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The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Kit is an in vitro qualitative assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples that have been found positive or equivocal using an enzyme immunoassay (EIA) or immunofluorescence assay (FA) test procedure for B. burgdorferi antibodies.

The Boston Biomedica, Inc. (BBI) Borrelia burgdorferi IgM and IgG Western Blot Test Kit is an in vitro qualitative assay for the detection of IgM and IgG antibodies to Borrelia burgdorferi in human serum. This device is composed of the reagents, controls and test strips intended for use in Western blot testing of human serum samples for the presence of IgM and/or IgG antibodies to B. burgdorferi. The device is similar in composition to the previously approved BBI Biotech Research Laboratories Borrelia burgdorferi IgM Western Blot Test Kit. The kit also includes Blot Reading Guides, report forms and a Package Insert.

Below is a summary of the acceptance criteria and study information for the Boston Biomedica, Inc. Borrelia burgdorferi IgM and IgG Western Blot Test Kit based on the provided document.

Acceptance Criteria and Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity and specificity thresholds. However, it implies that the device's performance was evaluated by comparing it against various sample types and the predicate device, aiming for performance that supports the intended use.

No explicit table of acceptance criteria and reported device performance is provided in the document. The document describes the clinical performance data without numerical targets or direct comparisons in a table format against predetermined criteria.

Study Information

1. Sample sizes used for the test set and the data provenance:

   • Test Set Description: The device was evaluated using:
     • Samples from patients who were culture-positive for B. burgdorferi.
     • Samples that had tested IgG EIA positive.
     • The CDC Lyme panel.
     • A commercially available panel of Lyme positive samples (PTL202).
     • Serum samples from random blood donors from Lyme endemic and non-endemic regions.
     • Samples from patients with ten other infectious diseases and conditions (e.g., syphilis, rheumatoid arthritis, systemic lupus erythematosus).
   • Sample Size: The exact sample sizes for each of these categories are not provided in the document.
   • Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, beyond mentioning "Lyme endemic and non-endemic regions."

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

   • Not specified. The document does not provide details on the number or qualifications of experts involved in establishing the ground truth for the test set.

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

   • Not specified. The document does not describe any adjudication method used for the test set.

4. 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, an MRMC study was not done. This device is an in vitro diagnostic test kit (Western Blot), not an AI-assisted diagnostic tool that would involve human readers and AI assistance in the way a typical MRMC study evaluates. The comparison was primarily between the applicant device and a predicate device, and various clinical sample types.

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

   • The "device" in this context is a laboratory test kit (Western Blot), which is inherently "standalone" in its technical performance, meaning the chemical and biological reactions produce a result. However, the interpretation of the Western Blot bands to determine a positive or negative result would typically involve a trained laboratory professional. The document does not report on a "standalone" algorithm performance in the way it would for imaging or computational AI. The "summary of clinical performance data" describes the device's accuracy in different clinical scenarios.

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

   • The ground truth appears to be established using a combination of methods:
     • Culture-positive for B. burgdorferi: This is a definitive microbiological confirmation for Borrelia burgdorferi infection.
     • CDC Lyme panel: This is a characterized panel often used for test validation.
     • Commercially available panel of Lyme positive samples (PTL202): Another characterized panel.
     • IgG EIA positive: This acts as a reference for B. burgdorferi antibody presence, although the Western Blot is intended as a confirmatory test for EIA/IFA positive or equivocal samples.
     • Patient samples from random blood donors from Lyme endemic and non-endemic regions: These serve as healthy controls or general population samples.
     • Samples from patients with other infectious diseases and conditions: Used to assess specificity and cross-reactivity.

7. The sample size for the training set:

   • Not applicable/Not specified. As an in vitro diagnostic kit based on biological reagents, there isn't a "training set" in the context of machine learning or AI algorithms. The kit's design and optimization would have relied on research and development data, but this is not analogous to an algorithm's training set as typically described in AI studies.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified. Given that there is no explicit "training set" in the context of an algorithm, the method for establishing ground truth for such a set is not detailed. The development of the kit's components and interpretation criteria would have been based on established scientific principles and studies on B. burgdorferi antigens and antibody responses.

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The BBI-Biotech B. burgdorferi IgM Western blot kit is intended to provide supportive evidence of infection with B. burgdorferi by determining the specific protein reactivities of human serum specimens previously found to be reactive on enzyme immunoassay or indirect immunofluorescence screening assays. The kits will be made available to clinical laboratory professionals in public health laboratories and clinical laboratories.

