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SAS™ FluAlert A Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of Influenza A viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. The test is not intended for the detection of Influenza Type B viral antigen or Influenza Type C viral antigen. This test is for professional use only.

Negative results do not preclude infection with influenza A and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.

The SASTM FluAlert A Test utilizes antibodies against influenza type A viral nucleoproteins. The SASTM FluAlert A Test begins with an extraction of Type A nucleoproteins. After the extraction has been completed, the sample is placed into the sample well of the test. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for influenza A viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of influenza A nucleoproteins, a "whole sandwich" immunocomplex is formed and a visible, pink-colored line develops in the specimen zone of the test device. In the absence of an influenza A antigen, a "sandwich" immunocomplex is not formed and a negative result is indicated. To serve as a procedural control, a pink-colored control line will always appear in the control zone of each strip regardless of the presence or absence of influenza A nucleoproteins.

The provided text describes the SASTM FluAlert A Test, a rapid immunoassay for the presumptive in-vitro qualitative detection of Influenza A viral nucleoprotein antigens. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SASTM FluAlert A Test are based on its analytical sensitivity (Limit of Detection - LoD) for various influenza A viral strains. The reported performance demonstrates the concentration at which the device can detect these strains.

Note: The document implies that the device is intended to "detect" these strains, thus the acceptance criteria are that the device demonstrates a measurable Limit of Detection for each. The specific numerical thresholds for acceptance were not explicitly defined as pass/fail criteria in the provided text, but the reported LoD values demonstrate the device's capability.

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

The provided text describes an analytical sensitivity study (Limit of Detection) rather than a clinical test set with human samples.

• Sample Size for the test set: For each influenza viral strain tested, the study involved serial dilutions to determine the Limit of Detection (LoD). The exact number of replicates or individual test instances at each dilution is not specified, but the methodology implies multiple tests per dilution series to establish the LoD.
• Data Provenance: The strains tested were obtained from ATCC (American Type Culture Collection), a global non-profit biological resource center. These are cultured viral strains, not directly human clinical samples. The document states "a positive human specimen" was used to culture the FluA/California/04/2009 (H1N1) virus, but the LoD study itself used the cultured strain rather than direct clinical specimens for this particular virus. The study is therefore retrospective in the sense that it uses established and archived viral strains. The country of origin of the ATCC strains is not specified in this document.

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

There were no human experts used to establish ground truth for this particular analytical sensitivity study. The ground truth was established by the known titers of the viral strains obtained from ATCC. The document states: "This viral strain used in this study was obtained from ATCC with a known titer. SA Scientific, Ltd did not verify this titer."

4. Adjudication Method for the Test Set

Not applicable. This was an analytical study determining the Limit of Detection using cultured viral strains with known titers, not a study involving human adjudication of results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is an analytical sensitivity study of the device's ability to detect specific viral strains, not a study comparing human reader performance with or without AI assistance.

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

Yes, this was a standalone performance study from the perspective of the device. The study evaluated the SASTM FluAlert A Test's ability to detect influenza A viral nucleoprotein antigens without human interpretation being part of the primary measurement for the LoD. The "visual" aspect of the assay implies a human performs the reading, but the study focuses on the lowest concentration the device can detect, independent of variations in human interpretation during clinical use.

7. The Type of Ground Truth Used

The type of ground truth used was known viral titers provided by ATCC for the various influenza A strains. This is a form of analytical ground truth, based on established biological standards.

8. The Sample Size for the Training Set

No information is provided about a "training set" in the context of machine learning or algorithm development. The SASTM FluAlert A Test is described as an "immunoassay utilizing immunochromatographic technology," which typically means it relies on biochemical reactions (antibody-antigen binding) rather than an AI algorithm that requires a training set.

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

Not applicable, as no training set for an AI algorithm appears to have been used in the development or evaluation of this immunoassay device.

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SAS™ FluAlert A & B Test is a visual and rapid assay for the presumptive in-vitro qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal washes and nasal aspirates of symptomatic patients. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type C viral antigen. This test is for professional use only. Negative results do not preclude infection with influenza A or B and should not be used as the sole basis for treatment or other patient management decisions. It is recommended that negative results be confirmed by cell culture.

