-polyethylene patella component for total knee arthroplasty. The provided text is a 510(k) submission summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to previously cleared devices rather than defining specific acceptance criteria based on performance studies.
Therefore, the following points address the questions based directly on the provided text, and it's important to note that a traditional "acceptance criteria" table as one might find for a diagnostic device or a study proving those criteria are met is not present in this type of regulatory submission for a medical implant like a knee patella component. Instead, substantial equivalence is established through comparing design, materials, intended use, and in vitro testing to predicate devices.
1. A table of acceptance criteria and the reported device performance
As this is a 510(k) submission for a medical implant, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices, rather than a specific set of clinical performance metrics. The reported "performance" is primarily in vitro mechanical testing comparing the new device to predicates.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance / Basis of Equivalence |
|---|---|
| Material Composition: Same as predicate device. | The material (all polyethylene) is the same as the original AMK All Polyethylene Patella. |
| Intended Use: Same as predicate device. | The intended use is the same as the original AMK All Polyethylene Patella. |
| Design of Articular Surface: Same as predicate device. | The design of the articular surface is the same as the original AMK All Polyethylene Patella. |
| Fixation Surface Design: Similar to predicate devices, with demonstrated equivalent mechanical performance. | The fixation surface changed from two circular arcs (original AMK) to 3 pegs. This 3-peg design is similar to the DePuy LCS All Polyethylene 3 Peg Patella. |
| Fixation Strength: Similar to predicate devices. | Testing indicates that the fixation strength of the AMK 3 Peg Patella is similar to those of the Johnson & Johnson PFC Oval Sombrero Patella and the Zimmer NexGen All Polyethylene Patella. |
| Compatibility with Existing System: Integrates with the AMK Total Knee System. | Intended for use with the DePuy AMK Total Knee System, utilizing existing femoral components, tibial trays, and tibial inserts. |
| Clinical Indications: Addresses same conditions as predicate devices. | Intended to replace severely disabled or painful joints resulting from osteoarthritis or post-traumatic arthritis, joints with correctable varus or valgus deformity, and joints with failed previous surgeries where pain, deformity or dysfunction persist (same as predicate AMK system). |
| Cemented Use Only: Must be equivalent for cemented fixation. | The FDA clearance explicitly states the device is "equivalent only to similar devices labeled and intended to be fixed within bone with acrylic 'bone cement'" and may not be labeled or promoted for non-cemented use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document refers to "testing" regarding fixation strength but does not provide details about the sample size, specific test methods, or the provenance of the data (e.g., in vitro lab testing, animal studies, or clinical data). Given it's a 510(k) for a mechanical implant, the "testing" is almost certainly in vitro mechanical testing performed in a lab, typically to ISO or ASTM standards, comparing the new design feature (3 pegs) to predicate devices. It is therefore not clinical data provenance.
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)
This question is not applicable to the provided document. A 510(k) for an orthopedic implant like a patella component relies on engineering and mechanical testing data (as mentioned in point 2), not "ground truth" established by clinical experts in the context of diagnostic performance or AI model validation. The "ground truth" for the mechanical testing would be the measured physical properties (e.g., pull-out strength, shear strength) against predefined engineering specifications or comparisons to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth for diagnostic AI, neither of which is described in this 510(k) 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 document is for a physical medical implant (a knee patella component), not a diagnostic device or an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document pertains to a physical medical implant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the conventional sense of diagnostic "ground truth." For a medical implant 510(k), "ground truth" for the referenced "testing" would relate to physical and mechanical properties, such as:
- Tensile strength of materials
- Fatigue life
- Fixation strength (e.g., pull-out resistance, rotational stability)
- Dimensional accuracy
- Biocompatibility
These are established through standardized in vitro engineering tests, not typically through clinical pathology or expert consensus on diagnostic assessment.
8. The sample size for the training set
Not applicable. This document is for a physical medical implant, not a data-driven AI/ML model for which "training sets" are used.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/ML model.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. 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 prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.