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ACCURUN™ 130 Borrelia burgdorferi IgG 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 IgG antibodies to Borrelia burgdorferi (Lyme Disease). This control is not intended as a substitute for controls provided with test kits.

ACCURUN™ 130 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.

Boston Biomedica intends to manufacture and market ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control, which is a human blood based single analyte unassayed run control designed to be used as an independent run control with tests for the detection of IgG antibodies to Borrelia burgdorferi (Lyme Disease). This control is not intended as a substitute for controls provided with test kits. This product is not FDA cleared for use in testing blood or plasma donors.

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 IgG antibodies to Borrelia burgdorferi in human serum.

ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control is manufactured from human serum or plasma containing IgG 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™ 130 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 IgG antibodies to Borrelia burgdorferi in human serum.

This control is supplied as 1 x 1 ml vial. ACCURUN™ 130 should be stored at 2-8°C. Once opened. ACCURUN™ 130 should be discarded after 60 days.

The provided document is a 510(k) notification for the ACCURUN™ 130 Borrelia burgdorferi IgG Positive Control. This device is a control for laboratory tests, not a diagnostic device that directly measures a patient's condition. As such, the concept of "acceptance criteria" and "device performance" in the traditional sense (e.g., sensitivity, specificity for a diagnostic test) does not directly apply.

Instead, the "acceptance criteria" for a control device relate to its stability and consistency to ensure it performs reliably as a positive control over time and under various conditions. The "study that proves the device meets the acceptance criteria" refers to the stability studies and clinical laboratory evaluations performed by Boston Biomedica, Inc.

Here's a breakdown of the requested information 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 describes the goals of the stability studies, which can be interpreted as the implicit acceptance criteria for a control device: that it remains stable and functions correctly as a positive control. The reported performance is the conclusion that these criteria were met.

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: Not explicitly stated as a single number. The studies included:
  • "five types of stability studies" (real time, ambient temperature, heat stress, freeze-thaw, open vial).
  • "clinical laboratory evaluations... at BBI, one blood bank and one clinical laboratory."
  • These evaluations involved "three manufactured ACCURUN™ 130 lots."
• Data Provenance: The studies were performed by Boston Biomedica, Inc. (BBI) and "one blood bank and one clinical laboratory." The location of these external labs is not specified, but BBI is located in West Bridgewater, MA, USA, suggesting the studies were likely conducted in the USA.
• Retrospective or Prospective: The studies appear to be prospective as they involved testing the device under specific conditions (stability studies) and in real-world clinical laboratory evaluations to observe its performance over time.

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 question is not applicable in the typical sense for a control device.

• The "ground truth" for the ACCURUN™ 130 is its known status as a "Borrelia burgdorferi IgG Positive Control," meaning it is intended to test positive for IgG antibodies to Borrelia burgdorferi.
• The "experts" involved are the laboratory personnel in the "one blood bank and one clinical laboratory" who performed the evaluations using existing in vitro diagnostic tests. Their specific qualifications (e.g., years of experience) are not provided, but they are implied to be "clinical laboratory professionals."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. The studies evaluated the control's performance as a positive control, primarily its stability and consistency in producing a positive result with Borrelia burgdorferi IgG tests. There isn't a "ground truth" that needs adjudication by multiple experts in the way a diagnostic image or clinical case might. The assessment would have been based on the expected positive reactivity in assays.

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

Not applicable. This is not an AI-assisted diagnostic device or a device where human reader performance is being evaluated or improved. It is a laboratory control.

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

Not applicable. This is not an algorithm-based device. It is a biological control material.

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

The "ground truth" for ACCURUN™ 130 is its intended function as a positive control for IgG antibodies to Borrelia burgdorferi. This is established by its manufacturing and purification process, ensuring it contains detectable levels of these antibodies. The studies aimed to confirm that this inherent "positive" characteristic (its ground truth) remained consistent and stable over time and under various conditions when tested with standard Borrelia burgdorferi IgG assays.

8. The sample size for the training set

Not applicable. As a control device, there isn't a "training set" in the machine learning sense. The device is manufactured to a specific specification. The "studies" are more akin to validation and verification of its performance and stability.

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

Not applicable, as there is no training set. The "ground truth" (its positive status) is inherent in the design and manufacturing of the control, derived from human serum or plasma known to contain IgG antibodies to Borrelia burgdorferi.

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