(44 days)
ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control is a human blood based single analyte run control designed to be used as an independent run control with tests for the detection of IgM antibodies to Borrelia burgdorferi (Lyme Disease). This control is not intended as a substitute for controls provided with test kits.
ACCURUN™ 132 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.
This product is not FDA cleared for use in testing blood or plasma donors.
ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control is manufactured from human serum or plasma containing IgM antibodies to Borrelia burgdorferi, but is nonreactive for antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV 1 and 2), antibodies to Human T-Lymphotropic Virus Type I (HTLV I) and antibodies to Hepatitis C (HCV). This control contains stabilizers (EDTA, buffering agents) and 0.1% ProClin™ as preservative. The manufacturer recommends that the user observe the Centers for Disease Control (CDC) recommended Universal Precautions for handling ACCURUN™ 132 and all human blood.
This product will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories for use with in vitro diagnostic tests for the detection of IgM antibodies to Borrelia burgdorferi in human serum.
This control is supplied as 1 x 1 ml vial. ACCURUN™ 132 should be stored at -10°C or colder. Once opened, ACCURUN™ 132 should be stored at 2-8°C and discarded after 60 days.
The provided text describes a 510(k) notification for the ACCURUN™ 132 Borrelia burgdorferi IgM Positive Control, a run control for diagnostic tests, rather than an AI/ML medical device. Therefore, many of the requested categories related to AI/ML device evaluation (like sample size for test/training sets, expert consensus for ground truth, MRMC studies, or standalone performance) are not applicable or cannot be extracted from the given information.
However, I can extract information related to the device's stability and clinical evaluation as described.
Here's an attempt to answer the questions based on the provided text, noting where information is not applicable or available:
1. A table of acceptance criteria and the reported device performance
The document doesn't specify explicit quantitative "acceptance criteria" for the performance of the control in detecting Borrelia burgdorferi IgM antibodies. Instead, the studies focused on the stability and consistency of the control product itself.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Stability at -10°C or colder (vialed form) | ACCURUN™ 132 can be stored at -10°C or colder in its vialed form. (Implies stability maintained.) |
| Tolerance to multiple freeze-thaw cycles | ACCURUN™ 132 is not affected by multiple freeze-thaw cycles. |
| Stability at ambient temperatures (short period) | ACCURUN™ 132 is stable at ambient temperatures for a short period of time with no adverse effects. |
| Stability under heat stress (short period) | ACCURUN™ 132 is stable under heat stress for a short period of time with no adverse effects. |
| Open vial stability at 2-8°C (for 60 days) | ACCURUN™ 132 remains stable for at least 60 days at 2-8°C, even after the vials have been repeatedly opened. |
| Consistency / Performance as an independent run control | Clinical trial data demonstrate that ACCURUN™ 132 is safe and effective in three different laboratories with three manufactured ACCURUN™ 132 lots, and under various conditions of stress. The data provided by external laboratories evaluated the consistency and performance in situations where it is most likely to be used. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document mentions "three manufactured ACCURUN™ 132 lots" tested in "three different laboratories." It does not specify the number of individual runs, samples, or patients involved in these evaluations.
- Data Provenance: The studies were performed at "BBI, one blood bank and one clinical laboratory." The country of origin is not explicitly stated but is implicitly the USA, given the FDA 510(k) submission. The studies appear to be prospective evaluations of the control's performance.
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)
This is not applicable as the device is a run control for laboratory tests, not a diagnostic device that interprets medical images or data requiring expert "ground truth" establishment in the traditional sense. The "ground truth" for the performance of the control would be its expected reactivity in validated assays for Borrelia burgdorferi IgM antibodies. The document refers to "clinical laboratory evaluations," implying testing by trained laboratory professionals, but no specific number or qualification of "experts" for ground truth establishment is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no scenario described that would require adjudication of expert readings/interpretations. The evaluation focused on the consistency and stability of the control product in laboratory tests.
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. The device is an in vitro diagnostic run control, not an AI/ML assistant for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical control product, not an algorithm. Its function is to be used with existing laboratory tests, always with human involvement in the lab process.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this positive control would be its known positive reactivity for IgM antibodies to Borrelia burgdorferi when tested with appropriate diagnostic assays. The studies implicitly confirmed that this known reactivity was consistently maintained under various conditions. The control itself is manufactured from human serum or plasma containing these antibodies.
8. The sample size for the training set
This is not applicable. The device is not an AI/ML model that requires a training set. The control product itself is manufactured and then tested for stability and performance.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for an AI/ML model. The "ground truth" of the control material (i.e., its confirmed positive status for Borrelia burgdorferi IgM antibodies) would have been established during the manufacturing and characterization process of the source human serum/plasma.
§ 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).