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The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.

The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant.

This document is an FDA 510(k) clearance letter for "The Poly stat Serum/Urine hCG Test." As such, it does not contain the detailed study information requested in the prompt. FDA clearance letters primarily confirm that a new device is "substantially equivalent" to an already legally marketed predicate device, meaning it performs as safely and effectively.

Specifically, the letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

Therefore, I cannot extract the following information from this document:

• Table of acceptance criteria and reported device performance: This letter doesn't detail performance metrics or specific acceptance criteria.
• Sample sizes used for the test set and data provenance: No information on test set size or origin is provided.
• Number of experts used to establish ground truth and their qualifications: This is not discussed in the letter.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study results: No such study is mentioned or referenced.
• Standalone algorithm performance: This is a diagnostic test, not an AI algorithm, so this concept doesn't apply directly.
• Type of ground truth used: Not specified.
• Sample size for the training set: This refers to AI/machine learning models, which is not applicable here.
• How ground truth for the training set was established: This refers to AI/machine learning models, which is not applicable here.

The document only provides:

• Device Name: The Poly stat Serum/Urine hCG Test
• Regulation Number: 21 CFR 862.1155
• Regulation Name: Human chorionic gonadotropin (HCG) test system
• Regulatory Class: Class II
• Product Code: JHI
• Indications For Use: The Poly stat Serum/Urine hCG Test is a qualitative test intended to detect the presence of human chorionic gonadotropin (hCG) in the serum or urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.

To obtain the detailed study information requested, one would typically need to review the original 510(k) submission document itself, which contains the scientific data and performance studies, rather than just the FDA's clearance letter.

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The Poly stat hCG Dipstick Test is intended to detect the presence of human chorionic gonadotrpin (hCG) in the urine of women who are suspected to be pregnant. The device is for the early detection of pregnancy.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA for "The Poly stat hCG Dipstick Test." While it states the device's indications for use and classification, it does not include detailed information regarding acceptance criteria, study design, or performance data that would typically be required to answer the requested questions. This document is an approval letter, not the submission itself.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated as missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in this document.
• Data Provenance: Not specified in this document.

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

• Number of Experts: Not specified in this document.
• Qualifications of Experts: Not specified in this document.

4. Adjudication method for the test set:

• Not specified in this 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:

• Not specified in this document. This is a HCG dipstick test, not an AI-assisted diagnostic device, so an MRMC study related to AI assistance is unlikely and not applicable based on the device description.

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

• Not specified in this document. As it's a dipstick test, it's inherently a standalone diagnostic and not an "algorithm only" device in the typical sense of AI/software. Performance would be assessed inherently as standalone.

7. The type of ground truth used:

• Not specified in this document. For an hCG test, ground truth would typically be established by laboratory reference methods (e.g., quantitative hCG assays) or clinical outcomes.

8. The sample size for the training set:

• Not specified in this document.

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

• Not specified in this document.

Conclusion:

The provided document is an FDA approval letter (510(k) clearance) for a human chorionic gonadotropin (hCG) dipstick test. It confirms the device's substantial equivalence to a predicate device and its intended use for early pregnancy detection. However, this letter does not contain the detailed study results, acceptance criteria, sample sizes, or ground truth establishment methods that would have been part of the original 510(k) submission. To answer the specific questions, one would need to access the full 510(k) submission (K021386) submitted by Alidex, Inc.

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