Search Results

The Facet Lancet is a sterile, disposable single used with a compatible proprietary lancet base (lancing device) to obtain a droplet of capillary blood from the finger for subsequent diagnostic testing. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.

The Facet Lancet is a sterile, single use, blood sampling device used to obtain a sample of capillary blood for diagnostic primarily for blood glucose monitoring in diabetic patients. The lancet is available in two needle sizes, 30 gauge and 33 gauge.

Facet lancets are intended to be used by diabetic patients to obtain a blood sample for assistance in self-monitoring of their blood glucose levels. The lancets consist of a 30G or 33G stainless steel needle overmolded with low density polyethylene (LDPE) and integral sterility cap. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-9.

The provided text describes a 510(k) premarket notification for the Facet Blood Lancets, seeking to demonstrate substantial equivalence to a predicate device. The information focuses on non-clinical bench testing to ensure the device meets predetermined criteria and special controls.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document provides a "Summary of Nonclinical Tests Performed" (Table 2) which lists the properties/characteristics tested and their importance. While it doesn't explicitly state quantitative acceptance criteria for each test, it implies that meeting these criteria demonstrates acceptable performance for substantial equivalence. The reported performance is generally stated as "met predetermined criteria" in the text, rather than specific numerical results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the non-clinical bench tests (test set). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective), but given it describes a 510(k) submission, the tests were conducted by or for the manufacturer (Facet Technologies LLC) as part of a prospective evaluation for regulatory approval.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable to the non-clinical, bench testing described for this device. Ground truth, in the context of expert consensus, is typically relevant for studies involving human interpretation or diagnosis, which is not the nature of these mechanical and biocompatibility tests.

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

Adjudication methods are typically associated with studies involving human interpretation or subjective assessments. For the objective, non-clinical bench tests described here, an adjudication method is not applicable. The results would be based on direct measurements and adherence to specified test procedures.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. These studies are typically used for diagnostic imaging devices where human readers (e.g., radiologists) interpret images with and without AI assistance. The Facet Blood Lancet is a physical medical device for blood sampling, not an AI-powered diagnostic tool.

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

A "standalone" algorithm performance assessment is not applicable here as the Facet Blood Lancet is a physical medical device and does not involve any algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests described:

• Bond Strength and Cap Torque: The "ground truth" would be established by the engineer's design specifications and defined pass/fail criteria based on mechanical engineering principles and relevant standards.
• Compatibility: The "ground truth" would be successful operation with commercially available lancing devices, likely defined by visual inspection and ease of use.
• Biocompatibility: The "ground truth" is established by adherence to recognized international standards (ISO 10993 series) which dictate the acceptable biological response to device materials.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI models. The tests performed are physical and biological evaluations of the device itself.

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

As there is no "training set" for this type of device and study, this question is not applicable.

Ask a specific question about this device