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The GEM® Hemochron™ 100 System is a battery-operated portable instrument that performs individual in vitro quantitative coagulation tests on fresh whole blood. The system is intended to be used with test cartridges available from the manufacturer and include tests for Activated Clotting Time (ACT+) and Low Range Activated Clotting Time (ACT-LR). The system is intended for use only in point-of-care settings for patients aged 18 years and above.

The GEM® Hemochron™ 100 ACT+ (Activated Clotting Time Plus) test is a quantitative assay for monitoring anticoagulation with moderate to high unfractionated heparin (UFH) doses in fresh whole blood samples. This test is mended for monitoring UFH administered during cardiovascular surgery and cardiac ablation procedures. The GEM® Hemochron™ 100 ACT+ demonstrates linear correlation to the anticoagulation effects of UFH concentrations of 1.0 to 6.0 units/mL.

The GEM® Hemochron™ 100 ACT-LR (Low Range Activated Clotting Time) test is a quantitative assay for monitoring anticoagulation with low to moderate unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during extracorporeal life support and cardiology procedures. The GEM® Hemochron™ 100 ACT-LR test demonstrates linear correlation to the anticoagulation effects of UFH concentrations up to 2.5 units/mL.

For in vitro diagnostic use. For Professional Use, Rx Only ..

GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+):

The GEM® Hemochron™ 100 ACT+ (Activated Clotting Time Plus) test is a quantitative assay for monitoring . anticoagulation with moderate to high unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during cardiovascular surgery and cardiac ablation procedures. The GEM® Hemochron™ 100 ACT+ demonstrates linear correlation to the anticoagulation effects of UFH concentrations of 1.0 to 6.0 units/mL.

The GEM® Hemochron™ 100 ACT+ test can be performed on the GEM® Hemochron™ 100 System and any model of Hemochron™ Signature Series device. Each instrument is portable, which allows testing at the point-of-care. For in vitro diagnostic use.

For Professional Use, Rx Only

GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR):

The GEM® Hemochron™ 100 ACT-LR (Low Range Activated Clotting Time) test is a quantitative assay for monitoring anticoagulation with low to moderate unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during extracorporeal life support and cardiology procedures. The GEM® Hemochron™ 100 ACT-LR test demonstrates linear correlation effects of UFH concentrations up to 2.5 units/mL.

The GEM Hemochron 100 ACT-LR test can be performed on the GEM® Hemochron™ 100 system and any model of Hemochron™ Signature Series device. Instruments are portable, which allows testing at the point-of-care. For in vitto diagnostic use.

For Professional Use, Rx Only.

directCHECK Whole Blood Controls:

The directCHECK™ Whole Blood Quality Controls are dried whole blood preparations which have been assayed and are intended to be used to perform quality control assays using the Hemochron™ test cartridges

For in vitro Diagnostic Use. For Professional Use, Rx Only.

The GEM® Hemochron™ 100 system is a battery-operated, point-of-care coagulation analyzer that represents the next generation platform of the predicate Hemochron™ Signature Elite microcoagulation system. The analyzer employs the same fundamental opto-mechanical clot detection technology and the same analytical algorithms used by the predicate device for calculating test results. The single-use test cartridges for Activated Whole Blood Clotting Time Plus (ACT+) or Low Range ACT (ACT-LR) assays are identical to the cartridges used by the predicate analyzer. Whole Blood Controls used on the GEM® Hemochron™ 100 system are identical to those used on the Hemochron™ Signature Elite. The system is intended for use only in clinical settings requiring point of care testing. ACT results for patient blood samples or liquid control material are displayed as ACT Celite-equivalent values (CEV) in seconds.

The analyzer contains a test chamber which warms a test cartridge to the required temperature, and it performs all operations to measure the clotting time of a whole blood sample after it is placed in the test cartridge and the test is started by the operator. The user interface includes a color touch screen that displays various action keys and an external barcode scanner for reading Operator identification number (OID), Patient identification (PID) number and lot numbers and expiry dates of liquid quality controls (QC). The operator uses the touch screen to select a command, set software configurations or enter information. The GEM® Hemochron™ 100 system is POCT1-A2 compliant and has Wi-Fi and Ethernet networking capability. It has increased storage for 10,000 patient and QC records. ACT+ and ACT-LR cartridge labels are modified to include a 2D barcode that identifies test type, lot number and expiry date, which is readable by the internal camera. Quality control features such as designation of QC levels, tagging of test results with date and time, and entry of OID and PID numbers are included and are similar to the predicate device.

