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Prestiae Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit.

Prestige Aqueous Glucose Control Low Prestige Agueous Glucose Control High

Here's an analysis of the provided text regarding acceptance criteria and a study for the "Prestige Aqueous Glucose Controls" device:

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

Unfortunately, the provided text does not contain any specific acceptance criteria or detailed device performance data. The document is an FDA 510(k) clearance letter, which states that the device has been found "substantially equivalent" to predicate devices. This means it has met the regulatory requirements for marketing based on a comparison to an already legally marketed device, but the letter itself does not typically detail the specific performance metrics or acceptance thresholds used in the underlying studies.

Therefore, without more information, I cannot create this table.

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

The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective nature). The 510(k) clearance letter is a summary of the FDA's decision, not a detailed scientific report of the studies performed.

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)

The document does not mention the number of experts or their qualifications used to establish ground truth. As this device is a glucose control solution, the "ground truth" would likely be established through analytical reference methods, not human expert interpretation in the way it would be for imaging devices.

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

The document does not describe any adjudication method. This concept is typically relevant for studies involving human interpretation (e.g., radiologists reviewing images), not for the analytical performance of a control solution.

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

No MRMC comparative effectiveness study was done or mentioned. This type of study is completely irrelevant for a glucose control solution, which is an in vitro diagnostic product used to verify the accuracy of a blood glucose monitoring kit, not an AI-powered diagnostic tool requiring human interpretation.

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

This question is not applicable. The "Prestige Aqueous Glucose Controls" is a chemical solution used for quality control, not an algorithm. Therefore, the concept of "standalone performance" of an algorithm is not relevant.

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

Given that this is an aqueous glucose control solution, the ground truth for its performance would typically involve reference analytical methods for glucose concentration. This would involve precise laboratory measurements using highly accurate and calibrated instruments (e.g., YSI glucose analyzer, hexokinase method) to determine the true glucose concentration of the control solution. This is not "expert consensus," "pathology," or "outcomes data" in the traditional sense for diagnostic devices.

8. The sample size for the training set

The document does not provide any information regarding a "training set." Training sets are relevant for machine learning algorithms. This device is a biochemical control, not an AI model.

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

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

Summary of what the document does provide:

• Device Name: Prestige Aqueous Glucose Control Low, Prestige Aqueous Glucose Control High
• Indication for Use: "Ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit." They are used by individuals with diabetes and healthcare professionals to monitor and treat fluctuations in blood glucose levels.
• Regulatory Status: Cleared under 510(k) as substantially equivalent to predicate devices. Classified as Regulatory Class: I, Product Code: JJX.
• Approval Date: December 16, 1997.

Crucially, the provided text is an FDA clearance letter, which confirms regulatory approval based on demonstrating substantial equivalence. It does not provide the detailed study reports, performance data, or methodology that would be found in a scientific publication or the full 510(k) submission. To answer most of your questions, one would need to review the actual 510(k) submission document (K973676) that Sorrento Biochemical, Inc. submitted to the FDA, which would contain the study details.

Ask a specific question about this device

Diascan Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit.

Glucose monitoring has become a major adjunct to the care of individuals with diabetes mellitus in the past decade. It is now possible for the individual with diabetes and the health-care professional to measure and record blood glucose levels frequently with portable devices. In the hospital, blood glucose monitor kits are often used instead of routine laboratory glucose testing methods to quickly obtain blood glucose concentrations from patients in the ER, ICU. CCU. OR, or other bedside locations. Used at home, these kits allow individuals with diabetes to monitor and treat fluctuations in blood glucose levels daily.

Diascan Aqueous Glucose Control Low
Diascan Aqueous Glucose Control High

The provided text is related to a 510(k) submission for "Diascan Aqueous Glucose Controls" and details the FDA's decision regarding its substantial equivalence. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The document is a regulatory letter and an "Indication for Use" statement, not a scientific study report.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device

Ultra + Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit.

Ultra + Aqueous Glucose Control Low and Ultra + Aqueous Glucose Control High are ready to use solutions, which contain a specific amount of glucose.

This document is a 510(k) clearance letter from the FDA for a medical device called "Ultra Aqueous Glucose Controls." It is a regulatory approval document and does not contain the information requested in your prompt regarding acceptance criteria and study details.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls. It mentions the product code (JJX) and regulatory class (I), and states the intended use: "Ultra + Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit."

To answer your specific questions, a different type of document, such as a summary of safety and effectiveness, a clinical study report, or even the original 510(k) submission, would be required. This letter only provides the outcome of the FDA's review, not the detailed data or studies performed.

Ask a specific question about this device