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The HemoSite® Test System is a device for in vitro diagnostic use only. The GDS® HemoSite® Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® Meter in a point-of-care setting such as a physician's office or hospital.

The HemoSite® Test System is a whole blood hemoglobin measurement device which consists of the Stat-Site® Meter (K911801), HemoSite® Test Card and {lot-specific} HemoSite® Test Module. The test employs dry reagent technology based on the azidemethemoglobin method. The blood sample is applied to one side of the HemoSite® Test Card and the color develops on the opposite side. The color produced is directly proportional to the concentration of hemoglobin in the sample and is read using light reflectance at a specific wavelength; the reflectance reading is performed and reported by the Stat-Site® meter.

The provided text describes the HemoSite® Test System, a whole blood hemoglobin measurement device. Here's an analysis of the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only provides these three statistical parameters from a regression analysis. It does not explicitly state pre-defined thresholds for "acceptance" for each of these metrics. The conclusion states that the results "compare acceptably with the reference methods," implying that these values were within acceptable limits for FDA clearance.

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

• Sample Size: 151 whole blood clinical samples.
• Data Provenance: The samples were obtained at 3 independent physician's office sites. This indicates prospective data collection. The country of origin is not explicitly stated, but given the FDA submission, it is highly likely to be the United States.

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

The ground truth was established using a "certified reference standard." The document does not mention the number of experts, their qualifications, or their role in establishing this reference standard. It is implied that the reference standard itself is considered the expert "ground truth."

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established by comparison to a "certified reference standard," not through expert adjudication of 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

No, an MRMC comparative effectiveness study was not done. The HemoSite® Test System is a device for quantitative determination of hemoglobin, not an AI-assisted diagnostic imaging or interpretation tool that would involve human readers.

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

Yes, this was a standalone performance study. The HemoSite® Test System, which includes the Stat-Site® Meter, HemoSite® Test Card, and Test Module, directly provides the hemoglobin measurement. The study evaluated the performance of this system against a reference standard. There is no mention of human-in-the-loop performance being a variable in the study design.

7. The Type of Ground Truth Used

The ground truth used was a "certified reference standard" for whole blood hemoglobin determination.

8. The Sample Size for the Training Set

The document does not mention a training set. The study described is a clinical validation against a reference standard for the purpose of demonstrating substantial equivalence, not the development or training of a machine learning model.

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

Not applicable, as no training set is mentioned in the document.

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The GDS® CholeSite® Test System is an in vitro diagnostic product for the quantitative determination of total cholesterol in whole blood. It is intended for the sole use with the GDS® Stat-Site® Meter.

This whole blood cholesterol test system consists of a CholeSite® Test Card, Test Card specific Test Module, and the hand-held Stat-Site® electronic reflectance photometer (Meter), The test methodology employs a dry reagent technology based on the cholesterel esterase method. When a drop of whole blood is applied to the top opening on the Test Card. The cholesters present in the patient's blood sample are hydrolyzed by cholesterol esterase. The free cholesterol is then oxidized by cholesterol oxidase, producing hydrogen peroxide, which substantially reacts with TOOS in a reaction catalyzed by peroxidase to produce a colored compound on the bottom of the Test Card. The Stat-Site® Meter, using reflectance at 660 nm, measures the color characteristics produced and converts the reflectance reading to a correlated cholesterol concentration value,

CholeSite® Test System: Acceptance Criteria and Performance Study Summary

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria for the CholeSite® Test System. However, the study aims to demonstrate acceptable comparison with established reference methods. We can infer the performance metrics reported are intended to show this acceptability.

2. Sample Sizes and Data Provenance for Test Set

• Clinical Samples:
  • Venous whole blood: 148 samples
  • Capillary whole blood: 148 samples
  • Provenance: Obtained at 3 different physician's office sites (Prospective, US-based as per FDA context).
• In-House Samples:
  • Venous whole blood: 40 samples
  • Capillary whole blood: 40 samples
  • Provenance: In-house testing.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The study does not mention the use of "experts" in the traditional sense (e.g., radiologists interpreting images). Instead, the ground truth for the test set was established by established laboratory methods and reference instruments. Therefore, the concept of "number of experts" and "qualifications of experts" as typically applied to image interpretation or clinical diagnosis does not directly apply here. The expertise lies in the validated methodologies and operation of the reference instruments.

