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The BioStar® CdTOX A OlA assay is an Optical ImmunoAssay test for the rapid qualitative detection of Clostridium difficile Toxin A in human fecal samples from patients suspected of having Clostridium difficile associated disease (CDAD). This test is intended for in vitro diagnostic use as an aid in the diagnosis of CDAD.

The CdTOX A OIA test involves the qualitative detection of the enterctoxin (Toxin A) produced by Clostridium difficile. The Optical Immuno Assay technology enables the direction of a physical change in the optical thickness of molecular this change is a result of antigen-antibody binding on an optical surface (silicon wafer). When a sample containing Toxin A (antigen) from Clostridium difficile is placed directly on the optical surface, the immobilized specific antibody captures the antigen. After washing, the substrate is added, increasing the thickness (Mass Enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color changes in optical thickness produce a distinct, visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the surface retains the original gold color indicating a negative result.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the BioStar® CdTOX A OIA® assay.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate list with specific numerical targets for all metrics. However, it presents analytical and clinical performance data in comparison to a predicate device and a reference method (cytotoxicity assay), implying these are the metrics against which the device's performance is judged. The primary comparison is often to demonstrate substantial equivalence to the predicate device and acceptable performance against a gold standard (cytotoxicity assay).

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

• Analytical Sensitivity: No specific sample size is given for the "test set" in the traditional sense. It involved adding known concentrations of Toxin A to five specimens each of liquid, semi-solid, and solid stools, tested in duplicate.
• Analytical Specificity (Cross Reactivity) & Interfering Substances: Microorganisms grown to ~1.0 X 10 cfu/mL or greater; Cryptosporidium parvum and Giardia lamblia rested at 1.25 X 10^6 cysts for cross-reactivity. For interfering substances, whole blood, RBC, WBC, mucous (25mg/g), and barium sulfate (58% w/w suspension) were tested. The number of specimens tested with interfering substances is not explicitly stated.
• Reproducibility:
  • Three hospital laboratories study: 10 blinded samples tested at each site at three separate times. Total: 10 samples * 3 sites * 3 times = 90 tests.
  • Artificial stool matrix study (four hospital labs and three physician office labs): Comparable samples prepared and tested. Total: 210 tests.
• Clinical Sensitivity and Specificity (vs. CTA): A study performed at a central hospital lab. Number of samples used for this specific comparison is not explicitly stated.
• Clinical Performance Evaluation (versus Premier EIA): 874 specimens.
• Data Provenance:
  • Clinical Sensitivity and Specificity (vs. CTA): "a central hospital lab."
  • Clinical Performance Evaluation (versus Premier EIA): "four clinical trial sites (central hospital labs) located in the Southwest, Mid-Atlantic and East Coast regions of the United States."
  • Reproducibility: "three hospital laboratories" and "four hospital laboratories and three physician office laboratories (POLs)".
  • All clinical samples were "from patients suspected of having or with a history of CDAD." The clinical studies appear to be retrospective as samples were "submitted for C. difficile testing on the basis of clinical history of the patient."

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

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

4. Adjudication method for the test set:

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable as the device is a diagnostic assay (in vitro diagnostic device) for detecting a toxin, not an AI-assisted imaging or interpretation device that would involve human readers.

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

The device (CdTOX A OIA) itself is a standalone assay. It's a chemical test ("Optical ImmunoAssay technology") that provides a visual result ("A positive result appears as a purple spot on the predominant gold background"). There is no "algorithm" or human-in-the-loop interpretation beyond visual inspection of the color change, which is inherent to the test's design. The clinical studies evaluated the performance of this standalone assay.

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

• For the clinical sensitivity and specificity evaluation, the cytotoxicity assay (CTA) was used as the ground truth.
• For the comparison with the predicate device, the Premier EIA (another commercial immunoassay) was used as a comparative method, not strictly a ground truth, although concordance was evaluated against it.