The device is a collection of cGMP manufactured critical components needed to perform a Western blot test that will detect B. burgdorferi IgM antibody in naturally infected humans. It includes nitrocellulose strips upon which sodium dodecyl sulfate solubilized and polyacrylamide separated B. burgdorferi proteins have been transferred, an IgM Positive Control, a Negative Control, an anti-IgM alkaline phosphatase concentrate, a buffer concentrate, diluent powder, an NBT/BCIP substrate, Blot Reading Guide, Package Insert, and Results Record Forms.

This document describes a 510(k) submission for the BBI-Biotech B. burgdorferi IgM Western blot kit. The document lacks detailed acceptance criteria and a dedicated study section with specific performance metrics for the device. Instead, it makes a general claim of "substantial equivalence" based on comparisons with a predicate device.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific numerical acceptance criteria for the device's performance. Instead, it concludes the device is "substantially equivalent" to a predicate device.

Study Information

The document describes performance comparisons rather than a standalone study with defined endpoints.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The document mentions "first physician visit, verified infected patient samples," "randomly selected enzyme immunoassay positive patient samples," "blood samples from random blood donors," and "patients with syphilis antibody, rheumatoid arthritis, and systemic lupus erythematosus." However, the exact number of samples in each category is not quantified.
   • Data Provenance: Not explicitly stated (e.g., country of origin). The data appears to be retrospective, as it refers to "verified infected patient samples" and "previously found to be reactive" samples.

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

   • Not mentioned. The document refers to "verified infected patient samples" but does not specify how this verification was performed or by whom.

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

   • Not mentioned.

4. 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. This device is an in-vitro diagnostic (IVD) kit for laboratory use, not an AI-assisted diagnostic tool that would typically involve human readers in this context.

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

   • This is an IVD kit, which inherently operates as a "standalone" test performed in a lab setting, where a technician interprets the Western blot bands according to a provided "Blot Reading Guide" and "positive interpretation criterion." The document does not describe a performance study in the manner typically presented for software algorithms.

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

   • The ground truth for "verified infected patient samples" is implied but not explicitly defined. For other samples, the ground truth is based on clinical diagnoses (syphilis antibody, rheumatoid arthritis, systemic lupus erythematosus) or donor status (random blood donors). The "first physician visit, verified infected patient samples" suggests a clinical diagnosis of infection.

7. The sample size for the training set:

   • Not mentioned. The document describes a performance comparison study, not a machine learning model requiring a distinct training set.

8. How the ground truth for the training set was established:

   • Not applicable, as no training set for a machine learning model is described.

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ACCURUN™ 150 HSV 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 herpes simplex virus (HSV). This control is not intended as a substitute for controls provided with test kits.

ACCURUN™ 150 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.

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 HSV in human serum.

ACCURUN™ 150 HSV IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to herpes simplex virus, 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™ 150 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 HSV in human serum.

This control is supplied as 1 x 1 ml vial and 1 x 5 ml vial. ACCURUN™ 150 should be stored at 2-8°C. Once opened, ACCURUN™ 150 should be discarded after 60 days.

Here's an analysis of the provided text regarding the ACCURUN™ 150 HSV IgG Positive Control, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a control product, not a diagnostic device that measures a specific outcome. Therefore, the "acceptance criteria" and "device performance" are focused on the control's stability and its ability to consistently perform in laboratory settings using existing IgG antibody detection tests.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a number of individual samples. The study involved "three different laboratories with three manufactured ACCURUN™ 150 lots." The data was collected through "clinical laboratory evaluations" performed at BBI (Boston Biomedica, Inc.) and at "two clinical laboratories."
• Data Provenance: Retrospective, as the study was completed to support the 510(k) submission. The country of origin is not explicitly stated, but given that Boston Biomedica, Inc. is a U.S.-based company and the FDA approval is for marketing in the U.S., it can be inferred the data largely originated from the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The "ground truth" for a control material like this isn't typically established by expert consensus in the same way a diagnostic test is. Instead, it relies on the intrinsic properties of the control material (presence of IgG antibodies to HSV) and its consistent behavior when tested by standard HSV IgG assays.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a control material study, a formal adjudication method for ground truth in the sense of a diagnostic outcome is unlikely to have been applied. The "evaluation" would likely involve assessing the consistency of results obtained when the control was run through various HSV IgG 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

No, an MRMC comparative effectiveness study was not done. This product is a positive control for detecting HSV IgG antibodies, not an AI-powered diagnostic device, and therefore does not involve human readers or AI assistance in its function.