4. Adjudication Method for Test Set

Not applicable. The ground truth was established by direct measurement using reference standard methodologies and instruments, not through expert consensus requiring adjudication.

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

Not applicable. This is a study evaluating a diagnostic device for total cholesterol measurement against laboratory reference methods, not an AI-assisted interpretation system for human readers. Therefore, an MRMC study and the concept of "human readers improve with AI vs without AI assistance" are not relevant here.

6. Standalone Performance (Algorithm Only)

Yes, a standalone performance study was conducted. The CholeSite® Test System, which includes the Test Card, Test Module, and Stat-Site® electronic reflectance photometer (Meter), performed the measurements and generated the cholesterol concentration values independently of human interpretation influence. Its performance was then compared directly to the reference methods.

7. Type of Ground Truth Used

Two types of ground truth were used:

• Abell-Kendall Reference Standard Methodology: This is described as the "industry 'gold standard' cholesterol test reference method." This represents a highly accurate and established laboratory method.
• COBAS Bio Reference (GDS® reference method): This was used for in-house testing and serves as another established laboratory reference instrument for cholesterol determination.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" or a machine learning model being trained. The CholeSite® Test System appears to be a dry reagent technology with a photometric measurement system, implying that its underlying principles are based on known biochemical reactions and calibration, rather than a data-driven machine learning model requiring a large training dataset in the conventional sense. If any form of calibration or internal adjustment was performed, the data used for that is not specified as a "training set."

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

As noted in point 8, a "training set" in the context of machine learning is not explicitly mentioned or implied. The system's operation is based on biochemical reactions and a calibrated photometer. Any initial calibration or validation would likely have used commercially available reference standards or samples analyzed by established laboratory methods. However, the details of such a process are not provided or referred to as a "training set."

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The GDS® HemoSite® Test System is a device for in vitro diagnostic use only. The GDS® HemoSite® Test Card is intended for the quantitative determination of hemoglobin in whole blood. It is intended for use with the Stat-Site® Meter.

The HemoSite® Test Cards are dry-chemistry Test Cards that contain chemicals which react and produce color when hemoglobin is present. The Stat-Site® Meter is a reflectance colorimeter that reads color intensity. A Test Module is provided with each box of Test Cards. The Test-Module contains all current calibration information for the specific lot of reagent. The Test Module and Test Cards are coded to each other, and the Stat-Site® Meter will only operate if they are properly matched. HemoSite® Test Cards are dry reagent cards based on the azidemethemoglobin method. When a drop of whole blood is applied to the top of the Test Card, hemolysis occurs, with the release of hemoglobin. Sodium nitrite converts the hemoglobin to methemoglobin. Sodium azide converts methemoglobin to azidemethemoglobin to produce a brown color that is measured at 580 nm using the Stat-Site® Meter. The Stat-Site® Meter measures the color intensity and calculates the hemoglobin concentration.

Here's an analysis of the provided text regarding the HemoSite® Test System, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for the regression analysis or precision. Instead, it presents the results of a comparison study against a predicate device and concludes that the results "compare well." Based on the provided data, we can infer the performance metrics reported.

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

• Sample Size for the Test Set: A total of 212 venous and capillary blood samples were used.
• Data Provenance: The samples were obtained internally and at three different physician's office sites. This suggests a blend of controlled laboratory and real-world point-of-care settings. The document does not specify the country of origin, but given the submission is to the FDA, it is highly probable the data is from the United States. The study appears to be prospective in nature, as it describes obtaining samples to compare the new device against a reference method.

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

This type of information is not applicable to this submission. The ground truth for this device (hemoglobin concentration) is established by a quantitative measurement from a predicate laboratory instrument, not by expert interpretation.

4. Adjudication Method for the Test Set

This type of information is not applicable to this submission. Adjudication methods are typically used when subjective interpretations (e.g., image readings) require consensus among experts. Here, the comparison is direct quantitative measurement against a reference method.

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 type of study is not applicable to the HemoSite® Test System. This device is a standalone diagnostic test for hemoglobin, not an AI-assisted interpretation system 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 done. The HemoSite® Test System itself is the "algorithm only" in this context. Its quantitative measurements were compared against the established reference method (Coulter® JT) without human interpretation as part of the measurement process. The device's performance (regression statistics and precision) represents its standalone capability.

