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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.

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AimStep™ Pregnancy is intended for non-professional use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

The test utilizes a combination of monochonal and polyclonal antibody reagents to selectively devect elevated levels of hCG. The assay is conducted by adding urine to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membranc to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line on the "Test Region" of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Region will always appear regardless of the presence or absence of hCG.

This document describes the acceptance criteria and study proving the performance of the AimStep™ Pregnancy (Home Test).

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 137 female participants.
• Data Provenance: The document does not explicitly state the country of origin. It is a "clinical trial," which implies prospective data collection, but this is not explicitly confirmed. Given the context of a 510(k) submission to the FDA, it is highly likely the study was conducted in the USA.

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

The document does not mention the use of experts to establish ground truth for the test set. The comparison was made against a predicate device (Clearview™ Easy HCG Pregnancy Test), which itself is a legally marketed device for pregnancy determination. The results of the predicate device served as the reference for comparison.

4. Adjudication Method for the Test Set

Not applicable. The study compared the device's results directly to a predicate device, not against an adjudicated ground truth from multiple experts.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study focused on the performance of the device against a predicate device, not on the improvement of human readers with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted in the sense that the AimStep™ Pregnancy device was evaluated on its own ability to detect hCG and its correlation with a predicate device. The accuracy of detecting hCG at 20 mIU/ml and greater, and the lack of cross-reactivity, represent standalone performance metrics.

7. Type of Ground Truth Used

The ground truth for the clinical trial was established by the results of the legally marketed predicate device, the Clearview™ Easy HCG Pregnancy Test. This implies a "device-to-device comparison" ground truth where the established accuracy of the predicate device is assumed to be the truth for the purpose of comparison. The primary function of the test is for "identification of hCG," and its ability to detect specific concentrations and show no cross-reactivity suggests a chemical/biological assay's intrinsic truth as well.

8. Sample Size for the Training Set

The document does not explicitly mention a training set or its sample size. The description of the device's performance (e.g., detection limit, cross-reactivity) suggests laboratory testing and standardization, which would involve samples, but these are not referred to as a "training set" in the context of machine learning.

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

Not applicable, as a "training set" in the context of machine learning is not described. The device's performance characteristics (detection limit, cross-reactivity) would have been established through laboratory experiments and standardization to the World Health Organization Third International Standard, which serves as a definitive reference for hCG measurement.

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AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy is intended for non-professional over-the-counter use for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

The test utilizes a combination of monoclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by dipping the absorbent wick of the test in urine and observing for the formation of colored liness. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specific antibody-hCG-colored conjugate and form a colored line on the Specimen portion of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line at the Control Zone will always appear regardless of the presence or absence of hCG.

Here's an analysis of the provided text regarding the AccuDip™ Home Pregnancy Test, formatted to address your specific questions:

AccuDip™ Home Pregnancy Test Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 73 female participants.
• Data Provenance: The document does not specify the country of origin. It can be inferred to be a prospective clinical trial given the description of "clinical trials using AccuDip™ Home Pregnancy and/or AimStick™ Pregnancy were conducted which included 73 female participants."

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

The document does not provide information on the number of experts or their qualifications used to establish the ground truth for the test set. It describes a "clinical trial" but does not detail how pregnancy status (ground truth) was definitively determined for the 73 participants.

4. Adjudication Method (for the test set)

The document does not specify any adjudication method for establishing the ground truth of the test set.

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

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic test for self-use, not a medical imaging or diagnostic interpretation system designed for human readers.

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

Yes, the primary "performance" described pertains to the standalone device's ability to detect hCG and its analytical specificity, as well as user comprehension. The test itself is designed for standalone use by consumers.