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

No, a standalone algorithm performance study was not done. Again, this product is a biological control material, not an algorithm. Its performance is evaluated by its consistency when used with existing diagnostic tests.

7. The Type of Ground Truth Used

The "ground truth" for this control is its known composition: it is "manufactured from human serum or plasma containing IgG antibodies to herpes simplex virus." The performance evaluation confirms that this known positive status is consistently detected by various HSV IgG tests and that the control remains stable under different conditions. It's essentially a known positive sample used to verify the proper functioning of other diagnostic tests.

8. The Sample Size for the Training Set

This product is not an AI algorithm and therefore does not have a "training set" in the conventional sense. Its development involved sourcing human serum/plasma with specific antibodies and then formulating it with stabilizers and preservatives. The stability studies and clinical laboratory evaluations served as validation, not training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of product. The "ground truth" (the presence of HSV IgG antibodies) in the source material would have been established using validated, commercially available HSV IgG detection assays at the time of sourcing.

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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.

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.

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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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ACCURUN™ 135 Toxoplasma 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 Toxoplasma gondii. This control is not intended as a substitute for controls provided with test kits. ACCURUN™ 135 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. 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 Taxoplasma gondii in human serum.

ACCURUN™ 135 Toxoplasma IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to Toxoplasma gondii, 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™ 135 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 Toxoplasma gondii in human serum and plasma. This control is supplied as 1 x 1 ml vial or 1 x 5 ml vial. ACCURUN™ 135 should be stored at 2-8°C. Once opened, ACCURUN™ 135 should be discarded after 60 days.

The provided document describes the safety and effectiveness summary for the ACCURUN™ 135 Toxoplasma IgG Positive Control. This device is a quality control material, not a diagnostic test itself, so the acceptance criteria and study design are focused on its stability and consistency as a control rather than diagnostic accuracy metrics like sensitivity or specificity.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the ACCURUN™ 135 Toxoplasma IgG Positive Control's performance. Instead, it describes general claims of stability and effectiveness, which implicitly serve as the performance goals.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify exact "sample sizes" in terms of number of patient samples. For stability studies, it refers to "five types of stability studies" (real time, ambient temperature, heat stress, freeze-thaw, and open vial) and implies multiple vials or aliquots were tested under these conditions. For clinical evaluations, it states that "three manufactured ACCURUN™ 135 lots" were evaluated.
• Data Provenance: The studies were performed "at BBI [Boston Biomedica, Inc.] and at two clinical laboratories." This suggests data was collected both internally and externally. The country of origin is implicitly the United States, as BBI is located in Massachusetts and the submission is to the US FDA. The studies appear to be prospective evaluations designed to test the stability and consistency of the manufactured control lots.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable to this device. The ACCURUN™ 135 is a positive control, not a diagnostic device intended to differentiate disease states or interpret findings. Therefore, explicit "ground truth" as established by experts for a test set (e.g., patient diagnosis confirmed by radiologists) is not relevant for this type of product. The "ground truth" here is the expected behavior of the control, which is to provide a positive signal for Toxoplasma IgG antibodies in a consistent manner. This is assessed by laboratory testing against established methodologies.

4. Adjudication Method for the Test Set

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among multiple experts when establishing a diagnostic ground truth for patient cases. Since this is a quality control device without a patient diagnostic "test set" requiring expert interpretation for ground truth, such adjudication is not performed. The "adjudication" in this context would be the internal quality control review of the test results for consistency and adherence to predefined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not done. This type of study investigates the impact of a device (e.g., AI assistance) on the performance of human readers in interpreting medical images or diagnostic tests. Since ACCURUN™ 135 is a laboratory control product and not an interpretative diagnostic device involving human readers for case diagnosis, an MRMC study is not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was not done in the context of an "algorithm only" performance. ACCURUN™ 135 is a biological reagent control; it does not involve a software algorithm that operates independently. Its "performance" is measured by its chemical/biological stability and its consistent reactivity in standard laboratory assays, which inherently involve human technicians and laboratory equipment.

7. Type of Ground Truth Used

The "ground truth" for the ACCURUN™ 135 control is its pre-defined positive status for Toxoplasma IgG antibodies and its consistency in performance over time and under various conditions. This is established through:

• Known composition/manufacturing: The control is manufactured from human serum/plasma known to contain IgG antibodies to Toxoplasma gondii.
• Laboratory testing parameters: The "ground truth" of its stability and effectiveness is determined by its consistent reactivity in various in vitro diagnostic tests for Toxoplasma gondii IgG, within acceptable ranges.
• Experimental data: The stability studies (real-time, ambient, heat stress, freeze-thaw, open vial) generate data that confirm the control continues to perform within expected parameters, thus validating its "ground truth" as a stable positive control.

