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The Rapidpoint Accent is an accessory to the Rapidpoint Coag Analyzer. When used in conjunction with the Rapidpoint Coag and the Heparin Management Panel Cards (Heparin Management Test, Heparin Titration Test, and Protamine Response Test) Cards, its intended use is to generate information on heparin management.

The Rapidpoint Accent is an accessory to the Rapidpoint Coag Analyzer. The Analyzer is a point of care instrument designed to determine hemostatic parameters of blood and plasma samples. The Accent works in conjunction with the Analyzer to provide dosing information for heparin and protamine during cardiopulmonary bypass procedures. The Accent determines this information by combining test results from the Analyzer with patient data entered into the Accent by the user. During the course of a CPB procedure, the user must perform a series of tests using the Analyzer, The test cards that must be used include the Heparin Management Test (HMT™), the Heparin Titration Test (HTT™), and the Protamine Response Test (PRT™). The results of these tests provide the Accent with information on how the patient's blood will respond to the addition of Heparin and Protamine. The Accent uses this information to calculate recommended dosages of Heparin or Protamine to be given to the patient to reach a target value entered into the Accent by the user. The target value may be either a heparin concentration or a clotting time.

The Accent includes an eight-inch diagonal touch screen for user interface and a built in printer for recording test results. The case is designed with a protective front cover that doubles as a holder for the Analyzer when the system is in use. The Accent is powered by an internal power supply that also orovides power to the Analyzer. The Accent and the Analyzer communicate through a serial cable that must be plugged into the Analyzer and is permanently attached to the Accent.

The HTT card provides a method to determine the response of a patient to heparin. Before heparin administration, baseline Heparin Management Test (HMT) and HTT values are determined for the patient with the Rapidpoint" Coag (formerly TAS) Analyzer. Using these values, the Rapidpoint ACCENT will calculate the dose of heparin necessary to produce a desired concentration or effect of this drug in the patient's blood. Both citrated or noncitrated whole blood samples can be used for these tests.

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 program the 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 is drawn 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.

The PRT card is made for use with citrated or noncitrated blood samples containing heparin. The PRT is a modification of the HMT card and consists of a single test card that contains calcium chloride to initiate coagulation in citrated blood samples, celite as activator, stabilizers. and protamine sulfate. The test results will depend on heparin activity in the blood, which in turn depend on the levels of heparin, of coagulation factors, and of heparin inhibitors in the sample. The higher the level of heparin activity, the greater the protamine sulfate dosage required to inhibit it. The results of the PRT card are used with values produced on HMT cards with samples taken just before protamine administration, to determine the response of the individual to the agent. The values are stored by the ACCENT, which performs the calculations to determine dose recommended to neutralize the heparin present in the patient.

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 program the 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 is drawn 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 regarding the acceptance criteria and study for the Rapidpoint Accent, Heparin Titration Test (HTT) Card, and Protamine Response Test (PRT) Card:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly state quantitative acceptance criteria in a pass/fail format. Instead, the studies aim to demonstrate "substantial equivalence" to predicate devices. For both the HTT and PRT cards, the key outcome measured was the calculated heparin/protamine dosage, and the acceptance criterion was "No significant differences (p = ≥0.05) in dosage were observed between the two systems by ANOVA testing."

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The new TAS PT-NC Controls are intended to be used with the TAS Analyzer and PT-NC test cards to provide a method for quality control of the system. The controls produce clotting times which must be within accepted, standard ranges, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of PT-NC test card results. These controls were designed to allow CVDI's point of care customers to maintain accepted laboratory standards and requirements. These controls also can be used to determine system (TAS Analyzer and PT-NC test cards) precision. The controls are substantially equivalent in Intended use to other control materials used in coagulation tests.

The controls for TAS PT-NC test cards consist of two separate vials. One was designed to mimic a sample from a normal individual, and the second to mimic a sample from a patient with an abnormally prolonged clotting time due to a deficiency of extrinsic coagulation factors. These controls are made with human plasma screened for antibodies to and antigens of hepatitis and Human Immunodeficiency viruses. To make the controls as easy to use as possible for point-of-care testing, we chose the patented packaging system of EDITek (Burlington, NC). This consists of a closed, crushable glass ampoule containing lyophilized plasma which is inside a plastic sleeve. The sleeve contains water for diluent and has a capped dropper top with a filter in the tip (to remove glass shards from the sample). The entire assembly is shrink wrapped with a label and plastic seal. To use, the ampoule is crushed inside the plastic sleeve, which allows the diluent to mix with the lyophilized plasma. The mixture is reconstituted by shaking or vortexing the capped vial. The plastic seal and cap are removed and three drops of plasma suspension are discarded into a biohazard waste container (to eliminate the dilution effect of the diluent that is contained in the filter). A drop of the plasma suspension is added to a TAS PT-NC test card in an analyzer. The rest of the test procedure and the manner of signal production is identical to that for a patient sample.

