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EZESure™ (Excel) Urine Midstream Early Pregnancy Home Test is Excel Scientific, Inc.'s device for OTC use of EZ Sure™ (Excel) Urine Midstream Early Pregnancy Home Test for the qualitative detection of human chorionic gonadotropin (hCG) in urine.

The EZ Sure™ (Excel) Urine Midstream Pregnancy Home Test is a sandwich solid phase dye-conjugate non-enzyme immunoassay. The stream of urine goes directly into the absorbent windows of the reaction device. The labeled antibody dye-conjugate binds to the hCG in the specimen forming an antibody-antigen complex. This complex binds to the antibody in the positive reaction zone and produces a rose-pink color band when hCG concentration is equal to or greater than 25 mIU/mL. In the absence of hCG, there is no line formation in the positive reaction zone. The reaction mixture continues to flow through the device and migrates to the control reaction zone by producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly.

Here's a breakdown of the acceptance criteria and study information for the EZESure™ (Excel) Urine Midstream Early Pregnancy Home Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only explicitly states "greater than 99% in agreement" with the predicate device as an acceptance criterion being met. Other criteria like sensitivity, simplicity, and speed are mentioned as characteristics of the device and supported by consumer comments implicitly indicating acceptable performance.

2. Sample Size and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "comparative data with Syntron Quikpac II pregnancy test (BeSure Home Test)."

3. Number of Experts and Qualifications

The document does not mention the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method

The document does not mention an adjudication method for the test set.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study described is a comparison of the EZESure™ device's performance against a predicate device (Syntron Quikpac II/BeSure Home Test), not a study involving human readers with and without AI assistance to measure improvement.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study comparing the EZESure™ device to a predicate device's performance was done, indicating "greater than 99% in agreement." This refers to the performance of the EZESure™ device on its own, relative to an established test.

7. Type of Ground Truth Used

The ground truth for the comparison was established by the performance of the predicate device, the Syntron Quikpac II (BeSure Home Test). The document states the EZESure™'s performance is based on "comparative data with Syntron Quikpac II pregnancy test (BeSure Home Test)." This implies that the results from the BeSure Home Test were considered the reference or "ground truth" against which the EZESure™ device was evaluated. The underlying gold standard for both tests is the detection of human chorionic gonadotropin (hCG).

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The description of the device's mechanism (sandwich solid phase dye-conjugate immunoassay) and the comparison study suggest a validation or performance evaluation approach rather than a machine learning "training set" in the typical sense.

9. How Ground Truth for Training Set Was Established

Since there is no mention of a separate training set for a machine learning algorithm, the concept of establishing ground truth for a training set in this context is not applicable. The device's performance and "agreement" are based on its ability to detect hCG at a specific cutoff, validated against an existing, marketed test.

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EZYSure™ OneStep Ovulation Predictor Home Test Kit is Excel Scientific. Inc.'s name for OTC use of solld phase 1. immunoassay in vitro diagnostic test kit for the qualitative determination of Luteinizing Hormone (LH) in urine

The EZY Sure™ OneStep Ovulation Prodictor Homo Test Kit is a sandwich solld phase dye-conjugato non-enzyme immunoassay. As the specimen is added to the reaction device, the gold-sol-antibody conjugate binds to the LH in the specimen forming an antibody-antigen complex birds to the anti-LH antibody in the positive reaction zone and produces a rese pink color band when LH concentration is present in the abserve of LH, there is no rosepink line in the postive reaction cultinues to flow through the absorbent device, pass the positive reaction zurie, producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly.

Here's an analysis of the provided text regarding the EZYSure™ OneStep Ovulation Predictor Home Test Kit, structured according to your request:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 103 female volunteers (for the user performance study).
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study used "patient urine specimens," which suggests a prospective collection for the purpose of the study. It refers to a comparison with a quantitative microtiter EIA LH assay (Medix) on the "same patient urine specimens," implying these were freshly collected or used within an appropriate timeframe for LH testing.

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

• Number of Experts: This test directly compares lay user results to those obtained by "trained laboratory technicians." The document does not specify a number of technicians, nor their specific qualifications (e.g., certification, years of experience), beyond being "trained." The Medix quantitative microtiter EIA LH assay served as the gold standard for LH level determination, which is an objective measurement rather than an expert interpretation of the device itself.

