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The iKnee Distal Femoral Cutting Guide is indicated for use as a stereotaxic accessory instrument that acts as a cutting guide for the distal femur during a total knee arthroplasty using computer navigation. The iKnee Distal Femoral Cutting Guide requires the use of a Stryker Smart Instrument navigation tracker in conjunction with a compatible Stryker navigation system.

The Operativ iKnee Distal Femoral Cutting Guide is a device used to cut the distal femur during a computer navigated total knee arthroplasty. The iKnee Distal Femoral Cutting Guide can control all three plains (varus/valgus, flexion/extension and depth) independently to allow for easy adjustments to ensure accuracy and ease of use. The iKnee Distal Femoral Cutting Guide is used with the Stryker Navigation Unit and associated stereotaxic Smart Instruments (K010204) to cut the distal femur during a total knee arthroplasty.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., "accuracy must be within X mm" or "error must be less than Y degrees"). Instead, the acceptance criterion for each test is consistently described as the subject device exhibiting "no significant error" or being "as accurate as" the predicate device system.

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

• Test Set Sample Size: The document does not specify a numerical sample size for any of the bench tests. It describes comparative testing against the predicate device system.
• Data Provenance: The data is retrospective, as it comprises bench tests performed by the manufacturer (Evergreen Orthopedic Research Lab d/b/a Operativ) to demonstrate substantial equivalence. The tests compare the subject device to existing predicate devices (Stryker and Zimmer). The country of origin for the data is not explicitly stated but can be inferred as the USA, given the manufacturer's location and the FDA submission.

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

Not applicable. This was a bench test evaluating the physical and functional accuracy of a surgical cutting guide in conjunction with a navigation system, not a study requiring expert interpretation of medical images or outcomes to establish ground truth. The "ground truth" was established by direct physical measurements and the performance of the predicate device's established accuracy.

4. Adjudication Method for the Test Set

Not applicable. As a bench test comparing instrumental accuracy, an adjudication method for reconciling expert opinions is not relevant.

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 document describes a bench test of a surgical cutting guide, not an AI-powered diagnostic device or an MRMC study.

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

This scenario is partially applicable in the sense that the device's inherent accuracy and communication with the navigation system are tested, representing its "standalone" functional capability as a tool. However, it's crucial to understand that this is a surgical instrument, not an AI algorithm. Its performance is evaluated mechanically/electronically in conjunction with a navigation unit, not as an autonomous decision-making system. The tests evaluate the instrument's ability to accurately translate the navigation system's guidance into a physical position for cutting.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for these bench tests was the established accuracy and performance of the legally marketed predicate devices (Stryker and Zimmer cutting guide systems in conjunction with their respective navigation units). The subject device's performance was measured against the established and expected performance of these predicate systems, essentially using the predicate's known characteristics as the benchmark for "ground truth" in terms of accuracy and function. This inherently relies on the previously validated performance standards of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device (surgical cutting guide), not a machine learning or AI algorithm that requires a "training set."

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

Not applicable. See point 8.

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The Orthopilot® 2 Navigation Platform is a system for computer-aided navigation of surgical instruments. Its purpose is to optimally position endoprosthesis in arthroplasty such as the Search Evolution Knee system and the Gem Knee system in the patient. It aids the surgeon in accurately positioning the cutting guides, drills and reamers for total endoprosthesis replacement surgery and provides intraoperative measurements of bone alignment. It indicates optimized angles and positions for implant placement. (Does not include an indication for High Tibial Osteotomy (HTO) module).

Orthopilot® 2 Navigation Platform uses transmitters that are mounted to the patients bones, or are flexible to palpate landmarks and a camera to monitor the spatial location of those transmitters in relation to each other and the medical instruments. These locations are used to locate the centers of rotation of the femur head, ankle, knee. These measurements allow for greater accuracy than mechanical methods of ascertaining implantation sites and positions.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) premarket notification for the Orthopilot 2 Navigation Platform. It focuses on regulatory compliance, device description, indications for use, and substantial equivalence to previously cleared devices.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily states that the Orthopilot 2 Navigation Platform complies with general safety and electromagnetic compatibility standards (IEC 60601-1, IEC 60601-1-2, CAN/CSA-C22.2 No. 601.1-M90), but these are performance standards for electrical and medical equipment safety, not clinical performance acceptance criteria for the navigation system's accuracy or efficacy in positioning endoprostheses. The FDA's letter also indicates that no applicable performance standards have been promulgated under Section 514 specifically for this device system.

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