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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 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.

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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.

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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 Rapidpoint Low range Heparin Management Test Card is to be used with the Rapidpoint Coag (formerly TAS) Analyzer to monitor the effects of low to moderate levels of unfractionated heparin on coagulation in noncitrated arterial whole blood samples from patients undergoing diagnostic and interventional procedures.

The test is for in vitro diagnostic use. It is especially suited for professional use in decentralized areas of the hospital near the patient's bedside, in the cardiac catheterization lab, and other areas where patients are treated with low to moderate levels of heparin.

The Rapidpoint LHMT provides a method to measure the response of a patient to heparin. A noncitrated whole blood sample can be used for this test. The test card has a magnetic stripe on the back, which encodes lot specific information such as number, expiration date, and mathematical factors specific to that lot. A room temperature test card is removed from the pouch and the card is passed through the card reader of the instrument to instrument to run a test. The instrument instructs the operator to insert a test card and then requests patient and sample information. The card is warmed and the operator is prompted to add a drop of blood to the card sample well. The sample flows into the card and rehydrates the reagent, which begins the reaction. As the reaction proceeds and clotting begins, the movement of the particles decreases, and the instrument signals the clotting time.

Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets those criteria:

Device: Rapidpoint Low range Heparin Management Test (LHMT) Card

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner. However, it does describe performance characteristics that were likely evaluated for market clearance. The primary evidence presented is the correlation to a predicate device.

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

• Sample Size:
  • Normal Donors: 120 (59 males, 61 females) for establishing normal ranges.
  • Patient Samples: 429 samples from 232 individuals undergoing various treatments.
• Data Provenance:
  • Normal Donors: "normal, healthy donors," likely gathered prospectively for this study.
  • Patient Samples: "samples drawn from individuals expected to have abnormal LHMT results" undergoing "a variety of treatments." The description "Field testing and clinical testing were done at large hospitals" suggests these were prospective clinical studies in multiple locations. The document does not specify the country of origin, but given the submission to the FDA in the US, it's highly probable the studies were conducted in the US.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of consensus reading or adjudication. The ground truth for the comparison was established by:

• Predicate Device Results: The results from the Hemochron ACT or ACT-LR device served as a comparative "ground truth" for assessing equivalence.
• Chromogenic Anti-Xa Assay: A chromogenic anti-Xa assay (Diagnostica Stago's Stachrom Heparin) was used as a "reference, tiebreaker method" to determine heparin concentration, which is a more direct measure of heparin activity.

Therefore, no panel of human experts was used for adjudication or establishing ground truth in the way one might see in image-based diagnostic studies.

4. Adjudication Method for the Test Set:

Not applicable in the context of this device. The study design involved comparing the LHMT device's quantitative output to established, quantitative measurements from a predicate device and a reference assay. There was no subjective interpretation that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. This device is not an AI-assisted diagnostic tool for human interpretation; it's an automated in vitro diagnostic test for measuring coagulation time in the presence of heparin. Therefore, there's no "human reader" component to improve.

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

Yes, the study described is a standalone performance study of the Rapidpoint LHMT device. The device itself performs the measurement, and the results are then compared to other quantitative measures (predicate device, reference assay). There is no "human-in-the-loop" interaction in the production of the primary diagnostic result from the LHMT card.

7. The Type of Ground Truth Used:

The ground truth for evaluating the LHMT device's performance was:

• Comparative Measurement: Results from the predicate device (Hemochron ACT or ACT-LR) for assessing substantial equivalence.
• Reference Method: Results from a chromogenic anti-Xa assay (Stachrom Heparin), which directly measures heparin concentration and served as a "reference, tiebreaker method." This provides a more objective, gold-standard-like measure of heparin activity.

8. The Sample Size for the Training Set:

The document describes nonclinical performance data ("Preclinical testing was done at CDI") and then clinical performance data. It does not explicitly separate data into "training" and "test" sets in the context of a machine learning or algorithm development paradigm. The "nonclinical performance data" could be considered part of the development/training phase, but no specific sample size is given for it. The clinical data (120 normal donors, 429 patient samples) are presented as the primary "test set" for demonstrating performance and substantial equivalence.

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

As mentioned in point 8, the concept of a "training set" with established ground truth as distinct from a "test set" isn't explicitly detailed as it would be for an AI algorithm.

• Preclinical Testing: The preclinical testing likely involved internal laboratory studies to characterize the device's basic performance (linearity, sensitivity, specificity, temperature effects). The "ground truth" for these studies would have been established through controlled experimental conditions, using known concentrations of heparin and other interfering substances, and comparing results to established laboratory methods or internal standards.
• Clinical Testing: For the clinical evaluation data presented, the "ground truth" for comparison was the measurements from the predicate device (ACT) and the reference anti-Xa assay.

