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For In Vitro Diagnostic Use

HALO AP Dx is a software only device intended as an aid to the pathologist to review, interpret and manage digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue for the purposes of pathology primary diagnosis. HALO AP Dx is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. HALO AP Dx is intended for use with the Hamamatsu NanoZoomer S360MD Slide scanner and the JVC Kenwood JD-C240BN01A display.

HALO AP Dx, version 2.1 is a browser-based software-only device intended to aid pathology professionals in viewing, manipulating, management and interpretation of digital pathology whole slide images (WSI) of glass slides obtained from the Hamamatsu Photonics K.K. NanoZoomer S360MD scanner and viewed on the JVC Kenwood JD-C240BN01A display.

HALO AP Dx is typically operated as follows:

1. Image acquisition is performed using the predicate device, NanoZoomer S360MD Slide scanner according to its Instructions for Use. The operator performs quality control of the digital slides per the instructions of the NanoZoomer and lab specifications to determine if re-scans are necessary.
2. Once image acquisition is complete, the unaltered image is saved by the scanner's software to an image storage location. HALO AP Dx ingests the image, and a copy of image metadata is stored in the subject device's database to improve viewing response times.
3. Scanned images are reviewed by scanning personnel such as histotechnicians to confirm image quality and initiate any re-scans before making it available to the pathologist.
4. The reading pathologist selects a patient case from a selected worklist within HALO AP Dx whereby the subject device fetches the associated images from external image storage.
5. The reading pathologist uses the subject device to view the images and can perform the following actions, as needed:
   a. Zoom and pan the image.
   b. Measure distances and areas in the image.
   c. Annotate images.
   d. View multiple images side by side in a synchronized fashion.

The above steps are repeated as necessary.

After viewing all images belonging to a particular case (patient), the pathologist will make a diagnosis which is documented in another system, such as a Laboratory Information System (LIS).

The interoperable components of HALO AP Dx are provided in table 1 below:

Table 1. Interoperable Components for Use with HALO AP Dx

This FDA 510(k) clearance letter pertains to HALO AP Dx, a software-only device for digital pathology image review. The documentation indicates that the device has been deemed substantially equivalent to a predicate device, the Hamamatsu NanoZoomer S360MD Slide scanner system (K213883).

Here's an analysis 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 provided document defines the performance data points primarily through "Performance Data" and "Summary of Studies" sections, focusing on comparisons to the predicate device and usability. There are no explicit quantitative "acceptance criteria" presented as specific thresholds, but rather statements of adequacy and similarity to the predicate.

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