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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 Operativ Navigation Pin is indicated for use as temporary fixation pin to attach an orthopedic stereotaxic tracker holder to bone which allows the tracker to be referenced by the computer during a total knee arthroplasty.

The Navigation Pin is a partially threaded stainless steel (ASTM F138-08) pin with lengths of 100mm and 150mm. It has a diameter of 3mm. The Navigation Pins are driven into bone using a drill and collet driver. The pins hold the Stryker Navigation OrthoLock stereotaxic accessory device (6007-003-000) in place during a computer navigated total knee replacement. The Navigation Pins are placed in the distal femur and proximal tibia. Two pins are used for each Stryker Navigation OrthoLock stereotaxic accessory device (6007-003-000), one device for the femur and one for the tibia. The Navigation Pins are removed once the total knee replacement is completed. They are not meant for implanting.

This document describes the Navigation Pin by Operativ. The 510(k) summary focuses primarily on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance results for the Navigation Pin itself. The device is a sterile, single-use, partially threaded stainless steel pin designed for temporary fixation of an orthopedic stereotaxic tracker holder to bone during computer-navigated total knee replacement surgery.

Therefore, many of the requested elements for a study proving acceptance criteria are not directly applicable or available in the provided text.

Here's an analysis based on the given information:

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with reported device performance metrics in the way one would expect for a diagnostic or AI device study. The entire submission is built around demonstrating substantial equivalence to a predicate device, Zimmer CAS Fixation Pins (K100599), based on material, design, and intended use.

The "performance" is implicitly deemed acceptable if it matches the predicate device. The key characteristics compared are:

The "acceptance criteria" here are essentially the demonstration that the Operativ Navigation Pin is acceptably similar to the predicate device in terms of material, design, and intended use, and that any differences (such as slight variations in diameter and length) do not raise new questions of safety or effectiveness. No specific quantitative performance metrics (e.g., pull-out strength, bending stiffness) or thresholds are mentioned as "acceptance criteria" with corresponding "reported performance."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided in the document. This is a medical device 510(k) submission, not a study involving a test set of data points or images for a diagnostic algorithm. The "test" for this device involved comparing its physical and functional characteristics to a legally marketed predicate device.

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)

This information is not applicable and not provided. "Ground truth" in the context of this 510(k) submission refers to the established safety and efficacy of the predicate device, which is assumed to be true based on its prior market clearance. There were no human experts evaluating a "test set" in the context of ground truth for performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. No adjudication method was used as there was no test set of data requiring expert consensus or review.

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

This information is not applicable and not provided. An MRMC study is relevant for diagnostic imaging devices often involving AI. The Navigation Pin is a mechanical fixation pin, not a diagnostic or AI-assisted device.

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

This information is not applicable and not provided. The device is a physical pin, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" is typically the established safety and effectiveness of the legally marketed predicate device. The manufacturer demonstrated that their device is substantially equivalent to this predicate based on material, design, and intended use. There is no external "ground truth" established through clinical data, pathology, or outcomes specifically for the Navigation Pin outside of its comparison to the predicate.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" for a physical medical device like this pin. This concept is relevant for AI/ML algorithms.

9. How the ground truth for the training set was established

This information is not applicable and not provided. As there is no training set, there is no ground truth established for it.

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The Operativ Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

The Operativ internal/external fixation devices consist of various fixation pins and wires for in unilateral internal/external fixation. The various lengths, sizes and end configurations are offered to accommodate various patient anatomies, injuries and/or conditions, and physician preference. Calibrated wires provide etched markings every 1/2 inch. All Operativ internal/external fixation devices included in this submission are manufactured from stainless steel and will be offered non-sterile.

The provided document is a 510(k) summary for medical devices (Kirschner wires and Steinmann pins). It states that the determination of substantial equivalence was based on a detailed description and conformance with voluntary standards, and that "Based upon the similarities in materials and design to the predicate devices, the technological characteristics are sufficient to support a determination of substantial equivalence."

This type of submission does not include the kind of performance study data and acceptance criteria typically found for software or AI/ML-based devices. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document explicitly states that the substantial equivalence was determined based on material and design similarities to predicate devices, not on performance data from a clinical or analytical study.

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