The SAS™ FluAlert A & B Test utilizes antibodies against influenza type A and influenza type B viral nucleoproteins. After the extraction has been completed, the sample is placed into two separate sample wells. The specimen is absorbed and migrates via capillary action through membranes that contain dried gold conjugated antibody, which is specific for either influenza A or influenza B viral nucleoproteins. If these nucleoproteins are present, a "half-sandwich" immunocomplex is formed. The membrane contains immobilized antibody to influenza A or influenza B nucleoproteins, respectively, which bind the "half sandwich" complex. Thus, in the presence of influenza nucleoproteins, a "whole sandwich" immunocomplex is formed and a visible, pink-colored line develops in the specimen zone of the test device. In the absence of an influenza antigen, a "sandwich" immunocomplex is not formed and a negative result is indicated. To serve as a procedural control, a pink-colored control line will always appear in the control zone of each strip regardless of the presence or absence of influenza A or influenza B nucleoproteins.

Here's a breakdown of the acceptance criteria and study details for the SAS™ FluAlert A & B Test, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, the study aims to demonstrate "substantial equivalence" to predicate devices (SAS™ Influenza A Test and SAS™ Influenza B Test). The performance benchmarks are effectively the agreement rates with these predicate devices for positive and negative influenza cases.

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

• Prospective Clinical Study:
  • Sample Size: 461 nasal clinical specimens (nasal washes and nasal aspirates combined).
  • Data Provenance: Prospectively collected from four clinical trial sites in Texas and South Dakota, USA. An approximately equal mix of adult (>21 years) and pediatric patients (0-21 years) for nasal washes, and predominantly pediatric patients for nasal aspirates.
• Retrospective Study:
  • Sample Size: 191 frozen, archived nasal wash samples.
  • Data Provenance: Retrospective, from a children's hospital in Texas, USA.

In the prospective study, 13 samples yielded invalid results and were excluded from the totals.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth for the clinical specimens. The comparison is made against the predicate devices (SAS™ Influenza A Test and SAS™ Influenza B Test) and also mentions "cell culture or DFA" for those predicate devices in the "Results Summary" chart reference, but not explicitly for the new device's test set.

4. Adjudication Method for the Test Set

The document states that the clinical specimens were tested "blindly and prospectively comparing the SAS™ Influenza A Test and The SAS™ FluAlert A&B (combined) Test performance" and similarly for Influenza B. This implies that the results of the new device were compared against the established results of the predicate devices. There is no explicit mention of an adjudication method like 2+1 or 3+1 by human readers; the comparison is device-to-device.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study compares the new device's performance directly to the predicate devices, not human readers with and without AI assistance. The "reproducibility" section involved "non-professional users," but this was to assess consistent device results, not to evaluate human reader improvement with AI.

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

Yes, this is essentially a standalone performance study. The SAS™ FluAlert A & B Test is a rapid immunoassay (visual and rapid assay) that produces a visible, pink-colored line. Its performance is evaluated directly against predicate devices based on its ability to detect influenza viral nucleoprotein antigens. There is no "human-in-the-loop" component mentioned for interpreting the device's fundamental output beyond simply reading the presence or absence of a line.

7. The Type of Ground Truth Used

The primary ground truth for evaluating the SAS™ FluAlert A & B Test's performance in the clinical studies is the results from the substantially equivalent predicate devices (SAS™ Influenza A Test and SAS™ Influenza B Test). For these predicate devices, the document refers to a comparison to "cell culture or DFA" in an older summary, implying that those methods serve as a "gold standard" for the predicate devices, and by extension, for this new device's evaluation against the predicates.

8. The Sample Size for the Training Set

The document describes performance studies for a diagnostic device, not a machine learning algorithm that typically requires a separate training set. Therefore, there is no explicit training set or sample size for training mentioned as it's not applicable in the context of this type of diagnostic device submission.

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

As there is no explicit training set for a machine learning algorithm, there is no description of how ground truth for a training set was established. The studies conducted are for performance evaluation against established methods and devices.

