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The EasyTouch™ Lancing Device is for use with FreeStyle Lancets to collect capillary blood for testing purposes from the fingertip and from alternate sites, such as the palm, the upper arm, or the forearm. The EasyTouch Lancing Device is for single patient use in a home setting.

The EasyTouch Lancing Device is used with the FreeStyle Lancet, which was cleared under 510(k) K221433 under the device name Facet 28GUniversal Lancet. The intended use of the EasyTouch Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites. The EasyTouch Lancing Device is made of ABS plastic and SUS304 stainless-steel springs. The EasyTouch Lancing Device has 8 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is removed. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with soap and warm water and allowed to air dry after each use and disinfected per the IFU, as needed. If the patient is testing from a site other than the finger an optional AST Cap may be put onto the device instead of the "standard" lancing device end cap. The EasyTouch Lancing Device has an Alternative Site Test (AST) Cap, which is not sold separately. The AST Cap id only provided with the meter kit alongside the lancing device. The AST Cap allows the user to obtain a blood sample from parts of the body other than the fingers. The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a damp cloth and mild detergent to wipe the outside of the lancing device end cap, followed by wiping dry. The device is disinfected via wiping down with a cloth dampened in a bleach wipes) and allowed to air dry. The Alternate Site Testing (AST) Cap is a single-person multi-use optional plastic accessory for the lancing device. It may be used in place of the original lancing device end cap when a patient is taking a blood sample from a site on the body other than the finger. Proper use of the device requires that the user first verify with their physician and the Instructions for Use of the blood glucose test strips or meter they are using to determine if AST testing is appropriate.

Based on the provided text, the Acceptance Criteria and the Study that proves the device meets them relate to a Class II medical device, the EasyTouch Lancing Device, which is used for collecting capillary blood samples. The document is a 510(k) Premarket Notification from the FDA, focusing on the substantial equivalence of the new device to a legally marketed predicate device.

It's crucial to understand that for a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove absolute efficacy or safety through rigorous clinical trials as would be required for a "PMA" (Premarket Approval) device. Therefore, the "acceptance criteria" and "study" described herein are tailored to this regulatory pathway.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance:

The document describes non-clinical bench testing for mechanical design verification and validation, as well as biocompatibility. The "acceptance criteria" are implied by the performance of the predicate device and the adherence to special controls and specified requirements. "Reported device performance" is given as meeting these criteria.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: The document does not specify a numerical sample size for the non-clinical bench tests (e.g., how many lancing devices were drop-tested, or how many samples for biocompatibility). It generally states that "non-clinical bench testing was performed" and "a battery of tests" for biocompatibility.
• Data Provenance: The data is from non-clinical bench testing performed by the manufacturer (STAT Medical Devices). The location/country of origin of this specific testing is not explicitly stated, but it's part of a U.S. FDA 510(k) submission. The testing is assumed to be prospective as it was conducted specifically for this premarket submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable in the context of this 510(k) submission for a lancing device. Ground truth established by expert consensus (e.g., radiologists interpreting images) is typically relevant for interpretative devices like AI algorithms for diagnostics, not for mechanical devices like lancing devices. The "ground truth" for the performance of this device is based on objective, quantifiable physical and material properties (e.g., piercing depth measurement, force measurement, chemical reactivity).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers are interpreting data (e.g., medical images) to resolve discrepancies and establish a consensus "ground truth." For the mechanical and biocompatibility testing of a lancing device, the results are objectively measured or observed, and therefore do not require human adjudication in this manner.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This is not applicable. An MRMC study is designed to evaluate the performance of diagnostic systems (often involving AI) and human readers. The EasyTouch Lancing Device is a mechanical blood collection device, not an interpretative diagnostic device or AI algorithm.

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

• This is not applicable. The device is a mechanical lancing device, not an algorithm.

7. The type of ground truth used:

• The "ground truth" for the non-clinical testing of the EasyTouch Lancing Device is primarily established through objective engineering measurements, physical property testing, and established laboratory standards for biocompatibility. This is in contrast to "expert consensus" or "pathology" which are typically used for diagnostic devices. For example, "piercing depth" is measured directly, not subjectively interpreted.

8. The sample size for the training set:

• This is not applicable. "Training set" refers to data used to train machine learning models (AI). The EasyTouch Lancing Device is a mechanical device, not an AI or machine learning product.

9. How the ground truth for the training set was established:

• This is not applicable as there is no AI training set for this mechanical device.

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