(421 days)
MarDx Lyme Disease (IgM) Marblot Strip Test System is a Western blot assay for the qualitative detection of human IgM antibody to B. burgdorferi. The MarDx Lyme Disease (IgM) Marblot Strip Test System is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure.
The MarDx Lyme Disease (IgM) Marblot Strip Test System is a Western blot device for the detection of human IgM antibodies directed to the organism Borrelia burgdorferi. The device is similar in function to other solid phase enzyme immunoassays (EIA), but differs in its ability to discriminate the individual antibody specificities directed against the organism.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it implicitly sets the performance of predicate devices as the acceptance benchmark. The reported performance of the new device is stated descriptively.
| Acceptance Criteria (Implicit) | Reported Device Performance (MarDx Lyme Disease IgM Marblot Strip Test System) |
|---|---|
| Agreement with reference Western blot and EIA methodologies | Data indicates "high sensitivity relative to the Steere Western blot and the MarDx Lyme Disease IgM EIA Test System reference procedure" |
| Sensitivity relative to predicate devices | Performs "at least as well as the predicate devices" |
| Specificity relative to predicate devices | Not explicitly detailed, but implied to be acceptable given the overall conclusion of performing "at least as well" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 1341 sera
- Data Provenance: Not specified (country of origin or retrospective/prospective). The reference to "Academic Reference Centers (ARCs) panel maintained by the CDC, Fort Collins, CO" suggests US-based data, but this is for an internal reference panel, not explicitly for the 1341 sera.
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 ground truth was established using an Academic Reference Centers (ARCs) panel maintained by the CDC, Fort Collins, CO, and two reference methodologies (MarDx Lyme Disease IgM EIA Test System (K894293) and the Lyme Western blot procedure developed and utilized by Dr. Allen Steere, MD, Tufts Medical Center).
The document does not specify the number of experts or their specific qualifications if they were involved beyond the establishment of these reference methods. It mentions "The physicians diagnosis" for the ARC panel, indicating medical expertise was involved, but no further details.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document describes the use of the Academic Reference Centers (ARCs) panel maintained by the CDC, Fort Collins, CO, and two established reference methodologies. It does not detail a specific adjudication method like "2+1" or "3+1" for discrepancies between readers or tests. The determination of agreement, sensitivity, and specificity implies comparison against these established references rather than a human adjudication process for each case.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not applicable / not described. This is a device for detecting antibodies, not an AI-assisted diagnostic tool that would involve human readers interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this was a standalone (algorithm only) performance study. The MarDx Lyme Disease IgM Marblot Strip Test System is a Western blot device, which is a lab-based assay. Its performance was evaluated by comparing its results directly against reference methodologies on the serum samples. There is no "human-in-the-loop" component in the interpretation of the output of this specific assay as described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth was established using:
- Expert Consensus/Clinical Diagnosis: "The physicians diagnosis of the Academic Reference Centers (ARCs) panel maintained by the CDC, Fort Collins, CO."
- Reference Laboratory Methods:
- MarDx Lyme Disease IgM EIA Test System (K894293)
- The Lyme Western blot procedure developed and utilized by Dr. Allen Steere, MD, Tufts Medical Center.
8. The sample size for the training set
The document does not mention a "training set." This is a laboratory diagnostic device, not a machine learning model that typically undergoes a training phase. The study described is a clinical validation (test set) against established reference methods.
9. How the ground truth for the training set was established
As there was no training set mentioned or applicable for this type of device, this question is not applicable.
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).