4. Adjudication method for the test set

• The document implies a direct comparison, where the results obtained by the lay users with the EZYSure™ test were compared against the results from the Conceive® test (also read by trained laboratory technicians) and the Medix quantitative EIA LH assay. There’s no explicit mention of an adjudication method (like 2+1 or 3+1 consensus) for discrepancies between readings. The "equivalence" implies statistical comparison rather than a formal adjudication process amongst human readers for the device interpretation.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a home test kit for a biochemical marker (LH), not an imaging or diagnostic AI tool. The study involved comparing lay user performance with the device against laboratory technician performance using an existing test and a quantitative assay. It does not involve "AI assistance" or "human readers" in the context of interpretation that would typically necessitate an MRMC study.

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

• Yes, in essence, standalone performance was demonstrated through the inherent design of the test. The EZYSure™ OneStep Ovulation Predictor Home Test Kit is designed as a standalone, qualitative diagnostic device. The performance criteria related to LH surge detection, interference, and intra/inter-assay variation represent the "algorithm only" performance (the chemical reaction and visual readout mechanism) independent of user interpretation, though the final interpretation by the user is part of the "user performance" study. The test kit produces a visual colored band; there is no separate "algorithm" in the modern sense of AI.

7. The type of ground truth used

• The ground truth for LH surge detection and LH concentration was established by objective quantitative measurement: a quantitative microtiter EIA LH assay (Medix) on the same urine specimens.
• For user performance, the ground truth for comparison was the results obtained by trained laboratory technicians using both the comparative Conceive® test and the gold-standard Medix quantitative EIA LH assay.

8. The sample size for the training set

• The document does not explicitly mention a training set sample size. This is common for this type of in-vitro diagnostic device, as "training" often refers to the development and optimization of the chemical reagents and manufacturing process rather than a specific data-driven machine learning training phase. The described studies are primarily validation studies.

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

• Since a formal "training set" in the context of machine learning is not mentioned, the concept of establishing ground truth for it is not applicable here. The development and optimization of the EZYSure™ OneStep Ovulation Predictor Home Test Kit would have involved internal R&D, likely using characterized urine samples (spiked with known LH concentrations, or verified by established lab methods) to refine the sensitivity, specificity, and visual readout characteristics of the immunoassay. However, the document does not detail this developmental phase or any specific "training set" used therein.

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Excel OneStep Urine hCG Pregnancy DipStick Test is Excel Scientific, Inc.'s name for professional use of solid Ekol of one of the more regioner in vitro diagnostic test kit for the qualitative detection of human phonic Gonadotropin (hCG) in urine.

Excel OneStep Urine hCG Pregnancy DipStick Test is Excel Scientific, Inc.'s name for professional use of solid Ekol of one of the more regioner in vitro diagnostic test kit for the qualitative detection of human phonic Gonadotropin (hCG) in urine. Excel OneStep Urine hCG Pregnancy DipStick Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed.

The Principle of Excel OneStep Urine hCG Pregnancy DipStick Test is as follows:

• Both the Excel OneStep Urine hCG Pregnancy DipStick and the QuikStrip (or E.Z. Strip) Pregnancy Home 1. tests are a sandwich solid phase dye-conjugated non-enzyme immunoassay. When the Excel OneStep Urine hCG Pregnancy DipStick is placed in a urine test cup containing the urine specimen, the urine will migrate by capillary action. The gold sol-antibody conjugate in the gold sol pad of the Excel OneStep Urine hCG Pregnancy DipStick binds to the hCG molecules in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized in the positive reaction zone in the white membrane area and produces a rose-pink color band when the hCG concentration is at or greater than 25 mIU/mL. In the absence of detectable levels of hCG, there is no rose-pink band in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a rose-pink color band in the control zone of the white membrane area, demonstrating that the reagents and the device are functioning correctly.

This document describes the Excel OneStep Urine hCG Pregnancy DipStick Test, a qualitative in vitro diagnostic test for human chorionic gonadotropin (hCG) in urine. The study presented compares its performance to the Syntron Quikpac EIA, a currently marketed hCG assay.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the Excel OneStep device in a quantitative manner (e.g., sensitivity, specificity thresholds). However, it establishes a comparison to an existing, marketed device, the Syntron Quikpac EIA. The implication is that the Excel OneStep device should perform comparably to the Syntron Quikpac EIA, particularly in its cutoff sensitivity.

