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The directCHECK® Whole Blood ACT+ Level 1 (normal) and ACT+ Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT+ assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments.

The directCHECK® Whole Blood ACT-LR Level 1 (normal) and ACT-LR Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT-LR assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments.

The directCHECK® Whole Blood Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation tests. The directCHECK® whole blood control material is prepared from animal plasmas to which fixed animal red blood cells have been added. No human-based materials are contained in directCHECK® Whole Blood Controls. The whole blood control material is lyophilized in glass ampoules, and placed into an individual assembly with liquid diluent. When the glass ampoule is broken (activation of the assembly), the diluent rehydrates the lyophilized material, forming a liquid whole blood control.

The acceptance criteria and study proving device performance are described below based on the provided text.

Acceptance Criteria and Device Performance

Device: directCHECK® Whole Blood Control for HEMOCHRON® ACT+ assay and directCHECK® Whole Blood Control for HEMOCHRON® ACT-LR assay

Study Type: Non-clinical precision and stability testing. Clinical studies were not performed.

Note: The text explicitly states "this satisfies the Level 2 acceptance criteria of CV

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The IRMA TRUpoint™ Creatinine Control Kit is for use on the IRMA TRUpoint™ Blood Analysis System to perform Quality Control assays for Creatinine on the IRMA TRUpoint™ Blood Analysis System. For in vitro Diagnostic Use Only

The Creatinine Control Kit includes creatinine control materials at two levels for monitoring the IRMA analyzer performance at different points in the range of intended clinical utility. The control materials are packaged in capped luer lock syringes, each containing 1.5 ml of solution. The syringes are in turn packaged in pouches. Three (3) pouches/syringes for low level and three (3) pouches/syringes for high level are packaged in a box. The Cr control is an aqueous based solution of creatinine and sucrose. This control contains no human or biological materials.

The provided document is a 510(k) summary for the IRMA TRUpoint™ Creatinine Control Kit. This submission is for a quality control material intended to monitor the performance of an analyzer, not for a diagnostic device that measures patient analytes directly. Therefore, the concepts of sensitivity, specificity, or diagnostic accuracy as typically applied to medical devices for patient diagnosis or screening do not apply in the same way.

The "acceptance criteria" for a quality control material generally relate to its stability, consistency, and ability to generate expected values when tested on the intended analyzer. The study presented here is a demonstration of substantial equivalence to existing legally marketed predicate devices, rather than a performance study with traditional clinical acceptance criteria.

Here's an interpretation based on the provided text, aligning with the spirit of the request by describing the implicit "acceptance criteria" for a QC device and how the submission addresses them:

Acceptance Criteria and Device Performance for a Quality Control Material (Derived from Substantial Equivalence)

For a Quality Control material like the IRMA TRUpoint™ Creatinine Control Kit, the "acceptance criteria" are implicitly met if the device demonstrates substantial equivalence to predicate devices. This means it performs its intended function (monitoring analyzer performance) in a comparable manner, considering its form, matrix, intended use, and storage conditions.

Study Details (Based on the 510(k) Summary)

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicates rather than presenting de novo clinical study data with detailed performance metrics. Therefore, many of the requested details about specific study design (e.g., sample sizes, ground truth establishment, expert adjudication) are not applicable or not explicitly provided for this type of submission.

Here's an attempt to address the points based solely on the provided text, indicating when information is not available:

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

   • Addressed in the table above. The "acceptance criteria" are implied by the requirements for substantial equivalence. The "reported device performance" is the claim of substantial equivalence based on the comparisons made.

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

   • Not explicitly provided. This submission describes the device and compares its technical characteristics to predicates to establish substantial equivalence. It does not detail specific performance testing data (e.g., precision, accuracy, stability studies) that would typically involve a "test set" in the context of diagnostic accuracy. While such studies would have been performed by the manufacturer, the 510(k) summary focuses on the comparative argument.

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

   • Not applicable / Not provided. For a quality control material, "ground truth" isn't established by experts in the same way it would be for a diagnostic image or pathology slide. The "truth" for a QC material is its known concentration of the analyte, which is verified through analytical methods. The submission doesn't detail the analytical validation process for the control itself, only its comparison to predicates.

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

   • Not applicable / Not provided. Adjudication is relevant for subjective assessments (e.g., human reader interpretations). This is a technical comparison for a quality control material, not a diagnostic interpretation study.

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 submission is for a quality control material, not an AI or imaging diagnostic device that would involve human readers.

