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The CoagCare Anticoagulation Management System (CoagCare®) is an interactive, internet-based (web-based), rules-based expert software system for the long-term management of patients undergoing warfarin anticoagulation therapy. The system is an accessory to prescription home-use prothrombin time devices that measure International Normalized Ratios (INRs), and it facilitates remote clinical management between patient and caregiver.

The CoagCare system is a software accessory to prescription-home use prothrombin time (INR) devices for effective anticoagulation management with warfarin. System Overview: The system consists of two components, the CoagCare Patient Interface and the CoagCare Caregiver Interface, both of which are accessed through an internet browser. The interface provides a structured therapeutic regimen developed for the individual patient. It prompts the patient for INR values, symptoms, and other disease related data, and provides the patient with recommended doses of warfarin and an INR testing schedule that can be adjusted based on parameters specified by the patient's caregiver. The patient is given recommendations for warfarin doses for each day until the next time of required INR testing. In cases of marked abnormal INR readings or disease signs or symptoms suggestive of over-treatment, the Patient Interface instructs the patient to contact his/her healthcare provider for further instructions.

The second component of the CoagCare system is the Caregiver Interface. The caregiver monitoring the patient's anticoagulant therapy accesses the Caregiver Interface at least daily. The Caregiver Interface is programmed to automatically identify patient problems such as patients who report thromboembolic or hemorrhagic symptoms, failure to check their INR on a prescribed day, etc. The Caregiver Interface prioritizes problems requiring the caregiver's attention. Once patients have checked their INRs and transmitted their results, if the caregiver agrees with the warfarin dosing instructions provided by the patient interface, no further interventions are required for that day. Patients with markedly abnormal results or recurrent problems are prioritized for caregiver intervention, whereas stable patients are listed with their results, eliminating the need for direct patient contact by the caregiver. The Caregiver Interface also allows the caregiver to override therapeutic instructions provided by the Patient Interface, or send a text message to the patient through the Patient interface. (For more emergent issues, the patient can be contacted directly by the caregiver by telephone.)

Here's an analysis of the CoagCare Anticoagulation Management System based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 100 patients
  • 58 patients at Duke University Medical Center
  • 22 patients at the University of New Mexico Medical Center
  • 20 patients from a private practice in Miami
• Data Provenance: United States (Duke University, University of New Mexico, Miami private practice). The study was prospective, as patients were "switched to home INR monitoring and followed with the CoagCare system for six months" or "remained on the system from 3 to 4 months." Data on TTR prior to CoagCare was retrospective (likely collected from patient records before the intervention).

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

The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy studies. The study evaluates the effectiveness of the system in managing anticoagulation, where the "ground truth" is inferred from patient INR values (measured by home INR devices) and the resulting time in therapeutic range. The "caregivers" (physicians, nurses, pharmacists, or licensed professionals) monitoring the patients are the experts involved in overseeing the system and making clinical judgments.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method for the test set as would typically be done for diagnostic interpretations. The CoagCare system provides recommendations, and caregivers monitor and can override instructions. The "ground truth" for TTR is derived from INR measurements and the patient's adherence to the warfarin dosing recommendations generated by the system (or overridden by the caregiver).

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

This was not a traditional MRMC study. It was a comparative effectiveness study comparing patient outcomes with the CoagCare system to their outcomes without the system (their historical TTR). The "readers" (caregivers) involved in managing the patients using the CoagCare system had their efficiency and satisfaction assessed.

• Effect Size of Human Readers Improve with AI vs. without AI assistance: The study primarily focuses on patient outcomes (TTR) and caregiver efficiency.
  • Patient Outcome (TTR): The TTR increased by 11% (from 62.5% to 73.5%) with the CoagCare system (which includes AI-like capabilities for dosing recommendations and problem prioritization) compared to prior management. This suggests the system assists caregivers in achieving better patient outcomes.
  • Caregiver Efficiency: Caregivers managing between 20-58 patients reported it took only 15-25 minutes a day. The note "managing 48 patients with CoagCare did not take much more time than managing 20" strongly suggests an improvement in caregiver efficiency due to the system's automation, but a specific "effect size" of improvement (e.g., X% more patients managed per hour) is not quantified or compared to an unassisted baseline.

