(69 days)
The HEPtrac Electronic Quality Control, manufactured by Medtronic Blood Management, is an interactive mechanical and software controlled verification cartridge for use with instruments that utilize the Hepcon Hemostasis Management cartridges. The purpose of the HEPtrac is to provide a means for performing quality control of the instruments in the clinical testing environment.
The HEPtrac is an electronic control that has been developed to assist users of the Hepcon Hemostasis Management (HMS) Instrument (K894317) and associated cartridges and controls (K894317), to perform control testing as required under 42CFR493.1253. Sec. ( c ) "for all automated coagulation testing systems, the laboratory must include two levels control each eight hours of operation and each time a change in reagents occurs". The HEPtrac, electronic quality control is designed to minimize the use of liquid based controls by providing the operator a means to determine the operating condition of the instrument.
Here's a breakdown of the acceptance criteria and study information for the HEPtrac Electronic Quality Control device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define quantitative acceptance criteria in the way one might expect for a modern AI/ML device (e.g., target specificity, sensitivity, or AUC). Instead, the performance is demonstrated by its ability to perform specific checks on the HMS instrument. The criteria are implicitly tied to the proper functioning of these checks.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Ability to check Flag release force | "Performance testing was done to verify the HEPtrac's ability to check the condition of the HMS instrument for the following functions: |
- Flag release force" (The text indicates this test was successfully performed and verified the device's ability to check this function, implying it meets the implicit criterion). |
| Ability to check Reagent delivery | "Performance testing was done to verify the HEPtrac's ability to check the condition of the HMS instrument for the following functions: - Reagent delivery" (The text indicates this test was successfully performed and verified the device's ability to check this function, implying it meets the implicit criterion). |
| Ability to check Flag lift wire height | "Performance testing was done to verify the HEPtrac's ability to check the condition of the HMS instrument for the following functions: - Flag lift wire height" (The text indicates this test was successfully performed and verified the device's ability to check this function, implying it meets the implicit criterion). |
| Ability to check Flag sensors | "Performance testing was done to verify the HEPtrac's ability to check the condition of the HMS instrument for the following functions: - Flag sensors" (The text indicates this test was successfully performed and verified the device's ability to check this function, implying it meets the implicit criterion). |
| Substantial equivalence to the predicate device (ACTtrac) in: | The HEPtrac "is very similar to the ACTtrac electronic control for the ACT instrument in the following areas; intended use, operation, and function." The key difference is the number of channels (2 for ACTtrac vs. 6 for HEPtrac) and the addition of a "Flag release test" in HEPtrac. This implies that the device's performance is acceptable because it maintains the core functionalities of the predicate while enhancing capacity. |
| - Control Test Type | Both are "Electronic" (Table 1.1) |
| - Reagent delivery check | Both have "yes" (Table 1.1) |
| - Flag Sensor check | Both have "yes" (Table 1.1) |
| - Clot detection | Both have "yes" (Table 1.1) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set. It broadly states, "Laboratory testing was done to confirm the devices performance in relation to the predicate device."
- Data Provenance: The testing was "Laboratory testing," implying it was conducted in a controlled environment. There is no information about 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 provided in the document. Given the nature of the device (an electronic quality control for an instrument), the "ground truth" would likely be defined by engineering specifications and the instrument's known functional parameters rather than expert medical interpretation.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable given the device's function. The testing described focuses on functional verification against engineering parameters rather than subjective interpretations requiring adjudication.
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. This device is an electronic quality control for a medical instrument, not an AI/ML diagnostic or assistive tool for human readers. Therefore, this type of study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is an "electronic control," which operates without human "interpretation" of results in the traditional sense of a diagnostic algorithm. Its function is to verify the performance of the main instrument. The performance testing "to verify the HEPtrac's ability to check the condition of the HMS instrument" can be considered a standalone performance evaluation of the control device in its intended function. There is no "human-in-the-loop" aspect to the HEPtrac's function itself; it's a verification tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this device's performance evaluation would be the engineering specifications and known functional parameters of the Hepcon Hemostasis Management (HMS) Instrument. The HEPtrac is designed to test if the HMS instrument is operating within its defined parameters for flag release force, reagent delivery, flag lift wire height, and flag sensors.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. The HEPtrac is described as an "electronic control" and a "mechanical and software controlled verification cartridge." It does not appear to utilize machine learning or AI that would require a "training set" in the conventional sense. Its function is based on programmed logic and mechanical interactions to test an existing instrument.
9. How the Ground Truth for the Training Set was Established
As there is no indication of a "training set" for AI/ML, this question is not applicable. The device's "knowledge" of what constitutes correct instrument operation is built into its design and programming, based on the specifications of the HMS instrument it is designed to test.
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.