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

   • Not applicable. This is a quality control material, not an algorithm.

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

   • Not explicitly stated/Not applicable in the human-centric sense. For a quality control material, the "ground truth" would be the assigned value or target value for creatinine, determined through highly accurate reference methods or inter-laboratory consensus, which the control material is manufactured to. The document does not detail how these target values were established for the IRMA TRUpoint™ Creatinine Control Kit, but focuses on its equivalence in form and function to other marketed QC materials.

8. The sample size for the training set:

   • Not applicable. This is a physical quality control material, not a machine learning model, so there is no "training set."

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

   • Not applicable. See point 8.

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The HEMOCHRON® Signature Elite™ is a battery operated, hand-held instrument that performs individual point-of-care coagulation tests on fresh or citrated whole blood. The system is intended Incilitiation point coughtton toots of mare coagulation testing. Whole blood test results are displayed as clotting times (in seconds). The HEMOCHRON® Signature Elite™ also displays ulsplayed as clouing times (in socondo). The Hame equivalent values, and the PT INR value.

For in vitro Diagnostic Use Only

The HEMOCHRON® Signature Elite™ Whole Blood Microcoagulation System is a batteryr ne real over to re in the nement that performs individual point-of-care coagulation tests on fresh or operated, norial morantents include: Activated Clotting Time (ACT+ and ACT-LR), Activated Partial Thromboplastin Time (APTT and APTT Citrate), and Prothrombin Time (PT and PT Citrate). The system is intended to be used with test cuvettes that are available from ITC.

Data management capabilities are included with the instrument. These capabilities include Storage of up to 600 patient results and 600 quality control results, designation of quality control levels, tagging of test results with date and time, entry of Patient ID and/or Operator ID or levers, tagging of toot room and bate HEMOCHRON® Configuration Manager software is included with the instrument. This software allows the user to connect a personal computer to the included with the instrument. This octtivation functions using a Microsoft Windows® user interface. HEMOCHRON® ReportMaker" and idms " software which are provided separately, allow the user to connect a personal computer to the instrument and perform various data management and data reporting functions.

For in vitro Diagnostic Use

Here's a breakdown of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating quantitative acceptance criteria for a new device. However, the core implication is that the HEMOCHRON® Signature Elite™ must perform equivalently to the HEMOCHRON® Jr. Signature+ in terms of coagulation test results.

Table 1: Implied Acceptance Criteria and Reported Device Performance

Study Details for Substantial Equivalence:

The provided text describes studies conducted to demonstrate substantial equivalence, rather than a single study designed to meet specific new performance acceptance criteria.

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

   • Laboratory Comparison: "ITC whole blood control products for each currently 510(k) cleared assay for the HEMOCHRON® Jr. Signature+ instrument (predicate)." The exact number of samples or runs is not specified.
   • Clinical Comparison: "split patient blood samples on the two instrument systems using each currently 510(k) cleared assay for the HEMOCHRON® Jr. Signature+ instrument system." The exact number of patient samples is not specified.
   • Data Provenance: The studies appear to be internal laboratory and clinical comparisons to the predicate device, implying a retrospective (or at minimum, comparative) structure based on existing assays and clinical samples, likely conducted within the United States where ITC is based. No specific country of origin for the data is mentioned outside of the company's US location.

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

   • This information is not provided in the document. The studies are comparisons to a predicate device, and the "ground truth" for the predicate device's measurements would have been established during its own validation. For this submission, the predicate device itself serves as the reference point for "truth."

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

   • This information is not provided in the document. Given it's a comparative study of a diagnostic instrument rather than interpretation of images or complex clinical scenarios, a formal adjudication method by experts is unlikely to have been part of the primary data comparison. The comparison would involve statistical analysis of the numerical results from both devices.

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:

   • No, an MRMC comparative effectiveness study was not done. This document describes a medical device (a microcoagulation system) that performs automated tests. It is not an AI-assisted diagnostic tool for human interpretation, thus, MRMC studies and "human readers" are not applicable in this context.

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

   • This device, the HEMOCHRON® Signature Elite™, is an automated diagnostic instrument. Its performance is inherently standalone in terms of generating coagulation test results. The studies compared its results directly to the predicate device's results. There isn't a separate "algorithm only" performance reported as distinct from the device's operational performance, as the device is the implementation of the algorithm.