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

• Sample Size: The document does not specify the sample size used for the comparative study or test set.
• Data Provenance: The document states the study is "based on comparative data with Syntron Quikpac EIA," but does not mention the country of origin of the data or whether it was retrospective or prospective. It appears to be an internal comparison or validation study, not a large-scale clinical trial with detailed demographics.

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

• The document does not provide information about the number or qualifications of experts used to establish ground truth for the test set.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method.

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 a qualitative diagnostic test (a dipstick for visual detection of a rose-pink band). It does not involve AI, human readers interpreting complex images, or an MRMC study.

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

• This is a standalone diagnostic test in the sense that the device itself produces the result (a color change). There is no "algorithm only" performance separate from the physical dipstick reaction, as it's a chemical immunoassay, not an AI or software-based algorithm. The interpretation is visual by a human, but the test itself is complete upon color change.

7. The Type of Ground Truth Used

• The ground truth is implied to be actual hCG concentrations in urine specimens, as demonstrated by a qualitative cutoff of "25 mIU/mL". This is a biochemical or analytical ground truth (presence/absence of hCG at a specific threshold) rather than expert consensus on images or pathology. The performance is gauged against an existing, marketed device, the Syntron Quikpac EIA, which presumably has its own established analytical performance standards.

8. The Sample Size for the Training Set

• The document describes a comparative study, not a machine learning study that would typically involve distinct training and test sets. Therefore, there is no mention of a training set sample size.

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

• As there's no mention of a training set, this information is not applicable.

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EZ > Sure™ Urine DipStick Pregnancy Home Test is Excel Scientific, Inc.'s name for OTC use of solid phase L Four - Online Diponor Programo Tivitro diagnostic test kit for the qualitative detection of human Chorionic migatory chomalogiaphy in manododay in the CipStick Pregnancy Home Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed.

EZ > Sure™ Urine DipStick Pregnancy Home Test is Excel Scientific, Inc.'s name for OTC use of solid phase L Four - Online Diponor Programo Tivitro diagnostic test kit for the qualitative detection of human Chorionic migatory chomalogiaphy in manododay in the CipStick Pregnancy Home Test is based on comparative data with Syntron Quikpac EIA, an assay for human Chorionic Gonadotropin currently being marketed.

The Principle of EZ&Sure™ Urine DipStick Pregnancy Home Test is as follows:

• Both the EZ$ Sure™ Urine DipStick Pregnancy Home Test and the QuikStrip (or E.Z. Strip) Pregnancy Home 1. boon the E2 Pour - Smo Dipease regiugated non-enzyme immunoassay. When the EZ $ Sure™ Urine .o.&fick Pregnancy Home Test is placed in a urine test cup containing the urine specimen, the urine will Dipoton Prognanoy Profile Tothe Total Sol-antibody conjugate in the gold sol pad of the EZ $ Sure™ Urine migrate by capillary active to the hCG molecules in the specimen forming an antibody-antigen Dipolon't roghano 110mle 100 the antibody immobilized in the positive reaction zone in the white complox. This complex a rose-pink color band when the hCG concentration is at or greater than 25 millione area and produces of hCG, there is no rose-pink band in the positive reaction zone. The reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a rose-pink color band in the control zone of the white membrane area, demonstrating that the reagents and the device are functioning correctly.

The provided document focuses on the description and comparison of the EZ Sure™ Urine DipStick Pregnancy Home Test and other existing pregnancy tests, primarily for regulatory submission (K970425). It outlines the test's principle, its differences from comparator products, and contact information.

However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects requested in the prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training set details).

Therefore, I cannot provide the requested information based on the given text. The document is a summary of safety and effectiveness, but it lacks the scientific study details required to answer your prompt.

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the professional use of solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine.

solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine.

The provided document (K96323) is a "Summary of Safety and Effectiveness" for the Excel OneStep Urine hCG Pregnancy Module Test, dated June 24, 1995. This document is a pre-market notification (510(k)) submission to the FDA. Such documents describe the device and compare it to a legally marketed predicate device, but they typically do not contain detailed study results, acceptance criteria, or comprehensive performance data in the format typically requested for AI/ML device evaluations.

Based on the content of K96323, here's what can be extracted and what information is not available:

Information Available:

• Device: Excel OneStep Urine hCG Pregnancy Module Test (for qualitative determination of human chorionic gonadotropin in urine).
• Predicate Device: Syntron QuikPac I enzyme immunoassay.
• Cutoff: 25 mIU/mL (for both the new device and the predicate).
• Mechanism: Sandwich solid phase dye-conjugate non-enzyme chromatographic immunoassay.

