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The MICROLET®NEXT lancing device is intended for collecting capillary blood from the fingertip or palm for blood glucose testing or other testing utilizing small amounts of blood. The MICROLET NEXT lancing device is for singlepatient use. The MICROLET NEXT lancing device is used with disposable, sterile MICROLET® lancets. The MICROLET NEXT lancing device with the MICROLET lancet are intended for collecting fingertip capillary blood from persons age two years and older. The alternative site testing endcap is intended for collecting capillary blood from the palm in adults only.

Ascensia's blood lancets consists of two components. First component is a re-usable base which is referred as MICROLET® NEXT lancing device and the second component is a sterile single use blade which is referred as MICROLET® Lancet. The subject MICROLET® NEXT Lancing Device is a pen-like instruments to be used with the compatible subject MICROLET® NEXT Lancets (28 G) for the controlled puncture of the skin to obtain the capillary blood droplet sample for testing. The MICROLET® NEXT Lancing Device is available with two endcaps: the Black/White cap for fingertip sampling and the Clear Alternative Site Testing (AST) for palm sampling. The Black/White cap has a dial control that allows the user to adjust the blade penetration depth for comfort when obtaining the blood droplet. The subject MICROLET® Lancet is a disposable single-use sterile device intended for drawing a blood sample. It is intended to be used with compatible lancing devices. The lancets are sterile, single-use devices. They must be discarded after each use. The lancet comprises the following elements: a steel needle body with a protective cap. The lancet remains sterile until the cap is removed. The product is sterilized with gamma radiation. They are available with 28G (0.36mm) diameter lancets. Together, they are intended for obtaining a capillary blood sample for blood glucose testing or other testing utilizing small amounts of blood. The lancet needle consists of stainless steel which is coated with medical grade silicone for smooth penetration of the skin. The lancet needle is siliconized. This is encased in a plastic cover. The proposed MICROLET® Lancets are offered in a variety of colors. Figure-2 shows different colored lancets (seven colors-Yellow. Orange, Red, Green, Blue, Purple and Pink). The needle tip is hidden by a protective cap, which has to be removed before usage and creates the sterile barrier. After usage the lancet can be placed back into the protective cap for disposal. thereby protecting users from unintended injuries. The proposed MICROLET® Lancet can be stored for 5 years without losing its function or sterility if the protective cap is not removed. The MICROLET® Lancet is a disposable single-use sterile device intended for drawing a blood sample. It is Intended to be used with compatible lancing device. The lancet comprises the following elements: a steel needle, needle body with a protective cap. The lancet remains sterile until the cap is removed. The product is sterilized with gamma radiation. The product can be stored for 5 years without losing its function or sterility if the protective cap is not removed. The MICROLET® NEXT lancing device is used for obtaining capillary blood samples from the fingertip. Capillary samples can be obtained from the palm as well The lancing device is for use only on a single patient.

Ascensia Diabetes Care's MICROLET® NEXT Lancing Device and MICROLET® Lancet were evaluated through a clinical study and extensive non-clinical performance testing to demonstrate their safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria for the clinical study with specific quantitative targets (e.g., "X% of subjects must obtain sufficient blood volume"). However, the study aims and conclusions implicitly serve as the acceptance criteria for clinical performance related to blood collection, while non-clinical tests have pass/fail criteria.

Here's a summary:

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

• Sample Size for Test Set (Clinical Study): 119 lay persons.
• Data Provenance: The study was conducted at the "Mishawaka site," which generally refers to a clinical study location within the country where the submission is made (USA in this case, given the FDA filing). The document doesn't explicitly state the country for the clinical study, but it is implied to be within the US. The study appears to be prospective as participants were enrolled and tested with the device.

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

• The document refers to "study staff testing the blood on a Contour next family of blood glucose meters" to determine the acceptability of capillary blood volume.
• It does not specify the number or qualifications of these "study staff" experts. It also doesn't mention expert review of images or specific clinical diagnoses by independent experts to establish ground truth in the way one might see for diagnostic AI. In this context, "acceptability" refers to whether enough blood was collected for a meter reading, which is a functional assessment rather than a diagnostic one requiring expert consensus on a disease state.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for the clinical study results in the traditional sense of resolving discrepancies between multiple readers or systems. The determination of "sufficient capillary blood volume" was made by "study staff testing the blood on a Contour next family of blood glucose meters." This implies a direct, objective assessment by the meters and observation by staff, rather than a subjective interpretation requiring adjudication among experts.

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

• No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is not applicable here as the device is a lancing device and lancet, not an AI diagnostic tool. The clinical study focused on the device's ability to collect blood and its safe usage by lay persons.

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

• No, a standalone algorithm-only performance study was not done. The device is a physical medical device (lancing device and lancet), not a software algorithm. Its performance is assessed through mechanical, biological, and user experience testing, not algorithmic accuracy.

7. The Type of Ground Truth Used

• For the clinical study, the "ground truth" for success was defined by the ability to obtain sufficient capillary blood volume as determined by a blood glucose meter ("Contour next family of blood glucose meters"). This is a form of outcomes data pertaining to device functionality (i.e., whether the device successfully facilitates blood collection for testing).
• For non-clinical tests, the ground truth was adherence to predetermined acceptable ranges or conditions (e.g., "no external damage or deterioration," "results were within the acceptance range," "no corrosion," "all devices met min 1.3 mm needle tip distance").

8. The Sample Size for the Training Set

• The document is for a physical medical device (lancing device and lancets), not an AI/ML algorithm. Therefore, the concept of a "training set" for an algorithm is not applicable.

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

• As the device is not an AI/ML algorithm, there is no training set and thus no ground truth established for a training set. The development of the device would have involved engineering specifications, materials science, and usability design, leading to the device submitted for testing.

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