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

   • For the laboratory comparison, "whole blood control products" were used. These controls have known or expected values, serving as a form of reference standard.
   • For the clinical comparison, "split patient blood samples" were used. In this case, the "ground truth" for each sample was implicitly the result obtained from the predicate device (HEMOCHRON® Jr. Signature+), as the study aimed to demonstrate equivalence to it.

7. The sample size for the training set:

   • This information is not provided. The device utilizes "the same reagent system, the same closed end method and clot detection algorithms as the predicate device." This suggests the core algorithms were already established and validated with the predicate device. This submission focuses on hardware and software interface upgrades, therefore, a new "training set" for the coagulation algorithms is unlikely to have been part of this 510(k) submission.

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

   • This information is not provided. As mentioned above, the underlying coagulation algorithms are stated to be the same as the predicate device. The ground truth for those original algorithms would have been established during the development and validation of the HEMOCHRON® Jr. Signature+ system, likely through comparison with reference laboratory methods and clinical correlation, but details are not in this document.

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The HEMOCHRON ® Response is intended for professional use for hemostasis management in a variety of clinical settings for the quantitative determination of an assortment of coagulation test assays including the following HEMOCHRON Whole Blood Coagulation Assays Activated Clotting Time (ACT) - All HEMOCHRON types Activated Partial Thromboplastin Time (APTT) - All HEMOCHRON types Prothrombin Time (PT) - All HEMOCHRON types Thrombin Time (TT) Heparin Neutralized Thrombin Time (HNTT) High Dose Thrombin Time (HiTT) Fibrinogen (FIB) Protamine Dose Assay (PDA) - All HEMOCHRON types Heparin Response Time (HRT) - All HEMOCHRON types Protamine Response Time (PRT) - All HEMOCHRON types For In Vitro Diagnostic Use Only

The Hemochron Response instrument/system described herein is a software upgrade (Version 2.0) to the current Hemochron Response Instrument, which has been cleared under K983475 (May 1999). The HEMOCHRON® Response is a portable, dual-well microprocessor-controlled coagulation instrument with an integral barcode reader, laboratory communication interface and a printer designed to perform whole blood coagulation tests using fresh or citrated whole blood. The system is intended for use in many clinical settings requiring point-of-care testing. The modified Response instrument performs the same assays as the predicate instrument. There are no changes to the clot detection algorithm. The patented clot detection mechanism is an electro-mechanical system consisting of two test wells into which disposable test tube assays are inserted. The test tube assays contain specific reagent for the test performed and a precision magnet. Immediately after adding a blood sample to the test tube and pressing the start button, the test tube is placed in the test well and is automatically rotated at a slow controlled speed and incubated at 37°C. When a fibrin clot begins to form, it causes the magnet in the test tube to be displaced. Two magnetic detectors located in the test well continuously monitor the precise position of the magnet. When a pre-determined displacement occurs, the elapsed time form the start of the test and the clot endpoint is displayed as the coagulation time in seconds.

The provided document describes a 510(k) submission for a software upgrade (Version 2.0) to the HEMOCHRON® Response Instrument/System, which is a whole blood coagulation test system. The study compares the performance of the new version (V2.00) with the predicate device (V1.52) to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or threshold format. Instead, it demonstrates equivalence to a predicate device, implying that the new device's performance is acceptable if it is comparable to the established predicate. The performance is assessed through linear correlation for accuracy and precision (CV%) for reproducibility.

Note: The phrase "The linear correlations between the instruments were excellent" explicitly supports the device meeting the implied acceptance criterion for accuracy. For precision, the CV% values for V2.00 are generally very similar to or slightly better/worse than V1.52, indicating comparable reproducibility.

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

• Test Set (Accuracy/Correlation Studies):
  • Sample Size:
    • ACT Tubes: 18 (n=18)
    • Specialty Tubes: 15 (n=15)
    • RxDx Tubes: 17 (n=17)
  • Data Provenance: Blood samples were drawn from "four different donors and heparinized in vitro." This suggests controlled laboratory conditions. The country of origin is not specified but implicitly US, given the FDA submission. The data is prospective for the purpose of this submission, as it was generated specifically to compare V2.00 and V1.52.
• Test Set (Precision Studies):
  • Sample Size: "n=10 per instrument type" (2 V1.52 and 2 V2.00 instruments) for each of two control levels per assay. This means 10 measurements per instrument per control level, totaling 20 measurements per assay per instrument type (e.g., for ACT, 20 for V2.00 and 20 for V1.52 at each control level).
  • Data Provenance: Laboratory studies using assay-specific controls. Implicitly US, prospective.

