Search Results

The Indicard™ test is an enzyme activity test for use in the detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens from patients suspected of having vaginosis.

The Indicard™ test is indicated for professional use only and may be used at point of care. It is not intended for home use.

The Indicard™ test is an enzyme activity test.

This document is a 510(k) clearance letter from the FDA for the "INDICARD Test." It primarily focuses on the regulatory approval and indications for use, rather than detailed study results. Therefore, much of the requested information about acceptance criteria and study particulars cannot be fully extracted from this document.

Here's what can be inferred and what cannot:

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

The document does not provide specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study. The FDA clearance is based on "substantial equivalence" to a predicate device, meaning it performs similarly, but the actual performance values are not detailed here.

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

This information is not available in the provided document.

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 available in the provided document.

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

This information is not available 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

This is not an AI device. The INDICARD Test is described as an "enzyme activity test" for detecting bacterial vaginosis. Therefore, an MRMC study and AI-related performance improvements are not applicable.

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

This is not an AI algorithm. The device is a "test" and is indicated for "professional use," implying human involvement in performing and interpreting the test.

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

The document states the device is for "detection of Gardnerella vaginalis Proline IminoPeptidase (PIP) activity in vaginal fluid specimens from patients suspected of having vaginosis." The ground truth for such a device would typically involve a definitive diagnostic method for Gardnerella vaginalis or bacterial vaginosis, such as Gram stain (Nugent score), culture, or PCR, but this is not specified in the document.

8. The sample size for the training set

This information is not available in the provided document.

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

This information is not available in the provided document.

In summary, this FDA clearance letter is a regulatory document confirming that the INDICARD Test is substantially equivalent to a pre-existing device and outlining its indications for use. It does not contain the detailed technical or clinical study data that would address most of your questions. To obtain such information, one would typically need to review the full 510(k) submission or supporting technical documentation for K964015.

Ask a specific question about this device

The FemExam® TestCard™ contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaginal fluid pH less than pH 4.7 from vaginal fluid pH equal to or greater than pH 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid.

The FemExam® TestCard™ contains two qualitative, colorimetric tests: a pH test and an amine test. The pH test uses nitrazine yellow to produce a visual color change within two minutes of specimen application, indicating pH less than or greater than 4.7. It includes a positive procedural control and a negative background control. The amine test uses bromocresol green (BCG) and sodium aluminate to produce a visual color change within two minutes of specimen application, indicating the presence of alkali volatilizable amines. It also includes a positive procedural control and a negative background control.

The provided text describes the FemExam® TestCard™, a device with two qualitative, colorimetric tests for vaginal fluid: a pH test and an amine test. The information needed for a comprehensive study description, such as specific acceptance criteria and detailed performance data, sample sizes, and ground truth establishment for training, is not fully available in the provided text. However, based on the given information, here's an attempt to structure the answer:

Device: FemExam® TestCard™ pH and Amine Tests

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

The document does not explicitly state numerical acceptance criteria (e.g., minimum sensitivity, specificity, or agreement percentages). However, it reports statistically significant overall agreement for both tests.

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

• Sample Size: Not specified. The document only mentions "a statistically designed clinical study."
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It is a clinical study, suggesting prospective data collection, but this is not explicitly stated.

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)

• pH Test Ground Truth: The ground truth was established by comparing to a "commercial pH test strip (ColorpHast® pH test strip) routinely used in clinical studies to estimate vaginal fluid pH." No experts are explicitly mentioned for this ground truth.
• Amine Test Ground Truth: The ground truth was established by comparing to "the whiff test, an accepted clinical standard for ascertaining volatile vaginal fluid amines." While the whiff test is a clinical standard, the number and qualifications of individuals performing and interpreting the whiff test (who would effectively be establishing ground truth) are not provided.

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

Not specified. The document does not describe any adjudication process for the results of either the FemExam® TestCard™ or the reference methods.

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

This is not applicable to the FemExam® TestCard™. This device is a diagnostic test kit, not an AI assistance tool for human readers. It provides direct qualitative results.

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

Yes, this was a standalone performance study. The FemExam® TestCard™ itself generates qualitative colorimetric results (blue plus/minus signs against specific backgrounds) that are interpreted directly. There doesn't appear to be a human-in-the-loop interpretation that significantly alters the test's outcome; rather, the test provides a direct result.

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

• pH Test: A commercial pH test strip (ColorpHast® pH test strip), which serves as a widely accepted clinical reference method for pH estimation.
• Amine Test: The whiff test, which is an "accepted clinical standard for ascertaining volatile vaginal fluid amines."

8. The sample size for the training set

Not applicable. The FemExam® TestCard™ is a chemical assay kit, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device