(18 days)
The indications for use for Biomet knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, theumatoid arthritis, traumatic arthritis where one or more compartments are involved; 2) Correction of varus, valgus, or posttraumatic deformity; and 3) Corrections or revision of unsuccessful osteotomy, arhtrodesis, or failure of previous joint replacement procedure. This device is for use with bone cement
The Ascent Closed Box Posterior Stabilized Femoral Component is a stemmable knee component designed for use in cases where extensive ligament damage has occurred. This design is based upon the features of the currently marketed Performance Closed Box Knee Components with certain modifications. There are five sizes available in both right and left configurations. The femoral articulation is the same as the Performance Posterior Stabilized Knee (K936274). The anatomic component design allows the surgeon to reconstruct the anatomic dimensions and kinematics of the natural femur. The femoral component has an Interlok finish for use in cemented applications. The Ascent Closed Box PS Femoral Component can be used with either a constrained or PS tibial bearing. The femoral component also has independent posterior and distal augments to correct bone loss deficiencies and can still be used with previously cleared Performance stems and locking screw.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document is an FDA 510(k) summary for a premarket notification, which typically focuses on demonstrating substantial equivalence rather than presenting a detailed performance study with acceptance criteria.
Key Observation: The provided document is an FDA 510(k) notification for the Ascent Knee System. This type of submission primarily aims to demonstrate substantial equivalence to a predicate device already on the market, rather than proving performance against specific acceptance criteria through a de novo clinical study. Therefore, robust performance data tables, detailed study designs, and ground truth methodologies as typically seen in a de novo approval or clinical trial report are not present in this document. The "device performance" described would relate to its similarity to the predicate device.
Description of Acceptance Criteria and Proving Device Meets Criteria
Given the nature of a 510(k) submission, the "acceptance criteria" are implicitly met if the device is found to be "substantially equivalent" to a legally marketed predicate device. The "study" that proves this is the 510(k) review process itself, where the FDA assesses the similarities and differences between the new device and the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance (as per 510(k) Summary) |
|---|---|
| Premarket Review Objective: Substantial Equivalence to a legally marketed predicate device. This includes assessing: | The FDA found the device to be "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976" (or to reclassified devices). |
The Ascent Closed Box Posterior Stabilized Femoral Component is described as:A stemmable knee component.Designed for use in cases of extensive ligament damage.Based on currently marketed Performance Closed Box Knee Components (K936274).Available in five sizes, right and left configurations.Femoral articulation same as Performance Posterior Stabilized Knee (K936274).Anatomic component design to reconstruct anatomic dimensions and kinematics.Interlok finish for cemented applications.Can be used with constrained or PS tibial bearing.Features independent posterior and distal augments for bone loss correction.Compatible with previously cleared Performance stems and locking screw.The document states that the potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to: reaction to bone cement, deformity of the joint, cardiovascular diseases, fracture of the cement, implant loosening/migration, tissue growth failure, blood vessel damage, soft tissue imbalance, delayed wound healing, metal sensitivity, fracture of the components, nerve damage, bone fracture, infection, hematoma, and dislocation, and excessive wear. |
| 1. Indications for Use: Are the indications for use the same or sufficiently similar to the predicate device? | The stated indications for use are:
- painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved;
- Correction of varus, valgus, or post-traumatic deformity; and
- Corrections or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The device is for use with bone cement. These indications are standard for knee replacement prostheses. |
| 2. Technological Characteristics: Are the technological characteristics (materials, design, performance) sufficiently similar to the predicate device? Any differences must not raise new questions of safety or effectiveness. | The device is described as being "based upon the features of the currently marketed Performance Closed Box Knee Components with certain modifications." The femoral articulation is "the same as the Performance Posterior Stabilized Knee (K936274)." It uses an "Interlok finish for use in cemented applications." The description implies that the design changes are within the scope of existing, approved technology. The enumerated "Potential Risks" are generic to joint replacement, suggesting no new or unanticipated risks from the design. |
| 3. Performance Data (if applicable): If there are any differences in technological characteristics, does non-clinical or clinical performance data demonstrate safety and effectiveness? (This is often mechanical testing or bench testing for orthopedic implants, not clinical trials in a 510(k)). | The document does not explicitly detail performance data (e.g., mechanical testing reports). However, for a 510(k) for an orthopedic implant, the FDA typically reviews bench testing (e.g., fatigue, wear, strength) to demonstrate that any modifications do not negatively impact the performance compared to the predicate device. The statement that the device is "substantially equivalent" implies that such data, if required, was submitted and found acceptable. |
Detailed Information (Based on 510(k) nature, many points are not applicable or explicitly stated):
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 stated. This document does not describe a clinical study with a "test set" of patients. The "testing" for a 510(k) is usually non-clinical (e.g., bench testing or comparison to existing predicate data). If any such testing was done, the sample size (e.g., number of implants tested mechanically) and data provenance are not provided in this summary.
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. As no clinical "test set" and associated "ground truth" determination by experts is described for this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring expert adjudication is described.
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 knee implant, not an AI-powered diagnostic tool. MRMC studies are not relevant to its approval pathway.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical knee implant, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. As described, this is a 510(k) for a knee implant, not a diagnostic device requiring ground truth for accuracy assessment in a clinical study. The "ground truth" for substantial equivalence is the safety and effectiveness profile of the predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device requiring a training set.
§ 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.