The GEM® Hemochron™ 100 system is intended for use at the point of care professional healthcare environments such as the Cardiovascular Operating Room and Catheterization lab and is designed to perform its essential tasks of performing in-vitro diagnostic blood coagulation-time tests without the use of a network connection. The device contains an 802.11 interface which supports WPA2 encryption as well as EAP authentication framework. The device is able to connect to a Wireless Local Area Network (WLAN) via 802.11 b/g/n connections at 2.4 and 5 GHz. The communications interfaces supported by the device are utilized to configure or update the device software by supervisory staff before deployment to the intended use environment and in the reporting of test results to the Laboratory or Hospital Information Systems (LIS/HIS) by the clinical operators at the point of care. Test results are used directly at the point of care in aiding medical decision making, and the device's intended use is not reliant on the device's ability to transmit the information to the LIS/HIS.

GEM® Hemochron™ 100 ACT+ cartridges are single-use disposable test devices with a well for application of liquid QC and whole blood samples. When a liquid QC or patient test is requested, the instrument prompts the Operator to insert a cartridge into the instrument. After the instrument warms the cartridge, it prompts the Operator to apply the sample into the sample well of the cartridge. The ACT+ test cartridge is a self-contained disposable test chamber preloaded with a dried preparation of silica, kaolin, phospholipid, stabilizers, and buffers that provide maximum activation as defined by clinical practice guidelines. Each cartridge is sealed in a foil pouch labeled with lot number and expiry date. Reagents in GEM® Hemochron™ 100 ACT+ cartridges (000GACT+) are identical in composition to those in the predicate Hemochron™ ACT+ cuvettes (JACT-LR). A 2D barcode added to the cartridge label identifies the test type, lot number and expiry date. This information is automatically read by the internal camera. Each box of GEM® Hemochron™ 100 ACT+ cartridges contain 45 pouches, each pouch containing one GEM® Hemochron™ 100 ACT+ cartridge and one desiccant packet.

GEM® Hemochron™ cartridges are single-use disposable test devices with wells for application of samples. When a patient test or an LQC test is requested, the instrument prompts the Operator to insert a cartridge into the instrument. After the instrument warms the cartridge, it prompts the Operator to apply the sample into the sample well of the cartridge. Each GEM® Hemochron™ 100 ACT-LR cartridge is sealed in a foil pouch labeled with lot number and expiry date. The cartridge is a self-contained disposable test chamber preloaded with a dried preparation of Celite and silicon dioxide activators, potato dextrin, stabilizers, and buffers to provide maximum activation as defined by clinical practice guidelines. Reagents in GEM® Hemochron™ 100 ACT-LR cartridges (000GACT-LR) are identical in composition to those in the predicate Hemochron™ ACT-LR cuvettes (JACT-LR). A 2D barcode added to the cartridge label identifies the test type, lot number and expiry date. This information is automatically read by a new internal camera. Each box of GEM® Hemochron™ 100 ACT-LR cartridges contain 45 pouches, each pouch containing one GEM® Hemochron™ 100 ACT-LR cartridge and one desiccant.

Blood coagulation instruments and assays should be quality controlled prior to and during routine use. Performance ranges are provided with each control product against which users should compare results. Quality assurance programs include instrument service, quality control and complete performance records. directCHECK™ Quality Control products are to be used with Hemochron Systems (GEM® Hemochron™ 100 and Hemochron™ Signature Series). Level 1 and Level 2 QC products are provided in separate packaging. These preparations consist of dried fixed bovine red blood cells, rabbit cephalin, buffered sheep and horse plasma. Assayed clotting time values are provided with each lot of material. Each control preparation is provided in a dropper vial. Each dropper vial also contains diluent used to rehydrate the dried whole blood control. Diluent preparations consist of distilled water, sodium chloride, Tween® 20, ProClin®, and anticoagulant.

