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The Heparin Dose Response (HDR) controls are used to verify the performance of the HDR cartridges and the HMS Plus instrument.

The HDR Control set is an in vitro diagnostic device. The primary function is to identify if each pair of heparinized channels of the HDR cartridge has normal or abnormal function by measuring if the clotting time ratios between heparinized and unheparinized channels are within or outside a specified range. HDR control 1 is used to verify that channels 1,2, 5 and 6 of the HDR cartridge are functioning correctly. HDR control 2 is used to verify that channels 3, 4, 5 and 6 of the HDR cartridge are functioning correctly.

The HDR controls are single use, non-sterile, point of care, in-vitro diagnostic plasma controls for use with the HMS Plus instrument.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Heparin Dose Response Controls, based on the K051040 submission.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the Heparin Dose Response Controls. It describes the device's function and states that "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device."

However, we can infer the type of acceptance criteria based on the device description:

Important Note: The K051040 submission for the Heparin Dose Response Control is for a "control set" for an instrument, not a diagnostic device that outputs patient results directly. Therefore, the "performance" here refers to its ability to verify the proper functioning of the main diagnostic system (HDR cartridges and HMS Plus instrument), rather than a diagnostic accuracy metric like sensitivity or specificity for a disease. The typical acceptance criteria for such controls would involve demonstrating that they consistently produce the expected "normal" or "abnormal" results when tested on the system, indicating the system's operational integrity.

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

• Test Set Sample Size: Not explicitly stated. The submission mentions "Validation testing," but does not provide a sample size for this testing.
• Data Provenance: Not explicitly stated. The document doesn't specify the country of origin of the data or whether it was retrospective or prospective.

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

• This information is not applicable and not provided in the document. As "controls," the ground truth is established by the known properties of the control material itself (i.e., whether it should yield a "normal" or "abnormal" result based on its formulation) when run on a properly functioning system. It does not involve expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

• Not applicable and not provided. Ground truth for control materials doesn't typically involve expert adjudication, as their expected behavior is pre-defined.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size of how much human readers improve with AI vs without AI assistance.

• No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic control, not an AI-powered diagnostic tool for human interpretation. Therefore, the concept of human readers improving with or without AI assistance does not apply.

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

• Yes, in spirit, a "standalone" assessment of the control's performance was done. The device itself is a "control" that produces a result (within or outside a specified range) when run on the HMS Plus instrument. Its performance is evaluated intrinsically through "Validation testing" to ensure it correctly identifies the function of the HDR cartridge channels. There is no "human-in-the-loop" for the control's function itself, only for the subsequent interpretation of the HMS Plus instrument's results when using the control.

7. The Type of Ground Truth Used

• The ground truth for this device is based on known chemical/physical properties of the control material and its intended interaction with the HMS Plus instrument and HDR cartridges. The controls are designed to yield specific clotting time ratios that indicate "normal" or "abnormal" function of the system. This is a form of design-based or reference-based ground truth, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable and not provided. This device is not an AI/machine learning algorithm, so there is no concept of a "training set" in the context of this 510(k) submission.

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

• Not applicable and not provided, as there is no training set for this type of IVD control device.

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The Heparin Dose Response (HDR) controls are used to verify the performance of the HDR cartridges and the HMS Plus instrument.

The HDR Control set is an in vitro diagnostic device. The primary function is to identify if each pair of heparinized channels of the HDR cartridge has normal or abnormal function by measuring if the clotting time ratios between heparinized and unheparinized channels are within or outside a specified range. HDR control 1 is used to verify that channels 1,2, 5 and 6 of the HDR cartridge are functioning correctly. HDR control 2 is used to verify that channels 3, 4, 5 and 6 of the HDR cartridge are functioning correctly. The HDR Control set is similar in design and use (vial size and reconstitution method) to the existing liquid controls being used in the HMS platform. The HDR controls are single use, non-sterile, point of care, in-vitro diagnostic plasma controls for use with the HMS Plus instrument.

This 510(k) summary does not contain detailed information about acceptance criteria and specific study results in the format requested. It is a high-level summary confirming substantial equivalence to a predicate device.

However, based on the provided text, here's what can be extracted and inferred:

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

The document states, "The primary function is to identify if each pair of heparinized channels of the HDR cartridge has normal or abnormal function by measuring if the clotting time ratios between heparinized and unheparinized channels are within or outside a specified range." This implies that the acceptance criteria are related to these clotting time ratios falling within or outside a predefined "normal" or "abnormal" range.

The phrase "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device" suggests that the device did meet these established criteria. However, the specific numerical acceptance criteria and the actual reported performance values are not provided in this summary.

Inferred Table:

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

This information is not provided in the summary. The summary refers to "Validation testing" but does not detail the size or nature of the test set, nor the data provenance.

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 summary. The HDR Controls are an in vitro diagnostic device for verifying instrument performance, so "expert ground truth" in the clinical imaging sense is not directly applicable. The "ground truth" would likely be established by the expected chemical/biochemical reactions within the controls themselves, verified through analytical methods.

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

This information is not provided in the summary.

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 is not applicable. The device is an in vitro diagnostic control for instrument performance, 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:

The device described is an "in vitro diagnostic device" (HDR Control set) designed to verify the performance of the "HMS Plus instrument" and "HDR cartridges." This implies a standalone performance evaluation where the control's ability to trigger expected responses from the instrument/cartridge is assessed. The "algorithm" here would be the expected chemical reaction and the instrument's detection capabilities. The summary states, "The primary function is to identify if each pair of heparinized channels of the HDR cartridge has normal or abnormal function by measuring if the clotting time ratios between heparinized and unheparinized channels are within or outside a specified range." This heavily suggests a standalone performance evaluation of the control and the instrument's interaction with it.

However, the specific details of this "standalone" study (e.g., how many controls were tested, how many times, under what conditions) are not provided in this summary.

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

For an in vitro diagnostic control device, the ground truth would be established by the inherent, expected chemical and physical properties of the control material itself, which are designed to produce a specific, known response when tested by the HMS Plus instrument and HDR cartridges. This "ground truth" is typically ensured by rigorous manufacturing, analytical testing of the control material, and established scientific principles of coagulation. It's not "expert consensus" or "pathology" in the typical clinical sense, but rather a known, engineered outcome.

8. The sample size for the training set:

This is not applicable in the context of an in vitro diagnostic control device for instrument verification. There is no AI model being "trained" in the conventional sense. The "training" would be the initial development and optimization of the control formulation to consistently produce the desired clotting time ratios.

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

As mentioned above, there isn't a "training set" in the AI sense. The "ground truth" for the control materials would be established during their design, formulation, and manufacturing processes, where the concentrations of active ingredients are precisely controlled to ensure they yield specific, predictable results (i.e., normal or abnormal clotting time ratios) when interacting with the HMS Plus instrument and HDR cartridges according to established biochemical principles and validated analytical methods.

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