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The RPS Adeno Detector Plus is a rapid immunoassay test for the visual, qualitative in vitro detection of Adenoviral antigens (hexon protein) directly from human eye fluid. The test is intended for professional use as an aid in the rapid differential diagnosis of acute conjunctivitis.

Negative results do not preclude Adenovirus infection nor are thev intended to rule out other microbial-caused infections of the conjunctiva. and should not be used as the sole basis for treatment or other management decisions.

The RPS Adeno Detector Plus™ consists of three (3) parts: a Sample Collector, an immunoassay test strip in a plastic Test Cassette housing, and a Buffer. The Sample Collector is used to take a sample of ocular fluid. The separately packaged and sterile Sample Collector has a contoured end with a Dacron fleece to collect the samples. The plastic housing of the Test Cassette body protects the strip from unintended physical influence. Additionally the housing guarantees correct sample transfer onto the lateral flow assay strip. The Buffer is a buffered salt solution containing proteins, detergents and preservatives. The Buffer functions as the solution that initiates the test, extracts the Adenoviral proteins, filters unwanted cellular debris, and transports the immune complex and the control conjugate to the Test and Control Lines on the test strip membrane.

Mechanism of action - RPS Adeno Detector Plus™ is based on the principle of lateral flow immunoassays using Direct Sampling Micro-filtration technology. Viral particles or virus antigens are captured by an antigen specific antibody. A single monoclonal antibody highly specific to the Adenoviral hexon protein is labeled with colloidal gold and also is immobilized as the Test Line.

Here's a summary of the acceptance criteria and study details for the RPS Adeno Detector Plus™, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of target sensitivity, specificity, etc. However, the reported performance from the clinical trial is provided. We can infer that the reported values met the unstated acceptance criteria for the FDA to issue a substantial equivalence determination.

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

• Sample Size: N = 128 (Total number of patients in the clinical trial).
• Data Provenance: The study design was a prospective, sequential, masked, clinical trial with eight (8) Clinical Trial Sites. The country of origin is not explicitly stated, but the sponsor is based in Sarasota, FL, USA, suggesting the clinical trial was likely conducted in the United States.

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

• The ground truth was established by Cell Culture. This is a laboratory diagnostic method and does not involve human experts establishing a subjective ground truth for the test set.

4. Adjudication Method for the Test Set

• Not applicable, as the ground truth was established by Cell Culture, which is an objective laboratory method. There was no mention of human adjudication for the Cell Culture results themselves.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study solely evaluated the performance of the device against a gold standard (Cell Culture) and did not involve human readers comparing performance with and without AI assistance.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The clinical trial directly assessed the RPS Adeno Detector Plus™ performance (sensitivity, specificity, etc.) against Cell Culture, without any human interaction influencing the device's reading or interpretation for the purpose of the study's primary endpoint. The device itself is a rapid immunoassay test designed for "visual, qualitative in vitro detection," implying human visual interpretation, but the reported performance metrics are for the device's ability to accurately detect Adenovirus compared to culture.

7. Type of Ground Truth Used

• The ground truth used was Cell Culture, which is a laboratory-based gold standard for detecting the presence of Adenovirus.

8. Sample Size for the Training Set

• The document does not specify a separate training set or its sample size. This device is a rapid immunoassay test, not a machine learning or AI-based algorithm that typically requires a distinct training phase with a dedicated dataset. Its development would involve analytical testing and validation rather than "training" in the AI sense.

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

• Given that a training set is not mentioned and the device is an immunoassay, the concept of establishing ground truth for a training set in the context of an algorithm's learning is not applicable. The immunoassay operates based on biochemical reactions with a fixed design. Its "training" would be more akin to optimizing reagents and manufacturing processes through bench testing.

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The RPS Adeno Detector is a rapid immunochromatography test for visual, qualitative in-vitro detection of adenoviral antigens (hexon protein) directly from human eye fluid. The test is intended for use as an aid in the rapid differential diagnosis of acute adenoviral conjunctivitis. All negative test results should be confirmed by cell culture.

The RPS Adeno Detector utilizes technology based on lateral flow immunochromatography. Adenoviral antigen, hexon protein, when present in the patient sample is captured between two antigen specific antibodies. One antibody is immobilized in the detection zone of the device. The second antibody is labeled with colloidal gold. The detector is a disposable, rapid test requiring 10 minutes for a result. The patient's lower eyelid is gently retracted to expose the inferior fornix. The eye fluid is collected on the sterile sample collector by gently swabbing the inferior fornix with the sampling pad on the test cover to gain a sample of tears for point of care analysis. The sample collector is reassembled to the immunoassay cassette. Sample transfer happens automatically. Analysis of the sample starts when the absorbant pad of the strip is dipped into a provided buffering solution. After 1-10 minutes, red colored lines in the read out area will appear. One line (control line) only indicates a (Adenoviral) negative result, where as two lines (control line and test line) indicate a (Adenoviral) positive result. It is best used within 7 days of developing a red eye consistent with infectious conjunctivitis.