7. The Type of Ground Truth Used

The document broadly refers to "clinical trials" and the "determination of pregnancy." For the analytical performance (hCG detection and cross-reactivity), it implies:

• Known hCG concentrations: For the "detection of hCG concentrations of 20 mIU/ml and greater." This would likely involve spiked samples or serially diluted known positive samples.
• Known concentrations of interferents: For the cross-reactivity study with hLH, hFSH, and hTSH, likely using samples with known concentrations of these hormones and known hCG status (0 mIU/ml or 20 mIU/ml).
• For the user study with 73 participants, the ground truth for "pregnancy status" is not explicitly stated but would ideally be confirmed by a gold standard method (e.g., laboratory quantitative hCG test) a short time after the home test. The focus of this part of the study seems to be on user comprehension and ease of use, not necessarily the diagnostic accuracy of the device against a clinical gold standard performed at the same time.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This type of diagnostic device (lateral flow immunoassay) typically does not involve machine learning or AI models with distinct "training" and "test" sets in the way that software algorithms do. The development and validation process focuses on analytical performance and clinical evaluation.

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

As there is no mention of a training set in the context of machine learning, this question is not applicable. The ground truth for the analytical and clinical studies described in the summary would have been established through laboratory controls (known concentrations) and, presumably, standard clinical methods for pregnancy determination.

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AimStep™ Combo Pregnancy is intended for the rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination of pregnancy. This test is for professional use.

The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by adding specimen to the test device and observing for the formation of colored lines. The specimen migrates via capillary action along the membrane to react with the colored coningate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored line in the Specimen Area of the membrane. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line in the Control Area will always appear regardless of the presence or absence of hCG.

Here's an analysis of the provided text regarding the AimStep™ Combo Pregnancy device's acceptance criteria and studies:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the device demonstrating "100% concordance" with a "commercially available serum/urine membrane test." The performance is reported as follows:

• AimStep™ Combo: 71 Positive, 88 Negative
• Commercially Available Test: 71 Positive, 88 Negative
• Concordance: 100% |
  | 100% concordance with a commercially available test for serum specimens | Serum Specimens:
• AimStep™ Combo: 21 Positive, 51 Negative, 1 Inconclusive
• Commercially Available Test: 21 Positive, 51 Negative, 1 Inconclusive
• Concordance: 100% |
  | Detection of hCG concentrations of 20 mIU/ml and greater, standardized to the World Health Organization Third International Standard | The test "detects hCG concentrations of 20 mIU/ml and greater." "The test has been standardized to the World Health Organization Third International Standard." |
  | No cross-reactivity with hLH, hFSH, and hTSH | "The addition of hLH (500 mIUml), hFSH (1000 mIU/ml), and hTSH (1000 ulU/ml) to negative and positive serum and urine specimens showed no cross-reactivity." |

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

• Sample Size:
  • Urine specimens: 159
  • Serum specimens: 73
  • Total specimens: 232
• Data Provenance: The study was a "multi-center clinical evaluation." The country of origin is not explicitly stated, but the submission is to the US FDA, implying at least some relevance to the US. The study is retrospective, as it compared results obtained using the AimStep™ Combo Pregnancy and another commercially available test, suggesting these specimens were likely previously collected and tested, or tested concurrently as part of a comparative evaluation rather than a de novo prospective collection for the AimStep device alone.

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

The document does not explicitly state the number of experts or their qualifications. The ground truth for the comparison was established by the "results obtained using another commercially available serum/urine membrane test." This implies that the 'ground truth' was essentially the result from the predicate device, not necessarily an independent expert panel review of clinical outcomes or pathology.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for disagreements. Since the study reported "100% concordance," it's possible there were no disagreements, or any disagreements were resolved in an unstated manner, or specimens leading to disagreement were simply excluded.

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

• No, an MRMC comparative effectiveness study was not done. This was a comparison between two devices, not between human readers with and without AI assistance. The AimStep™ Combo Pregnancy is a qualitative rapid diagnostic test, not an AI-based diagnostic tool that assists human readers.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done. The device itself, which functions as a qualitative rapid diagnostic test (an "algorithm" in a very broad sense, as it interprets color changes), was evaluated independently of human interpretation influence beyond reading the result. Its performance was measured by its ability to correctly identify hCG and its concordance with a predicate device.