7. The Type of Ground Truth Used

The ground truth used was measurements from a predicate laboratory instrument: the Coulter® JT hematology analyzer. This is a form of reference standard/comparative method rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. This is a 1998 510(k) submission for a diagnostic device that performs a chemical reaction and colorimetry. While the device likely has internal calibration and validation processes (which could be considered analogous to "training" in a very broad sense), the submission focuses on the performance of the final device against a predicate, not on the development of a complex algorithm that requires a distinct, external training set in the modern AI sense. The "Test Module" provided with each box of Test Cards contains "all current calibration information for the specific lot of reagent," implying internal calibration data, but the size or nature of this data is not detailed as a "training set."

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

Since a "training set" in the modern sense of AI/machine learning isn't explicitly described or applicable, the method for establishing its ground truth is also not applicable. The device's function relies on established chemical principles and colorimetric measurement, with calibration data likely derived from known hemoglobin standards.

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The GDS® GlucoSite® Test System is a device for in vitro diagnostic use only. The GDS® GlucoSite® Test Card is ultagi looks are quantitative determination of glucose in whole blood. It is intended for use with the Stat-Site® Meter.

This whole blood glucose test system consists of a GlucoSite® Test Card, test card specific Test Module, and a portable, hand held Stat-Site® electronic reflectance photometer (Meter). The test method employs a dry reagent technology based on the glucose oxidase method and is specific for D-Glucose. When a drop of whole blood is applied to the top opening on the test card, the red blood cells are separated allowing only the plasma to pass through. Glucose oxidase catalyzes the oxidation of the glucose in the plasma to produce gluconic acid and hydrogen peroxide in the presence of atmospheric oxygen. The second enzyme peroxidase then catalyzes the reduction of hydrogen peroxide in presence of 4-amino-antipyrine with concomitant oxidation of the chromogen TOOS [N-ethyl-N-(2-hydroxy-3sulfopropyl)-m-toluidine] to produce a purple color that is measured at 660 nm. The intensity of color developed is correlated with the glucose concentration in the whole blood sample. The Stat-Site® Meter measures the reflectance of the color produced at 660 nm and converts the reflectance reading to corresponding plasma glucose values.

Here's a breakdown of the acceptance criteria and the study details for the GlucoSite® Test System:

Acceptance Criteria and Device Performance

Study Details

• Sample Size Used for the Test Set:

  • 152 venous whole blood clinical samples
  • 152 capillary finger stick blood samples
  • 10 additional venous whole blood samples (spiked to 3 different glucose concentrations)
  • Total: 314 samples

• Data Provenance: Retrospective and prospective. Clinical samples were obtained from 3 different physician's office sites (indicates prospective collection). The additional 10 spiked samples were generated "in house." Country of origin is not explicitly stated but implied to be the US, given the FDA submission.

• Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications: Not applicable. For glucose meters, the ground truth is established by a reference laboratory method (Hexokinase) or a highly accurate predicate device (YSI 2300 STAT PLUS Analyzer), not by human experts interpreting results.

• Adjudication Method for the Test Set: Not applicable. Glucose measurements are quantitative and are directly compared to the reference methods, not adjudicated by human consensus.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC study was not done. This type of study is typically performed for imaging or interpretive diagnostic devices where human reader performance is a key factor. This is a standalone diagnostic device.

• Standalone (i.e., algorithm only without human-in-the-loop performance) Study: Yes, this was a standalone study. The performance of the Stat-Site®/GlucoSite® Test System was directly compared to the reference methods. Human interpretation or assistance is not part of the device's function or the study design.

• Type of Ground Truth Used:

  • Reference Method: Hexokinase plasma glucose method.
  • Predicate Device: YSI 2300 STAT PLUS Analyzer (also a highly accurate glucose measurement device).

• Sample Size for the Training Set: Not explicitly stated as a separate "training set." For this type of device, calibration and internal algorithm development would occur during the device's R&D phase, likely using a different set of samples. The described study focuses on validation using clinical and spiked samples.

• How the Ground Truth for the Training Set Was Established: Not detailed in this summary. However, typically, the ground truth for calibrating such a device would also be established using highly accurate laboratory reference methods like Hexokinase on a large set of samples covering the intended measurement range.

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