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The Tasso+ device is a sterile, disposable blood lancet. After attachment of a compatible third-party collection tube, the backing is removed from the medical adhesive that is located on the skin side of the device is adhered, in position, to the skin by this adhesive backing.

The device is actuated by pressing the button, causing an energized spring to release and swing the lancet assembly containing a single stainless-steel lancet in an arching motion to create an incision. The lancet contacts the patient momentarily, less than one second, to create a single incision. The mechanism automatically positions the lancet in an inactive position after it has made the incision to prevent sharps injury or re-actuation.

In addition to deploying the lancet, the push of the button generates a slight vacuum to facilitate blood flow under gravity into the blood collection tube. The blood flows from the incision via an open channel in the base and into the compatible tube. The blood flow is one-way, from the skin to the tube, preventing blood re-exposure.

The user is instructed to stop blood collection after a maximum of five minutes of draw time or when the blood reaches the maximum volume fill indicator on the attached tube. The device is then peeled off the skin, and the compatible third-party tube is removed and capped for transport.

AI/ML Overview

The document describes the acceptance criteria and the study that proves the device (Tasso+) meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Criteria	Reported Device Performance
Non-Clinical Performance (Regulatory Compliance, Safety, and Design Specifications)	Compliance with various FDA-recognized consensus standards for sterilization, packaging, biological evaluation, labeling, performance testing of packages, accelerated aging, leak detection, hemolytic properties, sharps injury protection, and usability engineering. Compliance with special controls described in 21 CFR 878.4850(a)(2).	All verification and validation testing for Tasso+ confirms that product specifications are met and are equivalent in design and technological and performance characteristics as the predicate device. Tasso+ is also in compliance with the special controls described in 21 CFR 878.4850(a)(2).
Clinical Performance (Ability to collect blood samples)	The device must demonstrate its ability to collect blood samples from the upper arm of human subjects according to device labeling. The minimum acceptable volume collected must be within the lower limit of the 90% confidence interval. Performance as intended with a compatible tube.	The Tasso+ successfully demonstrated its ability to collect blood samples from the upper arm of human subjects according to the device labeling. The devices demonstrated that the minimum acceptable volume collected was within the lower limit of the 90% confidence interval. The devices had a total success rate of 94.2% and demonstrated that they performed as intended with a compatible tube.

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

Sample Size: Not explicitly stated, but derived from the success rate, it would be the total number of attempts made by subjects in the clinical performance study. The 94.2% success rate indicates a significant number of samples were taken.
Data Provenance: The study involved "human subjects" who "self-collected their blood samples." This indicates a prospective clinical study where data was collected specifically for the purpose of evaluating the Tasso+ device. The document does not specify the country of origin of the data.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not provided in the document. The clinical study focuses on the device's ability to physically collect blood samples, rather than a diagnostic interpretation where expert ground truth would typically be established. The "ground truth" here is the successful collection of blood and achieving a minimum volume, which can be objectively measured.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the clinical study appears to focus on objective physical measurements (blood collection success, volume) rather than subjective assessments requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described is a performance study of the Tasso+ device itself, not a comparison of human readers with and without AI assistance.

6. If a Standalone Performance Study Was Done

Yes, a standalone (algorithm only without human-in-the-loop performance) study was effectively done for the non-clinical performance data, where the device's physical and technical specifications were tested against established standards. From the clinical performance perspective, users operated the device directly (self-collection), so the "algorithm" is the device's mechanical function, and its performance was assessed in a standalone manner (without another human intervening in the blood collection process once initiated by the user).

7. The Type of Ground Truth Used

Clinical Performance: The ground truth for the clinical performance study was objective measurement of successful blood collection and minimum acceptable volume achievement. The document states that the "devices demonstrated that the minimum acceptable volume collected was within the lower limit of the 90% confidence interval" and had a "total success rate of 94.2%."
Non-Clinical Performance: For non-clinical performance, the ground truth was compliance with recognized consensus standards (e.g., ISO, ASTM standards) and meeting established product specifications.

8. The Sample Size for the Training Set

This information is not provided in the document. The Tasso+ is a physical blood lancing device, not an AI/ML algorithm that typically requires a training set. The development of such a device involves engineering design, prototyping, and testing, but not "training sets" in the context of machine learning.

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

This information is not applicable as the device is not an AI/ML algorithm. The "ground truth" during the device's development would be established through engineering design specifications, material science testing, and regulatory standards for blood lancing devices.

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