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The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.

The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.

The Sonoclot Analyzer System generates a qualitative graph, known a the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.

The Sonoclot Coaqulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.

The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.

The Sonoclot Analyzer System generates a qualitative graph, known as the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.

Sonoclot Viewer is a data collection, storage, and retrieval program for use with Sonoclot Analyzers. Sonoclot Viewer collects serial data from one or more Sonoclot Analyzers. This data is compressed, processed for certain performance results, displayed, and stored as data files.

Sonoclot Viewer enables users to assign patient, operator, and reagent information to a test, manage patient test results and analyzer/reagent quality control data, communicate with the hospital information system, and create reports to meet billing or regulatory compliance requirements.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets them because the provided text does not contain this information. The text is a 510(k) summary for the Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a study proving their fulfillment.

Instead, the document highlights:

• Device Name & Classification
• Legally Marketed Predicate Devices
• Device Description Summary
• Intended Use/Indications for Use
• Comparison of Indications for Use and Technology
• Non-Clinical and/or Clinical Test Summary & Conclusions for Software Reengineering

The "Non-Clinical and/or Clinical Test Summary & Conclusions" section mentions validation of reengineered software (Sonoclot Viewer) against the predicate software (Signature Viewer) to ensure equivalent calculated results. However, it does not define specific acceptance criteria for performance metrics (like accuracy, precision, sensitivity, specificity, etc.) nor does it describe a study design with sample sizes, expert involvement, or ground truth establishment in the way requested for a typical AI/device performance study.

Without this specific information regarding acceptance criteria and a detailed study report, I cannot fulfill your request.

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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:

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The i-STAT 1 Wireless Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide and pH), creatinine, lactate, activated clotting time, prothrombin time, bicarbonate/carbon dioxide, troponin, creatine phosphokinase, and beta natriuretic peptide.

• Sodium measurements are used for monitoring electrolyte imbalances.
• Potassium measurements are used for diagnosis and monitoring of diseases and clinical conditions that manifest high and low Potassium levels.
• Chloride measurements are primarily used in the diagnosis, monitoring and treatment of electrolyte and metabolic disorders including but not limited to cystic fibrosis, diabetic acidosis and hydration disorders.
• Glucose measurements are used in the diagnosis, monitoring and treatment of carbohydrate metabolism disorders including but not limited to diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
• Hematocrit measurements can aid in the determination and monitoring of normal or abnormal total red cell volume status including but not limited to conditions such anemia and erythrocytosis and blood loss related to trauma and surgery.
• Blood urea nitrogen measurements are used for the diagnosis, monitoring and treatment of certain renal and metabolic diseases.
• Ionized calcium measurements are used in the diagnosis, monitoring and treatment of conditions including but not limited to parathyroid disease, a variety of bone diseases, chronic renal disease and tetany and disturbances related to surgical and intensive care.
• pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-base disturbances.
• Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
• The i-STAT lactate test is useful for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acid/base status, (2) monitoring tissue hypoxia and strenuous physical exertion, and (3) diagnosis of hyperlactatemia.
• The i-STAT Kaolin Activated Clotting Time (ACT) test is an in vitro diagnostic test used to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.
• The i-STAT PT, a prothrombin time test. is useful in monitory patients receiving oral anticoagulation therapy such as Coumadin or warfarin.
• Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
• The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.
• The i-STAT CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).
• The i-STAT BNP test is an in vitro diagnostic test for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure.
• The i-STAT Celite ACT test is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery, organ transplant and dialysis

The i-STAT 1 Wireless Analyzer (Model 300W) is a variant of the predicate i-STAT 1 Analyzer (Model 300) (K001387) and it provides an additional and alternate method for communication of data to a facility database. The i-STAT 1 Analyzer together with single use i-STAT Cartridges is a complete analytical system that can be used at the point of patient care. The primary purpose of the analyzer is to run a variety of tests contained in disposable. single-use i-STAT Cartridges. The enabling technology for the i-STAT system is in the microfabricated electrochemical sensors located in the disposable cartridges. The functions related to testing patient samples using this technology are not affected by the addition of the wireless capability. The capability of the Wireless Analyzer to transmit test results and information by Radio Frequency (RF) transmission is an option that the user may choose but it is not required for the Wireless analyzer to fulfill the intended use or to meet the indications for use.

This document is a 510(k) summary for the i-STAT 1 Wireless Analyzer, which is a modified version of the i-STAT 1 Analyzer. The submission argues for substantial equivalence primarily based on the fact that the measurement cycle of the device is identical to the predicate device, and the wireless functionality is temporally distinct and does not affect the core measurement performance. As such, the document does not report on a study comparing the diagnostic performance of the i-STAT 1 Wireless Analyzer against specific acceptance criteria for each analyte. Instead, it focuses on the differences and safety aspects related to the addition of wireless communication.

