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NOVA View® Automated Fluorescence Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. It is intended as an aid in the detection and classification of certain antibodies by indirect immunofluorescence technology. The device can only be used with cleared or approved in vitro diagnostic assays that are indicated for use with the device. A trained operator must confirm results generated with the device.

NOVA View is an automated fluorescence microscope that acquires, analyses, stores and displays digital images of stained indirect immunofluorescent slides.

The NOVA View AUTOLoader is an optional hardware accessory that performs the automated transfer of slide carriers to and from NOVA View, thereby providing a continuous load capability without human interaction.

AUTOLoader hardware components consist of a NOVA View alignment base, 3-position stack base, 3 slide carrier stacks (labelled as "Pending", "Completed", "and "Error"), telescoping arm with rotary gripper, and a 2D barcode scanner station. The AUTOLoader can be connected to up to two NOVA View devices.

Below is a summary of the acceptance criteria and study information for the NOVA View® Automated Fluorescence Microscope with AUTOLoader, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the NOVA View® Automated Fluorescence Microscope with AUTOLoader as an aid in the detection and classification of certain antibodies. It explicitly states that "A trained operator must confirm results generated with the device." This implies that the device is not intended as a standalone diagnostic tool, but rather as one that assists a human expert.

Given this context and the fact that this is a Special 510(k) submission for the addition of an AUTOLoader, the primary focus of the performance evaluation appears to be on demonstrating that the addition of the AUTOLoader does not negatively impact the existing functionality of the NOVA View, and that the AUTOLoader itself performs its mechanical tasks reliably and accurately.

The document does not provide specific numerical acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) for the diagnostic performance of the device (i.e., its ability to correctly detect and classify antibodies). Instead, it focuses on demonstrating that the system functionality is maintained with the addition of the AUTOLoader.

Acceptance Criteria for AUTOLoader Functionality (Inferred):

Note on Diagnostic Performance: The document explicitly states "Analytical performance characteristics n/A" and "Clinical performance n/a." This indicates that this specific submission for the AUTOLoader addition did not involve new analytical or clinical performance studies related to the diagnostic accuracy of antibody detection. The regulatory submission leverages the established performance of the predicate device (NOVA View without AUTOLoader) for its core diagnostic function.

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

The document does not specify a distinct "test set" in the traditional sense for evaluating diagnostic performance. The studies described are focused on the functionality of the AUTOLoader and the integration of new software.

• Software Testing: "All new functions were tested during software verification, and regression testing has been performed to demonstrate that NOVA View functionality has not changed." The sample size (number of test cases, scenarios, etc.) for this software testing is not provided.
• AUTOLoader Mechanical Testing: "This procedure [automated handling of slide carriers] is automatically repeated with the rest of the carriers that are in the Pending stack." While the number of carriers per stack (up to 12) is mentioned, the total number of carriers or repeated cycles used for testing the AUTOLoader's mechanical reliability is not specified.
• Data Provenance: Not explicitly stated as the primary focus is on system functionality and software verification rather than a clinical dataset.

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

Not applicable in the context of the studies described. The "ground truth" here pertains to the correct functioning of the AUTOLoader and software, which is evaluated through verification and validation processes rather than expert clinical consensus on diagnostic outcomes. The device's diagnostic "results" still require confirmation by a "trained operator."

4. Adjudication Method for the Test Set

Not applicable for the described functionality and software verification testing.

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 comparative effectiveness study is mentioned. The device is intended as an "aid" for a "trained operator" who "must confirm results." This inherently suggests a human-in-the-loop system, but a formal study comparing human performance with and without the device's assistance is not part of this specific submission.

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

No standalone performance study is explicitly described. The "Indications for Use" clearly state that "A trained operator must confirm results generated with the device," indicating it's not a standalone diagnostic device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the specific performance studies described in this submission (AUTOLoader addition):

• Functional 'Ground Truth': The expected operational behavior of the AUTOLoader (e.g., correctly picking up, barcode scanning, placing carriers) and the established, unchanged functionality of the NOVA View software. This is assessed through engineering and software verification standards rather than clinical ground truth types.

8. The Sample Size for the Training Set

Not applicable. The document does not describe any machine learning or AI components that would require a "training set" in the conventional sense for diagnostic algorithm development. The software update is for controlling the AUTOLoader and preserving existing NOVA View functionality.

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

Not applicable, as no training set for AI/ML was mentioned.

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