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

This document does not describe studies needing expert adjudication or ground truth establishment in the way typically seen for image analysis or diagnostic interpretation by human experts. The "ground truth" in this context is the measurement provided by a predicate device (HEMOCHRON® Response V1.52) and highly controlled, standardized laboratory controls. Therefore, no human experts are mentioned for establishing ground truth for the test set.

4. Adjudication Method for the Test Set

Not applicable. The study involves direct comparison of instrument measurements (new vs. predicate, or new vs. its own repeated measurements for precision) rather than human interpretation requiring 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 a study comparing human reader performance with or without AI assistance. It’s a comparison of two versions of an automated coagulation instrument.

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

The studies presented are standalone in the sense that they evaluate the performance of the instrument (V2.00) itself, comparing its measurements to a predicate instrument (V1.52) or against laboratory controls. There is no human-in-the-loop performance evaluated or described in these specific performance studies. The system is designed for professional use, but the reported performance data focuses solely on the device's measurement capabilities.

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

• For Accuracy/Correlation Studies: The ground truth is established by the measurements from the predicate device (HEMOCHRON® Response V1.52). The goal is to show the new version correlates well with the previously cleared and accepted device.
• For Precision Studies: The ground truth is the assigned value of the assay-specific controls, against which the instrument's reproducibility is measured.

8. The Sample Size for the Training Set

This document does not describe a machine learning algorithm or a new diagnostic model that requires a training set. The changes primarily involve a software upgrade to activate existing functionalities (like the RxDx module) and enhance user programming, not to develop a new analytical algorithm. Therefore, there is no training set mentioned or applicable in this context.

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

Not applicable, as no training set is described.

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The Hgb Pro Professional Hemoglobin Testing System™ consists of a portable, battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary or venous (EDTA) whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility. The Hgb Pro Professional Hemoglobin Testing System is not intended for home use.

For In Vitro Diagnostic Use Only

The Hgb Pro Professional Hemoglobin Testing System™ consists of a portable, battery operated meter and single-use test strips for the quantitative measurement of total hemoglobin from capillary or venous (EDTA) whole blood. The Hgb Pro Professional Hemoglobin Testing System is designed for near patient testing in a professional facility. The Hgb Pro Professional Hemoglobin Testing System is not intended for home use.

The Hgb Pro meter utilizes optical reflectance for determination of total hemoglobin. The test strip, containing a membrane preloaded with a dried reagent containing a red cell lysing agent, is inserted into the meter. A drop of whole blood is applied to the test location on the strip after a baseline reading is taken. Blood immediately disperses within the membrane, resulting in lysis of red blood cells and release of hemoglobin. The meter's optical detectors automatically measure the change in membrane reflectance.

The meter calculates and displays the total hemoglobin concentration in grams/deciliter (s/dL, equivalent to percent) or millimole/L) based on a mathematical conversion table, which is programmed into the instrument. Minor adjustments may be made to the conversion on a lot-by-lot basis based on variation of the raw materials and process to ensure accuracy with the laboratory system. The test result will be displayed in 30 seconds or less.

Here's a breakdown of the acceptance criteria and study information for the ITC Hgb Pro Professional Hemoglobin Testing System, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Summary of Performance Data, Linearity and Precision" section, where the device's performance is compared against known standards and other devices. While explicit "acceptance criteria" are not formally listed with specific thresholds as such, the reported performance demonstrates "substantial equivalence" to a standard clinical laboratory instrument (Coulter MD8) and "clinical equivalence" to the Hemocue Test System.

Table of Performance Data:

Study Information:

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

   • Linearity Study: 7 hemoglobin concentrations prepared from a single normal donor. Multiple Hgb Pro instruments (n=5) were tested twice at each concentration.
   • Precision (Commercial Controls): n=80 for each of the three levels of commercial controls.
   • Precision (Whole Blood Samples): Level I: N=87; Level II: N=90; Level III: N=90. These were freshly prepared whole blood samples from normal donors.
   • Accuracy (Hgb Pro vs. HemoCue / Coulter, venous samples):
     • All ages combined: n=232 (Hgb Pro vs. HemoCue); n=226 (Hgb Pro vs. Coulter).
     • Adults only: n=162.
     • Neonate / Pediatric: n=70 (Hgb Pro vs. HemoCue); n=64 (Hgb Pro vs. Coulter).
   • Accuracy (Hgb Pro vs. HemoCue / Coulter, fingerstick samples): n=87.
   • Data Provenance: The document does not explicitly state the country of origin for the patient data. It mentions "Physician Office and Hospital Populations combined" and "normal donor" samples. It appears to be prospective for linearity and precision studies as samples were prepared and tested. For accuracy studies, it is implied to be clinical data from "Physician Office and Hospital Populations," which could be prospective or retrospective collections, but the wording suggests data collection for the purpose of the study.