Therefore, much of the requested information cannot be extracted directly from this 510(k) summary because the evaluation approach was not based on a new clinical performance study for the analytes.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This section cannot be fully constructed as a typical acceptance criteria table for diagnostic accuracy because the submission's core argument is that the measurement performance of the i-STAT 1 Wireless Analyzer is identical to the predicate device (i-STAT 1 Analyzer) for all cartridge tests. The only "performance" discussed in relation to the new wireless feature is its safety and data integrity.

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

Not applicable/Not provided for diagnostic accuracy. As noted, no new cartridge tests were performed to compare the diagnostic performance because the measurement cycle is identical to the predicate device. The testing focused on the wireless functionality itself, which does not involve patient samples or diagnostic data in the same way.

The document discusses "Specific Absorption Rate tests conducted by the supplier of the radio frequency module" but does not provide sample sizes or data provenance for these engineering tests.

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

Not applicable. No diagnostic ground truth was established for a new clinical performance test set, as the device's diagnostic measurement capabilities are considered identical to its predicate.

4. Adjudication method for the test set

Not applicable. No new clinical performance test set was conducted that would require adjudication of diagnostic results.

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 device is an in vitro diagnostic analyzer, not an AI-assisted diagnostic imaging or interpretation system for human readers. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, implicitly in the context of the device's core function. The i-STAT 1 Wireless Analyzer, like its predicate, is a standalone device that performs quantitative measurements of various analytes. The output (a numerical value for an analyte) does not require human-in-the-loop for its generation. However, the study supporting this submission did not involve a new standalone performance evaluation for the analytes; it relied on the established performance of the predicate device. The wireless functionality itself is an "algorithm only" in terms of data transmission, operating independently of human intervention during the transmission process once configured.

7. The type of ground truth used

Not applicable for a new clinical performance study. The original ground truth for the predicate i-STAT 1 Analyzer's diagnostic measurements would have been established through methods appropriate for each analyte (e.g., comparison to laboratory reference methods, clinical outcomes where relevant). For this 510(k) submission, the ground truth for the wireless transmission involved verifying signal integrity and proper data transfer, but this is an engineering ground truth, not a diagnostic one.

8. The sample size for the training set

Not applicable. This submission does not describe a machine learning algorithm that requires a training set in the conventional sense for diagnostic performance.

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

Not applicable. (See point 8).

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The CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control is used to verify the performance of the ACT instrument and the Heparinase (HR-HTC) cartridges. For In Vitro Diagnostic Use.

The modification to the current control is to replace old USP heparin with revised USP heparin. The source of the heparin remains porcine.

The provided text does not contain detailed information about specific acceptance criteria for a device's performance, nor does it describe a study with performance data against such criteria.

The document is a 510(k) summary for a device modification (CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control). It states that the modification is to replace old USP heparin with revised USP heparin, and that the device still has the "Same intended use," "Same operating principle," "Same technological characteristics," and "Same performance claims" as the predicate device (K042175).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, or training set information.

The document's conclusion simply states that the modified device is "substantially equivalent" to the predicate device because the fundamental scientific technology and intended use are unchanged. This suggests that extensive new performance studies to establish new acceptance criteria were likely not conducted or required for this type of 510(k) submission, as substantial equivalence to a previously cleared device implies that the new device meets the performance characteristics demonstrated by the predicate.

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The RapidTEG™ TEG®-ACT Test is a quantitative in vitro diagnostic test intended to monitor heparin anticoagulation in adult patients. It is intended for the use with the Thrombelastograph® (TEG®) Hemostasis System.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA. It does not contain the detailed acceptance criteria or the study information requested. The letter only states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information from the given input.

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The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.

The aiACT Kit is intended only for high dose heparin anticoagulation management (ACT ≥ 400 seconds on Sonoclot Analyzer) as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment.

The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.

The aiACT Kit is a yellow plastic lidded cuvette containing contact activator and magnetic stir bar.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the aiACT Kit.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the aiACT Kit as specific thresholds for regulatory approval. However, it presents "Normal Ranges" for the aiACT test. While this isn't framed as a pass/fail criteria, it serves as a performance benchmark against healthy individuals without heparin.

Note: The document only provides the normal range itself as the "reported device performance." It doesn't present a separate study cohort demonstrating the aiACT kit's performance relative to these ranges from an external dataset. It's implied that the observed normal range is the performance of the device in a normal, unheparinized population.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used to establish the "Normal Range" for the aiACT Kit. It only refers to a "Normal Population, No Heparin" for "Native Whole Blood."

• Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated (e.g., country of origin). It can be inferred that it is retrospective or prospective data collected to establish the normal range, but the methodology is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as the document does not describe the use of experts to establish a "ground truth" for the test set in the context of diagnostic accuracy. The ground truth, in this case, is simply the observed range of ACT/Onset and Clot Rate results from a presumably healthy, unheparinized population. There's no mention of a diagnostic task requiring expert interpretation.

4. Adjudication Method for the Test Set

This section is not applicable as the document does not describe a scenario requiring adjudication, such as conflicting expert interpretations or complex diagnostic judgments. The "ground truth" is based on direct measurement of clotting parameters in a normal population.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This section is not applicable. The document describes a comparison of the aiACT Kit with the SonACT Kit, but it is a comparison of technological characteristics and expected performance, not an MRMC study assessing human reader improvement with or without AI assistance. The aiACT Kit is an in vitro diagnostic test, not an AI-assisted diagnostic tool for Human Readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, implicit in the document, a standalone performance of the device (aiACT Kit with Sonoclot Analyzer) was assessed. The "Normal Range" values (ACT/Onset and Clot RATE) are the direct output of the device itself without human interpretation in a diagnostic loop.

7. The Type of Ground Truth Used

The ground truth used for establishing the normal ranges is based on direct physiological measurement of Activated Clotting Time (ACT/Onset) and Clot Rate from a "Normal Population" with "Native Whole Blood" (i.e., not heparanized). It's an empirical observation of typical values in a healthy state.

8. The Sample Size for the Training Set

The document does not explicitly mention a training set or its sample size. This is common for in vitro diagnostic devices where "training" in the machine learning sense is not typically applicable for establishing performance characteristics like normal ranges. The normal ranges are typically derived from a studied population.

9. How the Ground Truth for the Training Set Was Established

As no explicit "training set" is mentioned in the context of machine learning, this question doesn't entirely apply. However, if we consider the data used to define the "Normal Range" as the equivalent of data used to establish expected performance, the ground truth (the observed ACT/Onset and Clot RATE values) was established by direct measurement using the aiACT Kit on native whole blood samples from a "Normal Population" without heparin. The methodology of this measurement (e.g., number of subjects, how "normal" was defined, protocol for measurement) is not detailed in this summary.

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The i-STAT Kaolin Activated Clotting Time (ACT) test is an in vitro diagnostic test which uses fresh whole blood to monitor high-dose heparin anticoaqulation frequently associated with cardiovascular surgery. The test is to be used with the i-STAT Portable Clinical Analyzer (Models 200 and 300), but not the Philips Medical Systems (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-STAT System, the Kaolin ACT test is to be used by trained and certified health care professionals in accordance with a facility's policies and procedures.

The i-STAT Kaolin ACT test is contained in a single test cartridge. In use, approximately 40 microliters of fresh whole blood are placed in the cartridge is inserted into the thermally controlled i-STAT Model 200 or Model 300 Portable Clinical Analyzer, and all analytical steps are performed automatically. Patient and user information may be entered into the analyzer via a keypad during the automated analysis cycle. During the test the blood sample is mixed with reagents which are coated on the cartridge cover in a segment of the sensor channel. The reagent layer includes an activating agent, a thrombin substrate, and inert matrix components. These reagents allow activation of the coagulation cascade and detection of clot formation. In the i-STAT ACT test, the endpoint is indicated by the appearance of an electroactive marker generated by the thrombin-mediated conversion of a synthetic substrate included in the reagent. Detection of the marker indicates generation of thrombin and therefore complete activation of the coagulation cascade. The reported result is calculated from the time and rate of the substrate conversion and is given in seconds. The reported result correlates to the result of a traditional ACT in which the endpoint is indicated by physical clot formation.

The provided text describes the i-STAT Kaolin ACT test and its comparison to the predicate device, the Hemochron ACT test.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document doesn't explicitly state "acceptance criteria" with numerical targets for each performance metric. Instead, it presents the results of a comparison study against a predicate device and concludes that the i-STAT Kaolin ACT test shows "acceptable correlation" and "comparable" performance to the predicate. Based on the "Summary of Clinical Test Performance," we can infer the implied acceptance criteria were related to achieving a strong correlation and similar bias to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size:
  • Site 1: 311 patient samples
  • Site 2: 352 patient samples
  • Site 3: 313 patient samples
  • Total Clinical Samples: 976 patient samples
• Data Provenance: The studies were conducted at "three external sites" and used "samples taken during cardiovascular surgery procedures." This indicates a prospective collection of real-world patient samples. The document does not specify the country of origin, but given the submission is to the FDA (U.S.), it is highly probable the studies were conducted in the U.S.

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)

This is not applicable as the "ground truth" for this device is a quantitative measurement (Activated Clotting Time), not an interpretation by experts. The comparison is against a predicate device, which itself measures ACT.

