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510(k) Data Aggregation
(364 days)
The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, protein, and carbohydrate in human milk. The Miris HMA also provides calculated values for total solids and energy. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants. This device is intended for use in healthcare by trained healthcare personnel at clinical laboratories. The Miris HMA is also intended for use by personnel trained in the use of the device at Human Milk Banking Association of North America (HMBANA) accredited human milk banks, for the purpose of labeling milk donations and in the processing of milk donations.
The Miris Human Milk Analyzer (HMA) includes a mid-infrared (mid-IR) spectroscopy system and a man-machine interface (MMI). The user is guided by the interactive MMI, via the screen, through the measurement process by use of the six-button controlled menu system. Milk samples are injected into the measuring unit (cuvette) via the instrument inlet using a syringe (sample volume 3 mL), excess sample and waste exiting via the outlet.
The device consists of the following components and accessories: an instrument casing with sample inlet and outlet holding a measurement unit and electronics mainboard, with AC/DC adapter, syringes for injection of sample, zero-setting solution, quality control solutions, and cleaning agent, waste container (not provided by the manufacturer), and outlet tubes.
The Miris Human Milk Analyzer (HMA) is a medical device that quantitatively measures the concentration of fat, protein, and carbohydrate in human milk. It also provides calculated values for total solids and energy, which can be used alongside other clinical assessments to aid in the nutritional management of newborns and infants. The device is intended for use by trained healthcare personnel in clinical laboratories and by personnel in Human Milk Banking Association of North America (HMBANA) accredited human milk banks.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details various performance characteristics. Below is a table summarizing the acceptance criteria and the device's reported performance where available and explicitly stated. For some categories, the acceptance criteria are implied by the "acceptable" or "met all expected performance" statements as explicit numerical criteria are not always provided.
| Performance Characteristic | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Precision | Repeatability (CV): Fat, Crude protein, True protein ≤5% at 1 g/mL; Carbohydrate, Total solids, Energy ≤3% Accuracy: Fat, Crude protein, True protein, Total solids, Energy ±10%; Carbohydrate ±13% | "The results of the precision study show that Miris HMA demonstrated acceptable results for the intended use of the device similar to the predicate device." "In all instances, the Miris HMA functioned as intended and the precision in the milk bank setting... was as expected." The exact CV and Accuracy values are not detailed in this section, but the overall conclusion affirms acceptance compared to predicate. |
| Detection Capability | LoB below 0.1 g/100 mL for fat, crude protein, and carbohydrate. LoB ≤ LoD |
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(312 days)
The Miris Human Milk Analyzer (HMA) quantitatively measures the concentration of fat, carbohydrate, and protein in human milk. The Miris HMA also provides calculated values for total solids and energy. These measurements, in conjunction with other clinical assessments, may be used to aid in the nutritional management of newborns, including preterm, and infants. This device is intended for use in healthcare by trained healthcare personnel at clinical laboratories.
The Miris Human Milk Analyzer (HMA) is a system for the quantitative measurement of fat, protein, and total carbohydrate content in human milk. The measurements of fat, protein and carbohydrate are also used in calculating the total solids and the energy content of human milk samples. The HMA unit includes a mid-infrared (mid-IR) spectroscopy system and a user interface. The user is guided by the interactive interface, via the screen, through the measurement process by use of the six-button controlled menu system. Milk samples (3 mL) are injected into the measuring unit (cuvette) via the instrument inlet using a syringe, with excess sample and waste exiting via the outlet.
The HMA device is comprised of a sample cuvette, hardware consisting of a mainboard and central processing unit (CPU) board, a display, touch button, fan, case, and consumables. The hardware consists of a mainboard with a CPU-board, detector board, and emitter board.
Here's a breakdown of the acceptance criteria and the study details for the Miris Human Milk Analyzer, based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria are generally implied by the various performance studies conducted and the statements regarding the device's suitability for its intended use. The performance characteristics sections (L.1 and L.2) provide the reported device performance.