Information NOT Available in the Provided Document:

The document does not contain the detailed study results required to fill out a table of acceptance criteria vs. reported device performance, nor does it provide information on sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance. This type of detailed study data is generally found in a separate study report, often referenced in or summarized in more detail within a comprehensive 510(k) submission, but not typically in the "Summary of Safety and Effectiveness" itself.

Therefore, for almost all points requested, the answer is "Not available in the provided document."

Detailed Response based on available information (and noting what is missing):

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

   • Acceptance Criteria: Not explicitly stated in this summary. For a qualitative pregnancy test, typical acceptance criteria would involve sensitivity (detection limits, often comparing to known hCG concentrations) and specificity (accuracy in negative samples, no cross-reactivity), and sometimes reproducibility. The document only states the cutoff is 25 mIU/mL, implying this is the performance target for hCG detection.
   • Reported Device Performance: Not detailed in this summary. No performance metrics like sensitivity, specificity, accuracy, positive predictive value, or negative predictive value are provided. The summary describes the mechanism by which a positive (pink-rose color band at 25 mIU/mL or greater) or negative result is indicated, and how the control zone functions.

   Acceptance Criteria	Reported Device Performance
   Not specified	Not specified

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

   • 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)

   • Not applicable/available. For a qualitative chemical assay like a pregnancy test, the "ground truth" is typically established by known concentrations of the analyte (hCG in this case) in control samples, and/or by a reference method with established accuracy, rather than expert interpretation of results. No information on this is provided.

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

   • Not applicable/available. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which isn't the primary method for validating a chemical immunoassay.

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. This is a point-of-care, qualitative immunoassay, not an AI/ML device requiring human-in-the-loop studies.

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

   • This device is the standalone test. The performance of the immunoassay itself is what would be evaluated. However, the results of such an evaluation are not detailed in this summary document.

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

   • Not explicitly stated, but for this type of device, ground truth would typically be established by:
     • Known concentrations of hCG in spiked urine samples.
     • Comparison to a highly accurate reference method (e.g., quantitative laboratory hCG assay or the predicate device itself as a comparator).
     • Clinical correlation (e.g., follow-up for pregnancy confirmation).
   • The document mentions the cutoff of 25 mIU/mL, implying that detection at or above this concentration is the "true positive" benchmark.

8. The sample size for the training set

   • Not available in the provided document. For a non-AI device, the concept of a "training set" in the machine learning sense doesn't directly apply. However, method development and optimization would have involved numerous samples, but their numbers are not specified here.

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

   • Not available/applicable for a non-AI device in the context of "training set" as understood in ML. For method development, ground truth would have been established as described in point 7.

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solid phase migratory chromatography immunoassay in vitro diagnostic test kit

Here's an analysis of the provided text regarding the Excel OneStep Group A Strep Antigen Module Test, structured according to your requested information.

The provided text describes a Summary of Safety and Effectiveness for the Excel OneStep Group A Strep Antigen Module Test, a device used for the qualitative detection of Group A Strep antigen from throat swabs.

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific performance thresholds that the device had to meet. Instead, it describes a correlation study where the device's performance was compared against a recognized gold standard (culture). The reported performance metrics from this correlation study serve as the factual performance of the device.

Table of Acceptance Criteria and Reported Device Performance

Note: The provided text describes the study design and the methodologies but does not report the numerical results (sensitivity, specificity, accuracy, etc.) of the correlation study. Therefore, the "Reported Device Performance" column cannot be filled with quantitative values from this document. It only states that the study was conducted.

2. Sample Size and Data Provenance

• Sample Size (Test Set): Not explicitly stated in the provided text. The document refers to "each throat swab" suggesting a collection of samples, but no total number is given.
• Data Provenance: Not explicitly stated. The document refers to "throat swabs" without specifying the country of origin or whether the data was retrospective or prospective. Given the nature of a medical device submission, it is highly likely to be prospective data collected for the purpose of the study.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable in the traditional sense of human readers interpreting images. The ground truth for the test set was established through laboratory procedures (culture and latex agglutination), not by human expert interpretation of the test device itself.
• Qualifications of Experts: The ground truth involved standard microbiological laboratory techniques. While personnel performing these tests would be qualified laboratory technicians/microbiologists, the document does not elaborate on their specific qualifications.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth for each throat swab was established by a definitive laboratory method (culture followed by latex agglutination for confirmation). This is an objective, multi-step process for determining the presence of Group A Strep, not an interpretative task requiring human adjudication for discrepancies. The "gold standard" here is a sequential laboratory process.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided text. This study is a standalone performance assessment of the device against a laboratory gold standard, not a comparison of human reader performance with and without AI assistance.