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SAS™ Influenza B Test is a visual and rapid assay for the presumptive qualitative detection of Influenza Type B antigens from nasal washes and aspirates. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type A or C viral antigen. The test is for professional use.

The SAS™ Influenza B test utilizes a set monoclonal antibodies against Influenza Type B viral nucleoproteins. The SAS™ Influenza test begins with an extraction of Type B nucleoproteins. After the extraction has been completed, the sample is placed into the test and observed for the formation of colored lines. The specimen is absorbed and migrates via capillary action through a membrane that contains dried gold conjugated antibody, which is specific for Influenza Type B nucleoproteins. If Type B nucleoproteins are present, a "half-sandwich" immuno-complex is formed. The membrane contains immobilized antibody to Influenza Type B nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of Influenza nucleoproteins, a "whole sandwich" immuno-complex is formed and a visible, pink colored line develops in the specimen zone of the test device. In the absence of an Influenza antigen, a "sandwich" immuno-complex is not formed and a negative result is indicated. To serve as a procedural control, a pink colored control line will always appear in the control zone regardless of the presence or absence of Influenza B nucleoproteins.

Acceptance Criteria and Study for SAS™ Influenza B Test

The provided document describes the SAS™ Influenza B Test, an immunoassay for the presumptive qualitative detection of Influenza Type B antigens. The primary study presented aims to demonstrate substantial equivalence to a predicate device, the Binax™ NOW® Flu B Test.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity, specificity, or positive/negative predictive values. Instead, the acceptance criterion appears to be demonstrating substantial equivalence to the predicate device. The performance summary indirectly addresses this by stating the device performed "substantially equivalent" when compared to the predicate using freshly collected nasal wash specimens.

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

• Sample Size: Not explicitly stated. The document indicates that the comparison was made using "freshly collected nasal wash specimens." The exact number of specimens is not provided.
• Data Provenance: The data is described as using "freshly collected nasal wash specimens," implying the data is prospective in nature. The country of origin is not specified, but the submission is from SA Scientific, Inc. in San Antonio, TX, USA, suggesting the data is likely from the United States.

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 a "ground truth" for the test set in the traditional sense (e.g., expert consensus on images). Instead, the study's ground truth for comparison is likely derived from the predicate device's results, or potentially in conjunction with a more definitive method like viral culture, though culture is only mentioned for confirming negative results in the "Indications for Use."

4. Adjudication Method for the Test Set

No adjudication method is described. The study appears to be a direct comparison of the investigational device's results against the predicate device's results, or against a reference standard without mention of a formal adjudication process.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a rapid immunoassay test, which typically provides a single, objective result (positive/negative) without requiring interpretation by multiple readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this type of device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone performance study was done. The SAS™ Influenza B Test is a visual immunoassay that produces a direct result. Its performance is evaluated intrinsically through its ability to detect the target antigen, not as an algorithm assisting a human. The performance summary describes its direct comparison to the predicate device, indicating a standalone evaluation.

7. Type of Ground Truth Used

The primary ground truth for establishing substantial equivalence was likely the results from the predicate device (Binax™ NOW® Flu B Test) using the same "freshly collected nasal wash specimens." While the "Indications for Use" section states that "Negative results should be confirmed via culture," it's not explicitly stated that viral culture was used as the definitive ground truth for the equivalence study itself, but rather as a clinical follow-up for specific results.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable as this is a rapid immunoassay device, not a machine learning or AI algorithm. Therefore, no training set size is mentioned.

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

As there is no training set for this type of device, this question is not applicable.

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SAS™ Influenza A Test is a visual and rapid assay for the presumptive qualitative detection of Influenza Type A antigens from nasal washes and aspirates. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type B or C viral antigen. The test is for professional use.

