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The LXN™ Fructosamine Test System is a device intended to measure fructosamine quantitatively in blood. The LXN™ Fructosamine Test System is intended for use by diabetics to monitor their blood fructosamine levels in a home use setting.

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This document is a 510(k) premarket notification acceptance letter and does not contain the detailed study information needed to fully answer the request. The letter only confirms that the LXN Fructosamine Test System is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide concrete answers to most of the specific questions. However, based on the limited information available, here's what can be inferred or stated:

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

• This information is not present in the provided document. The 510(k) letter confirms substantial equivalence but does not detail the specific performance criteria or the results from the studies demonstrating that performance.

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

• This information is not present in the provided document. The letter does not describe the test set or its origin.

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 information is not present in the provided document as it pertains to the details of the performance study.

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

• This information is not present in the provided document.

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

• The device is a "Fructosamine Test System," which is an in vitro diagnostic (IVD) quantitative blood test. This type of device does not typically involve "human readers" in the context of interpretation of images or complex data in the same way an AI-powered diagnostic imaging system would. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device.

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

• This refers to the performance of the analytical instrument itself. While a standalone analytical performance study would have been conducted as part of the 510(k) submission, the results and methodology are not detailed in this acceptance letter.

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

• For a quantitative diagnostic test like a fructosamine system, the "ground truth" would typically be established by a reference method or another highly validated, perhaps more precise, laboratory method for measuring fructosamine in blood samples. This information is not present in the provided document.

8. The sample size for the training set

• This information is not present in the provided document. For an IVD device, the concept of a "training set" might apply to calibration curves or algorithm development, but the specifics are not disclosed here.

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

• This information is not present in the provided document. Similar to point 7, it would likely involve a reference method, but the details are missing.

In summary: The provided document is an FDA 510(k) clearance letter, which confirms substantial equivalence but does not elaborate on the specific studies, performance metrics, or methodologies that were part of the submission. To obtain the detailed information requested, one would need to access the full 510(k) submission summary or associated performance studies, which are not included here.

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