| Acceptance Criterion | Reported Device Performance (Summary) |
|---|---|
| Precision | Fat: Total CV% ranges from (b)(4)% to 18.66% across different samples and sites. |
| Crude Protein: Total CV% ranges from 3.00% to 9.78% across different samples and sites. | |
| True Protein: Total CV% ranges from (b)(4)% to (b)(4)% across different samples and sites. | |
| Carbohydrates: Total CV% ranges from (b)(4)% to (b)(4)% across different samples and sites. | |
| (Detailed SD and %CV for each sample at each site are provided in the document for Between Day, Within Run, Between Run, and Total precision.) | |
| Linearity/Assay Reportable Range | Fat: R² = 0.9972, Slope = 1.0119, Intercept = -0.0724 (Claimed Range: 0.6-4.0 g/100mL) |
| Crude Protein: R² = 0.9964, Slope = 0.9925, Intercept = 0.0364 (Claimed Range: 0.8-3.0 g/100mL) | |
| True Protein: R² = 0.9967, Slope = 0.9811, Intercept = 0.0647 (Claimed Range: 0.6-2.4 g/100mL) | |
| Carbohydrates: R² = 0.9854, Slope = 0.9457, Intercept = 0.5095 (Claimed Range: 6.6-8.7 g/100mL) | |
| Calibration Stability | Calibration stable for up to (b)(4) weeks. |
| Detection Limits (LoB, LoD, LoQ) | Fat: LoB=0.06, LoD=0.11, LoQ=0.41 g/100mL |
| Crude Protein: LoB=0.06, LoD=0.25, LoQ=0.42 g/100mL | |
| True Protein: LoB=0.05, LoD=0.20, LoQ=0.34 g/100mL | |
| Carbohydrate: LoB=0.04, LoD=0.35, LoQ=3.00 g/100mL | |
| Analytical Specificity (Interference) | Identified maximum concentrations for 20+ substances that do not interfere. Identified 7 substances (Citalopram, Sertraline, Ampicillin, Vancomycin, Clindamycin, Cephalexin, Pseudoephedrine) and (b)(4) which do interfere with specific analytes. |
| Accuracy (Method Comparison with Reference Method) | Fat: N=80, R²=0.99, Slope=1.11, Intercept=-0.11 |
| Crude Protein: N=112, R²=0.96, Slope=1.19, Intercept=-0.33 | |
| True Protein: N=112, R²=0.96, Slope=1.19, Intercept=-0.27 | |
| Carbohydrates: N=106, R²=0.85, Slope=0.90, Intercept=0.62 | |
| Total Solids: N=112, R²=0.96, Slope=0.97, Intercept=0.32 | |
| Bias values (g/100mL) and 95% CI are provided for low, medium, and high concentrations for each analyte. | |
| Energy Accuracy (Bomb Calorimetry) | Bias (kcal/100mL) and 95% CI are provided for energy values at 45, 70, and 110 kcal/100mL. |
| Carryover | Specific carry-over for water to milk and milk to water determined as (b)(4) and (b)(4) respectively. |
Study Details for Miris Human Milk Analyzer
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Sample size used for the test set and the data provenance:
- Precision Studies:
- Site 1: Minimum of 3 milk samples, 80 measurements per sample (20 days, 2 runs/day, 2 replicates/run).
- Sites 2 & 3: Milk samples (number not specified, but at least 4-5 based on table rows), 30 measurements per sample (5 days, 2 runs/day, 3 replicates/run).
- Provenance: "Native human milk samples." No specific country of origin is mentioned, but it's implied to be retrospective as samples are collected and then tested.
- Linearity Studies: Minimum of 12 samples of known relative concentration. Provenance not specified.
- Detection Limit Studies:
- LoB: 4 blank samples, 60 measurements (5 days, 3 replicates/day/sample).
- LoD & LoQ: 7 milk samples with low fat, and 7 samples with low protein/carbohydrate levels, 105 replicates per variable (5 days, 3 replicates/day/sample). Provenance not specified.
- Analytical Specificity (Interference) Studies: 2 milk sample pools. Provenance not specified.
- Accuracy (Method Comparison): 112 native human milk samples. Provenance not specified; implied retrospective.
- Energy Accuracy (Bomb Calorimetry): (b)(4) native human milk samples. Provenance not specified.
- Precision Studies:
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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):
- No information is provided about experts establishing ground truth. Instead, reference laboratory methods were used. The document states: "The Miris Human Milk Analyzer is traceable to certified reference materials and validated chemical methods. The validation of these chemical methods was reviewed and found to be acceptable." For the accuracy studies, "validated comparative chemical methods" and a "validated bomb calorimetric method" were used.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- There was no mention of an adjudication method in the context of expert review. For the method comparison studies, the reference method results were often a "mean of the triplicates results."
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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 MRMC comparative effectiveness study was conducted. This device is an analyzer for macronutrient composition, not an AI-assisted diagnostic device for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this entire evaluation describes the performance of the device in a standalone capacity. It quantitatively measures analytes in human milk directly, without human interpretation of raw data for results. The results are then used by healthcare providers.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth was established by validated chemical reference methods and certified reference materials. For energy, a validated bomb calorimetric method was used.
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The sample size for the training set:
- The document states that the instrument is "calibrated at the manufacturer site" using "(b)(4) calibration samples designed to cover the instrument calibration range." The specific number of samples beyond this redacted information is not provided.
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How the ground truth for the training set was established:
- For the training (calibration) set, "The calibration samples are prepared, and values are assigned using validated methods." This implies that the ground truth for calibration samples is also established using reference chemical methods, similar to the method comparison studies.
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