(60 days)
The heparin dose response cartridge is intended for determining in vitro individual responses to heparinization using whole blood on the HMS or HMS Plus instruments.
The Heparin Dose Response (HDR) cartridge is an in vitro diagnostic test. The HDR cartridge uses fresh whole blood for determining in vitro individual responses to heparinization based on a target activated clotting time (ACT). The cartridge is for use in the HMS or HMS Plus (Hemostasis Management System) instruments.
The provided text describes a 510(k) premarket notification for a medical device, the Heparin Dose Response (HDR) Cartridge. This document is a summary of the notification and a letter from the FDA.
Here's an analysis of the acceptance criteria and the study as requested, based solely on the provided text.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It broadly states that "Functional testing such as stability, accuracy and precision were used to establish the performance characteristic of the modifications of this device from the previously marketed device."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for the test set, nor does it provide information on the data provenance (country of origin, retrospective or prospective).
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)
The document does not mention the use of experts to establish ground truth for a test set. This device is an in vitro diagnostic test for determining responses to heparinization, suggesting that the "ground truth" would likely be derived from laboratory measurements or established clinical reference methods, not expert consensus on image interpretation or similar.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for a test set, as it does not rely on expert interpretation for its validation.
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 such study (MRMC or AI-assisted performance) is mentioned. This device is an in vitro diagnostic tool, not an AI-assisted diagnostic imaging device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance of the device itself (the HDR cartridge and HMS/HMS Plus instruments). The summary states: "Functional testing such as stability, accuracy and precision were used to establish the performance characteristic of the modifications of this device from the previously marketed device." This implies standalone performance testing was conducted for these specific characteristics. However, detailed results or specific methodology for these tests are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For an in vitro diagnostic test determining individual responses to heparinization, the "ground truth" would typically refer to:
- Reference laboratory methods: Established and validated laboratory techniques for measuring heparin response or activated clotting time, which the device's measurements are compared against.
- Clinical outcomes (potentially secondary): While not explicitly stated as "ground truth" for direct performance evaluation, the ultimate clinical utility would tie into patient outcomes related to heparinization.
The document refers to "accuracy," implying a comparison to a known or reference value, but does not specify the exact nature of this reference or "ground truth."
8. The sample size for the training set
The document does not mention a training set. This is a 510(k) for an in vitro diagnostic device, not an AI-based system that typically uses training and test sets in the same manner. Its validation focuses on functional performance like stability, accuracy, and precision against a predicate device.
9. How the ground truth for the training set was established
Not applicable, as no training set is mentioned or relevant to the reported validation approach.
§ 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).