Essentially, the "ground truth" is the empirically validated performance characteristics of the control itself, rather than external patient outcome data or expert consensus on clinical cases.

8. Sample Size for the Training Set

This section is not applicable. ACCURUN™ 135 is a laboratory reagent control, not a machine learning or AI-based diagnostic device that requires a "training set" to develop an algorithm.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reasons as point 8.

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ACCURUN™ 140 Rubella 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 Rubella virus. This control is not intended as a substitute for controls provided with test kits.

ACCURUN™ 140 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.

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 Rubella virus in human serum and plasma.

ACCURUN™ 140 Rubella IgG Positive Control is manufactured from human serum or plasma containing IgG antibodies to Rubella, 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™ 140 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 Rubella virus in human serum and plasma.

This control is supplied as 1 x 1 ml vial or 1 x 5 ml vial. ACCURUN™ 140 should be stored at 2-8°C. Once opened, ACCURUN™ 140 should be discarded after 60 days.

The provided document describes the ACCURUN™ 140 Rubella IgG Positive Control and its substantial equivalence determination, but it does not contain specific acceptance criteria or a study directly comparing reported device performance against numerical acceptance criteria in a table format.

The document focuses on:

• Device description: Ingredients, storage, intended use.
• Existing products and practices: States it's substantially equivalent to other commercial controls.
• Summary of studies: Mentions stability studies (real-time, ambient temperature, heat stress, freeze-thaw, open vial) and clinical laboratory evaluations at BBI and two external labs.
• Conclusions drawn from studies: Indicates the product is stable under various conditions and that "The clinical trial data demonstrate that ACCURUN™ 140 is safe and effective in three different laboratories with three manufactured ACCURUN™ 140 lots, and under various conditions of stress."

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance using the provided text. The document describes the types of studies conducted and their general conclusions but does not quantify performance metrics against pre-defined thresholds.

Here's a breakdown of what can be extracted or inferred from the document regarding the other points, along with what cannot be provided:

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

• Not available in the provided text. The document states general conclusions about stability and effectiveness but does not present specific numerical acceptance criteria (e.g., "stability must be maintained within X% for Y days") or quantitative device performance data against such criteria.

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. The document mentions "clinical laboratory evaluations were performed at BBI and at two clinical laboratories" and that "three manufactured ACCURUN™ 140 lots" were used. It refers to "clinical trial data" but doesn't quantify the number of tests, specimens, or specific patient samples in these evaluations.
• Data provenance: While the sponsor, Boston Biomedica, Inc., is based in West Bridgewater, MA, USA, the specific country of origin for the clinical evaluation data is not mentioned, other than being conducted at BBI and "two clinical laboratories" (location unspecified). The studies appear to be prospective for the purpose of demonstrating stability and performance for regulatory submission.

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

• Not applicable/Not available. This device is a positive control, not a diagnostic device that interprets clinical findings. Its "ground truth" is its known positive status for Rubella IgG antibodies. Ground truth in the context of expert review for diagnostic interpretation isn't relevant here. The clinical evaluations would have assessed its consistency and performance in detecting Rubella IgG in test systems, not its ability to diagnose a patient.

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

• Not applicable/Not available. As a control, adjudication of results in the traditional sense of resolving discrepancies in diagnoses is not relevant. The performance was likely assessed through consistency and expected reactivity in various Rubella IgG 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 device is a control, not an AI-powered diagnostic tool. Therefore, MRMC studies and "human readers improve with AI" are not relevant to this product.

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

• Not applicable. This is a human-blood-based laboratory control, not an algorithm or AI device.

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

• The "ground truth" for this positive control is its inherent positivity for Rubella IgG antibodies, manufactured from human serum or plasma containing these antibodies. This is established during its manufacturing and characterization rather than through expert consensus, pathology, or outcomes data in the context of patient diagnosis. Its performance is then evaluated by testing its reactivity in Rubella IgG assays.

8. The sample size for the training set

• Not applicable. This is a biological control, not a machine learning or AI device that uses a "training set."

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

• Not applicable. See point 8.