The provided text details the 510(k) summary for the Accriva Diagnostics, Inc. GEM Hemochron 100 System and associated tests and controls. This document aims to demonstrate the substantial equivalence of the new device to existing legally marketed predicate devices. The study described focuses on the comparison between the new GEM Hemochron 100 system and the predicate Hemochron Signature Elite, rather than proving the device meets acceptance criteria in a traditional sense of a clinical trial with predefined success/failure thresholds against a ground truth.

Instead, the provided text describes performance data collected to demonstrate substantial equivalence to an already cleared predicate device. This is a common pathway for FDA 510(k) clearance, where a new device is compared to a legally marketed predicate to show it is as safe and effective.

Here's an attempt to answer your questions based on the provided text, reinterpreting "acceptance criteria" as the performance metrics and comparability demonstrated for substantial equivalence:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, "acceptance criteria" for performance studies are typically framed as demonstrating equivalence or non-inferiority to the predicate device within acceptable statistical bounds. The reported performance is then compared to that of the predicate. The document doesn't explicitly state quantitative acceptance criteria in a "pass/fail" table format, but rather presents the results of equivalence studies.

Here's a summary of the performance data presented, emphasizing the comparison to the predicate:

2. Sample size(s) used for the test set and the data provenance

• Precision (Liquid Quality Controls):
  • Sample Size: N=640 for each level (Level 1 and Level 2) for both ACT+ and ACT-LR.
  • Provenance: This data is generated internally as part of method validation. It is not specified, but typically this would be prospective data collected for the submission. The location is not specified, but likely within the manufacturer's R&D facilities.
• Precision (Donor Whole Blood Samples):
  • Sample Size: N=20 for each sample target range (ACT+ and ACT-LR). Note: One sample for ACT+ had N=19.
  • Provenance: "Donor whole blood samples" suggests human biological samples. This would be prospective data collected for the submission. The country of origin is not specified.
• Method Comparison Study:
  • Sample Size: 280 samples for ACT+ (derived from 40 normal subjects at baseline and 6 spiked UFH concentrations). 215 samples for ACT-LR (derived from 40 normal subjects at baseline and 4 spiked UFH concentrations).
  • Provenance: "Whole blood samples from 40 normal subjects." This is prospective clinical data. The study was "in accordance with CLSI EP09-A3," a standard for method comparison, and was an "in-house method comparison study." The country of origin is not specified but is typically internal to the applicant's operations or affiliated clinical sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of submission (for a coagulation system) does not typically involve expert readers or adjudication for "ground truth" in the way an imaging AI device might. The "ground truth" is typically the reference method or the predicate device's measurement which the new device is being compared against. In this case:

• For precision, the performance of the device itself (repeatability and reproducibility) is the focus, not comparison to external expert-defined ground truth.
• For method comparison, the "ground truth" or reference is the measurements generated by the predicate device (Hemochron Signature Elite) on the same samples. There are no human experts involved in establishing this type of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are used in medical imaging studies where human experts provide subjective interpretations that need to be reconciled to form a consensus ground truth. Here, the measurements are quantitative.

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

Not applicable. This is an in vitro diagnostic device for measuring blood coagulation, not an AI imaging device involving human readers.

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 the coagulation tests. Its performance is measured directly (e.g., precision, method comparison to a predicate instrument). There isn't a separate "algorithm only" component that would perform independently of the physical instrument and its cartridges. The studies described (precision and method comparison) are essentially standalone performance evaluations of the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For precision studies, the "ground truth" is the true value of the quality control material or the mean of repeated measurements for patient samples. This is established by the properties of the controls or the statistical analysis of the measurements.
• For method comparison studies, the "ground truth" is the result obtained from the predicate device (Hemochron™ Signature Elite). The new device's measurements are compared to those of the predicate to demonstrate substantial equivalence.

8. The sample size for the training set

The concept of a "training set" is typically associated with machine learning or artificial intelligence models. This document describes a traditional medical device (an in vitro diagnostic coagulation system) that uses established opto-mechanical clot detection technology and analytical algorithms, which are stated to be "identical to the cartridges used by the predicate analyzer." Therefore, there is no explicit mention or implication of a distinct "training set" for a machine learning model, as the device's operational principles are based on known physical and chemical reactions, not adaptive algorithms trained on large datasets.

9. How the ground truth for the training set was established

As there is no mention of a "training set" in the context of machine learning, this question is not applicable. The device's underlying principles are based on established scientific methods for coagulation testing, which inherently define the measurement parameters.

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