The SASTM Influenza A test utilizes a set monoclonal antibodies against Influenza Type A viral nucleoproteins. The SASTM Influenza test begins with an extraction of Type A nucleoproteins. After the extraction has been completed, the sample is placed into the test and observed for the formation of colored lines. The specimen is absorbed and migrates via capillary action through a membrane that contains dried gold conjugated antibody, which is specific for Influenza Type A nucleoproteins. If Type A nucleoproteins are present, a "half-sandwich" immuno-complex is formed. The membrane contains immobilized antibody to Influenza Type A nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of Influenza nucleoproteins, a "whole sandwich" immuno-complex is formed and a visible, pink colored line develops in the specimen zone of the test device. In the absence of an Influenza antigen, a "sandwich" immuno-complex is not formed and a negative result is indicated. To serve as a procedural control, a pink colored control line will always appear in the control zone regardless of the presence or absence of Influenza nucleoproteins.

Here's an analysis of the provided text regarding the SAS™ Influenza A Test, focusing on the acceptance criteria and the supporting study:

The provided document describes a 510(k) submission for the SAS™ Influenza A Test. It claims substantial equivalence to a predicate device, the Binax™ NOW® Flu A Test, based on performance with freshly collected nasal wash specimens.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device. The performance of the SAS™ Influenza A Test is reported in comparison to the predicate.

Note: The document focuses on showing substantial equivalence and mentions "Performance Summary: The SAS™ Influenza A test performed substantially equivalent to the predicate device, Binax™ NOW® Flu A test. This was verified by comparison to freshly collected nasal wash specimens." Specific metrics like sensitivity, specificity, or agreement rates are not explicitly provided within this summary, but are inferred to be comparable to the predicate for substantial equivalence.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size used for the comparison study. It only mentions "freshly collected nasal wash specimens."
• Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the study was conducted to support a US FDA 510(k) submission, suggesting it was likely conducted in the US or under US regulatory standards. The study design is prospective, as it used "freshly collected nasal wash specimens."

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

• Number of Experts: Not specified.
• Qualifications of Experts: The ground truth for positive influenza A cases was "confirmed via culture." The document does not specify who performed or interpreted these cultures, or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for reconciling discordant results between the SAS™ Influenza A Test, the predicate device, and the culture confirmation.

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 question is not applicable to this device. The SAS™ Influenza A Test is an in vitro diagnostic immunoassay that provides a visual result (colored lines) and does not involve human readers interpreting complex images or AI assistance.

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

This question is not applicable to this device. It is a rapid immunoassay, a "standalone" device in the sense that it produces a result directly without requiring an additional algorithm or human interpretation beyond observing the presence or absence of colored lines.

7. The Type of Ground Truth Used

The ground truth used for positive cases was culture confirmation. Specifically, "Negative results should be confirmed via culture." and "confirmed via culture." for positive cases.

8. The Sample Size for the Training Set

This question is not applicable to this device. The SAS™ Influenza A Test is a rapid immunoassay that utilizes monoclonal antibodies and immunochromatographic technology. It is not an algorithm or AI-based device that requires a "training set."

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

This question is not applicable for the same reasons as point 8. No training set was used.

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SAS™ RSV Control Kit are controls for use with the SAS™ RSV Test Kit.

The test is for professional use.

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I am sorry, but based on the provided document, there is no information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "SASTM RSV Control Kit."

This letter primarily focuses on:

• Substantial Equivalence Determination: Stating that the device is substantially equivalent to legally marketed predicate devices.
• Regulatory Classification: Identifying the device as Class I and its regulation number and product code.
• General Controls: Reminding the applicant of general control provisions of the Act (registration, listing, GMP, labeling, etc.).
• Indications for Use: Confirming the intended use of the SASTM RSV Control Kit as controls for use with the SASTM RSV Test Kit.

The document does not include any performance data, study designs, sample sizes, ground truth methodologies, or expert qualifications that would be required to describe acceptance criteria and a study proving device performance against them.

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SAS™ RSV antigen test kit is a visual and rapid assay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimens. The test is for professional use.

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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific criteria. The document is an FDA 510(k) clearance letter for the SASTM RSV Test, indicating that the device has been found substantially equivalent to legally marketed predicate devices.