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The i-STAT Celite Activated Clotting Time (ACT) test cartridge is an in vitro diagnostic test used to monitor moderate- and high-level hevarin therapy through analysis of arterial and venous whole blood samples. The cartridge is to be used with the i-STAT System 200 model analyzer.

As part of the i-STAT System, the Celite ACT test cartridge is to be used by trained and certified health care professionals in accordance with a facility's policies and procedures.

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 Celite ACT test is contained in a single test cartridge. In use, approximately 40 microliters of fresh whole blood are placed in the cartridge as described below. The cartridge is inserted into the thermally controlled i-STAT Model 200 Portable Clinical Analytical steps are performed automatically. Patient and user information may be entered into the analyzer via a keypad during the automated analysis cycle.

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 ACT cartridge is assembled from plastic components that provide the conduits for fluid handling and house the sensor chips. The coagulation test is identified to the user through the name and color code on the cartridge label and by the analyzer through features integral to the cartridge.

In the ACT cartridge the sensor comprises a gold film patterned on a silicon/silicon dioxide substrate.

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.

Whole blood is introduced into the sample well of the cartridge at the sample port and the cartridge is closed and inserted into the analyzer. Insertion of the cartridge initiates a controlled and monitored sequence of steps in the instrument. These are:

• Electrical contact is made between the analyzer electronic input circuits and the cartridge. The analyzer identifies the type of cartridge being used and the tests contained in the cartridge.
• The dry chips and sensor channel are heated to 37C.
• The blood is then moved forward. Feedback from the fluid position sensor is used to allow controlled oscillation of the blood segment resulting in dissolution of the reagent layer.
• Following mixing, a count up time is displayed.
• During the course of testing, the position of the blood segment is actively controlled to maintain the length of the blood containing the reagent coincident with the endpoint detector.
• Calculation of sample clot time is performed and displayed.

The provided 510(k) summary describes the i-STAT Celite ACT test and its comparison to a predicate device, the Hemochron Systems Activated Clotting Time. The document focuses on demonstrating substantial equivalence, not on pre-defined acceptance criteria in the way AI/ML devices typically present them. However, we can extract performance metrics and the study design to infer the criteria being met.

Here's an analysis based on the provided text, structured to align with your request for acceptance criteria and study details:

Acceptance Criteria and Device Performance

The acceptance criteria here are implicitly derived from demonstrating substantial equivalence to the predicate device, the Hemochron Systems Activated Clotting Time. The study's goal was to show that the i-STAT Celite ACT test performs comparably to the predicate device in various clinical settings.

Note: The document does not explicitly state numerical "acceptance criteria" but presents performance data to demonstrate "substantial equivalence" to the predicate device, which is the regulatory standard for 510(k) clearance. The favorable comparisons above (e.g., better precision, high correlation) implicitly meet these unstated criteria.

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Cardiac Catheterization and Bypass Procedures:
     • Site 1: 118 patient samples
     • Site 2: 74 patient samples
     • Site 3: 101 patient samples
   • Hemodialysis and Extra-corporeal Membrane Oxygenation:
     • Site 1: 52 patient samples
     • Site 2: 14 patient samples
   • Data Provenance: The studies were conducted at "three external sites" and "two sites" for different patient populations. The samples were "fresh whole blood samples" from patients undergoing the described procedures. The data is prospective in the sense that samples were collected and tested on both devices concurrently. Location (country of origin) is not explicitly stated but implies clinical sites within the same regulatory jurisdiction as the submission (likely USA).

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

   • Not applicable in the typical sense for an AI/ML device. For this in vitro diagnostic device, "ground truth" for the clinical studies was established by the predicate device (Hemochron® Systems Activated Clotting Time). The goal was to show correlation and agreement with an existing, legally marketed device, not to establish a new gold standard. Therefore, no "experts" for ground truth adjudication are described.

3. Adjudication method for the test set:

   • Not applicable as the "ground truth" was the measurement from the predicate device. The identical sample was tested on both the i-STAT device and the predicate device. Statistical comparisons (least squares regression, average bias) were then performed.

4. 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, not an AI/ML medical imaging device that requires human reader interpretation. The device provides a quantitative measurement (Activated Clotting Time).

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

   • Yes, implicitly. The performance data presented (linearity, precision, clinical correlation) represents the performance of the i-STAT device itself in generating an ACT result, compared to the predicate device. The i-STAT system automatically performs the analytical steps and calculates the result, so this is a standalone performance assessment in its context.

