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510(k) Data Aggregation
(179 days)
The Triton System is a software application intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges.
The Triton System is intended to be used with surgical sponges, software and accessory devices which have been validated for use with the Triton System to estimate the hemoglobin (Hb) mass contained on used surgical sponges. The Triton System is also intended to calculate an estimate of blood volume on used surgical sponges from the estimated Hb mass and a user-entered patient serum Hb value. The validated surgical sponges, hardware, accessory devices and Hb mass ranges are listed in the Instructions for Use.
The Triton System is also indicated for use to aid in counting surgical sponges and may be used to record and display case-specific blood components infused over time. The Triton System is additionally indicated for use to aid in managing surgical sponges, including providing a visual record of sponge images, and to record the user-entered weight of used surgical sponges in order to calculate an estimate of fluid volume on the sponges.
The Triton System is a software program (mobile medical application) used on an Apple iPad® tablet to capture images of used surgical sponges to assist surgical personnel in the management of surgical sponges after surgical use and to aid in the estimation of blood loss.
Here's a breakdown of the acceptance criteria and the study information for the Triton System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Special Control) | Reported Device Performance |
|---|---|
| 1. Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. Demonstration of the performance characteristics must include a comparison to a scientifically valid alternative method for measuring deposited hemoglobin mass. The following use conditions must be tested: A. Lighting conditions; B. Range of expected hemoglobin concentrations; C. Range of expected blood volume absorption; and D. Presence of other non-sanguineous fluids (e.g., saline irrigation fluid) | "There is no change to the performance data of the product with the device modifications subject to this submission. Therefore previous non clinical testing validate that device performs as intended under anticipated conditions of use." (Implies previous testing met this, and current submission does not introduce new performance change necessitating re-testing) |
| 2. Human factors testing and analysis must validate that the device design and labeling are sufficient for appropriate use by intended users of the device. | "Human factors testing and analysis validate the device design and labeling are appropriate for use by intended users of device." |
| 3. Appropriate analysis and non-clinical testing must validate the electromagnetic compatibility (EMC) and wireless performance of the device. | "No modifications made to the device that would change EMC compatibility or wireless performance of device." (Implies previous testing for EMC and wireless performance remains valid) |
| 4. Appropriate software verification, validation and hazard analysis must be performed. | "Software verification and hazard analysis was performed." |
| 5. Software display must include an estimate of the cumulative error associated with estimated blood loss values. | "An estimate of the cumulative error associated with blood loss values is displayed to the user with each estimated hemoglobin mass and blood loss value. The Bland-Altman methods inform the look-up tables and resultant values displayed on the user interface each time the Triton System is used for the estimation of hemoglobin mass and blood volume loss." |
| 6. Labeling must include: A. Warnings, cautions, and limitations needed for safe use of the device; B. A detailed summary of the performance testing pertinent to use of the device, including a description of the bias and variance the device exhibited during testing; C. The validated surgical materials, range of hemoglobin mass, software, hardware, and accessories that the device is intended to be used with; and D. EMC and wireless technology instructions, information, and precautions. | "Labeling includes all details as required by the special controls." |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the test set. It mentions "previous non clinical testing" for the performance criteria and verification testing for the current submission, but lacks details on the number of cases or samples.
The data provenance is not explicitly stated (e.g., country of origin). However, given that Gauss Surgical Inc. is located in Los Altos, California, USA, and this is an FDA submission, it's highly probable that the studies were conducted in the United States. The document does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information regarding the number of experts used to establish the ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
The document does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study. The submission focuses on comparing the Triton System to a predicate device (Pixel 3 System) based on technological characteristics and indications for use, rather than human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document describes the Triton System as a "software application intended to be used as an adjunct in the estimation of blood loss." This implies that it's designed to assist human users, rather than being a fully standalone diagnostic tool replacing human expertise. The performance data mentioned largely relates to the device's ability to measure hemoglobin mass and blood volume, which is a standalone function of the algorithm itself, to then be used by clinicians. However, no specific "standalone" study separate from its "adjunct" role is detailed. The focus is on the algorithm's accuracy in its intended use.
7. The Type of Ground Truth Used
The document mentions that the non-clinical performance data involved "comparison to a scientifically valid alternative method for measuring deposited hemoglobin mass." This indicates that the ground truth for blood loss estimation (specifically hemoglobin mass) was established using a scientifically valid, presumably quantitative, laboratory or reference method rather than expert consensus, pathology, or outcomes data in this context. While not explicitly named, it would likely be a gold standard measurement for hemoglobin.
8. The Sample Size for the Training Set
The document does not provide the sample size for the training set.
9. How the Ground Truth for the Training Set was Established
The document does not explicitly detail how the ground truth for the training set was established. It implicitly suggests that the ground truth for hemoglobin mass would be established through a "scientifically valid alternative method" as mentioned for the performance testing.
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