(25 days)
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:
| Acceptance Criterion (Inferred) | Reported Device Performance (Specificity and Sensitivity Inferred) |
|---|---|
| Clotting time ratio between heparinized and unheparinized channels falls within a specified range (Normal function) | Device accurately identifies normal function of HDR cartridge channels 1, 2, 5, 6 (using HDR Control 1) and 3, 4, 5, 6 (using HDR Control 2). Specific metrics (e.g., accuracy, sensitivity, specificity) are not provided. |
| Clotting time ratio between heparinized and unheparinized channels falls outside a specified range (Abnormal function) | Device accurately identifies abnormal function of HDR cartridge channels 1, 2, 5, 6 (using HDR Control 1) and 3, 4, 5, 6 (using HDR Control 2). Specific metrics are not provided. |
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.
§ 864.5680 Automated heparin analyzer.
(a)
Identification. An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.(b)
Classification. Class II (special controls).