8. The sample size for the training set:

The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. The development and analytical testing of an in vitro diagnostic device typically involve iterative design and optimization, but not in the same way as training a machine learning model.

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

As no explicit "training set" in a machine learning context is mentioned, this question is not applicable. The device's development likely relied on established biochemical principles and extensive internal analytical validation using spiked samples and characterization, rather than a separate training set with ground truth labels.

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The BioStar® STREP B OIA® assay is an Optical ImmunoAssay (OIA) test for the rapid detection of group B streptococcal antigen directly from cervical and vaginal swabs from intrapartum maternity patients. The STREP B OIA assay is intended for use as an adjunct to culture, clinical observation and other information available to the physician.

The STREP B OlA test involves the extraction of a carbohydrate antigen unique to group B Streptococi from the cervical or vaginal swab specimen and the subsequent use of Optical ImmunoAssay technology for the qualitative detection of this specific antigen. The Optical ImmunoAssay technology allows the direct visual detection of the physical change in optical thickness of molecular thing from the binding reactions between antibodies and antigens. The signal is generated by the reflection of light through the molecular thin films formed on an optical substrate. White light reflected through the molecular thin film results in a predominant visual background gold color. This color will not change unless the thickness of the optical molecular thin film is changed. When a liquid sample containing antigen from group B Streptococci is placed on the test surface, binding occurs between the antigen and immobilized antibody, causing an increased thickness in the molecular this reaction takes place, the optical path through the film is changed, causing a corresponding change in the gold color to purple/blue, thereby indicating a positive result. The change in optical thickness is due to the binding of specific antigen. If the antigen is not present in the sample, no binding takes place. The original molecular thickness remains unchanged and the test surface retains its original gold color, indicating a negative result. The clear endpoint and unequivocal results observed with the optical detection system lead to a very sensitive easily interpreted assay system.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the STREP B OIA® device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of sensitivity and specificity targets. However, the study results are presented with 95% Confidence Intervals (CI), which implicitly define a range of acceptable performance. The performance is reported in comparison to "Lim Broth Culture" as the reference standard.

Note: The document also reports sensitivity for "TSA Culture to Lim Broth Culture" for comparison, which achieved a sensitivity of 60.8% (CI: 53.7-67.6%) and specificity of 99.6% (CI: 98.8-99.9%). This suggests that the STREP B OIA®'s performance falls within a similar range of what would be expected from a non-selective culture method compared to a selective broth culture.

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

• Sample Size for Test Set: 947 samples (cervical and vaginal swabs).
• Data Provenance: The study was a "prospective evaluation of clinical specimens taken from women." The country of origin is not explicitly stated, but the submission is to the FDA (USA), implying the study was likely conducted in the USA or adhering to US regulatory standards.

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

The ground truth was established by microbiological culture methods (Lim broth culture and TSA culture), not by human experts interpreting results. The document does not mention the number or qualifications of personnel performing these lab procedures.

4. Adjudication Method for the Test Set

No explicit adjudication method (like 2+1 or 3+1 consensus) was used, as the ground truth was determined by laboratory culture results.

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 a rapid diagnostic test intended for laboratory use, not typically requiring human reader interpretation in the same way as imaging studies. The study compared the device's performance to a laboratory reference standard.

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

Yes, this study represents a standalone performance evaluation of the STREP B OIA® device. The device itself produces a clear visual positive or negative result, which is then recorded. The performance metrics presented are based on the device's output compared to the reference standard, without any human interpretation of the device's optical changes being part of the reported performance.

7. The Type of Ground Truth Used

The primary ground truth used for establishing clinical performance was Lim broth culture, which is a selective broth culture method considered a more sensitive reference standard for Group B Strep detection compared to direct agar culture. The document also mentions comparison to "routine microbiological Trypticase Soy Agar with 5% Sheep Blood (TSA) culture media" as an initial step.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or its size. In vitro diagnostic devices like the STREP B OIA® are typically developed and optimized by the manufacturer, and then clinical performance is assessed on a distinct set of samples. The study described in section H is referred to as a "clinical testing" or "clinical evaluation," implying it serves as the validation dataset.

