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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.

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

• Precision Study (Test Set 1):

  • Sample Size:
    • Main site (E): 5 human milk samples.
    • Secondary sites (F, G): 5 human milk samples (same as main site).
  • Data Provenance: The study was performed at three US human donor milk bank sites in February and March 2022. These were:
    • Mothers' Milk Bank (San José, USA) - Main site (E)
    • Mid-Atlantic Mothers' Milk Bank 'Three Rivers' (Pittsburgh, USA) - Secondary site (F)
    • The New York Milk Bank, Inc., (New York, USA) - Secondary site (G)
  • Nature of Data: Prospective, as it involved actively testing samples with the device at the specified sites.

• Linearity Study (Test Set 2):

  • Sample Size: Not explicitly stated as a number of distinct samples for the new linearity study. However, the study evaluated the linear range for Fat, CP, TP, CHO, TS, and E over specified intervals.
  • Data Provenance: Not explicitly stated, but it's a new study undertaken for this 510(k) submission, implying prospective data generation.

• Trueness, Method Comparison Testing (Test Set 3):

  • Sample Size: 112 human milk samples (plus 1 extra sample for replacement if needed).
  • Data Provenance: Not explicitly stated where the samples originated from, but the study compared Miris HMA analysis to biochemical standard methods. The study was conducted following CLSI EP09c guideline, implying a rigorous, likely prospective, assessment.

• Detection Capability, Interference, and Carry Over: For these studies, the document states "Data concerning the Miris HMA... were included in DEN180007." This indicates the data was retrospective (from the predicate device's submission). The sample sizes are not detailed in this section for those previous studies.

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

This information is not provided in the document. For the Miris HMA, the "ground truth" for macronutrient content is established by biochemical standard methods, not expert consensus. The experts involved would likely be laboratory technicians or specialists trained in performing these reference methods.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1 for resolving disagreements) are typically used in studies involving human interpretation of results, especially for imaging or diagnostic decision-making.

For the Miris HMA, the ground truth is established by objective biochemical standard methods and precise measurements, not by subjective human interpretation that would require an adjudication process. Therefore, an adjudication method as commonly understood in expert review is not applicable and not mentioned.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done.

MRMC studies typically compare the diagnostic accuracy of multiple readers interpreting medical cases, often with and without AI assistance, to measure the "effect size" of AI improvement. The Miris HMA is an automated analytical device that provides quantitative measurements, not an AI interpretation system requiring human readers. Therefore, this type of study design is not relevant to this device.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was done

Yes, the Miris HMA performance studies are essentially standalone.

The device itself is an automated analyzer. The precision, linearity, and method comparison studies evaluate the device's output (measurements of fat, protein, carbohydrate, total solids, and energy) without direct human intervention in the measurement process itself beyond operating the machine and preparing samples. The "ground truth" is established by independent, objective laboratory reference methods. The device's performance is assessed purely on how accurately and precisely it measures the macronutrients compared to these reference methods.

7. The Type of Ground Truth Used

The ground truth used for the Miris HMA performance studies (Trueness/Method Comparison) was based on biochemical standard methods:

• Fat: Röse Gottlieb (ISO 1211)
• Crude Protein: Kjeldahl (ISO 8968-1)
• True Protein: Kjeldahl crude protein * 0.8
• Total CHO (Carbohydrate): Calculated by difference from values obtained by comparative methods.
• Total Solids (TS): Drying oven (ISO 6731)
• Energy: Bomb calorimetry (ISO 1928)

These are recognized, validated laboratory reference methods for analyzing macronutrients in human milk.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set of the Miris HMA. The device uses mid-infrared spectroscopy with an internal calibration. While calibration involves a set of reference samples, the term "training set" is more commonly associated with machine learning or AI models. Given that the device is based on Beer's law (absorbance proportional to concentration) and an internal calibration, the training set would refer to the samples and methods used to establish and validate this internal calibration curve. This information is not detailed in the provided summary.

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

Similar to point 8, the specific details of how the ground truth for the training set (i.e., the samples used for the device's internal calibration) were established are not provided. However, it is highly probable that the ground truth for these calibration samples would have been established using the same (or similar) biochemical standard methods as described for the Trueness/Method Comparison study (Röse Gottlieb, Kjeldahl, Drying oven, Bomb calorimetry, etc.), as these are the gold-standard methods for determining macronutrient content in milk.

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