(27 days)
The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times.
The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times. Hardware modifications addressed in this submission are a direct response to the obsolescing of several major hardware components including the Print Circuit Board, the ADU Controller and the Printer. The HMS software has also been modified to run on Windows CE 5.0: A complete system verification and software verification of all requirements have been performed. The Display Adapter Hantronix PCBA and Power Interconnect PCBA have been incorporated into the Interface PCBA to reduce interconnects and have a more reliable device. The Common Processing Platform has been used to replace the Freescale HC11. A complete ADU software verification of all requirements has been performed. A new Printer has been selected that will work with the new Off the Shelf Computer PCBA. The voltage of the printer has been reduced from 24 V to 7V. The Operators Manual and Device labels have been updated to reference the IEC 61010-1: 2001, 2nd Edition standard.
The provided text describes a 510(k) premarket notification for the Hemostasis Management System Plus (HMS Plus). This submission focuses on hardware and software modifications to an already cleared device (HMS Plus, K101271). As such, the document primarily aims to demonstrate substantial equivalence to the predicate device rather than presenting a novel study to establish performance acceptance criteria.
The information requested regarding acceptance criteria and a study proving the device meets them is not present in the provided text in the typical format of a new clinical or performance study. The text explicitly states: "A complete system verification and software verification of all requirements have been performed." This suggests that the device's performance was verified against its existing, established requirements (those of the predicate device).
However, based on the provided text, I can infer and extract some relevant points:
1. A table of acceptance criteria and the reported device performance:
The document explicitly states:
- "Same intended use."
- "Same operating principle."
- "Same technological characteristics."
- "Same performance claims."
This strongly implies that the acceptance criteria for the modified device are identical to those of the predicate HMS Plus (K101271). The "reported device performance" is implicitly stated to be equivalent to the predicate device due to these similarities and the conducted verifications.
| Acceptance Criterion | Reported Device Performance (Implied) |
|---|---|
| Intended Use | Same as predicate HMS Plus |
| Operating Principle | Same as predicate HMS Plus |
| Technological Characteristics | Same as predicate HMS Plus |
| Performance Claims | Same as predicate HMS Plus |
2. Sample size used for the test set and the data provenance:
The document mentions "A complete system verification and software verification of all requirements have been performed." However, it does not specify the sample size, the type of test set (e.g., patient samples, simulated data), or the data provenance (e.g., country of origin, retrospective or prospective) for these verifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the text. The document refers to "system verification and software verification," which typically involves testing against specifications and defined outcomes, rather than expert-established ground truth in the context of diagnostic interpretation.
4. Adjudication method for the test set:
This information is not provided in the text.
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 type of study is not applicable to the information provided. The device is an "Automated Heparin Analyzer," which is a laboratory instrument, not an AI-powered diagnostic imaging system requiring human reader interaction for interpretation. The modifications described are hardware and software updates to an existing instrument, not the introduction of AI for human assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device (HMS Plus) is an "Automated Heparin Analyzer." Its operation, as described, is inherently "standalone" in performing the assays and providing results. The submission focuses on verifying that the modified hardware and software components maintain the original standalone performance. The text states: "A complete system verification and software verification of all requirements have been performed." This implies that the standalone performance requirements of the predicate device were met by the modified device.
7. The type of ground truth used:
Given that the device performs "in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times," the "ground truth" for its performance would typically be established by established laboratory methods, reference standards, and control materials with known values, against which the device's measurements are validated. The document explicitly mentions "system verification and software verification of all requirements," implying verification against predefined performance standards and expected analytical results for these assays.
8. The sample size for the training set:
The document does not describe a "training set" in the context of machine learning, as this submission is about hardware/software modifications to an existing, cleared medical device for "Automated Heparin Analyzer." While software was modified to run on Windows CE 5.0, the type of "training" typically associated with AI models is not discussed.
9. How the ground truth for the training set was established:
As no "training set" for an AI model is described, this information is not applicable.
§ 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).