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InflammaDry is a rapid, immunoassay test for the visual, qualitative in vitro detection of elevated levels of the MMP-9 protein in human tears from patients suspected of having dry eye to aid in the diagnosis of dry eye in conjunction with other methods of clinical evaluation. This test is intended for prescription use at point-of-care sites.

InflammaDry External Controls are QC materials used for verifying the performance of the InflammaDry test reagents and assay. These controls can also be used to assist in operator training and troubleshoot invalid results.

InflammaDry™ consists of three (3) parts: a sterile Sample Collector, an immunoassay test strip in a plastic Test Cassette housing, and Buffer in a vial. The Sample Collector is used to take a sample of human tears. The separately packaged and sterile Sample Collector has a contoured end with a Dacron fleece to collect the tear sample from the inside of the lower eyelid. 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 vial contains a buffered salt solution containing proteins, detergents and preservatives. The Buffer functions as the solution that initiates the test, carries antigen through a microfiltration process to remove unwanted cellular debris, and transports the immune complex and the control conjugate to the Test and Control Lines on the test strip membrane.

InflammaDry External Controls are to be used with the InflammaDry test only and are intended to verify that the test reagents are working and that the test is performed correctly. Both Negative and Positive external controls for InflammaDrv™ are supplied as lyophilized powder in small glass vials with screw caps. 200 ul of recombinant MMP-9 in Stabilizing buffer solution is quickly frozen and lyophilized under vacuum. A soft and pliable plastic dropper bottle filled with a Dl water diluent is provided with each set of external controls. The InflammaDry external controls are sold as a separate catalog item.

The InflammaDry™ test is based on the principle of lateral flow immunoassays using Direct Sampling Micro-Filtration technology. Matrix metalloproteinase-9 (MMP-9) present in the tear fluid is captured between two (2) highly specific anti-MMP-9 antibodies: a monoclonal mouse anti-MMP-9 antibody and a polyclonal goat antihuman antibody. This antigen-antibody complex is captured at an immobilized Test Line. The formation of a blue color line at the control zone line with a red color line at the test zone line is considered as a positive result, a blue color line at the control zone only is considered as a negative result, if a blue color line in the control zone does not appear the test is considered invalid.

The test is a disposable, rapid test requiring 10-15 minutes for a result.

Here's a summary of the acceptance criteria and study details for the InflammaDry™ device, extracted from the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state pre-defined acceptance criteria for the clinical performance regarding sensitivity, specificity, accuracy, positive predictive value, or negative predictive value. Instead, it presents observed performance metrics. The "Device Performance" section of the clinical study simply states the range of performance demonstrated in the multicenter study.

However, based on the provided data, we can infer that the device demonstrated the following performance ranges in comparison to clinical assessment:

Study Information

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

As mentioned above, explicit acceptance criteria were not listed, but the observed performance is tabulated above.

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

• Sample Size: 237 patients were initially enrolled, but 17 were excluded due to a protocol deviation, resulting in a test set of 220 patients. (Calculated from 237 - 17 = 220, though the individual site totals sum to 237) Correction: The text explicitly states "N = 237" with individual site totals summing to 237 (90+85+12+50), so the 17 excluded patients are likely accounted for within the 237 enrolled if the protocol deviation led to their exclusion from analysis rather than just the enrollment count.
• Data Provenance: Prospective, sequential, masked, clinical trial conducted at academic centers and private practices from various regions across the United States.

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

• Number of Experts: Not explicitly stated, but clinical assessment for dry eye was performed by "ophthalmic clinician[s]" at each study site. The number of individual clinicians is not specified.
• Qualifications of Experts: "Ophthalmic clinician" - no further specific qualifications (e.g., years of experience, subspecialty) are provided.

4. Adjudication method for the test set

• Adjudication Method: Not explicitly stated. The "clinical assessment" for dry eye was presumably developed and applied by the ophthalmic clinicians. The DEWS criteria, with some modifications, were used to categorize patients. There is no mention of a separate adjudication panel or method for resolving discrepancies among clinicians.

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

• MRMC Study: No. This device is a standalone diagnostic test (immunoassay) for MMP-9 levels, not an AI-assisted interpretation tool for human readers. Therefore, an MRMC comparative effectiveness study regarding human reader improvement with AI assistance is not applicable.

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

• Standalone Performance: Yes, the clinical study directly evaluated the performance of the InflammaDry™ device (algorithm/test strip only) against the clinical assessment (ground truth). The results in the tables for "Device Performance" are based on the device's qualitative output (positive/negative) compared to the clinical assessment.

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

• Ground Truth Type: Clinical assessment of dry eye based on a combination of symptoms and signs, derived from the DEWS criteria. This involved an "ophthalmic clinician" evaluating OSDI score, TBUT, Schirmer tear testing, and corneal staining.

8. The sample size for the training set

• Sample Size: Not explicitly mentioned in the provided text. The document focuses on the performance testing (analytical bench tests and clinical study), implying that any training would have occurred prior to these evaluations.

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

• Ground Truth Establishment: Not explicitly mentioned in the provided text.

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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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