(197 days)
The portable, battery operated HEMOCHRON® Jr. Generation II and Signature are microcoagulation instruments designed to perform whole blood coagulation tests using fresh whole blood at the point-of-care. The system is intended to be used in numerous clinical settings requiring point-of-care testing. Test results are displayed as whole blood test results and plasma equivalent values, in seconds. For the ACT, the instrument also displays correlated celite equivalent values. The APTT and PT correlated values are based on regression analyses of comparative whole blood/plasma studies.
The Generation II system performs the same tests as the predicate Jr. system, APTT, PT, ACT+, and ACT-LR with the same end point detection system. All assays are intended to be performed at point of care (POC). Blood is placed in a collection reservoir of the test cuvette and automatically sampled into a test channel which contains reagents required to perform the respective assay. Excess blood is drawn into a waste cuvette. The clot detection mechanism is a combination mechanical-optical system. As blood is actively pumped back and forth in the test channel, two LED detectors measure the position of the blood. As clotting occurs, the movement of the blood decreases below a pre-determined rate and an endpoint is recorded. Test results for the APTT and PT are displayed as whole blood clotting times and plasma equivalent times. Test results for the ACT+ and ACT-LR are displayed as traditional HEMOCHRON® celite ACT values.
The provided document is a 510(k) Summary for a medical device called the HEMOCHRON® Jr. Generation II Microcoagulation System. It focuses on the device's technological characteristics, intended use, and its substantial equivalence to a predicate device, rather than presenting a detailed study report with acceptance criteria and comprehensive performance data. Therefore, many of the requested items cannot be fully extracted from this specific document.
However, based on the available information, here's what can be inferred and stated:
1. A table of acceptance criteria and the reported device performance:
This document does not explicitly state specific acceptance criteria (e.g., a required accuracy, precision, or correlation coefficient) for the device's performance. It describes the device's function and claims the new system "performs the same tests as the predicate Jr. system, APTT, PT, ACT+, and ACT-LR with the same end point detection system."
The main "performance" described is the display of:
- Whole blood clotting times and plasma equivalent times for APTT and PT.
- Traditional HEMOCHRON® celite ACT values for ACT+ and ACT-LR.
- Correlated values based on regression analyses of comparative whole blood/plasma studies.
Without specific performance metrics or acceptance thresholds in the provided text, a table like the one requested cannot be fully populated.
2. Sample size used for the test set and the data provenance:
The document mentions "regression analyses of comparative whole blood/plasma studies" as the basis for correlated values, but does not provide details on the sample size used for these studies or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available in the provided 510(k) summary.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not available in the provided 510(k) 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 device is a microcoagulation system, not an imaging or diagnostic AI device that involves "human readers" in the sense of interpreting images or complex data with AI assistance. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and is not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone instrument that performs coagulation tests. The "performance" in this context refers to the accuracy and reliability of its measurements compared to established laboratory methods. While its operation is automated once blood is loaded, the summary does not detail specific "standalone" performance studies or their results beyond stating it performs the same tests as the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document implies that the ground truth for establishing correlated values was based on comparative studies with established laboratory plasma coagulation tests. For the ACT, it mentions "correlated celite equivalent values," suggesting a comparison against traditional celite-based Activated Clotting Time methods as a ground truth.
8. The sample size for the training set:
The document does not provide information on a "training set" sample size. This terminology is more common for machine learning or AI algorithm development which is not the primary focus of this 510(k) (which is an upgrade for advanced program and interface capability, not a new measurement algorithm). The "regression analyses" for correlated values would have used a dataset, but its size is not specified.
9. How the ground truth for the training set was established:
Similar to question 8, the document does not speak in terms of "training sets." It states that "The APTT and PT correlated values are based on regression analyses of comparative whole blood/plasma studies." This implies that the ground truth for these correlations was established by comparing the device's whole blood results to simultaneously obtained plasma results from a reference laboratory method. For ACT, traditional HEMOCHRON® celite ACT values served as a basis for correlation.
§ 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.