7. Type of Ground Truth Used

The primary ground truth used for the comparative clinical evaluation was the results obtained from a "commercially available serum/urine membrane test." Additionally, the device's analytical performance (detection limit and cross-reactivity) was evaluated against established standards (WHO Third International Standard) and specific known concentrations of related hormones.

8. Sample Size for the Training Set

The document does not mention a training set or any training process for the AimStep™ Combo Pregnancy device. This type of diagnostic device, based on immunoassay, is typically developed through analytical chemistry and immunoassay design, rather than machine learning requiring a "training set" of data.

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

As no training set is mentioned, this question is not applicable to the provided information.

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AimStep™ Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the early determination of pregnancy. This test is for professional use.

The test utilizes a combination of monoclonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by dipping the test strip into urine and observing for the formation of colored bands. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.

Here's a breakdown of the acceptance criteria and the study details for the AimStep Pregnancy device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria (e.g., "sensitivity must be >X%"). Instead, the primary acceptance criterion appears to be 100% concordance with a commercially available predicate device.

• AimStep™ positive results: 64
• Commercially available test positive results: 64
• AimStep™ negative results: 84
• Commercially available test negative results: 84 |
  | Detects hCG concentrations of 20 mIU/ml and greater. | Detection Limit: 20 mIU/ml (This is stated as a capability, not directly verified against a specific acceptance threshold in the study summary, but it's part of the standard performance claim). |
  | No cross-reactivity with hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 ulU/ml) in negative and positive urine. | No cross-reactivity observed. (This is stated as a direct finding, not a specific criterion in the table, but it's an important performance characteristic.) |

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

• Sample Size: 148 urine specimens
• Data Provenance: "A multi-center clinical evaluation was conducted." The document does not specify the country of origin or whether the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:

The document does not explicitly state the number of experts used or their qualifications to establish the ground truth. The "ground truth" for the comparative study was based on the results of "another commercially available test." This implies that the commercially available test itself served as the reference standard.

4. Adjudication Method for the Test Set:

There is no mention of an adjudication method. The comparison was a direct concordance between the AimStep™ device and the commercially available test.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study compares the performance of a device against another commercially available test, not human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance assessment was effectively done. The study directly evaluated the performance of the AimStep (device only) against another commercially available test. There is no human interpretation component described in the test procedure or the study, other than reading the colored bands. Therefore, the reported performance is the "algorithm only" or device-only performance.

7. Type of Ground Truth Used:

The ground truth used was concordance with an existing "commercially available test." This suggests that the predicate device's results were accepted as the known state (positive or negative for hCG).

8. Sample Size for the Training Set:

The document does not provide any information about a training set size. This type of diagnostic device (lateral flow immunoassay) typically does not involve a "training set" in the machine learning sense. Its development relies on biochemical engineering and validation, not algorithms trained on data.

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

As there is no mention of a "training set" in the context of machine learning, this information is not applicable and therefore not provided in the document. The device's underlying mechanism is based on antigen-antibody reactions, where the "ground truth" for its development would be based on the known biochemical properties of hCG and the specificity/sensitivity of the antibodies used.

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AimStick™ PBD Combo Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine or serum to aid in the determination of pregnancy. This test is for professional use.

The test utilizes a combination of monoclonal antibodies to selectively detect elevated levels of hCG. The test strip is inserted into the specimen and the formation of colored bands is observed. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

Acceptance Criteria and Device Performance for AimStick™ PBD Combo Pregnancy

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided "Summary of Safety & Effectiveness," the primary acceptance criterion appears to be 100% concordance with a commercially available serum/urine pregnancy test.