The letter mentions:

• Trade/Device Name: SASTM RSV Test
• Regulation Number: 21 CFR 866.3480
• Regulation Name: Respiratory Syncytial Virus Serological Reagents.
• Regulatory Class: Class I
• Indications for Use: "SAS™ RSV antigen test kit is a visual and rapid assay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimens. The test is for professional use."

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample size, data provenance, number of experts, adjudication methods for a test set.
• Information on MRMC comparative effectiveness studies or standalone algorithm performance.
• Details about the type of ground truth used or the sample size and ground truth establishment for a training set.

The FDA 510(k) clearance process focuses on substantial equivalence to a predicate device, and while it requires demonstration of safety and effectiveness, the provided document does not contain the specific study details you are asking for. Such information would typically be found in the 510(k) submission itself or related study reports, not in the clearance letter.

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SASTM Blood/Serum/Urine hCG is a visual and rapid test for the qualitative determination of human chorionic gonadotropin (hCG) in whole blood, serum or urine to aid in the early detection of pregnancy. The test is for professional use.

The SAS Blood/Serum/Urine Test utilizes the same antibodies and 90% of the same test construction of the Modified SAS Serum/Urine test. The most significant difference in the SAS Blood/Serum/Test is that it utilizes a red blood cell separation media that separates plasma from the whole blood cell component.

The provided text describes a 510(k) submission for the SASTM Blood/Serum/Urine hCG diagnostic device. This is a point-of-care test for pregnancy detection. The submission primarily focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

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

The provided text does not explicitly state specific acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy percentages) or detailed performance data for the SASTM Blood/Serum/Urine hCG device against such criteria. Instead, it focuses on comparing the new device's features and characteristics to a modified version of a predicate device (Modified SAS Serum/Urine hCG Test) and asserts that "These modifications do not affect the performance, safety or efficacy of the product."

The table provided is a comparison of device characteristics, not a performance table against pre-defined acceptance criteria.

The statement "These modifications do not affect the performance, safety or efficacy of the product. Please refer to the data included in this submission" strongly implies that the performance (sensitivity and specificity) is expected to be equivalent to the predicate, with the primary change being the addition of whole blood testing capability and the associated blood cell separation media. However, the specific data demonstrating this equivalence is not present in the provided snippets.

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

The provided text does not include information on the sample size used for any test set or the data provenance (country of origin, retrospective/prospective). It mentions "data included in this submission" but the data itself is not provided.

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)

The provided text does not include information on the number or qualifications of experts used to establish ground truth. For a pregnancy test, ground truth would typically be established by laboratory methods (e.g., quantitative hCG assays) rather than expert review of images, but the document doesn't detail this.

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

The provided text does not include information on 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 question is not applicable to the SASTM Blood/Serum/Urine hCG device. This device is a rapid diagnostic test for hCG, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data with or without AI assistance.

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

This question is not applicable to the SASTM Blood/Serum/Urine hCG device. It is a lateral flow immunoassay that human users read visually, not an algorithm.

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

The provided text does not explicitly state the type of ground truth used. However, for an hCG test, the typical ground truth would be established by comparing the rapid test results to a more sensitive and quantitative laboratory method (e.g., a laboratory-based quantitative immunoassay for hCG) or clinical outcomes (e.g., confirmation of pregnancy by ultrasound or subsequent clinical events).

8. The sample size for the training set

The provided text does not include information on any training set sample size. This type of information is typically relevant for machine learning or AI models, which is not the case for this device.

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

The provided text does not include information on how ground truth was established for a training set. As mentioned in point 8, this device is not an AI/ML system.

In summary:

The provided document is a 510(k) summary for a rapid diagnostic pregnancy test, focusing on demonstrating substantial equivalence to a predicate device based on manufacturing and design similarities. It lacks detailed performance data, study methodologies, or information about specific acceptance criteria, expert involvement, or ground truth establishment that would be present in a comprehensive study report. The core assertion is that the modifications (primarily adding whole blood compatibility) do not affect the device's performance, safety, or efficacy, and this is supported by "data included in this submission" which is not provided here.

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SASTM StrepAlert is a rapid visual test for the presumptive, qualitative detection of group A streptococcal antigen from throat swab specimens. The test is for professional use.