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

   • The document does not mention the use of experts or their qualifications for establishing ground truth. The ground truth for quantitative hemoglobin measurements is typically established by reference laboratory instruments or validated methods, not by human expert opinion.

3. Adjudication Method for the Test Set:

   • No adjudication method is mentioned as this device measures a quantitative value and does not rely on subjective interpretation by multiple readers.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC study was done. This device provides quantitative measurements, not diagnostic images or interpretations that typically involve multiple readers. The comparison is against established laboratory instruments and other point-of-care devices.

5. Standalone (i.e. algorithm only without human-in-the loop performance) Study:

   • Yes, the performance data presented are for the standalone device (Hgb Pro system) measuring hemoglobin concentration. There is no mention of a "human-in-the-loop" component for interpretation; the device displays a numerical result. The accuracy studies compare the Hgb Pro's numerical output against other standalone devices (HemoCue and Coulter MD8).

6. Type of Ground Truth Used:

   • Reference Instrument/Method: The primary ground truth for accuracy and precision studies was established by comparing the Hgb Pro device's readings against a standard clinical laboratory instrument (Coulter MD8) and another commercial device, the Hemocue Test System. For precision with whole blood samples, the daily-prepared control hemoglobin levels were confirmed with the Coulter MD8 Laboratory instrument. For linearity, the ground truth was derived from prepared concentrations of hemoglobin, and the expectation was linearity relative to these known concentrations.

7. Sample Size for the Training Set:

   • The document does not specify a separate "training set" sample size. The Hgb Pro system is described as utilizing optical reflectance with a "mathematical conversion table, which is programmed into the instrument." It also states "Minor adjustments may be made to the conversion on a lot-by-lot basis based on variation of the raw materials and process to ensure accuracy with the laboratory system." This suggests that calibration and algorithm development might have used internal data, but these details are not provided as a distinct "training set." The performance data presented are primarily validation data.

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

   • As noted above, a distinct "training set" and its ground truth establishment are not explicitly described in the provided text. The implication is that the instrument's programmed conversion table and lot-by-lot adjustments are developed and validated to align with established laboratory methods (like the Coulter MD8).

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The HEMOCHRON® Signature+ is a portable, battery-operated point of care microcoagulation instrument designed to perform whole blood coagulation tests using fresh or citrated whole blood. The system is intended for use in many clinical settings requiring point-of-care testing. Whole blood test results are displayed as clotting times (in seconds). The Signature+ also displays correlated Celite® equivalent ACT values, APTT and PT plasma equivalent values, and the PT INR value. For In Vitro Diagnostic Use Only

The Hemochron Jr. Signature + instrument is an upgrade to the current Hemochron Jr. Signature instrument cleared under K974799 (July 1998). The HEMOCHRON® Signature+ is a portable, battery-operated point of care microcoagulation instrument designed to perform whole blood coagulation tests using fresh or citrated whole blood. The system is intended for use in many clinical settings requiring point-of-care testing. The Signature Plus instrument performs the same assays as the predicate instrument. There are no modifications to the clot detection algorithm. The Signature Plus instrument employs the same clot detection mechanism as the predicate Signature. The clot detection mechanism is a combination mechanical-optical system. Blood is placed in a collection reservoir of a test cuvette and subsequently drawn into the test channel of the cuvette, which contains the reagent required to perform the respective coagulation assay. As blood is actively pumped back and forth in the test channel, LED detectors measure the position of the blood. As clotting begins to occur, the movement of the blood decreases below a pre-determined rate where the endpoint is recorded. The HEMOCHRON® Signature+ provides data management capabilities including the following: Patient and quality control result storage, Input of operator and patient identification, Designation of quality control level, Date and time stamp for all test results, Printer access, Tests performed are tracked by test type and quality control failures. The HEMOCHRON® Signature+ Configuration Manager (HCM) is a Windows-based software application. With this software, the Point-of-Care Coordinator (POCC) or Supervisor, may configure the HEMOCHRON® Signature+ to meet the needs of the clinical setting. The functionality addressed with the Configuration Manager allows the POCC to set mandatory requirements for the input of operator and patient identifications, set limitations for liquid and electronic quality control, can prohibit operators from erasing database information or changing time/date settings. The POCC may also use the HCM to load predetermined notes (up to nine notes) into the Signature+ instrument that may be appended to the patient or quality control test. The HCM may be used to synchronize several HEMOCHRON® Signature+ instruments to the same requirements via the PC connection. The modifications to the Hemochron Jr. Signature+ system include a software revision to the instrument, which allows for enhanced programming capability and flexibility for the user through the use of the Hemochron Configuration Manager (HCM Application Software), which is provided to the user for use in a Personal Computer (PC). Accessing the PC interface is accomplished through the use of special hot keys on the instrument, which enables the user to interact with the instrument database and the HCM. The Signature + software modifications allow the user many additional programmable features. The user interface for the clinician remains consistent with the previously cleared system with the exception of the enhanced features described in the revised operators manual including the features associated with the (HCM).

