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SYMPHONY Navigation Ready Instruments:

The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of SYMPHONY OCT System is indicated,

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

The SYMPHONY Navigation Ready Instruments are intended to support indicated cervical and thoracic polyaxial sorew placement.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrac can be identified relative to the aquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays.

These procedures include but are not limited to spinal fusion. The DePuy Synthes Navieation Ready Instrument, when used with UNAS, can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

SYMPHONY Navigation Ready Instruments:

The SYMPHONY Navigation Ready Instruments are reusable instruments used for the preparation for and insertion of SYMPHONY OCT screws, in either open or percutaneous procedures. These instruments are designed for navigated and nonnavigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments. The UNAS can only be used with Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes:

• Brainlab compatible UNAS Navigation Arrays, ●
• Brainlab compatible Navigation Ring and ●
• Medtronic compatible Navigation Ring ST. ●

The Navigation Ring and Navigation Ring ST mates with compatible DePuy Synthes Navigation Ready Instruments. These instruments include drill guides, probe, taps and screwdrivers. Drills and trocar are indirectly navigable through the drill guide.

When the Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument, a UNAS Navigation Array can be attached and the instrument can be used only with the Brainlab Navigation System as either a manually calibrated or pre-calibrated instrument.

When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only with the Medtronic StealthStation navigation system.

The provided text is a 510(k) summary for the SYMPHONY™ Navigation Ready Instruments and Universal Navigation Adaptor Set. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on demonstrating equivalence rather than establishing new acceptance criteria and conducting a primary study to prove them.

Therefore, the document does not contain information about:

• Acceptance Criteria in the sense of predefined performance thresholds for a novel device. Instead, it describes performance evaluations to show that the new device's performance aligns with that of predicate devices.
• A "study that proves the device meets the acceptance criteria" in the context of a clinical trial or a statistically powered study to demonstrate a new performance claim. The performance data presented are evaluations for substantial equivalence, not a standalone clinical validation study.
• Effect size of human readers improving with AI vs. without AI assistance, as this device is a surgical instrument and navigation accessory, not an AI-powered diagnostic or assistive tool for image interpretation.
• Standalone (algorithm only without human-in-the-loop performance), as this is not an algorithm-based device.
• Ground truth types (expert consensus, pathology, outcomes data, etc.), as this is not a diagnostic device requiring this type of ground truth establishment.
• Training set size and ground truth establishment for a training set, as this is not an AI/ML device.

However, it does provide information about the performance evaluations conducted to support substantial equivalence. Here's a breakdown of what is available:

1. Table of acceptance criteria and the reported device performance:

Since explicit acceptance criteria are not stated in a numerical or categorical format, and "reported device performance" refers to the results of assessments for substantial equivalence, I will list the evaluations performed and the implied objective (consistency with predicate devices).

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

The document does not detail specific sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for each of the performance evaluations. The evaluations appear to be bench testing and simulated use, not human subject studies.

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

This information is not provided. The evaluations are primarily technical assessments against design specifications and functional requirements, not expert-based ground truth establishment as would be seen in diagnostic imaging studies.

4. Adjudication method for the test set:

Not applicable, as no expert-based ground truth or adjudication process is mentioned for these technical performance evaluations.

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-powered diagnostic device.

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

Not applicable. This is a surgical instrument and navigation accessory, not an algorithm. The "Navigation Connection Repeatability for Pre-Calibrated Instruments" and "Confirmation of Array Recognition" could be considered "standalone" functional tests of the device's interaction with navigation systems, but these are not the same as algorithmic performance.

7. The type of ground truth used:

The "ground truth" for these evaluations would be the engineering specifications, design requirements, and known performance characteristics of the predicate devices and compatible navigation systems. For example:

• Accuracy Verification: Ground truth would be the defined accuracy requirements of the compatible navigation systems.
• Instrument Length Comparison: Ground truth would be the measurements of the predicate device's instruments.
• Array Characteristics Comparison: Ground truth would be the established specifications of the predicate device's arrays.
• Implant/instrument mating conditions: Ground truth would be the design specifications for proper fit and mechanical integrity.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

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SYMPHONY Navigation Ready Instruments:

The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of SYMPHONY OCT System is indicated.

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system which includes tracking arrays supplied by the navigation system manufacturer.

These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments require manual calibration with the Medtronic StealthStation navigation system.

The SYMPHONY Navigation Ready Instruments are intended to support cervical and thoracic polyaxial screw placement.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system which includes tracking arrays supplied by the navigation system manufacturer. These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instrument, when used with UNAS, requires manual calibration with the Medtronic StealthStation navigation system.

SYMPHONY Navigation Ready Instruments:

The SYMPHONY Navigation Ready Instruments are reusable instruments used for the preparation for and insertion of SYMPHONY OCT screws, in either open or percutaneous procedures. These instruments are designed for navigated and nonnavigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set contains the Navigation Ring ST used to aid in determining the correct location and trajectory of spinal instruments and implants. The Navigation Ring ST has an interface between the Medtronic StealthStation® navigation system and the DePuy Synthes Navigation Ready Instruments.

The Navigation Ready Instruments include drills, trocar, probe, taps and screwdriver. When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Passive Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated with the Medtronic StealthStation navigation system.

This document describes the FDA's 510(k) clearance for the SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set. The key aspects regarding acceptance criteria and supporting studies are extracted below.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria or detailed numerical results for the performance tests. The conclusion of substantial equivalence implies that the device met the necessary performance standards to be considered safe and effective as its predicate.

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

The document does not specify the exact sample sizes (e.g., number of instruments, number of measurements) for the accuracy verification tests or the simulated use evaluation.
The data provenance for the test set (e.g., country of origin, retrospective/prospective) is not explicitly stated. However, given it's a pre-market notification for a medical device seeking FDA clearance, the testing would typically be conducted under controlled laboratory conditions rather than using patient data. The simulated use evaluation used "sawbones models," which are synthetic bone models, indicating a prospective, lab-based study.

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

The document does not mention the use of experts to establish ground truth for the test set. The accuracy verification likely relied on engineering measurements against known specifications, and the simulated use evaluation would have been assessed by engineering and potentially clinical staff involved in the study.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication for establishing ground truth is not mentioned as part of the performance data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. The document describes a technical and simulated use evaluation rather than a clinical study involving human readers or a comparison of human performance with and without AI assistance. The device is a surgical instrument set, not an AI-based diagnostic tool.

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

Yes, in a sense. The "performance data" sections (Accuracy Verification, Implant/instrument mating, Simulated Use Evaluation) represent the standalone performance of the device (instruments and adaptor set) in conjunction with a navigation system. It's not an algorithm in the AI sense, but rather the functional performance of the hardware. The simulated use evaluation specifically describes the device, when manually calibrated with the Medtronic StealthStation navigation system, being used to prepare holes and insert screws, and the final screw position was compared to a post-operative scan and sawbones model. This assesses the system's ability to guide the surgeon accurately.

7. The Type of Ground Truth Used

• Accuracy Verification: The ground truth for accuracy (positional, angular, length) would likely be based on engineering specifications, calibrated measurement devices, or a statistically reliable "true" value derived from multiple precise measurements.
• Simulated Use Evaluation: The ground truth for the simulated use was based on:
  • The "final screw position in the software" (from the Medtronic StealthStation navigation system).
  • Comparison with a "post-operative scan" of the sawbones model.
  • Comparison with the "sawbones model" itself.
    This implies a comparison against the intended surgical plan or ideal placement within the physical model.

8. The Sample Size for the Training Set

Not applicable. This device is a set of physical surgical instruments and an adaptor, not an AI or machine learning model that requires a training set.

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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