6. The type of ground truth used:

   • For the clinical correlation studies, the "ground truth" was effectively the measurement obtained from the predicate device (Hemochron® Systems Activated Clotting Time). The internal studies for linearity and precision used established methods for determining heparin concentration and control material values.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/ML algorithm that requires a "training set" in the conventional sense. Its underlying principles are electrochemical detection and established chemical reactions, not machine learning from a dataset. The development likely involved internal validation and calibration using various samples, but this is not generally referred to as a "training set" for such a device.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no traditional "training set" for this type of medical device. The "ground truth" for method development would be based on established analytical standards, reference methods, and gravimetric/volumetric preparations for control materials.

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The CoaguChek Pro ACT test is for the quantitative determination of the activated clotting time of freshly drawn whole blood, using the CoaguChek Pro System.
The CoaguChek Pro ACT test cartridge is for the quantitative determination of the activated clotting time of freshly drawn whole blood, using the CoaguChek Pro System. It is intended for health care professional use only.

The activated clotting time test is used to measure coagulation by activating the clotting pathway. The ACT test monitors the effectiveness of heparin during several types of medical procedures. Many procedures such as Percutaneous Transluminal Coronary Angioplasty (PTCA), cardiac catheterization, hemodialysis, and Extracorporeal Membrane Oxygenation (ECMO) require the administration of low to moderate heparin doses. Sensitivity to heparin can vary significantly from patient to patient, and lack of adequate control of the heparin dose can lead to either bleeding or thrombosis.

The ACT test is initiated by inserting a CoaguChek Pro ACT test cartridge into the instrument. The instrument reads a code on the test cartridge to determine test identity and lot number. The test cartridge contains a sample application well, a reagent chamber, and a reaction path. After the instrument heats the test cartridge, a drop of fresh, whole blood is placed on the test cartridge sample application well. Blood is drawn into the reagent chamber by capillary action, where it mixes with the reagent to initiate coagulation. The blood sample moves along the reaction path until a clot forms. The laser optical system detects the clot by monitoring blood flow; endpoint is reached when the blood stops moving. The time from sample application to clot detection is the activated clotting time. The displayed result is equivalent to the ACT result obtained from a commercially available system. Because each newly-manufactured lot is calibrated to an internal reference lot, any lot-to-lot variability between reagents is corrected electronically using information coded on the lot-specific code key.

Here's a summary of the acceptance criteria and the study details for the ACT Test and Controls for the CoaguChek Pro System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies acceptance criteria by comparing the performance characteristics to a predicate device. Specific numerical "acceptance criteria" are not explicitly stated for each characteristic in the way they might be in a formal test plan. Instead, the comparison to the existing predicate device's performance (or lack thereof, for new metrics) serves as the basis for substantial equivalence.

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

• Test Set Sample Size:
  • Accuracy: N=539 (for arterial whole blood comparison against the Hemochron).
  • Precision with Blood: Not explicitly stated as a number of samples, but mentions "duplicate results."
  • Precision with Liquid Controls: Not explicitly stated, implied to be sufficient for calculating Mean and CV for two levels.
• Data Provenance: Not explicitly stated but clinical studies are generally considered prospective or a mix. The document does not specify country of origin for the data.

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

• This device is an in-vitro diagnostic (IVD) based on measuring a physiological parameter (activated clotting time). The "ground truth" is established by the reading from a predicate device (Hemochron ACT Test) or by the inherent measurement of the physical phenomenon of clotting.
• Therefore, the concept of "experts establishing ground truth" in the same way it would apply to image interpretation (e.g., radiologists) does not directly apply here. The accuracy study compares the device's reading to that of a reference method (the predicate device).

4. Adjudication Method for the Test Set

• Not applicable as this is a quantitative measurement device compared against a predicate device, not an interpretation where multiple human experts would adjudicate a finding.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for diagnostic aids where human interpretation is involved.
• The study performed was a direct comparison of the device's quantitative output against a predicate device.

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

• Yes, the study presented for "Accuracy" and "Precision" reflects the standalone performance of the CoaguChek Pro ACT Test system (instrument and cartridge). The device automatically detects the clot and reports the time, without human intervention in the measurement process itself, although a human initiates the test and reads the result.

7. The Type of Ground Truth Used

• Comparative Ground Truth: The primary "ground truth" for the accuracy study was the measurement obtained from the predicate device, the Hemochron ACT Test. The study aimed to show substantial equivalence through correlation.
• For precision, the "ground truth" is the reproducibility of the device's own measurements.

8. The Sample Size for the Training Set

• The document does not specify a separate "training set" size. For IVD devices like this, the development likely involves various stages of internal testing and calibration. The data presented here is for validation (test set).

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

• Not described in the provided 510(k) summary. For devices of this nature, the "ground truth" for training (e.g., calibrating the device or developing the algorithm for clot detection) would typically involve using known samples or primary reference methods to ensure accurate and precise measurement of the activated clotting time.

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