Here's a breakdown of the acceptance criteria and study information for the Hemochron® Jr. Signature +, based on the provided 510(k) summary:

The provided document is a 510(k) summary for a premarket notification for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study report with specific acceptance criteria and performance data in the format requested. Therefore, some requested categories (like statistical significance, multi-reader multi-case studies, and detailed ground truth establishment for a training set) are not applicable or not provided in this type of document.

Acceptance Criteria and Device Performance (Not explicitly stated as criteria in this document, but implied by the comparison to the predicate device)

The 510(k) summary focuses on demonstrating substantial equivalence by stating that the Hemochron® Jr. Signature + performs the same assays with the same clot detection algorithm as its predicate device (Hemochron Jr. Signature, K974799). The "acceptance criteria" are implicitly met if the new device functions identically in its core measurement capabilities to the previously cleared predicate.

Additional Study Information:

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

   • Sample Size: Not explicitly stated. The document focuses on the technological changes (software upgrade and improved PC interface) and states that the core coagulation measurement algorithms and mechanisms are unchanged from the predicate device. Therefore, new clinical performance data for coagulation measurements would likely not have been generated for this 510(k). The focus is on demonstrating that the modifications do not adversely affect safety or effectiveness.
   • Data Provenance: Not provided, as detailed clinical efficacy data is not the primary subject of this 510(k) for a software upgrade.

2. 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)

   • Not applicable as detailed clinical test set data with expert-established ground truth is not presented in this 510(k) summary for a software upgrade. The device measures coagulation times, which are typically compared against established laboratory methods or reference values, not expert interpretation.

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

   • Not applicable. The device measures objective clotting times, not subjective interpretations requiring adjudication.

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 device is a point-of-care coagulation instrument, not an AI-assisted diagnostic imaging or interpretation system. "Human readers" in the context of diagnostic interpretation are not involved.

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

   • The device inherently operates as a standalone instrument for measuring coagulation times. Its "algorithm only" performance is its primary function. The 510(k) states that there are "no modifications to the clot detection algorithm" and it "employs the same clot detection mechanism" as the predicate. This implies that the standalone performance is considered equivalent to the predicate.

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

   • For coagulation tests, the "ground truth" would typically be established through comparison with established laboratory reference methods (e.g., standard plasma APTT or PT assays performed in a central lab), or potentially through the use of calibrated control materials. This 510(k) does not provide specific data on how the original ground truth for the predicate device's accuracy was established, and for the upgraded device, it relies on the predicate's established performance.

7. The sample size for the training set

   • Not applicable. This is a 510(k) for a physical instrument with a software upgrade, not a machine learning or AI algorithm development that typically involves a distinct training set. The "software revision" is for "enhanced programming capability and flexibility for the user," and "data management capabilities."

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

   • Not applicable, for the same reasons as #7.