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

Since no separate training set is explicitly mentioned, the method for establishing ground truth for the clinical evaluation (which serves as the basis for performance claims) was as follows:

• Cervical and vaginal specimens were collected using dual swabs.
• One swab was either:
  • Plated directly onto TSA within 24 hours of collection.
  • The pledget from the swab was placed in Lim broth, incubated, and then subcultured (10 ul) at 18-24 hours to a TSA plate.
• All plates were incubated, and beta-hemolytic streptococcal colonies were selected and confirmed using a streptococcal group serotyping method.
• Lim broth culture was identified as the reference standard against which the STREP B OIA®'s performance was compared.

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The BioStar® AB FLU OIA® assay is an Optical ImmunoAssay (OIA) test for the qualitative, rapid detection of influenza A and B viral antigen (nucleoprotein) from nasal aspirate, nasopharyngeal swab, throat swab, or sputum specimens. This test is intended for in vitro diagnostic use to aid in the diagnosis of influenza A and B viral infections. The AB FLU OIA test is not intended to detect influenza C. Negative test results should be confirmed by cell culture.

The AB FLU OIA test involves the extraction and detection of a protein antigen unique to influenza A or B (nucleoprotein). The Opical ImmunoAssay technology enables the direction of a physical change in the optical thickness of molecular thin films. This change is a result of antigen-antibody binding on an optical surface (silicon wafer). When extracted specimen is placed directly on the optical surface, the immobilized specific antibodies capture the antigen. After washing, the substrate is added, increasing the thickness (Mass Enhancement) of the molecular thin film. This change in thickness alters the reflected light path and is visually perceived as a color change. Slight changes in optical thickness produce a distinct visible color change. A positive result appears as a purple spot on the predominant gold background. When antigen is not present in the specimen, no binding takes place. Therefore, the optical thickness remains unchanged and the original gold indicating a negative result.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BioStar® AB FLU OIA Test Kit:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity and specificity thresholds. Instead, it presents the "relative sensitivity" and "relative specificity" as the results of the clinical study for different specimen types. The conclusion states that these results, combined with analytical sensitivity and specificity, demonstrate that the device is safe and effective. Therefore, the reported performance itself serves as the basis for acceptance. I will present the reported clinical performance.

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

• Sample Size for Test Set: 184 individuals exhibiting influenza-like symptoms.
• Data Provenance:
  • Country of Origin: United States (indicated by "Rocky Mountain region," "Midwest region," and "Southwestern region" for the three study sites).
  • Retrospective or Prospective: Prospective, as specimens were collected from individuals exhibiting symptoms as part of the evaluation.

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 or qualifications of experts used to establish the ground truth. It states that the ground truth was determined by "confirmed culture from any specimen type." This implies trained laboratory personnel performed and interpreted the cultures, but their specific qualifications (e.g., years of experience, specific certifications) are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1) for discordant results between the device and the ground truth (cell culture). The "relative sensitivity and specificity" were calculated by comparing the AB FLU OIA assay results directly to the 14-day culture 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, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or described. This is an in vitro diagnostic device (test kit) meant for laboratory use, not a device that directly assists human readers/clinicians in interpreting images or data. The comparison is between the test kit and a conventional laboratory method (cell culture).

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

Yes, this study represents a standalone performance evaluation of the device. The AB FLU OIA assay is a laboratory test kit, and its performance was assessed independently against cell culture without direct human interpretation influencing its results.

7. The Type of Ground Truth Used

The primary ground truth used for determining clinical performance (relative sensitivity and specificity) was cell culture (specifically, "14-day culture"). For analytical sensitivity, the ground truth was also cell culture (TCID/test values estimated by inoculating dilutions into cell culture).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" for the device, as it describes a finished diagnostic test kit rather than a machine learning algorithm that undergoes a distinct training phase with a specific dataset. The evaluation presented focuses on the device's performance characteristics.

