Search Results

The iASSIST Knee System is a computer assisted stereotaxic surgical instrument system intended to assist the surgeon in preparing the bone surfaces for the positioning of orthopedic implant system components intra-operatively. It involves surgical instruments and inertial sensors to determine alignment axes in relation to anatomical landmarks and to precisely position alignment instruments and cut guides relative to these axes.

The present iASSIST Knee System is designed for Total Knee Arthroplasty.

As in the predicates, the iASSIST Knee System consists of Pods (tracking sensors), a computer system, software, and surgical instruments designed to assist the surgeon in the placement of Total Knee Replacement components. The Pods combined with the surgical instruments provide positional information to help orient and locate the main femoral and tibial cutting planes as required in knee replacement surgery. This includes means for the surgeon to determine and thereafter track each of the bones' alignment axes relative to which the cutting planes are set. The computer system and software components control and sequence the functions of the Pods per the applicable knee surgery steps via wireless communication.

The provided text does not contain information about specific acceptance criteria or an associated study for the iASSIST Knee System that would allow me to populate all the requested fields. The document primarily describes the regulatory submission (510(k)) and its general performance testing, but lacks the detailed quantitative data, sample sizes, and expert information typically found in a study proving acceptance criteria.

However, based on the information available, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The text generally states that the device "is safe and effective and that the performances of the iASSIST Knee System are acceptable," but does not list specific quantitative criteria or performance metrics (e.g., accuracy, precision) with corresponding reported values.

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

The text mentions "full simulated use on cadaveric specimens" for the Validation Lab. It does not specify the number of cadaveric specimens used (the sample size) or their country of origin. The study appears to be prospective in nature, as it involves actual testing on specimens.

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

Not available in the provided text.

4. Adjudication Method for the Test Set

Not available in the provided text.

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. The iASSIST Knee System is described as a computer-assisted surgical instrument system, not an AI diagnostic or interpretive tool that would involve "human readers" or AI assistance in the sense of image interpretation for diagnosis. Its purpose is to assist the surgeon in bone surface preparation and positioning of orthopedic implants.

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

The device is inherently designed for "human-in-the-loop" performance, assisting a surgeon intra-operatively. Therefore, a standalone performance study in the absence of a surgeon would not be relevant or meaningful for this device's intended use. The validation lab involves "full simulated use on cadaveric specimens," implying the system is used as intended with human involvement.

7. The Type of Ground Truth Used

For the "Validation Lab" testing on cadaveric specimens, the ground truth would likely be established through:

• Direct measurement: Using highly accurate external instruments or established anatomical reference points to measure the actual alignment axes and cutting planes achieved by the system and surgical instruments on the cadaver bones.
• Expert surgical assessment: Evaluation by experienced orthopedic surgeons to determine if the achieved bone preparation and alignment match the surgical plan and accepted orthopedic standards.

The text does not explicitly state which method was used, but given the nature of the device, it would involve objective measurements against defined surgical parameters.

8. The Sample Size for the Training Set

Not applicable. The iASSIST Knee System is a stereotaxic surgical instrument system, not a machine learning model that requires a distinct "training set" in the conventional sense of AI/ML development. The software capabilities are likely developed and refined through engineering, modeling, and iterative testing, rather than being "trained" on a large dataset of patient images or outcomes.

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

Not applicable, as described in point 8. The "ground truth" for the development of such a system would involve engineering specifications, biomechanical principles, and established surgical techniques for total knee arthroplasty.

Ask a specific question about this device

PERSEUS is a computer-controlled system, intended to assist in distal femoral resection and tibial resection during Total Knee Arthroplasty, determining reference alignment axes in relation to anatomical and instrumentation structures during stereotaxic orthopaedic surgical procedures.

PERSEUS is a computer assisted system, that helps surgeon in the positioning of implant components, during total knee implant surgical procedure, according to the conventional reference axes in relation to anatomical landmarks. Perseus System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The device assists the surgeon in: Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur. Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia. Perseus system utilizes triaxial accelerometer and triaxial gyroscope to determine, through limb movement, reference axes of femur and tibia and relative orientation of distal femoral and tibial cutting guide with respect to frontal and sagittal planes of the limb.

Here's a detailed breakdown of the acceptance criteria and the studies proving the device's performance, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device