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Ask a specific question about this device

The HEMOCHRON ® Response is intended for professional use for hemostasis management in a variety of clinical settings for the quantitative determination of an assortment of coagulation test assays including the following HEMOCHRON Whole Blood Coagulation Assays

Activated Clotting Time (ACT) -- All HEMOCHRON types Activated Partial Thromboplastin Time (APTT) - All HEMOCHRON types Prothrombin Time (PT) - All HEMOCHRON types Thrombin Time (TT) Heparin Neutralized Thrombin Time (HNTT) High Dose Thrombin Time (HiTT) Fibrinogen (FIB) Protamine Dose Assay (PDA) - All HEMOCHRON types Heparin Response Time (HRT) - All HEMOCHRON types Protamine Response Time (PRT) - All HEMOCHRON types

For In Vitro Diagnostic Use Only

The HEMOCIIRON® Response is an upgrade of the HEMOCHRON® Coagulation Instruments, HFMOCHRON® Model 8000 that was approved under 510(k) K930068 and the HEMOCHRON® Models 401 and 801. The HEMOCHRON® Response performs the same tests as the predicate HEMOCHRON@ Instruments. All test assays are previously 510(k) approved. The IIEMOCIIRON® Response employs the same mechanical clot detection system as the predicate HEMOCHRON® Instruments. Mechanical systems can be used to monitor clotling times in either whole blood or plasma samples.

The HEMOCHRON® employs a mechanical clot detection system. The principle of operation is based on the electrical field generated by a magnet contained within a glass test tube when the magnet is in close proximity to the detector located within the test well.

To perform a test, blood is added to the test tube and placed in the test well. The magnet freely rotates within the tube, in a non-clotted sample. The magnet position is detected by two solid-state Hall effect sensors. When a clot forms the magnet is caught within the clot and is shifted out of the detection area. The electrical change that occurs due to the magnet rotation triggers the timer to stop with an audible beep signaling clot formation to the user.

The HEMOCHRON® Response is a sollware / firmware and mechanical upgrade of the HEMOCHRON® Instruments designed to perform the same tests as the predicate instruments. The upgrade provides the end user with additional quality features not currently available in the predicate HEMOCHRON® Instruments.

The HEMOCHRON@ Response is a modification of the HEMOCHRON® Instruments with improved test well operation and reliability through the use of two Hall Effect solidstate detectors. This provides for full magnet position tracking within the test tube and eliminates the calibration drift of well parameters.

In addition a UPC-E bar code detector has been added to automatically read the affixed bar code label and identify the test assay, expiration date and lot number of the test assay, The instrument provides advanced patient and OC data tracking and streamlined computer interface capabilities which provide essential quality features for the end users.

{
  "acceptance_criteria": {
    "ACT": "r = 0.94 (clinical), r = 0.96 (in vitro heparin dose response)",
    "APTT": "r = 0.99 (in vitro heparin dose response)",
    "PT (citrate)": "r = 0.986 (freshly obtained blood specimens from patients receiving low doses of oral anticoagulant)",
    "HITT": "r = 0.91 (in vitro heparin dose response)"
  },
  "reported_device_performance": {
    "ACT": "y = 0.912x + 24.77 (clinical), y = 0.95x + 18.00 (in vitro heparin dose response)",
    "APTT": "y = 1.03x - 4.51 (in vitro heparin dose response)",
    "PT (citrate)": "y = 1.00x - 3.876 (freshly obtained blood specimens from patients receiving low doses of oral anticoagulant)",
    "HITT": "y = 0.89x + 20.58 (in vitro heparin dose response)"
  },
  "study_details": {
    "sample_size_test_set": {
      "clinical_study": "42 patients (yielding 242 comparative ACT results)",
      "ACT_in_vitro": "n = 66",
      "APTT_in_vitro": "n = 41",
      "PT_citrate": "n = 22",
      "HITT_in_vitro": "n = 29"
    },
    "data_provenance": "Clinical data was collected using a split sample design. In vitro studies used normal donor blood.",
    "number_of_experts_ground_truth": "Not specified, as the ground truth appears to be established through direct comparison to a predicate device using split samples and in vitro dose responses. The study design doesn't indicate the use of human experts for ground truth establishment in the traditional sense of consensus or subjective assessment.",
    "qualifications_of_experts": "Not applicable given the nature of ground truth establishment.",
    "adjudication_method": "None explicitly mentioned. The study relies on direct comparison of measurements between the new device and the predicate device.",
    "multi_reader_multi_case_study": "No, this was not a multi-reader multi-case (MRMC) comparative effectiveness study. The study focuses on the performance comparison between two instruments.",
    "standalone_performance": "Yes, the study describes the performance of the HEMOCHRON® Response instrument in comparison to predicate HEMOCHRON® instruments, which is a standalone assessment of the new algorithm/device functionality.",
    "type_of_ground_truth": "The ground truth was established by comparing the results of the HEMOCHRON® Response to those obtained from the predicate HEMOCHRON® instruments (HEMOCHRON® Model 8000, 401, and 801). This is a form of comparative ground truth against an established device rather than independent expert consensus, pathology, or outcomes data.",
    "sample_size_training_set": "Not explicitly stated. The document describes a "510(k) Summary" for a substantial equivalence determination, implying that the device is an upgrade to an existing product. It's likely that the device's algorithms were developed and refined using prior data, but specific training set sizes are not provided for this submission.",
    "how_ground_truth_for_training_set_established": "Not explicitly stated. Given that the HEMOCHRON® Response is described as a software/firmware and mechanical upgrade of existing HEMOCHRON® instruments, it is probable that the algorithms were developed based on data from the predicate devices and their known performance characteristics. However, the document does not detail the specific process for establishing ground truth for any potential 'training set' specifically for this upgrade."
  }
}

