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The MeMed BV test is an automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatic serum and venous whole blood samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. MeMed BV is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for less than seven days. The MeMed BV test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

The MeMed BV® ("BV test" or the "test") is an In-Vitro-Diagnostic device that measures in parallel the blood concentrations of TRAIL, IP-10 and CRP. The test consists of an automated analyzer with built-in hardware and software that conduct chemiluminescence based analyte measurements of patient serum and venous whole blood samples and their computational integration (MeMed Key®), and a disposable cartridge that contains the reagents and controls needed to detect the analytes of interest (MeMed BV® cartridge). The test generates an answer to each sample, with a test run time of approximately 15 minutes.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for MeMed BV:

The MeMed BV test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection in patients presenting to the emergency department or urgent care center, or with samples collected at hospital admission, who have had symptoms for less than seven days. The device generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary details various analytical performance studies and a clinical study to support the expanded indications for use. Key acceptance criteria and reported performance include:

3. Absolute bias

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The MeMed BV test is an automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The MeMed BV is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for less than seven days. The MeMed BV test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

The Med BV® ("BV Test" or the "Test") is an In-Vitro-Diagnostic device that measures in parallel the blood concentrations of TRAIL, IP-10 and CRP. The Test consists of an automated analyzer with built-in hardware and software that conduct chemiluminescencebased analyte measurements of patient serum samples and their computational integration (MeMed Key®), and a disposable cartridge that contains the reagents and controls needed to detect the analytes of interest (MeMed BV® cartridge). The Test generates an answer to each sample, with a test run time of approximately 15 minutes.

The provided text is a 510(k) Summary for a modified medical device, the MeMed BV. It describes the device, its intended use, technological characteristics, and a comparison to a previously cleared predicate device. However, it explicitly states that the purpose of this specific 510(k) notice is for a modification to the already cleared device, primarily concerning an alternative manufacturing process for a component (Antibody-Alkaline Phosphatase conjugation chemistry) and a new buffer formulation.

The document does not provide detailed acceptance criteria or the full study findings that would typically be presented for a de novo clearance or a 510(k) for a novel device. Instead, it refers to prior studies for the original cleared device and asserts that the modified device's performance is equivalent.

Therefore, many of the requested details about acceptance criteria, detailed study results, sample sizes, ground truth establishment, and expert involvement are not present in the provided document for this specific submission (K222332). The document focuses on demonstrating that the modification does not negatively impact the performance, based on studies referencing the original device's validation.

Here's a breakdown of what can be extracted and what is missing:

1. Acceptance Criteria and Reported Device Performance

The document states: "The modified version of the MeMed BV has been tested according to the methods, protocols, and acceptance criteria used to support the previously 510(k)-cleared device. These methods apply to the device that is the subject of this Special 510(k) and were used in verification and validation ("V&V") of the modifications. The studies tested the performance of the measurement procedure for each individual measurand - CRP, IP-10, and TRAIL, as well as the performance of the measurement procedure for the MeMed BV® test score that is based on the computational integration of the three measurands. Testing included precision/reproducibility, LoQ, linearity, hook effect, interference/cross-reactivity, and method comparison testing. All testing indicated equivalent performance to the 510(k)-cleared MeMed BV."

This document does not list the specific numerical acceptance criteria or detailed results for performance metrics like sensitivity, specificity, or AUC as it is a Special 510(k) for a modification, not an initial clearance. It merely states that the modified device's performance was equivalent to the previously cleared predicate device, and the types of tests conducted for V&V.

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

The document does not provide details on the specific sample sizes used for the test set or the data provenance (country of origin, retrospective/prospective). It refers to the validation done for the previously cleared device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide details on the number or qualifications of experts used to establish ground truth because it's a submission for a modification, not a de novo clearance. Ground truth would have been established during the original device's clearance.

4. Adjudication Method for the Test Set

The document does not provide details on any adjudication method.

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

The document does not mention or describe an MRMC comparative effectiveness study or any effect size related to human readers improving with AI vs. without AI assistance. The MeMed BV is an in-vitro diagnostic (IVD) device measuring biomarkers, not an AI imaging or diagnostic algorithm designed to assist human readers in image interpretation.

6. Standalone (Algorithm Only) Performance Study

The document describes the device as an "automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP)... The MeMed BV test generates a numeric score that falls within discrete interpretation bins." This indicates it is a standalone algorithm in the sense that it processes the biomarker measurements and outputs a score. However, it's not a standalone AI performance study in the context of, for example, a diagnostic imaging algorithm being compared to expert interpretation. It's a measurement technology combined with a computational integration.