The provided text describes the RPS Adeno Detector, a rapid immunochromatography test for the visual, qualitative in-vitro detection of adenoviral antigens from human eye fluid, intended as an aid in the rapid differential diagnosis of acute adenoviral conjunctivitis.

Here's an analysis of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines the acceptance criteria by stating the clinical performance against the "gold standard" of viral cell culture. While explicit targets for sensitivity, specificity, and agreement are not clearly stated as "acceptance criteria," the reported performance metrics are presented as evidence of the device's suitability. For the purpose of this analysis, we will treat the reported performance values as the demonstrated achievement against an unstated but implied satisfactory threshold for market clearance.

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

• Sample Size for Test Set: 175 samples
• Data Provenance: The document states, "A total of 175 samples were collected and tested from patients who developed a red eye consistent with infectious conjunctivitis within the last 7 days." This indicates the data is prospective and collected from patients presenting with symptoms. The country of origin is not specified in the provided text.

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

The ground truth for the test set was established using viral cell culture as the "gold standard." This is a laboratory-based method. The number of experts involved in interpreting the cell culture results and their specific qualifications are not detailed in the provided text. However, cell culture requires trained laboratory personnel.

4. Adjudication method for the test set:

The document compares the RPS Adeno Detector's results directly against viral cell culture results. There is no mention of an adjudication method involving multiple human readers for the device's test results. It appears the device's output (presence/absence of two lines) was directly compared to the cell culture outcome.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The RPS Adeno Detector is a standalone device producing a visual, qualitative result (lines), not an AI-assisted diagnostic tool for human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

Yes, a standalone study was done. The clinical performance data presented (sensitivity, specificity, etc.) directly reflects the performance of the RPS Adeno Detector device itself, without human interpretation influencing its diagnostic output. The device produces a visual, qualitative result (one line for negative, two lines for positive) that is read directly.

7. The type of ground truth used:

The type of ground truth used was viral cell culture, which is described as the "gold standard" for identifying adenovirus in conjunctival specimens.

8. The sample size for the training set:

The provided text does not mention a separate training set or its sample size. The "Clinical Studies" section describes a single set of 175 samples used for performance evaluation against the gold standard. For devices utilizing lateral flow immunochromatography (like the RPS Adeno Detector), the "training" typically refers to the development and optimization of the assay components and their interactions, rather than a machine learning training set with labeled data for an algorithm.

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

As no specific "training set" in the context of machine learning is indicated, this question is not directly applicable. If "training set" refers to samples used during the development and optimization phases of the immunoassay, the ground truth would have likely been established using viral cell culture or well-characterized adenovirus samples, similar to how the ground truth for the clinical study was established. However, the document does not provide details on this development process.

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The SASTM Adeno Test is a membrane-based immunogold assay for the detection of adenovirus and adenovirus antigens. The test is a rapid visual test for the qualitative detection of adenovirus serotypes present in eye swabs, nasal and pharyngeal secretions, fecal samples, and cell culture supernatant. This test is for professional use only.

membrane-based immunogold assay

The provided text does not contain detailed information about acceptance criteria, device performance, sample sizes for test or training sets, ground truth establishment, or specific study designs (like MRMC or standalone performance). The document is a 510(k) clearance letter from the FDA for a device called "SAS™ Adeno Test," confirming its substantial equivalence to a predicate device.

The letter indicates the device's "Indications For Use" as a rapid visual test for the qualitative detection of adenovirus serotypes in various sample types. However, it does not provide the specific performance data or the study details to prove it meets acceptance criteria. The clearance is based on substantial equivalence, implying that its performance is considered comparable to already legally marketed devices.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes, ground truth, or study designs based solely on the provided text. The document is primarily a regulatory clearance notification, not a detailed scientific study report.

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The Adenovirus Antigen Detection ELISA Test System is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of Adenovirus antigen in human fecal samples as an aid in the diagnosis of acute non-bacterial gastro-enteritis. Performance for this assay has not been established on children over the age of five and immunocompromised patients. The antibody utilized in this assay is a group specific antigen and cannot differentiate between types of adenovirus. Performance of this assay has not been established for specimens other than human feces. For in vitro diagnostic use only.