• Positive Urine Results
• Negative Urine Results
• Positive Serum Results
• Negative Serum Results | 100% concordance (AimStick™ Combo matches Commercially Available Combo kit in all categories) |
  | Analytical Sensitivity: Detects hCG concentrations of 20 mIU/ml and greater. | Detects hCG concentrations of 20 mIU/ml and greater. |
  | Specificity (Cross-Reactivity): No cross-reactivity with hLH (300 mIU/ml), hFSH (1000 mIU/ml), and hTSH (1000 ulU/ml) in both negative (0 mIU/ml hCG) and positive (20 mIU/ml hCG) urine samples. | No cross-reactivity observed with hLH, hFSH, and hTSH at specified concentrations. |
  | Procedural Control: A colored band should always appear at the Control Zone regardless of the presence or absence of hCG. | (Implied to be met, as it's described as a mandatory feature of the test's mechanism). |

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

• Sample Size:
  • Urine specimens: 155
  • Serum specimens: 57
  • Total Test Set Size: 212 specimens
• Data Provenance:
  • Country of Origin: Not specified in the provided text.
  • Retrospective or Prospective: Not explicitly stated, but the description "A multi-center clinical evaluation was conducted comparing the results obtained using AimStick™ PBD Combo Pregnancy and another commercially available serum / urine test" suggests a prospective collection and testing of samples for this comparative study.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The study compares the AimStick™ Kit to "another commercially available serum / urine test" and finds 100% concordance. This implies that the "commercially available test" served as the reference standard, and no further adjudication (like 2+1 or 3+1 expert consensus) is described.

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

• No, an MRMC comparative effectiveness study was not done. The study design described is a comparison of two diagnostic devices (AimStick™ Kit vs. a commercial predicate) on a set of specimens, not a study involving multiple human readers using an AI vs. without an AI.

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

• Yes, a standalone performance evaluation was done. The AimStick™ PBD Combo Pregnancy device itself is an in-vitro diagnostic test. Its performance was directly compared against another commercial device, evaluating the detection of hCG by the device alone, without human interpretation variability being a primary focus of the performance data presented. The "reading" of the colored bands would be a human "in the loop" action, but the study focuses on the device's ability to produce the correct colored bands, not the variability of human readers interpreting those bands.

7. The Type of Ground Truth Used

• The ground truth was established by a "commercially available serum / urine test." This is a form of predicate device comparison, where the established performance of an existing, legally marketed diagnostic device serves as the reference standard. The implicit assumption is that the predicate device's results are accurate.

8. The Sample Size for the Training Set

• Not applicable / Not specified. This type of in-vitro diagnostic device (lateral flow immunoassay) typically does not involve a machine learning "training set" in the conventional sense. Its performance is based on the chemical and biological reactions of its components.

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

• Not applicable / Not specified. As noted above, there isn't a "training set" for an algorithm in this context. The manufacturing specification and quality control for the immunological reagents and test strip components would be critical for establishing the inherent "truth" of the device's design.

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AimStick™ PBD Pregnancy is intended for the qualitative identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy. This test is for professional use.

The test utilizes a combination of momelonal and polyclonal antibodies to selectively detect elevated levels of hCG. The assay is conducted by dipping the test strip into urine and observing for the formation of colored bands. The specimen migrates via capillary action along the membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence of hCG.

Here's a breakdown of the acceptance criteria and the study details for the AimStick™ PBD Pregnancy test, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or percentage format beyond the concordance. However, based on the study's design and reported results, the implied acceptance criterion for substantial equivalence in this context is 100% concordance with a legally marketed predicate device.

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

• Sample Size: 150 urine specimens.
• Data Provenance: Not specified (e.g., country of origin). The study is described as a "multi-center clinical evaluation," implying real-world samples. It is a retrospective study as it involves testing existing (collected) urine specimens.

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

The document does not provide information on the number or qualifications of experts used to establish the ground truth for the test set. Instead of expert consensus, the "ground truth" for the comparative study was the result obtained from the "other commercially available test."

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. Since the "ground truth" was based on a single comparative test, an adjudication process as typically understood (e.g., 2+1 adjudication by human readers) was not applicable in this context. The concordance was directly calculated by comparing the results of the two tests.