The performance studies mentioned ("precision/reproducibility, LoQ, linearity, hook effect, interference/cross-reactivity, and method comparison testing") are typical for standalone IVD device performance.

7. Type of Ground Truth Used

The document indicates the device "is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection." This strongly implies that the ground truth for the original validation studies would have been established based on clinical diagnoses, confirmed microbiological cultures/PCR, and a thorough review of patient outcomes and medical records by expert clinicians. However, the exact methodology for ground truth establishment for the original device is not detailed in this document.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. As this is an IVD device and not explicitly an AI/machine learning model where "training sets" are typically discussed, this information might not be presented in this format, or it would have been part of the original device's clearance. The "computational integration" aspect implies an algorithm, but training details are not given.

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

Similarly, the document does not provide any information on how the ground truth for any training set was established.

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The DiaSorin LIAISON® MeMed BV® is an automated in vitro diagnostic semi-quantitative assay that uses chemiluminescent immunoassay (CLIA) technology to measure three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The LIAISON® MeMed BV® assay is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for seven days or less. The LIAISON® MeMed BV® assay generates a numeric score that falls within discrete interpretation ranges based on the increasing likelihood of bacterial infection. The assay has to be performed on the automated LIAISON® XL Analyzer.

The DiaSorin LIAISON® MeMed BV® Control Set is intended for use as assayed quality control to monitor the performance of the DiaSorin LIAISON® MeMed BV® assay. The performance characteristics of the LIAISON® controls have not been established for any other assays or instrument platforms different from the automated LIAISON® XL Analyzer. The control set is intended for in vitro diagnostic use in a professional laboratory only.

The LIAISON MeMed BV assay consists of three individual chemiluminescence immunoassay (CLIA) for quantitative determination of TRAIL, IP-10, and CRP. The LIAISON MeMed BV test result is a score between 0 and 100 derived from computational integration of the measurements of the three proteins TRAIL, IP-10, and CRP, where low scores are indicative of viral infection and high score of bacterial infection. All three reagent packs must be the same lot and present at the same time on the same instrument used for sample testing. All three reagent packs are individually calibrated and quality controlled. Specimens are to be assigned to the MMBV assay protocol where all three reagent packs will be utilized to provide combined results and a final score.

The TRAIL reagent pack uses a monoclonal antibody for capture of TRAIL and a polyclonal antibody for the detection of TRAIL. The assay incubates sample, calibrator or control with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the TRAL. Following the incubation, an isoluminol conjugated polyconal antibody that recognizes TRAIL is then added to the reaction and incubated. The unbound conjugate is removed with a wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of TRAL present in the calibrators, controls or samples. The result of the TRAIL reagent pack is only used to calculate a final LIAISON MeMed BV Score and should not be used individually for diagnosis.

The IP-10 reagent pack uses a monoclonal antibody for the capture of IP-10 and a polyclonal antibody for the detection of IP-10. The assay incubates sample, calibrator or control with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the IP-10. Following the incubation, an isoluminol conjugated polyclonal antibody that recognizes IP-10 is then added to the reaction and incubated. The unbound conjugate is removed with a wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of IP-10 present in the calibrators, controls or samples. The result of the IP-10 reagent pack is only used to calculate a final LIAISON MeMed BV Score and should not be used individually for diagnosis.

The CRP reagent pack uses monoclonal antibodies for capture and detection of CRP. First the patient serum sample is pre-diluted 1:196 with assay buffer. The assay incubates the pre-diluted sample, calibrator or control with assay buffer and paramagnetic particles coated with a monoclonal antibody that specifically recognizes the CRP. Following the incubation, an isoluminol conjugated monoclonal antibody that recognizes CRP is then added to the reaction and incubated. The unbound conjugate is removed with a wash step. Starter reagents are then added and a flash chemiluminescent reaction is initiated. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of CRP present in the calibrators, controls or samples. The result of the CRP reagent pack is only used to calculate a final LIAISON MeMed BV Score and should not be used individually for diagnosis.

The provided document describes the FDA clearance (K213936) for the DiaSorin LIAISON® MeMed BV® assay, which aids in differentiating bacterial from viral infections. Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing predefined acceptance criteria with numerical targets. However, the performance data presented implies a set of internal acceptance criteria related to statistical significance, agreement with expert adjudication, and reproducibility.

