Search Results

The VS-SENSE™ TEST is a qualitative, visually-read swab for clinicians who wish to evaluate women with vaginal symptoms. The device is a vaginal pH indicator swab intended to be used in conjunction with other clinical examinations, such as the Amsel criteria or the Nugent Gram stain, to aid in determining conditions characterized by elevated vaginal pH, such as bacterial vaginosis.

The VS-SENSE™ comprises a regular vaginal swab with its tip coated by an indicating polymer. When the indicating tip has been in contact with vaginal secretion, with elevated pH level, the user will observe a blue or green stain on the yellow background of the tip. The stains on the tip are caused by the sensitivity of a proprietary polymer, which coats the tip and contains the traditional indicator - Nitrazine Yellow. The VS-SENSE™ polymer matrix has a specific composition of ingredients that changes color when the pH of the vaginal discharge is greater than 4.7 +0.3/-0.2.

Acceptance Criteria and Study for VS-SENSE™

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the VS-SENSE™ device are implicitly based on demonstrating substantial equivalence to the predicate device, PHEM-CHEK™. The key performance metrics compared are sensitivity and specificity, both as a standalone test and as a second test within the Amsel Criteria procedure.

Note: The document states that the VS-SENSETM's performance is "Based on pivotal study results," implying that these reported values represent the device's actual performance in the study and were considered acceptable for substantial equivalence.

2. Sample Size and Data Provenance for the Test Set

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). It only refers to "pivotal study results" when reporting the sensitivity and specificity values.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. However, it mentions that the device is intended to be used in conjunction with "other clinical examinations, such as the Amsel criteria or the Nugent Gram stain," which are often interpreted by trained medical professionals.

4. Adjudication Method for the Test Set

The document does not provide information on the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The comparison presented is between the standalone performance of the VS-SENSE™ and the predicate device, and their performance as a second test within the Amsel Criteria procedure. There is no information about how much human readers improve with AI vs. without AI assistance, as this device uses a visual indicator and not AI.

6. Standalone Performance Study

Yes, a standalone study was done. The document reports "Stand-alone" sensitivity and specificity for the VS-SENSE™ as 86.3% and 93.9% respectively, and for the predicate PHEM-CHEK™ as 91% and 84.2% respectively. This indicates that the algorithm's performance without human-in-the-loop assistance was evaluated. The device itself is a visually-read swab, so "algorithm" here refers to the chemical reaction and visual indication, interpreted by a user.

7. Type of Ground Truth Used

The type of ground truth used is implied to be based on an assessment of conditions characterized by elevated vaginal pH, such as bacterial vaginosis, likely diagnosed using established clinical methods like the Amsel criteria or Nugent Gram stain. These methods typically rely on expert interpretation of clinical signs and microscopic findings.

8. Sample Size for the Training Set

The document does not provide information about the sample size for the training set.

9. How Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for the training set was established.

Ask a specific question about this device

The AmniScreen Home Detection Liner Kit is intended to detect possible leakage of amniotic fluid when vaginal wetness is experienced during pregnancy by indicating pH level. pH levels greater than or equal to 5.2 produce a blue-green color. Patients are instructed to report or show test results to their healthcare provider for interpretation and medical care.

The AmniScreen™ Home Detection Liner Kit contains a Testing Panty-Liner (TPL) and a Drying Tray (DT). The TPL comprises a regular panty-liner and an indicator strip assembled into the panty-liner, covered with two layers of one-way perforated film. The indicator strip is removed after use and placed in the DT for 30 minutes before reading the test results. When the indicator strip has been in contact with amniotic fluid, the user will observe a blue-green stain on the yellow background of the strip. An elevated pH level of the fluid causes the stain. The stains on the strip are caused by the sensitivity of a proprietary polymer, which coats the strip and contains the traditional indicator - Nitrazine Yellow, to pH levels above 5.2 units. The proprietary polymer is also sensitive to certain concentrations of ammonium in the tested fluid, and when the color changes are created by fluids with a certain concentration level of ammonium, and pH levels up to 7.0 units, these color changes are reversible and during a drying period of 30 minutes the blue-green stains fade back to yellow.