6. Standalone Performance Study

• Standalone Performance Study: Yes, a standalone performance study was conducted. The entire description in the provided text focuses on the device's ability to detect Group A Strep antigen by itself, independent of human interpretation or assistance beyond performing the test procedure correctly. The device's results were directly compared to the culture-based ground truth.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was established through a two-step laboratory process:
  1. Culture: Throat swabs were used to inoculate sheep blood (trypticase) soy agar plates for the cultivation and isolation of microorganisms.
  2. Confirmation: Group A Streptococci isolated from the cultures were then confirmed by a latex agglutination assay (using a commercially available strep grouping kit from Diagnostic Product Corporation).

This combination provides a highly accepted and reliable laboratory-based ground truth for the presence of Group A Strep.

8. Sample Size for the Training Set

• Sample Size (Training Set): Not applicable. The Excel OneStep Group A Strep Antigen Module Test is a rule-based immunoassay, not an artificial intelligence (AI) or machine learning algorithm. Therefore, it does not have a "training set" in the computational sense. The device's mechanism is based on specific chemical reactions and antibody-antigen binding, which are inherently designed and manufactured, not "trained" on data.

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

• Ground Truth for Training Set: Not applicable, as this is not an AI/ML device that requires a training set. The "ground truth" related to its development would involve validation of the chemical and biological components during its manufacturing and quality control, ensuring the antibodies and reagents perform as intended.

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EZ Sure OneStep Pregnancy Test is Excel Scientific, Inc.'s name for OTC use of solid phase migratory chromatography immunoassay in vitro diagnostic test kit for the qualitative detection of human Chorionic Gonadotropin (hCG) in urine.

EZ Sure OneStep Pregnancy Test is a sandwich solid phase dyeconjugated non-enzyme immunoassay. When the specimen is added to the reaction device, the gold-sol-antibody conjugate binds to the hCG molecules in the specimen forming an antibody-antigen complex. This complex binds to the anti-hCG antibody immobilized in the position zone in the viewing window and produces a purple-pink color band when the hCG concentration is at or greater than 25 mIU/mL. In the absence of detectable levels of hCG, there is no purple-pink band in the positive reaction mixture continues to flow through the absorbent device, pass the positive reaction zone, producing a purple-pink color band in the control zone, demonstrating that the reagents and the device are functioning correctly.

Here's a breakdown 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

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

• Accuracy Study:

  • Sample Size: A total of 100 positive urine specimens. The table shows 90 positive and 70 negative results, implying a total of 160 specimens were included in the comparison with the predicate device.
  • Data Provenance: Not explicitly stated, but the context of the K962580 premarket notification suggests it's likely a retrospective study conducted by the manufacturer, Excel Scientific, Inc., or a contract lab. There is no information on the country of origin of the data.

• Sensitivity (Known amounts of hCG added to urine pool): Test was done on one urine pool spiked with various concentrations of hCG.

• Specificity (Menopausal Urines):

  • Sample Size: 20 urine specimens from postmenopausal women.
  • Data Provenance: Not explicitly stated, but likely a retrospective study.

• Specificity (Interfering Substances): Test was done on urine samples (0 and 25 mIU/mL hCG) spiked with specified substances.

• Precision Studies:

  • Sample Size: 11 replicates for intra-assay precision, and 11 independent assays with 3 different lots for inter-assay precision. Four specimens (0, 25, 100, 450,000 mIU/mL hCG) were used for each.
  • Data Provenance: Not explicitly stated, likely an internal study by the manufacturer.

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

There is no mention of experts being used to establish the ground truth for this device. The ground truth appears to be established by:

• Comparison to a predicate device (Syntron's BeSure OneStep hCG Test) for the accuracy study.
• Spiking urine with known concentrations of hCG for sensitivity and some specificity testing.
• The known status of urine samples (e.g., "postmenopausal women" for specificity).