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This document is a 510(k) clearance letter from the FDA for the SAS™ StrepAlert device, which is a rapid visual test for the presumptive, qualitative detection of group A streptococcal antigen from throat swab specimens.

Generally, 510(k) clearances establish substantial equivalence to a predicate device rather than showing proof of meeting specific acceptance criteria through a detailed study. Such studies are typically part of a PMA (Premarket Approval) application for higher-risk devices.

Based on the provided document, the following information can be extracted regarding the "study" referenced implicitly by the 510(k) clearance, which would be a comparison to a predicate device:

1. A table of acceptance criteria and the reported device performance
   The document does not explicitly state acceptance criteria or provide a table of performance data. For a 510(k), the "acceptance criteria" are generally demonstrating substantial equivalence to a legally marketed predicate device. This usually involves showing comparable performance (e.g., sensitivity, specificity) but detailed numerical criteria and results are not present in this summary letter.

2. Sample size used for the test set and the data provenance
   This information is not provided in the FDA clearance letter. Such details would typically be found in the 510(k) submission itself, not in the summary letter.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
   This information is not provided in the FDA clearance letter. For a test detecting a biological antigen, the "ground truth" would likely be established through bacterial culture.

4. Adjudication method for the test set
   This information is not provided in the FDA clearance letter.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
   This is highly unlikely for a rapid in vitro diagnostic test like StrepAlert. MRMC studies are typically for imaging devices where human readers interpret results "with and without AI assistance." The SAS™ StrepAlert is a "rapid visual test" for antigen detection, not an image interpretation system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   The device is described as a "rapid visual test," implying human interpretation of results (e.g., color change on a test strip). Therefore, a "standalone algorithm only" performance would not be applicable in the sense of a machine learning algorithm. Its performance is inherent to the chemical reactions and visual indicators.

7. The type of ground truth used
   While not explicitly stated in this document, for in vitro diagnostic tests for bacterial antigens, the gold standard "ground truth" is almost universally bacterial culture. That is, a throat swab would be cultured to definitively identify the presence or absence of Group A Streptococcus, and this result would be compared to the rapid test result.

8. The sample size for the training set
   This information is not provided. For this type of rapid diagnostic test, there isn't a "training set" in the machine learning sense. The device's performance is based on its chemical and biological design, which is validated through clinical studies rather than by training a model on data.

9. How the ground truth for the training set was established
   As there is no "training set" in the context of a machine learning algorithm, this question is not applicable. The device's performance characteristics are inherent to its design and validated against a biological gold standard (likely culture) in clinical trials.

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SASTM Value hCG is a visual test for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine.to aid in the early detection of pregnancy. The test is for professional use.

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I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

The document is an FDA 510(k) clearance letter for the "SASTM Value hCG" device, stating its substantial equivalence to a legally marketed predicate device. It defines the device's indications for use (qualitative detection of human chorionic gonadotropin in serum or urine to aid in early pregnancy detection for professional use). However, it does not include performance data or study details.

Therefore, I cannot fulfill your request for the specific information you've asked for.

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SASTM StrepAlert is a visual test for the qualitative detection of Group A Streptococcus antigen in throat swab specimens. The test is for professional use.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the SAS™ StrepAlert device. This document confirms the device's substantial equivalence to a legally marketed predicate device but does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a study report or a more extensive submission document.

Therefore, I cannot provide the requested table of acceptance criteria and device performance, or details about the study design, sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided FDA clearance letter.

The letter primarily focuses on:

• Device Name: SAS™ StrepAlert
• Regulation Number: 21 CFR 866.3740 (Streptococcus spp. Serological reagents)
• Regulatory Class: Class I
• Product Code: GTY
• Indications for Use: "SASTM StrepAlert is a visual test for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens. The test is for professional use."
• 510(k) Number: K013379

To obtain the detailed information regarding acceptance criteria and study results, one would typically need to refer to the original 510(k) submission document or a summary thereof, which often includes a "Summary of Safety and Effectiveness Data" that details the studies performed to demonstrate substantial equivalence. This information is not found within the provided FDA clearance letter.

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