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The HEMOCHRON® Electronic System Verification Tube is intended for in vitro diagnostic use in performing a quantitative electronic detection system verification of HEMOCHRON® Coagulation Instruments. The Electronic System Verification Tube electronically simulates test initiation and clot detection in the same manner as patient assay end points are recorded.

The device is a plastic tube with battery operated electronic circuitry that electronically simulate test initiation and clot detection using the same principles employed in a clotting time assay. Once started and placed in the Hemochron test well, the ESVT electronically simulates the operation of a 100, 300 and 500 second clotting time.

The comparison of the displayed Hemochron clotting time with the ESVT clotting time is a quality control test of the functionality of the test well and test detector.

The HEMOCHRON® Electronic System Verification Tube (ESVT) is an in vitro diagnostic device used for quantitative electronic detection system verification of HEMOCHRON® Coagulation Instruments. It electronically simulates test initiation and clot detection to check the timing capability and well rotation of HEMOCHRON instruments.

Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets these criteria:

1. Acceptance Criteria and Reported Device Performance

Analysis:
The reported mean values for all three control levels (Normal, Abnormal I, and Abnormal II) fall within their respective acceptable ranges. The low Standard Deviation and Coefficient of Variation percentages indicate high precision and reproducibility of the device's performance across different operators and days.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: For each of the three control levels (Normal, Abnormal I, Abnormal II), the sample size (N) was 120. This means 120 measurements were taken for each level.
• Data Provenance: The study was conducted by International Technidyne Corp., located in Edison, NJ, USA. The data is prospective, as it was generated specifically for the purpose of demonstrating the device's performance and supporting its 510(k) submission. There is no indication of retrospective data use.

3. Number of Experts and Qualifications for Ground Truth

The provided document describes a precision study for the HEMOCHRON® ESVT, not a study involving interpretation by human experts to establish ground truth for clinical outcomes or diagnoses. The "ground truth" in this context is the pre-defined ideal timing ranges for the electronic simulations, which are a characteristic of the device itself and its internal electronic circuitry.

Therefore:

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Since this is a precision study of an electronic device's timing accuracy against pre-defined electronic simulation ranges, there was no need for human adjudication of results in the traditional sense (e.g., for diagnostic discrepancies). The device's output (clotting time) was compared directly to the electronically simulated time.

Therefore:

• Adjudication method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not relevant for this device. The HEMOCHRON® ESVT is an electronic quality control device, not a diagnostic aid requiring human interpretation of clinical cases. Its purpose is to verify the functionality of a coagulation instrument, not to assist humans in making clinical diagnoses.

6. Standalone (Algorithm Only) Performance Study

Yes, the study described is a standalone performance study (algorithm only, though "algorithm" here refers to the electronic circuitry and its programmed timing). The device operates independently to simulate clotting times, and its outputs were measured and analyzed directly for accuracy and precision against preset electronic values. There is no human-in-the-loop component in the primary function being tested (electronic simulation and output).

7. Type of Ground Truth Used

The ground truth used is pre-defined electronic simulation timing values. These values were established based on the previous predicate device submission (K940957/S1) and represent the expected outputs for a properly functioning HEMOCHRON® instrument. The device is designed to simulate these specific clotting times.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. The HEMOCHRON® ESVT simulates fixed, predefined timing values. These timings are inherent to the device's design and function, rather than being "trained" on a dataset in the way a machine learning algorithm would be. The precision study assesses the device's consistent execution of these predefined timings.

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

As mentioned above, there isn't a traditional "training set" in the context of this device. The "ground truth" for the simulated times (90-110s, 290-310s, 490-510s) was established and previously approved in the predicate device submission (K940957/S1). These are intrinsic design specifications for the electronic quality control system, not data derived from training.

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