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

No, a standalone performance study was not done. The CoagCare system is explicitly described as a "software accessory" that facilitates "remote clinical management between patient and caregiver." The system provides recommendations, but "caregivers have the ability to override therapeutic instructions" and "requires tight professional oversight." It is a human-in-the-loop system.

7. The Type of Ground Truth Used

The primary "ground truth" or outcome measure used was:

• Outcomes Data: Specifically, the Time in Therapeutic Range (TTR) for International Normalized Ratios (INR) in warfarin-treated patients. This is a direct clinical outcome measure.
• Patient Feedback/Satisfaction: Self-reported patient preferences and perceptions of monitoring and control.
• Caregiver Reports: Reports on the time taken to manage patients.

8. The Sample Size for the Training Set

The document does not mention a distinct "training set" for the CoagCare system. The system "utilizes published and generally accepted algorithms to adjust medication doses and make treatment decisions." This implies that the algorithms were developed based on existing medical knowledge and clinical guidelines, rather than being trained on a specific, separate dataset within the context of this 510(k) submission.

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

As no specific training set is mentioned for the algorithm (which is described as rule-based using "published and generally accepted algorithms"), the concept of "ground truth for the training set" as it relates to machine learning models is not applicable here. The "ground truth" for these general algorithms would have been established through extensive medical research, clinical trials, and expert consensus over many years, leading to the "published and generally accepted algorithms" mentioned.

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The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The Fibrin-1, which uses clot formation as an endpoint, may be used for the performance of the Prothrombin Time Test (PT) and the Activated Partial Thromboplastin Test (APTT).

The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The instrument utilizes photo-optical principles for clot detection. The light source is a high intensity photodiode. The incubator block is temperature regulated to 36.5 - 37.5℃ and contains four measuring positions, 4 reagent and 4 cuvette pre-warming positions.

Here's a summary of the acceptance criteria and study findings for the Fibron-1 Coagulation Analyzer, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Instrument Correlation Studies (PT & APTT):

     • The exact sample size for the correlation studies (Fibron-1 vs. ACL 100 and Fibron-1 vs. Electra 900C) is not explicitly stated as a total number of patients, but rather states "Specimens were evaluated from healthy individuals and from patients with different pathological conditions." The clotting time range observed was 10 to 39 seconds.
     • Data Provenance: "in-house and at a community hospital." This suggests a mix of controlled laboratory environments and a real-world clinical setting. The country of origin is not specified but given the submitter's address (Newton, MA) and the FDA submission, it's likely US-based, at least for the community hospital. The study appears to be prospective, as specimens were evaluated as part of this specific testing.

   • Precision Studies:

     • Within-run Precision:
       • PT Control Level 1: n = 20
       • PT Control Level 2: n = 19
     • Day-to-Day Precision:
       • PT Normal Control: Day 1 (n=20), Day 2 (n=4), Day 3 (n=4), Day 4 (n=4), Day 5 (n=4)
       • PT Low Abnormal: Day 1 (n=19), Day 2 (n=4), Day 3 (n=4), Day 4 (n=4), Day 5 (n=4)
     • Precision (Duplicates):
       • PT Normal Control: 18 duplicates
       • PT Low Abnormal: 17 duplicates
       • PT High Abnormal: 18 duplicates
       • APTT Normal Control: 18 duplicates
       • APTT Low Abnormal: 16 duplicates
       • APTT High Abnormal: 18 duplicates
     • Data Provenance: "in-house" based on the context of the document.

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

   • This device is a laboratory instrument that provides quantitative measurements of clotting times. The "ground truth" for the test set is established by the measurements from the predicate devices (ACL 100, MLA-900C, Electra 900C) and established laboratory control materials. There is no mention of human experts establishing ground truth for the test set in the way one would for diagnostic imaging.

3. Adjudication method for the test set:

   • Not applicable. This is a comparison of instrument performance against predicate devices and known control values, not a subjective interpretation task 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:

   • No MRMC study was performed. This device is a standalone laboratory instrument, not an AI-assisted diagnostic tool for human readers.

