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The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The Mini Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.

The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting.

The TRUEdraw Lancing Device/ Mini Lancing Device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The TRUEdraw Lancing Device/ Mini Lancing Device is a reusable blood lancet holder intended to be used in conjunction with a sterile, single-use blood lancet for obtaining a capillary blood sample for testing purposes from the fingertip and from alternative sites, such as the forearm. TRUEdraw Lancing Device/ Mini Lancing Device is intended for multiple use by a single patient.

This document is a 510(k) Premarket Notification from Trividia Health for their TRUEdraw Lancing Device and Mini Lancing Device. It seeks to demonstrate substantial equivalence to a legally marketed predicate device, the Accu-Chek Softclix Blood Lancing Device (K214022).

The core of the submission revolves around non-clinical bench testing, as clinical testing was deemed not applicable for this device type. Thus, there is no discussion of human-in-the-loop performance, expert ground truth adjudication, or multi-reader multi-case studies typically associated with AI/ML device evaluations.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are primarily based on special controls outlined in 21 CFR 878.4850(c), which focus on design verification and validation testing. The reported performance indicates that the devices passed these tests.

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

Given that this is a mechanical safety and performance evaluation of a lancing device, the "test set" refers to the units of the device that underwent the listed mechanical and cleaning/disinfection tests.

• Sample Size: The document does not specify an exact number of devices tested for each category (e.g., how many TRUEdraw devices for mechanical performance, how many Mini Lancing Devices for cleaning validation). It generally states "Nonclinical bench testing was performed." For cleaning and disinfection validation, it specifies "1,095 cleaning and disinfecting cycles," implying multiple devices or a single device undergoing repeated cycles to simulate 3 years of daily use.
• Data Provenance: The data is generated from bench testing conducted by the manufacturer, Trividia Health. The country of origin for the testing is not explicitly stated, but the company is based in Fort Lauderdale, Florida, United States. The testing is prospective in the sense that it was conducted specifically for this submission.

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

N/A. This is a submission for a mechanical device, not an AI/ML device relying on expert interpretation of medical images. Ground truth is established through engineering and manufacturing specifications, and verification through standard bench testing protocols, rather than expert consensus on retrospective data.

4. Adjudication Method for the Test Set

N/A. As this is not an AI/ML device or a diagnostic device requiring human interpretive ground truth, there is no adjudication method in the context of expert review. Performance is measured against predefined engineering and safety specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

N/A. An MRMC study is not relevant for this type of device (a lancing device). The submission focuses on the mechanical and safety equivalence to a predicate device, not on assessing human reader performance with or without AI assistance.

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

N/A. This is a mechanical lancing device, not an algorithm. There is no software or AI component to evaluate in a standalone manner.

7. The Type of Ground Truth Used

The "ground truth" for this lancing device is based on engineering specifications, design requirements, and established safety and performance standards for lancing devices (e.g., the ability to function mechanically, withstand typical usage, be cleaned effectively, and pose no undue risk of injury or infection). This is verified through objective bench testing.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device; therefore, there is no "training set."

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

N/A. As there is no training set, this question is not applicable.

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