Search Results

The Evolution® Total Knee Systems can be implanted using the Kinematic Alignment technique. When the Kinematic Alignment approach is utilized, the devices are indicated for the following conditions:

• 1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• 2. inflammatory degenerative joint disease including rheumatoid arthritis;
• 3. correction of functional deformity;

The Evolution® Kinematic Alignment technique may only be used with Evolution® Primary Knee components or the Evolution® Stemmed CS Femur and Evolution® Revision Tibia Base.

The purpose of this submission is to seek clearance for the Evolution® Total Knematic Alignment Instrumentation and Technique. The instruments consist of resection and alignment guides, calipers, spacers, and trays that are used in conjunction with MicroPort's existing 510(k)-cleared knee instrumentation. The Kinematic Alignment technique is to duplicate the pre-arthritic native joint line. Unlike Mechanical Alignment where the focus is placed on making a perpendicular tibial resection, non-anatomic distal and posterior femoral cuts, and ligament releases if needed, Kinematic Alignment prioritizes the femoral cuts to replicate the native joint line. The Kinematic Alignment technique compensates for wear on the prearthritic joint line and strives for natural ligament tension.

The Evolution® Kinematic Alignment surgical technique is used with the following 510(k)-cleared knee components. No changes to the compatible Evolution® implants are being presented in this 510(k). The compatible implants are axactly the same as the previously cleared Evolution® implants.

• · Evolution® MP Total Knee System, K093552
• · Evolution® MP Total Knee System, K102380
• · Evolution® MP CS/CR Porous Femur, K140735
• · Evolution® Biofoam® Tibial Base and Evolution Biofoam Modular Keels, K152298
• · Evolution® Revision Tibia Base System, K162026
• · Evolution® Biofoam Tibial Base with Biofoam® Additive Manufacturing, K170288
• · Evolution® Stemmed CS Femur, K182125
• Evolution® NitrX™ Medial-Pivot Knee, K182251

The provided text is a 510(k) summary for the MicroPort Orthopedics Inc. "Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique." It outlines the regulatory clearance process for a new surgical technique and associated instrumentation, not an AI/ML-based medical device. Therefore, the information requested in your prompt regarding acceptance criteria, study design for AI performance, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and ground truth types is not applicable to this document.

This document describes a medical device (surgical instrumentation for knee replacement) that falls under traditional medical device regulations, where clearance is typically based on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices through non-clinical testing and comparison of technological characteristics. There is no mention of software with AI/ML components requiring performance evaluation against specific metrics like sensitivity, specificity, or accuracy, nor is there any data related to how human readers improve with AI assistance.

The document explicitly states: "Not applicable. Clinical data were not necessary for the subject device." and "The nonclinical analyses and validations demonstrate that the device is as safe and effective and performs as well or better than the legally marketed predicate and reference devices." This confirms that the clearance was based on non-clinical engineering and design validation, not clinical performance studies involving outcome data or expert consensus for AI/ML performance.

Therefore, I cannot provide the requested information based on the provided text. The prompt's questions are tailored for AI/ML medical devices, which this document does not describe.

Ask a specific question about this device

The ACL instruments are used for the reconstruction of anterior cruciate ligament with the patellar ligament using the press-fit technique.

The ACL instrument by Boszotta allows fast and standardized removal of the patellar ligament by an optimal arthroscopic press-fit technique. The standardized diameter of the bone plugs allows optimum bone contact and promotes rapid healing.

The provided document is a 510(k) summary for the Richard Wolf Medical Instruments Corporation's ACL instruments, submitted in 1997. This type of document is for medical device clearance, not for AI/ML software. Therefore, the questions related to AI/ML software performance, such as sample size for training sets, ground truth establishment, MRMC studies, and human reader improvement, are not applicable.

Here's an analysis based on the available information for a traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For traditional medical devices seeking 510(k) clearance, formal "acceptance criteria" and "reported device performance" in the sense of quantitative metrics (e.g., sensitivity, specificity for a diagnostic device) are generally not presented in the same way as for AI/ML systems. Instead, the focus is on demonstrating that the device is substantially equivalent to a legally marketed predicate device. This involves showing similar technological characteristics and performance, often through non-clinical laboratory testing, material testing, and sometimes limited clinical experience, rather than formal statistical performance against pre-defined criteria.

In this document, the "performance data" section serves the closest role to reporting on the device's acceptable use and safety.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: "more than 200 routine interventions"
• Data Provenance: "Eisenstadt Hospital for accident cases," used for "about three years." This is retrospective clinical experience from a specific hospital. The country of origin is not explicitly stated but can be inferred as likely being in Europe given the hospital name, possibly Austria (Eisenstadt is a city in Austria).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. For this type of medical device, "ground truth" as a reference standard for AI/ML performance is not established. The "performance data" is observational feedback from clinical use. There is no mention of independent experts evaluating this clinical use data in a structured way to establish a "ground truth."

4. Adjudication Method for the Test Set

Not applicable. There was no formal "test set" and no "adjudication method" in the context of expert review for ground truth establishment. The data represents clinical usage feedback.

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 is a traditional surgical instrument, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This is a traditional surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

Not applicable to traditional surgical instruments. The closest concept is "real-world clinical performance" as observed by the users (surgeons) and reported to the manufacturer. The "ground truth" for showing safety and effectiveness is largely based on the absence of reported problems during clinical use and the substantial equivalence to predicate devices, which implies similar clinical outcomes.

8. The Sample Size for the Training Set

Not applicable. This is a traditional surgical instrument. There is no concept of a "training set" for an AI/ML model for this device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Ask a specific question about this device