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Integrity Implants Navigated Instruments are intended to be used during the preparation and placement of Integrity Implants spinal implants during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.

Integrity Implants Navigated Instruments are specifically designed for use with Medtronic's StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR-based model, finages, or digitized landmarks of the anatomy.

The Integrity Implants Navigated Instruments include non-sterile screw drivers, cannulated and solid taps (4.0 - 10.5 mm), probes, and awls designed to function with the Medtronic StealthStation® System and NavLock® Tracker. The subject devices are for use with the Integrity Implants LineSider® Spinal System (K190360 and K203367). The instruments are manufactured from stainless steel and Radel.

The provided text is a 510(k) summary for the Integrity Implants Navigated Instruments. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets specific acceptance criteria for performance as an AI/ML-driven diagnostic or prognostic device.

However, I can extract information related to performance testing and acceptance criteria as much as possible from the provided text, while acknowledging that it's not a typical study report for acceptance criteria in the sense of accuracy, sensitivity, or specificity for AI/ML.

Here's a breakdown of the information based on your request, with limitations due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

Limitations: The document does not provide specific quantitative acceptance criteria (e.g., "positional accuracy must be within X mm") or specific quantitative results for each test. It states that tests were "completed to ensure" functionality and compatibility and that the devices are "as safe and effective" as the predicate, implying that acceptance criteria were met, but without detailing them.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set sample size" or "data provenance" in the context of typical AI/ML performance studies (e.g., number of images, patient demographics). The performance data cited refers to:

• Accuracy testing: Performed in accordance with ASTM F2554-18. This standard likely dictates the setup and number of measurements, but the specific details (e.g., number of physical instruments tested, number of measurement points per instrument) are not provided.
• Registration testing: Details on the sample size (e.g., number of instruments registered, number of registration attempts) are not provided.
• Dimensional analysis: This likely involved comparing instrument dimensions, but the "sample size" here refers to the number of device types/models evaluated, which can be inferred from Section IV and the comparison table.
• Cleaning and sterilization validation data: Leveraged from a previous 510(k) (K190360). This implies prior validation studies were conducted, but their specific sample sizes are not detailed in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the document. This device is a surgical instrument intended for use with a navigation system, not a diagnostic or prognostic AI/ML device that generates clinical findings requiring expert ground truth for a test set. The "ground truth" for its performance would be engineering measurements and physical tests.

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

Not applicable, as this is not an AI/ML diagnostic/prognostic device relying on human expert review for ground truth.

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 not an AI-assisted diagnostic or prognostic device that involves human readers interpreting output. It's a navigated surgical instrument.

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

This concept is somewhat applicable in the sense that the navigational system's accuracy and the instrument's compatibility with it can be tested independently of a surgeon's clinical use. The "accuracy testing in accordance with ASTM F2554-18" and "registration testing" would fall under this category of standalone performance assessment of the instrument's interaction with the navigation system. The document does not, however, detail specific performance metrics or results from these standalone tests beyond stating they were performed.

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

For the type of device described, the "ground truth" would be established through:

• Physical measurements and engineering standards: For accuracy (e.g., comparing navigated position to physically measured position in a test setup per ASTM F2554-18).
• Functional tests: To confirm proper registration and compatibility with the StealthStation system.
• Dimensional specifications: For dimensional analysis.

It is not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes a "training set" process.

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

Not applicable, as there is no "training set" for this type of device.

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The Practical Navigation Surgical Guidance System is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or Guide Tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in rigid patient anatomy and fiducials that can be identified on an O-arm scan. The Practical Navigation Surgical Guidance System is indicated for assisting the surgeon in placing pedicle in the posterior lumbar region (1-S1).

The system is designed for lumbar pedicle screw placement with the prone position and is compatible with the Integrity LineSider Pedicle Spinal System.

The Practical Navigation Surgical Guidance System (PNSGS) is an image guided system primarily comprised of a computer workstation, software, a trajectory system, including a targeting platform, a Camera, and various image guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The PNSGS system allows for registration of the patient's anatomy to O-arm images. Once the patient anatomy is registered, a surgical plan can be created and optically-tracked surgical instruments can be used to follow the surgical plan.

The provided text describes the "Practical Navigation Surgical Guidance System" and its substantial equivalence to a predicate device, focusing on its technical characteristics and indications for use. However, the document does not contain a detailed study report that proves the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

While the document mentions performance data, it lists only the types of tests conducted (non-clinical verification/validation, cadaver/simulated-use, and adherence to specific ASTM and IEC standards) rather than reporting the actual quantitative results or outlining acceptance criteria for those results.

Therefore, many of the requested details about acceptance criteria, reported performance, sample sizes, ground truth establishment, and MRMC studies cannot be extracted directly from this document.

Here's an analysis of what information is available:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: Not specified. The document mentions "cadaver and simulated-use testing," but no number of cadavers or simulated scenarios is provided.
• Data Provenance: Not specified. The document does not indicate the country of origin of any data or whether it was retrospective or prospective.

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 specified. The document does not detail how ground truth was established for any performance testing, nor does it mention the involvement or qualifications of experts for this purpose.

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

• Not specified. The document does not describe any adjudication method used for the test set.

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

• No MRMC study was done, nor is it applicable in this context. The device is a surgical guidance system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The closest related "assistance" would be its guidance for surgeons, but the document does not present any comparative effectiveness study with and without the device.

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

• A standalone performance evaluation of the system's accuracy was implicitly done. The document states: "ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems." This standard inherently evaluates the accuracy of the system itself (algorithm and hardware) in positioning, which can be considered a form of standalone performance. However, the results of this test are not provided.

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

• Not explicitly stated for the cadaver/simulated-use testing. For "Positional Accuracy," the ground truth typically involves highly accurate measurements from a reference system or physical targets, which serves as the "true" position against which the device's measurements are compared.

8. The sample size for the training set

• Not applicable / Not specified. This device is a surgical navigation system, not a machine learning model that would typically require a "training set" in the conventional sense (e.g., for image classification or diagnosis). Its software is likely developed using engineering principles and verification/validation against specifications, rather than trained on a large dataset of patient images in an AI/ML context.

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

• Not applicable / Not specified. As noted above, typical machine learning training sets are not relevant here.

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