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

   • Yes, the entire study focuses on the standalone performance of the Fibron-1 instrument. Its accuracy and precision are evaluated against predicate devices and control materials without any human interpretive component beyond operating the machines.

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

   • The "ground truth" for evaluating the Fibron-1's performance is derived from:
     • Measurements from legally marketed predicate devices (ACL 100, MLA-900C, Electra 900C).
     • Known values of laboratory control materials (Normal, Low Abnormal, High Abnormal levels).
     • Actual clotting times from patient and healthy individual samples.

7. The sample size for the training set:

   • This is a traditional medical device (a photo-optical instrument), not an AI/ML-based device that would typically have a separate "training set" for an algorithm. Therefore, no training set is mentioned or applicable in the context of this 510(k) summary.

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

   • Not applicable, as there is no training set for this type of device.

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The Pacific Hemostasis ThromboScreen® 400C is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma samples in the clinical laboratory. The ThromboScreen® 400C has both clot and chromogenic testing capabilities. Assays performed on the instrument include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Clauss and Derived methods), and PT and APTT-based factor assays. Chromogenic tests include assays such as Antithrombin III, Protein C and Heparin Xa.

The ThromboScreen® 400C (TS400C) is a photo-optical instrument used for the performance of in-vitro diagnostic clotting and chromogenic procedures in the clinical laboratory. The instrument utilizes photo-optical principles for both clotting and chromogenic assays. The ThromboScreen® 400C light source is provided by a halogen lamp. The incubator block is temperature regulated to 36.5 - 37.5℃ and contains four measuring positions, five reagent and 24 cuvette prewarming positions.

Here's an analysis of the provided text regarding the ThromboScreen® 400C, structured to address your request:

Acceptance Criteria and Device Performance Study

The ThromboScreen® 400C (TS400C) is a manual coagulation instrument using photo-optical principles for in-vitro diagnostic clotting and chromogenic procedures. The study aims to demonstrate its substantial equivalence to the MLA-900C and MLA-1000C. The acceptance criteria are implicitly defined by the performance of the predicate devices (MLA-900C and MLA-1000C) in precision and method comparison studies. The TS400C's performance is deemed acceptable if its results are comparable to those of the predicate devices.

1. Table of Acceptance Criteria (as implied by predicate devices) and Reported Device Performance (TS400C)

Summary of Device Performance:

• Precision: The TS400C demonstrated within-run and between-run precision comparable to the predicate MLA instruments, as detailed in Tables 1 and 2. For instance, PT within-run %CV for TS400C ranged from 1.9-5.2%, while the MLA ranged from 1.1-3.8% (Site 1) and 1.5-2.0% (Site 2). APTT within-run %CV for TS400C ranged from 2.4-5.4%, while the MLA ranged from 0.8-0.9% (Site 1) and 2.2-3.3% (Site 2). While not identical, the presented data is used to support substantial equivalence.
• Method Comparison: The TS400C showed high correlation coefficients (r-values ranging from 0.88 to 0.99) when compared to the MLA-900C/1000C for various coagulation tests (PT, APTT, Fibrinogen, Factor V, Factor VIII, Chromogenic ATIII), as shown in Table 3. This indicates a strong agreement between the results obtained from the TS400C and the predicate devices. The regression equations also suggest a close linear relationship.

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

• Test Set Sample Sizes:
  • Within-run Precision (Table 1): Unspecified number of samples for each "Low," "Normal," and "High" category for each test. The table implies at least three distinct sample types (Low, Normal, High) for most tests.
  • Between-run Precision (Table 2): Unspecified number of samples for each "Low," "Normal," and "High" category for each test.
  • Method Comparison (Table 3):
    • Prothrombin Time (seconds & INR): 94 samples (Site #1), 139 samples (Site #2)
    • Derived Fibrinogen: 47 samples (Site #1)
    • Activated Partial Thromboplastin Time: 93 samples (Site #1), 117 samples (Site #2)
    • Clauss Fibrinogen: 50 samples (Site #1), 20 samples (Site #2)
    • Factor VIII: 49 samples (Site #1)
    • Factor V: 50 samples (Site #1)
    • Chromogenic ATIII: 58 samples (Site #1)
• Data Provenance: The study was conducted at two sites, referred to as "Site 1" and "Site 2." Site 1 used the MLA-1000C as the predicate, and Site 2 used the MLA-900C. The data is from "specimens... from apparently healthy individuals and from patients with different pathological conditions." This indicates prospective and/or retrospective clinical samples, collected with a mix of healthy and diseased states, to ensure a wide range of values. The country of origin is not explicitly stated but implies testing within a clinical laboratory setting, likely in the US given the FDA submission.

