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The NanoDrop Lancet is intended for use to obtain a capillary blood sample. It does not collect or transport such samples.

The Drawbridge Health NanoDrop Lancet Device is a sterile, single-use, disposable lancet for capillary blood sampling. The device incorporates two (2) stainless steel needles with blade tips to make two (2) small incisions in the skin. The device is made of a gray plastic housing base that has a molded outer rim and a bowl-shaped cavity. The outer rim is covered by a hydrogeladhesive to better attach the device to the skin, with a cover over the hydrogel adhesive pad for its protection. The bowl shape provides space for the skin to be drawn up as slight controlled vacuum pressure is applied, and for the needle blades to access the skin after piercing through a septum and vacuum chamber foil. There are two (2) clearly marked gray push buttons on the device:

• The gray button marked "I" is for activation of the vacuum; and
• The gray button marked "II" is for deployment of the needle blades.
  There is a yellow removable plastic locking feature to prevent accidental activation of the button that deploys the needle blades(gray button marked "II"). There is also a white vacuum chamber lid securely attached on top of the base, over the gray lancet enclosure, where the two needle blades are held in a clear plastic needle holder, along with the main spring and retraction spring, and into which they automatically retract after use, with no access to this gray lancet enclosure possible. This prevents the lancet from being used more than once, and it keeps the blades retracted for sharps injury prevention safety and for disposal. A permanent plug obstructs the port and mitigates unintended connection of a collection container.
  The single model number is FD004.

Here's a breakdown of the acceptance criteria and study information for the NanoDrop Lancet device based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The following performance testing met all acceptance criteria" but does not explicitly list the quantitative acceptance criteria for each test. It only lists the tests performed and a general statement of meeting criteria. Thus, I will list the tests and the general performance statement where specific metrics are not provided.

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

• Sample Size (Clinical Study): 30 subjects (each with two samples for the NanoDrop Lancet and two samples for the predicate device, totaling four samples per subject).
• Data Provenance: The document does not explicitly state the country of origin. It also doesn't specify if the study was retrospective or prospective, though a "clinical study was performed" generally implies a prospective design.

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

This information is not provided in the document. The clinical study was focused on "safety and use" and "user's opinion," suggesting direct participant feedback rather than expert-adjudicated ground truth in the traditional sense of medical image analysis or diagnosis.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the study (safety, use, user opinion for a blood lancet), a formal adjudication method like "2+1" or "3+1" is unlikely to be applicable in the same way it would be for diagnostic device performance studies.

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

• Was an MRMC study done? A clinical study was performed comparing the NanoDrop Lancet Device to a comparable cleared OTC FMK fingerstick lancet (Acti-Lance K220643) to evaluate "safety and use" and "user's opinion with regards to handling characteristics." While it involved comparison, it doesn't explicitly fit the typical definition of an MRMC study focused on diagnostic accuracy with multiple human readers interpreting cases. It's more of a comparative user experience and safety study.
• Effect Size: The document does not provide specific quantitative effect sizes for how much human readers (or users, in this context) improve with the AI (device) vs. without the AI (predicate device). It only states that "All acceptance criteria were met, supporting safe and effective use of the NanoDrop Device unsupervised and self-administered by adults on the upper arm."

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

The device is a medical lancet, not an AI or algorithm-driven device. Therefore, the concept of "standalone performance" for an algorithm does not apply to this product. The non-clinical performance tests (like cut depth, vacuum, redeployment, etc.) are essentially evaluating the device's standalone mechanical and functional performance, but not in the context of an "algorithm."

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" was essentially:

• Device safety: Observed absence of adverse events or complications.
• Device effectiveness/use: Successful acquisition of capillary blood samples.
• User opinion: Subjective feedback from participants regarding handling characteristics.

This isn't ground truth established by pathology or expert consensus in a diagnostic sense, but rather direct observational and subjective feedback from participants in a usability and safety context.

8. The Sample Size for the Training Set

The document describes a clinical study as a performance evaluation for market clearance, not a study to train an algorithm. As this is not an AI/ML device, there is no training set in the traditional sense.

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

As there is no training set for an AI/ML algorithm, this information is not applicable.

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