Given the information provided, here's a table summarizing the reported device performance, with implicit acceptance criteria derived from the study's conclusions:

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

• Clinical Agreement Test Set: 285 serum samples.
  • Provenance: Collected at hospital admission, Emergency Department, and Urgent Care Centers. Patients ranged in age from 5 months to 92 years. The origin country is not explicitly stated, but the mention of "21 international experts" suggests a multi-national or at least internationally adjudicated dataset. The study is retrospective in the sense that samples were likely collected before the adjudication process and testing with the device.
• Method Correlation Test Set:
  • Primary Endpoint analysis: 285 clinical samples (the same as the clinical agreement test set).
  • Secondary Endpoint analysis: 257 clinical samples (28 of the 285 were excluded).
• Expected Values Test Set: 150 serum samples from apparently healthy asymptomatic adults.
  • Provenance: Collected in the Southwestern U.S.
• Reproducibility Study Test Set: 4 serum samples (1 normal, 1 viral, 1 bacterial, 1 equivocal) plus kit controls.
• Cross-Reactivity Study Test Set: Two (2) serum samples (one low, one high SCORE) for each cross-reactant being tested.
• Interfering Substances Study Test Set: Two (2) serum samples (one low, one high SCORE) for each interfering substance being tested.
• Matrix Equivalence Study Test Set: 43 fresh serum samples from individual patients, with 20 spiked for range coverage.
• Limit of Blank, Detection, Quantitation Test Set: Varied based on particular limit, ranging from 4-8 serum/spiked matrix samples for LoD/LoQ studies and 5 calibrator matrix samples for LoB.

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

• Number of Experts: A pool of 21 international experts.
• Qualifications of Experts: Clinicians with at least 7 years of relevant clinical experience. Each panel comprised at least three experts.

4. Adjudication Method for the Test Set

• Method: Expert adjudication.
  • Process: Panelists for each subject adjudication were drawn from the pool of 21 international experts. Each panel comprised at least three experts who independently adjudicated the etiologic label for each patient. The etiologic label was determined as bacterial, viral, or non-infectious. The adjudication was based on anonymized patient data. Critically, the adjudicators were blinded to the MeMed BV result (for the primary endpoint) and to CRT and PCT results (for the primary endpoint). For the secondary endpoint, adjudicators were un-blinded to PCT and CRP results.

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 document describes the analytical and clinical performance of an in vitro diagnostic assay (a laboratory test that measures protein levels and computes a score), not an AI-assisted diagnostic tool that human readers interpret. Therefore, an MRMC comparative effectiveness study involving human readers assisting with AI is not applicable and was not performed. The device itself is the "AI" (computational algorithm) that processes biomarker data.

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

• Yes, the performance presented for the "LIAISON MeMed BV" assay is a standalone performance of the device (assay and its integrated computational scoring). The "SCORE" is generated by the device's algorithm based on the measured protein levels (TRAIL, IP-10, and CRP), without a human in the loop for the scoring itself. The clinical utility is then evaluated by comparing this score to expert adjudication.

7. The Type of Ground Truth Used

• Type of Ground Truth: Expert consensus (physician expert adjudication). Specifically, physicians were forced to make a bacterial, viral, or non-infectious diagnosis.

8. The Sample Size for the Training Set

• The document does not specify the sample size used for training the algorithm (the "SCORE" computation). This document focuses on the validation of the device for FDA clearance. Typically, details of the training dataset are considered proprietary or part of the algorithm development process prior to clinical validation.

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

• Since the training set size and details are not provided, information on how its ground truth was established is also not available in this document. It is typical for such algorithms to be trained on large, well-characterized datasets, often with similar expert-adjudicated ground truth, but these details are not part of the premarket notification summary.

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The MeMed BV™ test is an automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples and is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. MeMed BV™ is indicated for use in patients presenting to the emergency department or urgent care center and with samples collected at hospital admission from patients with suspected acute bacterial or viral infection, who have had symptoms for less than seven days. The MeMed BV™ test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

The MeMed BV™ ("BV test" or the "test") is an In-Vitro-Diagnostic device that measures in parallel the blood concentrations of TRAIL, IP-10 and CRP. The test consists of an automated analyzer with built-in hardware and software that conduct chemiluminescence-based analyte measurements of patient serum samples and their computational integration (MeMed Key™), and a disposable cartridge that contains the reagents and controls needed to detect the analytes of interest (MeMed BV™ cartridge). The test generates an answer to each sample, with a test run time of approximately 15 minutes.

The MeMed BV™ test is an automated semi-quantitative immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples. It's intended for use in conjunction with clinical assessments and other laboratory findings to differentiate bacterial from viral infections in patients with suspected acute bacterial or viral infection, who have had symptoms for less than seven days, and are presenting to the emergency department or urgent care center or at hospital admission. The test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The provided document details various analytical performance criteria and associated results. The primary clinical study acceptance criteria are related to the statistical significance of the trend and likelihood ratios.

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