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

The concept of "experts" and "ground truth" as typically applied to image analysis or diagnostic interpretation by human readers is not directly applicable here. For a coagulation instrument, the "ground truth" is typically established by:

• The reference method (here, the predicate MLA-900C and MLA-1000C instruments).
• Clinically validated reagents and controls.
• Adherence to established laboratory assay protocols.

Therefore, no information on the number or qualifications of "experts" (e.g., radiologists) in this context is provided or expected. The expertise implicitly lies in the design and validation of the predicate devices and the laboratory personnel performing the assays.

4. Adjudication Method for the Test Set

Not applicable. As this is a comparison between two instruments measuring quantifiable analytes, there is no human adjudication process involved in establishing the "correct" measurement for each sample. The comparison is statistical (correlation, regression, precision metrics).

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

No. This is not an MRMC study. MRMC studies are typically used to assess reader performance (e.g., radiologists interpreting images) with and without AI assistance. This study involves comparing the performance of a new instrument against established predicate instruments for quantitative laboratory tests. Therefore, there is no "effect size of how much human readers improve with AI vs without AI assistance" to report.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, this is essentially a standalone (algorithm only) performance study of the TS400C. The instrument, while "manual" in that samples are pipetted by a user, performs the measurement and calculation independently of human interpretation of the results themselves. The data presented demonstrates the instrument's intrinsic accuracy and precision when performing specified assays, without a human interpretation step that the AI assists. The comparison is between the standalone TS400C and the standalone predicate MLA instruments.

7. Type of Ground Truth Used

The "ground truth" for the test set is established by the measurements obtained from the legally marketed predicate devices, the MLA-900C and MLA-1000C. These devices serve as the reference standard against which the new device's performance is compared. The use of "clinically significant ranges" and "patients with different pathological conditions" ensures that the comparison covers the relevant analytical range encountered in clinical practice.

8. Sample Size for the Training Set

The document does not describe a separate "training set" in the context of machine learning or AI models with distinct training and test phases. This is a traditional medical device validation study where the instrument's performance is evaluated. The "training" in this context would have occurred during the development and calibration of the TS400C by the manufacturer (Pacific Hemostasis). No specific sample size for such internal development is provided.

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

As explained above, the concept of a separate "ground truth" for a training set (as in AI/ML) is not explicitly detailed. The TS400C instrument's calibration and optimization would have been performed by the manufacturer, likely using internal standards, reference materials, and comparing against established laboratory methods, much like the predicate devices themselves would have been developed. This "ground truth" for development would involve the known values of calibrators and controls used to ensure the instrument's accuracy and linearity across its measuring range.

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The Pacific Hemostasis ThromboScreen® 200 is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma specimens in the clinical laboratory. Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Clauss and Derived methods), as well as PT and APTT-based factor assays.

The ThromboScreen® 200 (TS200) is a photo-optical instrument used for the performance of invitro diagnostic clotting procedures in the clinical laboratory. The instrument utilizes photo-optical principles to measure and record the time required for patient plasma specimens to clot. The ThromboScreen® 200 light source is provided by a 470 nm LASER. The incubator block is temperature regulated to 36.5 - 37.5℃ and contains two measuring positions, three reagent and 12 cuvette prewarming positions.

Here's an analysis of the provided text regarding the ThromboScreen® 200, structured to answer your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to predicate devices (MLA-900C and MLA-1000C). The ThromboScreen® 200 must demonstrate comparable performance in terms of correlation coefficients and precision.