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

As no specific training set is identified in the context of machine learning, this question is not directly applicable. If considering the development process of the assay, the ground truth for establishing acceptable performance characteristics (e.g., antibody binding, optical properties) would have been determined through internal validation using known positive and negative controls, spiked samples, and reference strains, likely confirmed by gold standard methods (like cell culture or genetic sequencing) during the assay's development. However, these specific developmental "training" details are not provided in this 510(k) summary.

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The BioStar® STREP A OIA® MAX assay is for the qualitative detection of Group A Streptococcal antigen directly from throat swabs. This test is intended for in vitro diagnostic use to rapidly identify Group A Streptococci in throat swab specimens from patients with suspected Group A streptococci-associated pharyngitis as an aid in the diagnosis of streptococcal infection.

Not Found

The provided document is a 510(k) clearance letter for the BioStar STREP A OIA® MAX assay, not a study report. As such, it does not contain the detailed information necessary to answer all the questions about acceptance criteria and a study proving the device meets them.

However, based on the context of a 510(k) clearance, we can infer some general aspects and extract limited information.

Here's what can be answered and what cannot:

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

• Cannot be fully answered from this document. This document is a clearance letter, not a clinical study report. It does not provide specific acceptance criteria values (e.g., minimum sensitivity, specificity) or the reported device performance against those criteria. Such details would typically be found in the 510(k) submission summary or a separate clinical study report.

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

• Cannot be answered from this document. The document does not specify the sample size of any test set or the provenance of the data used for validation.

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/Cannot be answered from this document. For an in vitro diagnostic device like this, the "ground truth" would typically be established by a reference method (e.g., bacterial culture) rather than expert consensus on images. The document does not provide details on how ground truth was established, nor does it refer to "experts" in this context.

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

• Not applicable/Cannot be answered from this document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical images or other subjective data. For an in vitro diagnostic assay, the "ground truth" is usually determined by objective laboratory methods, not by human adjudication of independent expert interpretations.

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. This is not applicable to an in vitro diagnostic device. MRMC studies are relevant for AI-powered image analysis devices where human readers interpret medical images. The BioStar STREP A OIA® MAX is a rapid in vitro diagnostic assay for antigen detection, not an AI-based imaging tool.

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

• Yes, implicitly. The device itself is a standalone in vitro diagnostic assay. Its performance is evaluated on its own ability to detect the Group A Streptococcal antigen. There isn't a "human-in-the-loop" aspect to its fundamental operation or interpretation. Its performance would be assessed as a standalone diagnostic tool.

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

• Inferred: For a diagnostic assay like Strep A OIA, the ground truth would almost certainly be established by a bacterial culture of the throat swab specimen. Culture is the gold standard for detecting the presence of Group A Streptococcus.

8. The sample size for the training set

• Not applicable/Cannot be answered from this document. This is an antigen detection assay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its development would involve optimization and validation, but not typically a labeled training data set for an algorithm.

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

• Not applicable. As mentioned above, there isn't a "training set" in the AI/ML context for this type of device.

Summary based on available information:

The provided document is limited to a 510(k) clearance letter for the BioStar® STREP A OIA® MAX assay. It indicates the device is for the qualitative detection of Group A Streptococcal antigen directly from throat swabs as an aid in diagnosing streptococcal pharyngitis.

While the letter confirms the device was found substantially equivalent to a predicate device, it does not contain the detailed performance data or study methodology typically found in a clinical study report or the 510(k) summary (which is a separate document). Therefore, most of the specific questions regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be definitively answered from this document alone. We can infer that its performance as a standalone in-vitro diagnostic was evaluated, with bacterial culture likely serving as the ground truth.

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