(103 days)
When used with the Patello-femoral System: The Cardo Medical Patellofemoral System patella components are for use in patellofemoral knee arthroplasty in patients with: - Degenerative arthritis in the distal femur and patella; . - A history of patellar dislocation or fracture; . - Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where . pain deformity or dysfunction persists. When used with the Total Knee System: The Cardo Medical Total Knee System patella components are for use in total knee arthroplasty as a result of: - Painful, disabling joint disease of the knee resulting from degenerative arthritis, . rheumatoid arthritis, or post-traumatic arthritis; - Post-traumatic loss of knee joint confiquration and function: . - Moderate varus, valgus or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability; - Revisions of previous unsuccessful knee replacement or other procedure. . Additional indications for posteriorly stabilized components: - Ligamentous instability requiring implant bearing surfaces with increased constraint: . - Absent or non-functioning posterior cruciate ligament. . The patella components are single use only and intended for implantation with bone cement.
The Cardo Medical Align 360 Medialized patella is manufactured from UHMWPE with pegs on the non-articulating surface. The surgeon uses the components to resurface the patella during either a patella-femoral replacement or a total knee replacement. The device is designed for cemented fixation only.
The provided text describes a Premarket Notification Submission (510(k)) for the Cardo Medical Align 360® Medialized Patella Component. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the way typically expected for performance claims (e.g., accuracy, sensitivity, specificity for diagnostic imaging devices).
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through comparisons of material, design, and intended use, and by confirming that the device meets general guidance documents for knee implants. The "tests" mentioned are likely mechanical or biocompatibility tests, rather than clinical performance studies.
Therefore, the following information is derived from the context of a 510(k) submission for a medical implant, where "acceptance criteria" and "study" typically refer to adherence to established standards and comparison to predicate devices, rather than a clinical trial with performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalence in Design: Same articulating surface | "The Cardo Medical Align 360° Medialized Patella components are manufactured from UHMWPE have the same articulating surface as the current dome patella." (The only difference is additional material around the edge of the dome.) |
| Equivalence in Material: Manufactured from UHMWPE | "The Cardo Medical Align 360° Medialized Patella components are manufactured from UHMWPE..." |
| Equivalence in Intended Use: Resurfacing patella | Intended for cemented use in resurfacing the patella during patellofemoral disease or total knee replacement. (Same as predicate) |
| Compliance with FDA Guidance: | "Testing has shown that the proposed device meets the requirements of the current FDA Guidance Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA." |
| Safety and Effectiveness: No negative impact from differences | "Cardo Medical has determined that any differences in the proposed device will not impact the safety or effectiveness of the Align 360° Medialized patella components for their intended use." |
| Equivalency to Predicate Device for all performed testing. | "Tests were performed on the Align 360° Medialized patellae system to ensure the proposed device is equivalent to the predicate device for all testing performed." (Specific test results not provided, but claims equivalence.) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The description mentions "tests were performed" and "testing has shown," which typically refers to mechanical and material testing rather than a patient-based test set or clinical trial. Hence, "sample size" in a clinical sense is not applicable here.
- Data Provenance: Not explicitly stated. Given the nature of a 510(k) for a medical device implant, the data would typically come from in-house mechanical testing or accredited laboratory testing on device prototypes/units. It would not typically involve patient data unless a clinical trial was specifically required, which is not indicated here for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This submission is for a medical implant and relies on mechanical and material testing, as well as comparison to predicate devices and adherence to regulatory guidance. It does not involve a diagnostic test where expert-established ground truth is required.
4. Adjudication method for the test set:
- Not applicable. This concept relates to studies where multiple readers or experts assess cases to establish a ground truth or resolve discrepancies. This submission pertains to device design, material, and mechanical performance, not diagnostic interpretations.
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 medical implant (patella component for knee replacement), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. As mentioned, this device is a physical implant, not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the equivalence claim, the "ground truth" is the performance and characteristics of the legally marketed predicate devices (Cardo Medical Dome Patella, Scorpio Knee System) and the requirements outlined in the FDA Guidance document. The device aims to demonstrate it is "substantially equivalent" to these established benchmarks.
- For the mechanical/material testing, the ground truth would be engineering specifications, material science standards, and performance metrics defined by relevant ISO standards or FDA guidance for knee implants.
8. The sample size for the training set:
- Not applicable. This submission is for a physical medical device implant and does not involve machine learning or AI, and thus no "training set" in that context.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
§ 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.