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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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The OneDraw™ A1C Test System, which consists of the OneDraw Blood Collection Device and the OneDraw A1C Test, is intended to collect capillary blood from the upper arm of individuals 18 years of age or older onto filter (matrix) paper within the collection device by a healthcare professional. Samples are delivered to the laboratory for the quantitative measurement of HbA1c for monitoring the long-term control of blood sugar (glucose) in people with diabetes. Testing performed on samples collected with this device should not be used to diagnose or screen for diabetes. The OneDraw A1C Test System should not be used with neonates.

The OneDraw™ A1C Test System includes the OneDraw Blood Collection Device and the OneDraw A 1C Test. The OneDraw Blood Collection Device is a single-use, sterile, capillary blood specimen collection device. The OneDraw Blood Collection Device includes a transport sleeve, accessories, and instructions (OneDraw Blood Collection Device Instructions for Use (IFU)) which are needed to collect, package, and mail the sample to the designated certified clinical laboratory for HbA1c testing, using the OneDraw A1C Test.

The OneDraw Blood Collection Device incorporates lancets to make incisions in the skin and a vacuum to draw blood at the surface of the skin through channels to deposit the blood onto collection and stabilization matrices (matrix strips). The matrix strips are contained within a cartridge which is removed from the device after the draw is complete. The cartridge is then inserted into the transport sleeve which encloses and protects the sample during shipping to the clinical laboratory.

Once the transport sleeve containing the sample is received by the clinical laboratory, one of the dry blood sample matrices is removed. The matrix is then eluted in Beckman Hemolyzing Reagent (BHR) in 2 mL tubes or 2.2 mL deepwell plates using an orbital shaker. Next, the sample is diluted in BHR to its final concentration and tested using FDA-cleared Beckman Coulter AU480 Chemistry Analyzer and A 1 c reagents, including calibrators, (K 120199) per the OneDraw A 1 C Test IFU.

The document describes the OneDraw™ A1C Test System, which includes the OneDraw Blood Collection Device and the OneDraw A1C Test. The device is intended to collect capillary blood from the upper arm for quantitative measurement of HbA1c in people with diabetes. The testing is not for diagnosis or screening of diabetes and should not be used with neonates. The following information outlines the acceptance criteria and the studies performed to demonstrate the device meets these criteria.

1. Table of Acceptance Criteria & Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Precision (Assay - Repeatability): 80 data points were collected. The source of the blood samples is not explicitly mentioned as a specific country of origin, but the testing was performed in the context of an FDA submission, implying a US-based or international study adhering to US regulatory standards. It is a prospective study as samples were specifically analyzed for the purpose of the study.
• Precision (Device - Lot-to-Lot Analysis): 23 participants. The study involved multiple collection sites, suggesting prospective data collection.
• Precision (Device - Operator-to-Operator): 25 participants. The study involved multiple collection sites, suggesting prospective data collection.
• Method Comparison: 107 participants. Blood collections were conducted at two different clinical sites. This implies prospective collection for the study.
• Linearity, Interference, Limits of Detection, Product Stability, Flex Studies: The sample sizes (e.g., number of replicates, levels tested, specific blood specimens) were described within each section (e.g., "at least 20 days, two runs per day" for assay precision, "two (2) HbA1c levels... six (6) blood volumes per level... 6 matrix strips per volume" for blood volume flex study). Data provenance is prospective testing conducted for the device's validation.

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

• The document does not mention the use of "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth for this in vitro diagnostic device.
• Instead, the ground truth for HbA1c measurements is established by comparison to a "standard venipuncture (tested using Beckman's NGSP-certified method on the Beckman Coulter AU480 Analyzer)" (for method comparison) and other established laboratory methods and guidelines (e.g., CLSI guidelines). The accuracy of these reference methods is implicitly accepted as the ground truth.
• The qualifications of the personnel operating the reference methods are not explicitly stated but are assumed to be trained laboratory professionals.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1) are typically used in image-based diagnostic studies where human interpretation of medical images can vary.
• For this in vitro diagnostic device, which provides quantitative measurements, there is no "adjudication" in the sense of reconciling differing expert opinions. The performance is assessed by comparing the device's quantitative results against established reference methods or accepted criteria through statistical analysis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted.
• MRMC studies are relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This device is a blood collection and testing system for HbA1c, not an AI diagnostic imaging tool or a system designed to assist human readers in interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, the performance studies described are essentially standalone performance evaluations of the OneDraw™ A1C Test System.
• The device functions as a blood collection and testing system, and its output (HbA1c levels) is directly measured and compared to reference methods. There is no "human-in-the-loop" interpretative step by a medical professional whose diagnostic accuracy is being augmented or tested. The healthcare professional collects the sample, but the analysis is done by the device system and associated laboratory methods.

7. Type of Ground Truth Used

• The ground truth used is primarily based on reference laboratory results obtained from "standard venipuncture (tested using Beckman's NGSP-certified method on the Beckman Coulter AU480 Analyzer)" for HbA1c measurement.
• Other ground truth validations include established ranges for linearity, known concentrations for interference testing, and performance against recognized CLSI guidelines for precision, stability, and limits. This is essentially measurement against accepted reference methods and established statistical criteria.

8. Sample Size for the Training Set

• The document does not describe explicit "training sets" in the context of machine learning or AI models.
• This device is an in vitro diagnostic system for quantitative measurement, not a machine learning algorithm that requires a training set in the typical sense.
• The "development" or "internal validation" data—distinct from the performance data presented for regulatory submission—is not detailed in this summary.

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

• As concluded in point 8, the document does not describe a "training set" for a machine learning model for which ground truth would need to be established. Therefore, this question is not applicable based on the provided information.

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