(141 days)
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:
| Performance Metric | Range of Performance |
|---|---|
| Positive Agreement | 66% - 97% |
| Negative Agreement | 97% - 98% |
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.
§ 862.1540 Osmolality test system.
(a)
Identification. An osmolality test system is a device intended to measure ionic and nonionic solute concentration in body fluids, such as serum and urine. Osmolality measurement is used as an adjunct to other tests in the evaluation of a variety of diseases, including kidney diseases (e.g., chronic progressive renal failure), diabetes insipidus, other endocrine and metabolic disorders, and fluid imbalances.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.