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

No, an MRMC comparative effectiveness study was not conducted. This study compares the performance of a new device against a predicate device, rather than assessing improvements in human reader performance with AI assistance.

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

Yes, a standalone performance evaluation was conducted. The AimStick™ PBD Pregnancy test is an in vitro diagnostic device, and its performance (detecting hCG, sensitivity, specificity/cross-reactivity) is assessed as a standalone product. The clinical evaluation compares its standalone performance to another standalone diagnostic. There is no "human-in-the-loop" component in the operation of this test strip.

7. The Type of Ground Truth Used

The primary ground truth for the "multi-center clinical evaluation" was the results obtained from a "commercially available test." This serves as a comparative ground truth for establishing substantial equivalence.

Additionally, internal validation was performed for the device's sensitivity and specificity:

• Sensitivity ground truth: Known concentrations of hCG (20 mIU/ml and greater) and negative urine (0 mIU/ml hCG) were used.
• Specificity/Cross-reactivity ground truth: Known concentrations of hLH, hFSH, and hTSH added to negative and positive urine were used.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. For in vitro diagnostic devices like pregnancy tests, "training sets" in the context of machine learning (AI) are not typically applicable. The device's components (monoclonal and polyclonal antibodies) are developed and optimized through laboratory research and development, not by "training" an algorithm on a dataset.

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

As noted in point 8, the concept of a "training set" and associated ground truth is not applicable to this type of diagnostic device. The performance characteristics of the antibodies and test strip components are established through controlled laboratory experiments and analytical studies, not through AI training protocols.

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MidStream™ Home Pregnancy Test is intended for nonprofessional use for the identification of hCG (human Chorionic Gonadotropin) in urine to aid in the determination of pregnancy.

The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated levels of hCG. The assay is conducted by urinating on the absorbent wick and observing for the formation of colored bands. The specimen migrates via capillary action along the wick and membrane to react with the colored conjugate. Positive specimens react with the specific antibody-hCG-colored conjugate and form a colored band on the Specimen portion of the membrane. Absence of this colored band suggests a negative result. To serve as a procedural control, a colored band at the Control Zone will always appear regardless of the presence or absence of hCG.

Here's a summary of the acceptance criteria and study details for the MidStream™ Home Pregnancy Test based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 112 female participants.
• Data Provenance: Not explicitly stated, but implied to be from a clinical trial in the context of a US regulatory submission (FDA). The data is prospective as it involves actively testing participants and gathering their results, comparing them to laboratory results.

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

The document does not explicitly state the number of "experts" used for establishing ground truth for the test set beyond the mention of "laboratory results." However, it implies that professional laboratory testing served as the reference standard. The qualifications of the personnel performing these laboratory tests are not detailed.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1). It states a "comparison study between the participants results and laboratory results," suggesting a direct comparison without complex adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the self-interpretation of the home test by participants to laboratory results, not the performance of human readers with vs. without AI assistance. This device is a standalone diagnostic kit, not an AI-assisted diagnostic tool.

6. Standalone Performance

Yes, a standalone performance study was done. The entire clinical trial evaluates the device's performance (i.e., the algorithm/test strip's ability to detect hCG) when used by the intended non-professional users. The comparison is between the users' interpretations of the device's results and professional laboratory results.

7. Type of Ground Truth Used

The ground truth used was laboratory results, which would typically involve high-sensitivity quantitative or qualitative hCG assays performed by trained laboratory personnel.

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This is a traditional in-vitro diagnostic device, not a machine learning model, so the concept of a "training set" in the AI sense does not apply. The inherent design and components of the test (antibodies, membrane chemistry) are developed and refined through R&D, not through an iterative machine learning training process with a distinct training dataset.

9. How Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" in the context of an AI/ML model is not applicable here. The "ground truth" for the development of the test strip itself would be based on established biochemical principles of antigen-antibody detection, using known concentrations of hCG and other structurally similar hormones to ensure specificity and sensitivity during product development and manufacturing quality control.

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