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The AutoMARQER™ is a differential spectrophotometer/reflectometer for sperm analysis and quantification, using MARQ™ Plus Test Kits.

The AutoMARQER™ functions as a differential spectrophotometer / reflectometer, using MARQ™ Plus Test Kits* for sperm analysis. The AutoMARQER conducts sequential measurement operations on a specimen introduced into the instrument on a special MARQ™ Plus Test Kit cassette designed for use with the AutoMARQER. When using the FertilMARQ Plus Test Kit,* the AutoMARQER measures sperm concentration, motility and velocity. The AutoMARQER performs as a spectrophotometer when measuring specimen concentration. When measuring motility and velocity, it measures light scatter that occurs as sperm intercept its laser beam. It measures number of sperm in a beam directly by counting sperm cells crossing the beam and determines their velocity by the length of bearn passage. Since the beam diameter is known, the crossing time gives the sperm velocity

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Hamilton Thorne Research AutoMARQER™ device:

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

The provided document does not explicitly state numerical acceptance criteria. Instead, it makes a general claim regarding equivalence, which serves as the implicit performance standard.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It only states that "Equivalent results are obtained on semen samples...".

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 information is not provided in the document. The ground truth appears to be based on the results from the predicate device, the IVOS™ Sperm analysis system, rather than expert consensus on individual cases.

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

This information is not provided in the document. Given that the comparison is to a predicate device, it's unlikely an adjudication method for human readers was used in this context.

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 with human readers assisting an AI (or vice-versa) was not done. This device is a standalone analytical instrument, not an AI-assisted diagnostic tool for human readers.

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

Yes, a standalone performance evaluation was conducted. The AutoMARQER™ is described as functioning independently to measure sperm concentration, motility, and velocity. The performance test involved directly comparing its results to those of a legally marketed predicate device, the IVOS™ Sperm analysis system.

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

The ground truth for the performance study was established by the legally marketed predicate device, the IVOS™ Sperm analysis system. The study's objective was to demonstrate "equivalent results" to this established device.

8. The sample size for the training set:

The document does not provide any information about a training set since the device is not described as utilizing a machine learning algorithm that requires explicit training data in the context of this 510(k) submission. It functions as a spectrophotometer/reflectometer.

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

This question is not applicable as the document does not indicate the use of a machine learning model requiring a training set or ground truth for such a set.

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The Automarqer™ is a differential spectrophotometer for quantification of results using MARQTM Test Kits for sperm analysis.

The Automarqer™ is a differential spectrophotometer for quantification of results for sperm analysis. The MARQ test kits employ a unique test cassette with four wells, each containing a filter to retain the test reagents and sample suspension. The test cassette is designed to be inserted into the Automarqer for reading of results after the sample has been processed. The Automarger provides the numeric analysis of the quantity of sperm or other sperm ejaculate component being evaluated.

The Automarqer operates by measuring the well reflectivity in two wavelengths (red and green) and deriving the optical absorption in DNA-specific dyes within the wells, generated by the staining reagents used in the MARQ test kits. Each well emits a signal in the color with which it is illuminated (either red or blue dye). The first well of the test cassette provides a standard signal (using a standardized latex bead suspension), the second well provides a null signal, and the third and fourth wells provide sample signals.

The Automarqer contains an optical assembly, microprocessor and program, cassette position sensor and readout screen. Software in the microprocessor ROM directs the operations. The microprocessor detects position of the cassette as each well is inserted, stores the value of the signal from each well separately under red and green wavelength illuminations, and computes the corresponding reflectivity of the sample, using the scale defined by the difference between the first two wells (the standard signal and the null signal). In this way, the system is self-calibrating on each cassette.

Here is an analysis of the provided text regarding the Automarqer™ device, focusing on its acceptance criteria and the study proving it.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical targets in the way typically seen in device submissions (e.g., "accuracy > 95%"). Instead, it describes performance in terms of variability and correlation to a predicate device. The implied acceptance criteria are that the device should have low internal variability and high correlation with the legally marketed predicate.

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

• Sample Size for Test Set:
  • Clinical Samples for Correlation: 35 clinical samples.
  • Samples for Operator Reproducibility: 11 samples (tested by 3 different operators).
• Data Provenance: The document does not specify the country of origin for the clinical samples. It indicates they are "clinical samples," suggesting they were collected from human subjects. The study appears to be retrospective in nature, as it is comparing results obtained by the new device with an existing, legally marketed device (IVOS).

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

The document does not mention the use of experts to establish ground truth for the sperm concentration analysis. The ground truth for the comparative study appears to be based on the measurements obtained from the predicate device, the IVOS sperm analysis system. Therefore, no information on the number or qualifications of experts for ground truth is provided.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. Since the ground truth for the comparative study uses the predicate device's measurements, and the sample variability is tied to "sample and its administration in the test," it implies a direct comparison without an external adjudication process.

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

No multi-reader multi-case (MRMC) comparative effectiveness study explicitly designed to measure the improvement of human readers with AI assistance is described. The study mentioned involves comparing the Automarqer™ device to the IVOS system, and then examining reproducibility with different operators for the Automarqer™. This is a device-to-device and intra-device reproducibility study, not an AI-assisted human reader study.

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

Yes, a standalone performance study was done. The Automarqer™ itself is the device being evaluated. Its performance is measured through:

• Its own internal well variability (< 0.15%).
• Cassette well variability (1.1%).
• The correlation of its output to the IVOS sperm analysis system (r = 0.997).
• The reproducibility of its results when operated by different individuals (using 11 samples and 3 operators).
  The device provides a "numeric analysis of the quantity of sperm," and the performance data presented are direct measurements from the device.

7. Type of Ground Truth Used

The ground truth for the main comparative study (correlation study) is the measurements obtained from the legally marketed predicate device, the IVOS sperm analysis system. For the variability and reproducibility studies, the "ground truth" is essentially the expected consistency of the device's own measurements.

8. Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. This suggests that the device's internal algorithms might be based on pre-established optical principles and calibration methods rather than machine learning requiring a distinct training phase.

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

Since no training set is mentioned, information on how its ground truth was established is not applicable.

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