The Adenovirus Antigen Detection ELISA test is an enzyme linked immunosorbent assay to detect adenovirus antigen in fecal samples. Purified monoclonal antibody specific to adenovirus is attached to a solid phase microtiter well. Diluted fecal sample is added to each well. If the adenovirus antigen is present, it will bind to the monoclonal antibody in the well. After incubation the wells are washed to remove unbound antigen. An enzyme labeled anti-adenovirus polyclonal antibody is added to each well. If antigen is present the conjugate antibody will bind to the antigen attached to the antibody on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

The Trinity Biotech plc. Adenovirus Antigen Detection ELISA Test System underwent several performance studies to establish its effectiveness. The acceptance criteria and reported device performance are summarized below, followed by details of each study.

1. Table of Acceptance Criteria and Reported Device Performance

*Note: Specific numerical acceptance criteria were not explicitly stated in the provided text, so they are inferred based on general expectations for diagnostic device performance. The reported performance values met the implicit high standards for sensitivity, specificity, and agreement compared to predicate methods and for reliability in precision within the context of an ELISA assay.

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

• Study 1 (Relative to Cell Culture):
  • Sample Size: 120 fecal specimens.
  • Data Provenance: Retrospective, frozen fecal specimens sent to a University Virus Reference Laboratory in Ireland for routine testing. 90% of specimens were from adults.
• Study 2 (Relative to Alternate EIA):
  • Sample Size: 481 sera (likely a typo and should be fecal specimens given the device description)
  • Data Provenance: Retrospective, frozen fecal specimens from a large public health lab in the UK. 57% of samples were from patients less than 5 years old and 43% from patients greater than five years old.
• Precision Study:
  • Sample Size: 6 samples (containing Type 2 adenovirus from cell culture), plus positive and negative controls. Each was run in triplicate over three days at three sites, totaling 216 determinations.
  • Data Provenance: Not explicitly stated, but implies laboratory-prepared samples for internal validation.

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

The studies do not mention the use of "experts" in the traditional sense for establishing ground truth, such as radiologists or pathologists making diagnoses. Instead, the ground truth was established by established laboratory methods:

• Study 1: Ground truth was established by cell culture isolation, with positive cultures confirmed by electron microscopy (EM) using a standard negative staining technique (considered presumptive for adenovirus types 40 and 41).
• Study 2: Ground truth was primarily established by a commercially available alternate adenovirus EIA. For discordant samples, Electron Microscopy (EM) was used for confirmation.

No specific number or qualifications of "experts" (e.g., a board-certified virologist with X years of experience) were provided for interpreting these laboratory results; it is assumed that these benchmark methods were performed by qualified laboratory personnel following standard procedures.

4. Adjudication Method for the Test Set

• Study 1: No specific adjudication method was described beyond the initial cell culture and EM confirmation. "Equivocals" (2 samples) were excluded from the final calculations but not explicitly adjudicated further.
• Study 2: For samples where the device ELISA and the alternate EIA produced discordant results, these discrepant samples were re-tested, and any remaining discordant samples (15 in total) were then tested by Electron Microscopy (EM) for resolution. This implies a form of sequential adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic ELISA test, not an AI-assisted diagnostic tool that involves human readers interpreting images or data alongside an AI.

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

• Yes, the performance characteristics described (Sensitivity, Specificity, Limit of Detection, Precision, Cross-Reactivity) represent the standalone performance of the ELISA test system itself, without human-in-the-loop performance considerations beyond standard laboratory procedures for running the assay and interpreting the quantitative optical density readings against a cut-off.

7. The Type of Ground Truth Used

• Study 1: The ground truth was based on a predicate laboratory method (cell culture isolation), confirmed by electron microscopy (EM). This is a form of laboratory gold standard for detecting the presence of adenovirus.
• Study 2: The primary comparison was against an alternate commercially available adenovirus EIA. For discordant results, electron microscopy (EM) served as the confirmatory ground truth.

8. The Sample Size for the Training Set

No explicit "training set" is mentioned in the context of machine learning. For an ELISA test, the development process involves identifying antibodies and optimizing assay parameters. The performance studies detailed are validation studies for the finalized assay.

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

As this is an ELISA diagnostic kit and not an AI/machine learning device, the concept of a "training set" and establishing ground truth for it in the AI context does not directly apply. The development of the antibody and assay would have relied on known positive and negative controls and characterized samples to establish appropriate binding and detection parameters, but these are not referred to as a "training set" in the document.

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