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The SurgiCount+ System Software is a multi-functional software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges and other absorbent items in operating and recovery rooms, procedure rooms, and surgical centers. The system incorporates three distinct software configurations: Triton AI, SC+ Sponge Counting, and Triton QBL. Additionally, combined workflows (SC+AI and SC+QBL) are provided for use in clinical environments that require both the tracking of absorbent surgical items and estimation of patient blood loss.

The Triton AI configuration is intended to be used with surgical sponges, software, hardware, and accessory devices that have been validated for use with the application to estimate the hemoglobin (Hb) mass contained on used surgical sponges. The configuration is also intended to calculate an estimate of blood volume on used surgical sponges from the estimated Hb mass and a user-entered patient Hb value. The validated surgical sponges, hardware, software, accessory devices and Hb mass ranges are listed in the Instructions for Use.

The SC+ Sponge Counting configuration is intended for use as an adjunctive technology for augmenting the manual process of counting, displaying, and recording the number of RFID-tagged absorbent articles used during surgical procedures, and providing a non-invasive means of locating RFID-tagged absorbent articles within an operating room and surgical sites.

The Triton QBL configuration is intended to be used to record the weight of used surgical sponges and other absorbent items in order to calculate the quantity of fluid volume on the sponges/absorbent items.

The SurgiCount+ System Software is a multifunctional software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges and other absorbent items in operating and recovery rooms, procedure rooms, and surgical centers.

The system incorporates three distinct software configurations: Triton AI, SC+ Sponge Counting, and Triton QBL. Additionally, combined workflows (SC+ AI and SC+QBL) are provided for use in clinical environments that require both the tracking of absorbent surgical items and estimation of patient blood loss.

The Triton AI software configuration estimates the hemoglobin (Hb) mass contained on used surgical sponges using an AI algorithm that analyzes the image of each sponge. It also calculates an estimate of blood volume on used surgical sponges from the estimated Hb mass and a user-entered patient Hb value. Workflow steps allow users to scan, identify, and count RFID-tagged surgical sponges and other absorbent items, and to locate missing surgical sponges inside the operating room and, noninvasively, in surgical sites.

The SaMD product includes the following nonmedical device and consumable and hardware accessories: a mobile device (Apple iPad Pro), RFID-tagged surgical sponges/absorbent items, an RFID reader, a Bluetooth-enabled scale, and a stand (or optional wall mount) that houses the hardware accessories and connects the accessory devices to electrical power.

The provided FDA 510(k) clearance letter for the SurgiCount+ System (K252282) states that no clinical testing was provided to support this submission and that the device effectively inherits its performance and safety validation from a predicate device (K232250) due to identical technological characteristics.

Therefore, the requested details regarding acceptance criteria, study design, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from the provided document as this information was not included in the submission for K252282.

The document explicitly states: "No clinical testing was provided to support this submission." It further clarifies, "The subject and predicate device have identical technological characteristics, and there have been no changes to the design, software, and fundamental scientific technology." This means the current clearance relies on the prior clearance of the predicate device (SurgiCount+ System – K232250) and a leverage of non-clinical design verification and validation testing for this specific submission.

Without the details of the predicate device's validation study, it is impossible to answer the specific questions about acceptance criteria and study particulars for the SurgiCount+ System.

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