Acceptance Criteria and Study Details for AmniScreen™ Home Detection Liner Kit

This information is extracted from the provided 510(k) summary for the AmniScreen™ Home Detection Liner Kit.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the claim of "substantial equivalence" to the predicate device, specifically regarding sensitivity and specificity. The provided summary only gives the reported performance of the AmniScreen device, with the predicate device's performance serving as the unstated benchmark.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 339 pregnant participants.
• Data Provenance: The study involved participants arriving at hospitals at three different test sites, suggesting a prospective, multi-site clinical study. The country of origin is not explicitly stated, but the submitter is based in Israel and the FDA review document is from the USA, so the study could have been conducted in either or both.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document mentions that the performance of AmniScreen™ was demonstrated by "a Nitrazine Paper test performed by clinicians."

• Number of Experts: Not explicitly stated, but implies multiple clinicians (as it refers to "clinicians" generically).
• Qualifications of Experts: "Clinicians." No specific qualifications (e.g., years of experience, specialty like OB/GYN) are provided beyond being a clinician who could perform a Nitrazine Paper test.

4. Adjudication Method for the Test Set

The adjudication method is not explicitly stated. However, given that the performance was "demonstrated by a Nitrazine Paper test performed by clinicians," it suggests that the Nitrazine Paper test results served as the reference standard or "ground truth" against which the AmniScreen™ results were compared. There is no mention of a consensus process among clinicians for determining the ground truth for each case.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly described in the provided summary. The study focused on the standalone performance of the AmniScreen™ device compared to a clinician-performed predicate (Nitrazine Paper test). There's no mention of human readers improving with or without AI assistance, as this is a diagnostic device, not an AI-assisted diagnostic tool.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was done. The "sensitivity and specificity of the AmniScreen™ Home Detection Liner Kit in the study" report the performance of the device itself (though it relies on a patient or trained staff to read the result, the performance metrics are for the device's ability to detect the condition). The study also examined the correlation between user readings and trained staff readings to assess its suitability for home use, which indirectly speaks to its standalone interpretation for the intended user.

7. The Type of Ground Truth Used

The ground truth used was predicate device performance / clinical assessment. Specifically, the summary states: "The sensitivity and specificity of the AmniScreen™ Home Detection Liner Kit in the study were substantially equivalent to predicate device performance, which was demonstrated by a Nitrazine Paper test performed by clinicians."

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set or its sample size. The summary describes a "pivotal clinical study" with 339 participants, which appears to be the primary study for performance evaluation (test set). For the device's development (training), the summary only mentions "Lab tests to prove efficacy and pH cutoff were performed in the developer's labs," but no specific training data set or size is provided.

9. How the Ground Truth for the Training Set Was Established

As no specific training set is detailed, the method for establishing its ground truth is not provided. The development process mentions "Lab tests to prove efficacy and pH cutoff," implying a controlled laboratory environment where pH levels were likely experimentally varied and verified to establish the device's response characteristics during its design and development phase.

Ask a specific question about this device

The AimStick® Urine Reagent Strips are intended for detection of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leukocytes in urine.

The AimStick® Urine Reagent Strips are intended for the qualitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine for persons to test by visual comparison with a color chart on the bottle label. This product is for professional use. Test results may provide information regarding the status of carbohydrate metabolism, kidney function, liver function, acid-base balance, and bacturia.

Plastic strips with reagent pads which provide a color change when exposed to urine.

The AimStick® Urine Reagent Strips are plastic strips to which Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocyte reagent pads are affixed. The reagent pads react with the urine and provide a visible color reaction. The product is packaged with a drying agent in a plastic bottle. Each strip is stable and ready to use upon removal from the bottle. The entire reagent strip is disposable. The directions must be followed exactly. Results are obtained by direct comparison of the test strip with the color blocks printed on the bottle label. Laboratory instrumentation is not required.

Here's a breakdown of the acceptance criteria and study information for the AimStick® Urine Reagent Strips, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria in terms of sensitivity, specificity, or agreement percentages. Instead, the acceptance criterion is implied as "substantial equivalence" to the predicate device (Bayer MultiStix® 10SG). The reported device performance is described as meeting this criterion through a comparative clinical trial.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 196 urine samples.
• Data Provenance: The text does not explicitly state the country of origin. It describes the study as a "clinical trial" comparing two devices, which implies prospective data collection for the purpose of the study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The text does not provide information on the number of experts used or their qualifications for establishing ground truth. The study design described is a direct comparison between the AimStick® and the predicate device (Bayer MultiStix® 10SG), implying the predicate device's results served as the reference for comparison, rather than an independent expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

The text does not describe an adjudication method. The study design directly compares the results of the AimStick® with the Bayer MultiStix® 10SG. This suggests a direct comparison method rather than an independent adjudication for establishing truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a visually read diagnostic strip (without AI) and the study described is a direct comparison between two test strip products.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) study was not done. This device is a manual, visually interpreted test strip, not an algorithm-based or AI-driven system. The "performance" is based on human visual interpretation of the color changes on the strip.

