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510(k) Data Aggregation
(215 days)
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.
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Analytical Performance | ||
| Limit of Quantitation (LoQ) | Total Error (TE) for TRAIL < 30%, IP-10 < 40%, CRP < 30%. | All tested samples passed the acceptance criteria for TE. Formal LLoQ established at TRAIL - 15 pg/mL, CRP - 1 mg/mL, IP-10 - 100 pg/mL. |
| Reproducibility/Precision (Measurands) | CV ≤ 15% for TRAIL, IP-10, and CRP (excluding healthy specimens for IP-10 and CRP where concentrations are below LoQ). | All measurands' CVs were within the acceptance criteria across repeatability, intermediate precision, and reproducibility studies (e.g., TRAIL CVs ranged from 6.6% to 12.7%, IP-10 CVs from 4.0% to 6.2%, CRP CVs from 4.9% to 11.6%). |
| Reproducibility/Precision (MeMed BV Score) | SD < 12.5 score units. | All scores' SDs were within the acceptance criteria (Repeatability SDs: 0.3-7.5; Intermediate Precision SDs: 0.3-7.7; Reproducibility SDs: 0.4-9.4). |
| Lot-to-Lot Reproducibility (Measurands) | CV ≤ 15% for TRAIL, IP-10, and CRP (excluding healthy specimens for IP-10 and CRP). | All measurands' CVs for between-lots analysis were within the acceptance criteria (e.g., TRAIL CVs 0.0-1.6%, IP-10 CVs 0.0-7.3%, CRP CVs 0.0-1.2%). |
| Lot-to-Lot Reproducibility (MeMed BV Score) | SD < 12.5 score units. | All scores' SDs for between-lots analysis were within the acceptance criteria (all 0.0). |
| Linearity | Measurement bias due to non-linearity < 10% or 10mg/L for CRP, 10% or 10 pg/mL for TRAIL, and 10% or 50 pg/mL for IP-10. | The degree of non-linearity for CRP and IP-10 (Lot 1 and Lot 2) was within the acceptance criteria. |
| Hook Effect | Responses obtained for concentrations up to Level 4 were no less than the response obtained for ULoQ. | No hook effect was observed for TRAIL up to 1,000 pg/mL, IP-10 up to 10,000 pg/mL, and CRP up to 500 mg/L. |
| Carry Over | Difference between average scores of high/low sequence no more than 12.5 score units. | Maximal difference in score was 1 score unit, demonstrating no carry-over. |
| Interference/Cross Reactivity | Bias between spiked and non-spiked score results was ± 12.5 score units. | The 95% confidence interval for the bias was within +/-12.5 score units for all tested interferents and cross-reactants. |
| HAMA Interference | TRAIL, CRP, and IP10 concentrations, when run on clinical serum sample mixed with HAMA positive sample, shall measure concentrations within +/- 10% compared to their nominal concentration. | For both HAMA samples, the recovery of TRAIL, IP-10, and CRP was within +/- 10%. |
| In-Use Stability | Mean values, regression lines, confidence intervals, and significance level of the difference of the slope from 0 were examined. | Allowable incubation time at room temperature before centrifugation was established at 120 minutes. |
| Freeze-Thaw Stability | All scores within the 95% confidence interval are within the same or adjacent score categories and do not result in a move between non-adjacent scores. | Frozen and fresh samples demonstrated score results corresponding to the same or adjacent scores within the 95% confidence interval, thus demonstrating equivalency. |
| Clinical Performance | ||
| Primary Objective Cohort: Cochran-Armitage (CA) Test | Significant trend in increasing probability of bacterial infection with higher MeMed BV™ score (p < 0.05). | p < 0.0001; trend in increasing probability of bacterial infection was demonstrated. |
| Primary Objective Cohort: Likelihood Ratio (LR) for bins | 95% CI of the LR for some bins (Bins 1,2,4,5) excluded 1. | 95% CI for Bins 1 (0.1-0.2), 2 (0.3-0.6), 4 (2.1-3.1), and 5 (6.3-10.5) excluded 1. |
| Secondary Objective Cohort: Cochran-Armitage (CA) Test | Significant trend in increasing probability of bacterial infection with higher MeMed BV™ score (p < 0.05). | p < 0.0001; trend in increasing probability of bacterial infection was demonstrated. |
| Secondary Objective Cohort: Likelihood Ratio (LR) for bins | 95% CI of the LR for some bins (Bins 1,2,4,5) excluded 1. | 95% CI for Bins 1 (0.0-0.1), 2 (0.0-0.3), 4 (1.5-4.0), and 5 (16.6-37.8) excluded 1. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Clinical Study Test Set Sample Size:
- Primary Objective Cohort: 1016 infectious subjects. This included 476 prospectively recruited adult and pediatric patients and 540 archived cases.
- Secondary Objective Cohort: 872 subjects (after removing 144 indeterminate cases from the primary cohort).
- Prospectively recruited patients (subgroup analysis): 476 patients.
- Archived cases (subgroup analysis): 540 cases.
- Data Provenance: The study was a prospective, multicenter, observational, and blinded study. Patients were recruited from 11 medical centers (9 in the US and 2 in Israel). Therefore, the data originates from both the United States and Israel, and it includes both prospective and retrospective (archived cases) data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document states that the ground truth for the clinical study was established using an "expert adjudication comparator method." It also mentions "experts blinded to C-reactive protein (CRP) and procalcitonin (PCT) values" for the primary objective, and "experts given CRP and PCT values" for the secondary objective.
The number of experts and their specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly detailed in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
The term "expert adjudication comparator method (forced diagnosis for indeterminate cases)" is used for the primary objective, and "expert adjudication comparator method (indeterminate cases removed from analysis)" for the secondary objective.
The specific method of adjudication (e.g., if multiple experts made independent decisions and how discrepancies were resolved like "2+1" or "3+1") is not explicitly stated in the provided text.
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 focusing on human readers' improvement with vs. without AI assistance was not described in the provided text. The clinical study assessed the standalone diagnostic performance of the MeMed BV™ test itself (algorithm only, as an aid to differentiate infection), not its impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done. The "Apollo Clinical Study" evaluated the diagnostic performance of the MeMed BV™ test (an automated immunoassay with computational integration) in differentiating bacterial from viral infection. The results tabulated in Tables 17 and 18, and Figures 1 and 2, demonstrate the performance of the device's algorithmic output (numeric score and interpretation bins) against the expert-adjudicated reference standard, without human-in-the-loop interaction being part of the primary outcome measurement itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The primary type of ground truth used for the clinical study was expert adjudication. For the primary objective cohort, it involved a "forced diagnosis for indeterminate cases" where experts were blinded to CRP and PCT values. For the secondary objective cohort, expert adjudication was used, but indeterminate cases were removed from the analysis, and experts were given CRP and PCT values.
8. The sample size for the training set:
The provided document does not specify the sample size used for the training set for the MeMed BV™ test's algorithm. The document focuses on the test set used for analytical and clinical validation.
9. How the ground truth for the training set was established:
The document does not provide information on how the ground truth for any potential training set was established. It only details the ground truth establishment method for the clinical study's test set.
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