4. Adjudication Method for the Test Set

No adjudication method is mentioned. The comparisons appear to be direct, without a separate review or consensus process for the test results.

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 study was done, nor is this an AI-driven device. This is an in-vitro diagnostic test kit.

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

This is a standalone in-vitro diagnostic test kit that produces a visual result (color band). The "standalone" performance is the core of the studies described. It's not an algorithm, but a chemical immunoassay.

7. The Type of Ground Truth Used

The ground truth used in these studies includes:

• Reference Device Comparison: Syntron's BeSure OneStep hCG Test for accuracy.
• Known Concentrations: hCG spiked into urine pools at specific mIU/mL values for sensitivity.
• Biological State: Urine from "postmenopausal women" to assess specificity against other hormones.
• Spiked Interfering Substances: Urine samples with known concentrations of potential interfering substances to assess specificity.

8. The Sample Size for the Training Set

There is no mention of a training set as this is not a machine learning or AI-based device. The device's "training" in a general sense would be the research and development phase where the assay components are optimized, but specifics of data used for that are not provided.

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

Not applicable, as there is no explicitly defined "training set" in the context of an immunoassay like there would be for a machine learning model. The development of the assay would involve laboratory optimization to achieve the desired performance characteristics (sensitivity, specificity) against known standards and samples.

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solid phase chromatographic immunoassay in vitro diagnostic test kit for the qualitative determination of human chorionic gonadotropin in urine or serum.

Here's an analysis of the provided text regarding acceptance criteria and the study conducted for the Excel OneStep Urine/Serum hCG Module Pregnancy Test:

Given the nature of the document (a "Summary of Safety and Effectiveness" from 1996 for a pregnancy test), it's important to note that the level of detail regarding study design and ground truth establishment will be significantly less comprehensive than what is typically expected for modern AI/ML device submissions. This document predates the widespread use of the detailed study design elements you've requested for AI/ML devices.

I will extract the information that is present and indicate when specific details are not provided in the document.

Acceptance Criteria and Reported Device Performance

The provided text describes the functional differences and cut-off for the Excel OneStep Urine/Serum hCG Module Pregnancy Test compared to a predicate device (Syntron Quikpac I EIA). It implies that the Excel OneStep device should perform at least as well as the predicate for qualitative determination of hCG at the 25 mIU/mL threshold. While explicit numerical acceptance criteria (e.g., sensitivity, specificity thresholds) are not stated in a formal table, the core performance criterion is the reliable detection of hCG at or above 25 mIU/mL.

Study Information

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

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document is a regulatory submission, so it implies a study was conducted, likely prospective, but details are absent.

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

   • This information is not provided. For a qualitative immunoassay, ground truth would typically be established by a reference method (e.g., quantitative laboratory assay) rather than expert interpretation of the test itself.

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

   • This information is not provided. Given the nature of a rapid qualitative immunoassay, adjudication by multiple experts is not a standard practice for establishing ground truth.

4. 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. This is a pregnancy test, not an AI/ML device where human readers interact with AI assistance. Therefore, an MRMC study with AI assistance is not applicable and was not performed. The "reader" is the individual visually interpreting the color bands on the test strip.

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

   • Yes, in essence. The Excel OneStep Urine/Serum hCG Module Pregnancy Test is a standalone device. Its "performance" is the direct visual output (color band) based on the presence or absence of hCG. There is no separate "algorithm" in the modern AI/ML sense; the chemistry and physics of the immunoassay are the "algorithm." The human simply reads the direct result.

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

   • This is not explicitly stated in the provided summary. However, for an hCG pregnancy test, the ground truth would typically be established using:
     • A quantitative reference laboratory assay: A highly accurate quantitative method (e.g., ELISA, chemiluminescent immunoassay) performed on the same urine/serum samples to determine the actual hCG concentration.
     • Clinical correlation: (Less likely to be the primary ground truth for in vitro diagnostic performance, but might be used to confirm clinical utility).

7. The sample size for the training set:

   • This information is not provided. For a traditional immunoassay, there isn't a "training set" in the machine learning sense. The device is developed and optimized through chemical and engineering principles.

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

   • This information is not provided, as the concept of a "training set" and its associated ground truth establishment process is not applicable to a traditional immunoassay in the same way it is for an AI/ML device. Device development would involve optimization against known concentrations of hCG, but this isn't structured as a machine learning training phase.

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