7. The Type of Ground Truth Used

The ground truth for the comparison was essentially the results obtained from the legally marketed predicate device, Bayer MultiStix® 10SG. The study aimed to demonstrate that the AimStick® results align with those of the established predicate device.

8. The Sample Size for the Training Set

The text does not mention a training set because this is a diagnostic device that relies on chemical reactions and visual interpretation, not an AI or machine learning model that would require a separate training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set mentioned or implied for this type of device.

Ask a specific question about this device

The QuickVue Advance pH and Amines gll test contains two colorimetric tests intended for the qualitative detection of elevated vaginal fluid pH (pH ≥ 4.7) and the presence of volatile vaginal fluid amines. The test is intended for use by health care professionals as an aid in the diagnosis of bacterial vaginosis.

The QuickVue Advance pH and Amines gll test contains two qualitative, colorimetric tests for use in the characterization of a vaginal fluid sample: (1) a pH test that differentiates vaqinal fluid pH 4.7; and (2) a test that detects alkali volatilizable amines in vaginal fluid. The test is intended for use by health care professionals as an aid in the diagnosis of bacterial vaginosis.

Here's a breakdown of the acceptance criteria and study information for the QuickVue® Advance pH and Amines gll test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

UriDynamics StoneGuard™ II Test Strips are intended for semiquantitative measurement of pH and specific gravity in fresh urine. They can be used to monitor conditions that may cause the formation of kidney stones, namely trends in urinary pH and hydration status.

Confirm Low™ and Confirm High™ Control Solutions are intended for in vitro (external) use only, for use as control materials for StoneGuard™ II Test Strips only.

UriDynamics StoneGuard™ II Test Strips consist of plastic carriers with two reagent pads attached. The pads respond to pH and specific gravity. StoneGuard™ II Test Strips are stored in an opaque vial with desiccant and are ready to use. Results may be read between 30 and 60 seconds after wetting with a freshly-voided urine sample. Results are obtained by comparing the color developed on the pads with a printed color chart. The results are semi-quantitative. Control solutions, Confirm Low™ and Confirm High™, intended for use with StoneGuard™ II Test Strips, are also included in this submission. Confirm Low™ and Confirm High™ contain buffers and salts that give a known response with StoneGuard™ II Test Strips. Confirm Low™ and Confirm High™ Control Solutions are ready to use in dispensers, and contain no biological ingredients.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Accuracy" and "Correlation of Consumer & Reference Results" sections. The reported performance refers to the results obtained in the studies.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 107 participants for the clinical studies.
• Data Provenance: The study was conducted at four sites in Indiana, USA. The data is prospective, as it involved recruiting participants for a "Clinical Studies" section, indicating data collected specifically for the purpose of this evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not explicitly state the number of experts or their qualifications for establishing ground truth. Instead, it refers to "reference results obtained by refractometer for specific gravity and pH meter for pH" (for specificity, Corning Model 313 pH Meter and eclipse Handheld Refractometer). This suggests that established laboratory instruments served as the "ground truth" rather than human experts.

4. Adjudication Method for the Test Set

The document does not describe any human adjudication method (e.g., 2+1, 3+1). The ground truth was established by laboratory instruments.

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

There was no MRMC comparative effectiveness study involving AI mentioned in the document. This device is a visual reagent test strip, not an AI-powered diagnostic. The study focused on assessing untrained consumers' ability to interpret results visually compared to reference instruments.

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

This is not applicable, as StoneGuard™ II is a visual test strip requiring human interpretation, not an algorithm. The "standalone" performance here refers to the performance of the chemical pads themselves responding to pH and specific gravity, which was tested for accuracy and precision against reference instruments.

7. The Type of Ground Truth Used

The ground truth used was instrument-based reference values.

• For pH: Readings from a Corning Model 313 pH Meter.
• For specific gravity: Readings from an eclipse Handheld Refractometer.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or algorithm development, as this is a chemical reagent strip. The studies described are for validation of the final product.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of this device. The "ground truth" for the performance evaluation was established by laboratory instruments as described in point 7.

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