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ACCURUN™ 146 CMV 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 Cytomegalovirus (CMV). This control is not intended as a substitute for controls provided with test kits. ACCURUN™ 146 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures. 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 CMV in human serum and plasma.

ACCURUN™ 146 CMV IgM Positive Control is manufactured from human serum or plasma containing IgM antibodies to CMV, but is nonreactive for Hepatitis B Surface Antigen (HBsAg) and 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. This control is supplied as 1 x 1 ml or 1 x 5 ml vial. ACCURUN™ 146 should be stored frozen at -10°C or colder. Once opened, ACCURUN™ 146 should be stored at 2-8°C and discarded after 60 days.

The provided document describes the ACCURUN™ 146 CMV IgM Positive Control, a human blood-based single analyte run control for detecting IgM antibodies to Cytomegalovirus (CMV). However, it does not explicitly state acceptance criteria in a quantitative manner or provide a detailed study report with performance metrics against pre-defined criteria.

Based on the available text, here's a breakdown of the information and what cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The document describes the types of stability studies performed and the conclusions drawn, but lacks specific quantitative acceptance criteria (e.g., "signal not to drop by more than X% after Y days at Z temperature"). The "reported device performance" is a summary of the conclusions rather than hard data points.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical laboratory evaluations were performed at BBI and two external sites, including one blood bank and a clinical laboratory" and "three manufactured ACCURUN™ 146 lots." However, the number of individual control vials or test events in these evaluations is not provided.
• Data Provenance: The studies were conducted at "BBI and two external sites, including one blood bank and a clinical laboratory." The countries of origin for these labs are not specified. The studies appear to be prospective evaluations of the device's stability and performance in a usability context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. This device is a positive control, meaning its purpose is to provide a known positive signal for CMV IgM. It does not output a diagnostic result that requires expert interpretation or ground truth establishment in the traditional sense of a diagnostic test. The "ground truth" for the control itself is its known composition (human serum/plasma containing IgM antibodies to CMV). The evaluations focused on the control's stability and consistency in producing an expected signal, not on its diagnostic accuracy against patient samples.

4. Adjudication Method for the Test Set:

• Not applicable. There was no "test set" in terms of patient samples requiring diagnostic interpretation and adjudication. The studies evaluated the stability and performance of the control itself.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is not applicable to a positive control device. MRMC studies are typically performed for diagnostic devices where human readers interpret medical images or data, and the comparison is between human performance with and without AI assistance. The ACCURUN™ 146 is a control material, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable. This device is a biological control material, not an algorithm.

7. Type of Ground Truth Used:

• For the composition of the control itself, the ground truth is the known presence of IgM antibodies to Cytomegalovirus (CMV) in the human serum or plasma used to manufacture it, along with confirmed non-reactivity for other specified viruses (HBsAg, HIV 1/2, HTLV I, HCV). The studies assessed the control's ability to maintain its intended characteristics (stability, consistent signal) over time and under various conditions.

8. Sample Size for the Training Set:

• Not applicable. This device is a biochemical control, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As above, no training set is relevant for this product.

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Boston Biomedica intends to manufacture and market ACCURUN 121 HAV IgM Positive Control, which 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 Hepatitis A Virus (HAV). This control is not intended as a substitute for controls provided with test kits.

This product will be made available to clinical laboratory professionals in blood banks, public health laboratories and clinical laboratories for use with in virro diagnostic tests for the detection of IgM antibodies to HAV in human serum and plasma.

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 Hepatitis A Virus (HAV).

This document is a 510(k) clearance letter from the FDA for a medical device called ACCURUN™ 121 HAV IgM Positive Control. It does not contain the specific information required to answer your request about acceptance criteria and a study proving device performance. The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document describes the intended use of the device: "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 Hepatitis A Virus (HAV)." It also mentions that the product will be available to clinical laboratory professionals for use with in vitro diagnostic tests. This indicates the device is a control material for diagnostic tests, not a diagnostic test itself or an AI-powered device.

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ACCURUN 117 HBeAg 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 Hepatitis B e Antigen (HBeAg). This control is not intended as a substitute for controls provided with test kits.

ACCURUN 117 control is intended to estimate laboratory testing precision and can be used to detect errors in laboratory testing procedures.

ACCURUN 117 HBeAg Positive Control is a human blood based single analyte run control.

This document is a letter from the FDA regarding a 510(k) notification for a medical device. It does not contain specific information about acceptance criteria, device performance study details, or ground truth establishment.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on the regulatory approval of the ACCURUN™ 117 HBeAg Positive Control and its classification.

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