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The ImPress is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.

The LetsGetChecked ImPress is a single-use blood lancing tool equipped with an integral sharps injury prevention feature. It is intended for use by health care professionals in producing capillary whole blood samples from the upper arm. To use the device, the user first removes the device tabs to expose the two internally contained lancets. The plastic strip liner is then removed, exposing a layer of medical adhesive. The device is then placed on the upper arm. Activation occurs when the device is compressed against the arm, causing two contact-activated lancets to puncture the skin. The lancets automatically retract to a safe position, preventing sharps injury and re-activation. The device operates solely through mechanical means. During activation, the device generates a vacuum against the skin, which facilitates the emergence of microliter quantities of capillary blood from the puncture site.

The provided FDA 510(k) summary for the LetsGetChecked ImPress blood lancing device (K242680) outlines several non-clinical performance studies conducted to demonstrate substantial equivalence to its predicate device (TAP Lancet, K223201). However, it does not include a table of acceptance criteria and reported device performance for the usability study, nor does it provide detailed information regarding the study design elements typically found for a study proving acceptance criteria.

The information provided primarily focuses on the device's technical characteristics and the types of non-clinical tests performed. It mentions usability testing but lacks specific performance metrics or acceptance criteria for that test.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given document. While it states that "Usability Testing was performed to verify user comprehensions for use, validate the ability to produce blood samples from the upper arm when device is used according to the instructions for use, and to measure the devices ease of use and user satisfaction with the device," it does not specify the quantitative or qualitative acceptance criteria for these aspects or the actual performance results against those criteria.

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

For the Usability Testing: The document does not specify the sample size used for this test. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

This information is not provided for the usability testing or any other test. "Ground truth" in the context of usability would typically refer to expert evaluation of user performance or validated criteria for "good" usability.

4. Adjudication method for the test set

This information is not provided.

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

An MRMC study is relevant for diagnostic imaging devices where human readers interpret results, often with AI assistance. This device is a blood lancing device, not an imaging diagnostic tool. Therefore, an MRMC study was not performed, and this question is not applicable.

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

This question is also more relevant for AI/ML-driven diagnostic or assistive devices. As the LetsGetChecked ImPress is a mechanical blood lancing device, it does not involve algorithms or AI. Therefore, a standalone algorithm-only performance study was not performed, and this question is not applicable.

7. The type of ground truth used

For the usability testing, the "ground truth" would likely be defined by a set of pre-established usability goals and criteria, as the device is mechanical and its function is to produce blood samples. The document states the usability testing aimed to "verify user comprehensions for use, validate the ability to produce blood samples from the upper arm when device is used according to the instructions for use, and to measure the devices ease of use and user satisfaction with the device." This implies a combination of:

• Performance-based criteria: Successful production of blood samples.
• Qualitative user feedback: Ease of use and user satisfaction.
• Compliance with instructions: Verification of user comprehension.

However, the specific methods for establishing these "truths" (e.g., expert observation, direct measurement, user questionnaires with pre-defined success rates) are not detailed.

8. The sample size for the training set

This question is applicable to devices involving machine learning or AI. As the ImPress is a mechanical device, there is no training set in the context of AI/ML.

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

As there is no training set (see point 8), this question is not applicable.

Summary of what is available and what is missing:

The document lists several non-clinical studies conducted (Shelf-life, Transport, Biocompatibility, Usability, Accidental Drop) and states their purpose (confirm specifications, intended use, substantial equivalence). For the Usability Testing, it broadly describes the goals (user comprehension, ability to produce samples, ease of use, satisfaction). However, it lacks the specific quantitative or qualitative acceptance criteria and the detailed results of these tests, which would directly "prove" the device meets acceptance criteria. Furthermore, details regarding sample sizes, ground truth establishment, expert involvement, and adjudication methods for the usability study are not provided in this specific FDA letter and summary.

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