Summary of Device Performance Meeting Acceptance Criteria:
The study demonstrates high correlation coefficients (ranging from 0.97 to 0.99) for all tested parameters when comparing the TS200 to the predicate devices. The precision data (within-run %CV and between-run %CV) for the TS200 also falls within a similar range or is sometimes better than the predicate devices, supporting the claim of substantial equivalence. For instance, for PT and APTT between-run precision, the TS200 shows comparable or better CVs than the predicate devices in several categories (e.g., PT Normal Plasma, APTT Abnormal Plasma). This suggests the device meets the implied acceptance criteria of performing comparably to legally marketed predicate devices.

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

• Sample Sizes for Correlation Studies (Test Set):
  • Prothrombin Time (PT): Site #1 (137 samples), Site #2 (141 samples)
  • Activated Partial Thromboplastin Time (APTT): Site #1 (104 samples), Site #2 (121 samples)
  • Clauss Fibrinogen: Site #1 (20 samples), Site #2 (20 samples), PH (49 samples)
  • Derived Fibrinogen: Site #1 (19 samples), Site #2 (47 samples)
  • Factor VIII: PH (49 samples)
  • Factor V: PH (45 samples)
• Sample Sizes for Precision Studies (Test Set):
  • PT & APTT Between-run: Normal Plasma (n=39 for TS200, n=40 for MLA), Abnormal Plasma (n=38 for TS200 PT, n=40 for MLA PT; n=40 for TS200 APTT, n=40 for MLA APTT).
  • Within-run: Not explicitly stated as a number of independent samples for each CV, but rather performed on "Low," "Normal," and "High" control levels. Usually, precision studies involve a certain number of replicates over a set number of days.
• Data Provenance: The data was collected from "in-house" (Pacific Hemostasis, PH) and "two external testing laboratories." The document states that "Specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions." The country of origin is not explicitly stated, but given the submission to the FDA (USA), it's highly probable the data originated in the USA. The study is prospective in the sense that fresh clinical samples were collected and tested on both the new device and predicate devices for comparison.

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

This type of device (manual coagulation instrument) does not typically involve human expert interpretation for establishing ground truth in the same way an image analysis device would. The "ground truth" for the test set is established by the results obtained from the legally marketed predicate devices (MLA-900C and MLA-1000C), which are considered the reference standard for these in-vitro diagnostic assays. Therefore, no human experts for "ground truth interpretation" are detailed or required in this context. The experts involved are likely laboratory personnel who performed the tests on both instruments, ensuring proper methodology.

4. Adjudication Method for the Test Set

Not applicable. The study is a method comparison study where the new device's results are directly compared to those of predicate devices. There is no ambiguous output from the device that would require adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in-vitro diagnostic instrument for coagulation testing, not a medical imaging device or a device involving human "readers" or AI assistance in interpretation.

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

Yes, the study primarily evaluates the standalone performance of the ThromboScreen® 200 instrument itself (algorithm only, if one considers the photo-optical clot detection as an "algorithm") against predicate instruments. The instrument provides a direct numerical readout (clotting time, concentration, etc.), and the study assesses its accuracy and precision in generating these results independently. Human intervention is limited to sample preparation and loading, which is standard for manual/semi-automated lab instruments.

7. The Type of Ground Truth Used

The ground truth is established by the results obtained from the legally marketed predicate devices (MLA-900C and MLA-1000C). These predicate devices are considered reliable and accurate for measuring coagulation parameters. The study assumes that if the ThromboScreen® 200 produces results highly correlated and comparable in precision to these established methods, then its measurements are also accurate.

8. The Sample Size for the Training Set

There is no mention of a "training set" in the context of this device and study. The ThromboScreen® 200 is an instrument that measures a physical property (clotting time) using photo-optical principles. It does not appear to involve machine learning or algorithms that require a separate training phase with labeled data in the way an AI-powered diagnostic might. The device's operational parameters (e.g., 470 nm laser, 37°C incubator) are fixed by its design and engineering, not trained on a data set.

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

Not applicable, as there is no specific "training set" described for this type of device.

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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 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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