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The GO Glucose Monitoring System is intended for the quantitative, colorimetric determination of glucose in whole blood specimens. The GO Glucose Monitoring System is intended for use by people with diabetes to monitor their blood glucose levels in a home use setting. This in vitro test kit is indicated for home use (over the counter).

GO Glucose Monitoring System

This document is a marketing approval letter for the "GO Glucose Monitoring System" and does not contain detailed information about the acceptance criteria or a study proving that the device meets those criteria. Such information is typically found in the 510(k) submission itself, which is a much larger document.

Therefore, I cannot directly answer your request using the provided text.

Here's why and what's missing:

• Acceptance Criteria & Reported Performance: The letter only states that the device is "substantially equivalent" to predicate devices. It does not list specific performance metrics (e.g., accuracy percentages, precision, bias) or the thresholds for those metrics (acceptance criteria).
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): None of these details are present in this regulatory approval letter. These would be part of the clinical and analytical studies submitted to the FDA to demonstrate safety and effectiveness.

To answer your request, you would need access to the actual 510(k) submission document (K991754) for the GO Glucose Monitoring System, which would contain the study protocols, results, and detailed methodologies.

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The Duet II Glucose Monitoring System is intended for the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens. The Duet II Glucose Monitoring System is to be used by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting. This is in vitro test kit is intended for home use (over the counter).

Duet II Glucose Control Monitoring System

The provided document is a 510(k) clearance letter from the FDA for the Duet II Glucose Control Monitoring System. It does not contain the specific technical performance data, acceptance criteria, or details of a study proving the device meets those criteria.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which means its performance has been deemed comparable. However, the letter itself does not provide the performance data or the study details that led to this determination.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need access to the actual 510(k) submission document (or a summary thereof) which typically includes the detailed performance studies.

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The DUETTM Glucose Control Monitoring System is intended for the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens. The DUET Fructosamine Test System is intended for use by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting. This in vitro test kit is intended for home use (over the counter).

Not Found

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific criteria for the "DUET™ Glucose Control Monitoring System." The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device.

It includes:

• Device Name: DUET™ Glucose Control Monitoring System
• Intended Use/Indications for Use: For the quantitative, colorimetric determination of glucose and fructosamine in whole blood specimens, intended for use by people with diabetes to monitor their blood glucose and fructosamine levels in a home use setting (over-the-counter).

However, it does not provide the following information requested in your prompt:

1. A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics or acceptance criteria for the DUET system.
2. Sample size used for the test set and the data provenance: No information about a test set, its size, or its origin is present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set details are provided.
4. Adjudication method for the test set: Not applicable.
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: Not applicable, as this device is a glucose control monitoring system, not an AI-assisted diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not specified, as no study details are provided.
8. The sample size for the training set: Not applicable, as no algorithm training details are provided.
9. How the ground truth for the training set was established: Not applicable.

To obtain the information you're looking for, you would typically need to refer to the full 510(k) submission, including the performance data summarized in the submission, which is not part of this FDA clearance letter.

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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.

Not Found

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.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device