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The NuVasive™ Guided Spinal Arthroscopy System consists of a Surgical Navigator with adjustable cannula guides, and various percutaneous surgical cannulae and instrumentation. This System is intended to assist in gaining controlled percutaneous access to, and visualization of, the spinal nerves, foramina, vertebra, intervertebral disc, and surrounding tissues of the spine via uniportal or biportal posterior, lateral, or posterolateral approach, where anatomical restrictions safely permit. It is intended for use under real-time, or near real-time (i.e., successive static image) radiographic visualization via image-intensified C-arm fluoroscopy. The System is designed for use with NuVasive™ spinal arthroscopes and percutaneous surgical instrumentation, but may be used with other arthroscopes and instrumentation having compatible diameter and length, and which are indicated for use in the spine.

The Hemi-Arc™ Surgical Navigator essentially serves as an instrument holder and guide which is intended to be aligned with the operative site using real time, or near real-time (i.e. success static images) image-intensified C-arm fluoroscopy. The Hemi-ArcTM guide frame is adjustable in several planes of motion, and their fluoroscopic alignment with spinal anatomical features provides the path of entry of subsequent arthroscopic instrumentation to be precisely controlled, thereby avoiding damage to surrounding tissues such as nerves or dura.

The NuVasive™ Hemi-Arc™ Surgical Navigator's 510(k) submission (K013257) does not include a detailed study with acceptance criteria and reported device performance in the way a clinical trial for a standalone diagnostic AI device would. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided information, addressing your points where data is available:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) submission for the Hemi-Arc™ Surgical Navigator states that "a comprehensive program of verification and validation activities demonstrating that acceptance criteria were met, and that design output satisfied design input" was conducted. However, no specific acceptance criteria (e.g., accuracy, precision, sensitivity, specificity) or reported performance metrics are detailed for the device itself. The focus is on the device's function as an instrument holder and guide for fluoroscopic alignment.

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

This information is not provided. The submission refers to "verification and validation activities" but does not detail the size or nature of any test set used in these activities.

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

This information is not provided. Given the nature of the device (a surgical navigator and guide), the "ground truth" would likely relate to the accuracy of instrument positioning, which would be assessed through design verification rather than expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

This information is not provided.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not applicable to this device. This device is a mechanical surgical navigator, not an AI or diagnostic imaging device that "reads" cases or assists "human readers." Its purpose is to guide surgical instruments.

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

A standalone performance study in the context of an algorithm or AI was not done and is not applicable. The Hemi-Arc™ Surgical Navigator is a physical instrument that requires a human operator (the surgeon) and real-time fluoroscopic imaging for its intended use. It is not an autonomous device or an algorithm that performs without human interaction.

7. The Type of Ground Truth Used

The document does not explicitly state the "type of ground truth" used for testing in the typical sense of a diagnostic device (e.g., pathology, outcomes data). For a surgical guide, the "ground truth" during verification and validation would likely involve:

• Dimensional accuracy: Ensuring the guide delivers instruments to the intended anatomical location based on fluoroscopic guidance.
• Mechanical performance: Verification of adjustment mechanisms, stability, and compatibility with other instruments.
• User feedback/simulated use: Testing the ability of the device to facilitate controlled percutaneous access to spinal structures as intended.

These would be assessed through engineering tests and potentially cadaveric or simulated surgical environments, rather than pathology or clinical outcome data in the context of a "test set" for diagnostic performance.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. This device does not employ machine learning or AI that would require a "training set."

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

This information is not provided and is not applicable, as there is no training set for this mechanical device.

Summary of the Study and Acceptance Criteria from the Document:

The provided document describes a Special 510(k) Premarket Notification for the NuVasive™ Hemi-Arc™ Surgical Navigator. The study that "proves the device meets the acceptance criteria" is broadly defined as:

• Design Control Activities: These included "a comprehensive Risk Analysis to identify potential risks and failures associated with operation of the device, any mitigations incorporated... and an assessment of residual risk."
• Verification and Validation Activities: The document states these activities "demonstrat[ed] that acceptance criteria were met, and that design output satisfied design input."

Crucially, no specific performance metrics, acceptance criteria thresholds, or quantitative results from these verification and validation activities are detailed in the publicly available 510(k) summary provided. The entire submission relies on establishing substantial equivalence to an existing predicate device (the Surgical Guide Frame currently manufactured by NuVasive™, Inc.).

The basis for FDA clearance is the assertion that:

• The device has "indications for use identical to those of its predicate."
• It "employs the same principles of operation."
• Due to this equivalency, "the device raises no new safety or effectiveness issues."

Therefore, the "study" demonstrating compliance is the design control and verification/validation process, which the FDA reviewed and found adequate for demonstrating substantial equivalence to the predicate device, rather than a clinical trial or performance study with defined acceptance criteria and reported results akin to an AI-powered diagnostic tool.

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