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510(k) Data Aggregation
(90 days)
The Osteonics® Series 7000 Total Knee Augmented Femoral Component is intended to replace the articulating surface of the distal femur in a total knee arthroplasty. This posteriorly stabilized femoral component is utilized when total knee replacement is indicated, the posterior cruciate ligament is non-functioning or absent, and femoral bone loss is present. This device is a single use component intended for cemented fixation. The indications for use are:
- Painful, disabling joint disease of the knee resulting from: degenerative arthritis, . rheumatoid arthritis or post-traumatic arthritis, complicated by the presence of bone loss.
- . Post-traumatic loss of knee joint configuration and function.
- Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be . returned to adequate function and stability.
- Revision of previous unsuccessful knee replacement or other procedure, accompanied by . bone loss.
- Ligamentous instability requiring implant bearing surface geometries with increased . constraint.
- Absent or non-functioning posterior cruciate ligament. .
The Osteonics® Series 7000 Total Knee Augmented Femoral Component features a posterior stabilizing housing, intercondylar cam, fixed intramedullary stem, waffled interior surface pattern, optional nitrogen ion implanted bearing surface treatment (LFIT™), and a distal and posterior build-up on the interior of the component to compensate for femoral bone loss.
This document is a 510(k) Premarket Notification for a medical device: the Osteonics® Series 7000 Total Knee Augmented Femoral Component. This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical studies to prove performance against specific acceptance criteria.
The information requested in the prompt (acceptance criteria, specific study details, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth types, training set details) is typically associated with a Premarket Approval (PMA) application or a de novo classification, where a novel device's safety and effectiveness are established through rigorous clinical trials and performance testing.
Given this context, the provided document does not contain the specific information required to complete the table or answer the detailed questions about acceptance criteria and a study demonstrating the device meets those criteria. The 510(k) process relies on demonstrating that the new device is "as safe and effective as, and performs as well as" a legally marketed predicate device. This is achieved by comparing technological characteristics, intended use, and materials.
However, based on the provided text, I can infer the "acceptance criteria" through the lens of substantial equivalence and how the "study" (the comparison process) addresses them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Safety: Device materials and design are safe for human implantation and fixation. | The Osteonics® Series 7000 Total Knee Augmented Femoral Component uses the same materials as the predicate device (Osteonics® Series 7000 Total Knee Posteriorly Stabilized Long Stem Femoral Component). This implies established safety profiles for these materials. |
| Effectiveness/Performance: The device effectively replaces the articulating surface of the distal femur and addresses specified conditions (non-functioning PCL, femoral bone loss). | The device shares basic design features with the predicate device, which is already marketed and presumed safe and effective for similar indications. The "applicable performance testing" demonstrates "no significant difference exists between this component and the predicate designs," suggesting comparable functional performance. |
| Intended Use: The device performs its intended function for the specified indications (e.g., total knee arthroplasty, management of posterior cruciate ligament absence, bone loss). | The device has the same indications and intended use as the predicate devices: replacing the articulating surface of the distal femur when total knee replacement is indicated, the posterior cruciate ligament is non-functioning or absent, and femoral bone loss is present. |
| Biocompatibility: Materials are biocompatible and do not elicit adverse reactions. | (Inferred) As the device uses the same materials (e.g., polymer/metal) as the predicate, it is assumed to share the predicate's established biocompatibility. |
| Mechanical Integrity/Durability: The component can withstand the stresses of knee articulation. | "Applicable performance testing demonstrates that no significant difference exists between this component and the predicate designs." While specific tests aren't detailed, this refers to mechanical and fatigue testing demonstrating comparable durability and structural integrity to the predicate. This would involve tests for aspects like wear, fatigue, and fixation strength. |
| Fixation Method: Compatibility with cemented fixation. | The device is explicitly designed for cemented fixation, matching the established method of the predicate and explicitly stated in the FDA letter. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This document is a 510(k) submission, not a report on a clinical trial with a "test set" in the context of an AI/diagnostic device. The "performance testing" mentioned likely refers to bench testing (mechanical, material properties) rather than human subject data. There is no mention of a test set size, data provenance, or retrospective/prospective nature of data for clinical evaluation.
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 / Not Provided. This information is not relevant to a 510(k) submission for a knee implant, which focuses on engineering comparisons to a predicate device, not clinical performance against ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. See answer for point 3.
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 / Not Provided. This is a medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This is a medical implant, not a standalone AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily the established safety and effectiveness profile of the predicate device, supported by technical specifications, materials data, and bench test results (e.g., mechanical testing, wear testing) which are compared to the predicate's known performance. Clinical outcomes data or pathology for "ground truthing" a new implant's performance would typically be part of a more extensive clinical trial, not usually required for a 510(k).
8. The sample size for the training set
- Not Applicable / Not Provided. There is no "training set" in the context of this 510(k) device submission.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. There is no "training set" in the context of this 510(k) device submission.
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