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

Not applicable. The study involves direct comparison of numerical results from two analytical devices, not subjective expert interpretations that would require 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

Not applicable. This is not an AI-assisted diagnostic device, but an in vitro diagnostic test for measuring Activated Clotting Time. No human readers or AI assistance are involved in the measurement process.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the studies presented are effectively standalone performance studies for the i-STAT Kaolin ACT test. The device automatically performs the analysis once the blood sample is introduced into the cartridge and inserted into the analyzer. There is no human intervention in the result generation process itself, and the study compares the results generated by the i-STAT system directly against those of the predicate device.

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

The "ground truth" in this context is the measurement provided by the predicate device, the Hemochron® Activated Whole Blood Clotting Time (Hemochron KACT). The study aimed to demonstrate that the i-STAT device's measurements are substantially equivalent to those of a legally marketed, established device.

8. The sample size for the training set

The document does not explicitly mention a "training set" for the device itself. Medical devices like this typically undergo a development and calibration phase, which involves extensive testing, but the term "training set" as understood in machine learning (where the algorithm learns from data) is not directly applicable here. The non-clinical studies (imprecision, linearity, sensitivity tests) represent development and validation data, but not a distinct "training set" in the AI sense.

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

Not applicable (see point 8). For the non-clinical studies, "ground truth" would generally refer to known control values, known heparin concentrations, or comparison to established laboratory methods for determining fibrinogen levels, etc.

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The Actalyke XL Activated Clotting Time Analyzer and Test Tubes are indicated for use in the measurement of the activated clotting time test (ACT). This system can be used in bypass surgery, vascular surgery, transplant surgery, cardiac catheterization, and coronary angioplasty.

Not Found

This is an FDA Premarket Notification (510(k)) letter for the Actalyke® XL Analyzer. It does not contain the detailed study information required to complete your request.

The 510(k) summary (or the full submission, which is not provided here) is where you would typically find the acceptance criteria, study design, and performance data to support substantial equivalence. The letter itself is simply the FDA's decision regarding the premarket notification.

Therefore, I cannot provide the requested information from the text provided.

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ActalykeR Mini™ Activated Clotting Time (ACT) Test System is used to perform the activated clotting time test, a whole blood coagulation assay commonly used to monitor heparin anticoagulation during various medical and surgical procedures. This unit is intended for use in a near-patient or patient-care environment.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Actalyke Mini device. It does not contain the specific details about acceptance criteria or a study that proves the device meets those criteria. The letter primarily focuses on the device's substantial equivalence to a legally marketed predicate device and regulatory compliance.

Therefore, I cannot extract the requested information from the provided document.

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The i-STAT System is used by trained medical professionals for running clinical chemistry tests for sodium, potassium, chloride, urea nitrogen, glucose, hematocrit, calcium, blood-gases (PCO2, PO2) and blood pH, creatinine, lactic acid, and activated whole blood clotting time in a variety of test panels contained in the i-STAT test cartridges.

The i-STAT System is used in conjunction with disposable i-STAT cartridges for determination of a variety of parameters in whole blood.

The provided text is a 510(k) summary for the i-STAT System, primarily focusing on a software modification to address interference in the PCO2 test. It does not contain a typical study design or acceptance criteria for a new device's performance directly. Instead, it references prior substantial equivalence determinations and focuses on the modification.

Therefore, many of the requested categories cannot be filled based on the provided document.

Here's an analysis of what information can be extracted or inferred, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or a detailed performance table for this specific software modification. It mentions that the software modification was made "to diminish the interference on the PCO2 test caused by the drugs thiopental sodium and propofol." This implies that the previous performance in the presence of these drugs was unsatisfactory, and the modification aims to improve it, but no specific targets (e.g., % reduction in error, specific bias limits) are provided.

2. Sample Size Used for the Test Set and Data Provenance:

Not specified in the document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

Not specified in the document.

4. Adjudication Method for the Test Set:

Not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This device is a clinical analyzer, not an imaging device typically evaluated with MRMC studies comparing human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The i-STAT System is a standalone clinical analyzer. The software modification described likely refers to an improvement in the algorithm that processes the PCO2 measurement from the sensor, without direct human-in-the-loop performance being a separate evaluation step. However, the document does not detail a specific standalone performance study for this modification. The device itself operates in a standalone manner.

7. The Type of Ground Truth Used:

Not specified in the document. For a clinical analyzer, ground truth would typically be established by a reference method (e.g., a laboratory-based blood gas analyzer) for the PCO2 measurement.

8. The Sample Size for the Training Set:

Not applicable/Not specified. This document describes a software modification to an existing device, not the training of a new AI model in the typical sense that would involve a "training set" with ground truth in the context of machine learning. The modification likely involved algorithm adjustments based on observed interference, rather than a large-scale machine learning training pipeline.

9. How the Ground Truth for the Training Set Was Established:

Not applicable/Not specified (as above).

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