Here's an analysis of the provided text to extract information about the device's acceptance criteria and the study proving it, formatted as requested:

Device: TAS PT-NC Controls

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical, pass/fail format for the performance studies. However, it implicitly uses a comparison to a predicate device and stability/precision metrics as indicators of acceptable performance. The "normal ranges" for the within-day precision essentially serve as the expected performance.

2. Sample Size for the Test Set and Data Provenance

• Sample Size:
  • Within-day precision: "Most of these studies were done with five to ten drops from the same vial." The tables show "mean ranges" for normal and abnormal controls, implying multiple measurements. For lot-to-lot precision, n = 40 each is stated, referring to individual measurements for each lot.
  • Field study: "tested at least in duplicate each day for 20 days" at each site. This means a minimum of 40 measurements per control type per site (2 measurements/day * 20 days).
• Data Provenance: Retrospective (implicitly, as the studies are completed before submission).
  • Country of Origin: United States (Cardiovascular Diagnostic, Inc. is in Raleigh, NC; EDITek is in Burlington, NC; clinical study sites are not explicitly named with country, but the submission is to FDA, implying US studies).
  • Type of Study: Laboratory studies for stability and precision, and a multi-site field study for variation.

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

Not applicable. This device is a quality control material, not a diagnostic device that interprets clinical data or images requiring expert consensus for ground truth. Its "ground truth" is its measured clotting time characteristics, stability, and precision when run on the TAS Analyzer.

4. Adjudication Method for the Test Set

Not applicable for a quality control device's performance study. The "ground truth" is the empirically measured clotting time.

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

No, an MRMC study was not done. This device is a quality control material intended to verify instrument and test card function, not a diagnostic tool requiring human interpretation or assistance.

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

Yes, the studies presented are essentially standalone performance evaluations of the TAS PT-NC Controls themselves, measuring their inherent characteristics (stability, precision) when used with the TAS Analyzer and PT-NC test cards. There is no human interpretation component of the control material's result that would be assisted by an "algorithm." The algorithm is embedded within the TAS Analyzer for determining the clotting time from the sample.

7. The Type of Ground Truth Used

The ground truth for this device (a quality control material) is based on:

• Empirical Measurement: Directly measured clotting times in seconds using the TAS Analyzer system.
• Comparison to Predicate: Performance is compared to the established TAS PT controls.
• Physiological Mimicry: The controls are designed to mimic a normal individual or a patient with an abnormally prolonged clotting time due to extrinsic coagulation factor deficiency.

8. The Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of machine learning or algorithm development. The device is a physical control material. The data presented are for validation/testing the performance of the manufactured control materials.

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

Not applicable as there is no mention of a "training set" for an algorithm. The ground truth for the development of the control material itself would involve careful formulation, characterization, and comparison to known clinical samples or established reference materials, but this information is not detailed in the summary provided.

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The new TAS HMT controls are intended to be used with the TAS Analyzer and HMT cards, previously cleared to market by the FDA, to provide a method for quality control of the system. The controls produce clotting times which must be within accepted, standard ranges, to indicate that the analyzer and test cards are functioning properly and thereby help assure the accuracy of the HMT test results. The controls are substantially equivalent in intended use to other controls used in coagulation assays.

The controls for TAS HMT cards consists of two separate vials. One was designed to mimic a sample from a normal individual, and the second to mimic a sample from a patient on a high dose of heparin. These controls are made with human plasma screened for antibodies to and antigens of human immunodeficiency and hepatitis viruses. To make the controls as easy to use as possible for point-of-care testing, we chose the patented packaging system of EDItek, This consists of a closed, crushable qlass ampule containing Ivophilized plasma which is inside a plastic sleeve. The sleeve contains water for diluent and has a capped dropper top with a filter tip. The entire assembly is shrink wrapped with a label and plastic seal. To use, the ampule is crushed inside the plastic sleeve, which allows the diluent to mix with the lyophilized plasma. The mixture is reconstituted by shaking or vortexing the capped vial. The plastic seal and cap are removed, two drops of plasma are discarded into a waste container, and a drcp of the plasma suspension is added to a TAS HMT test card in an analyzer. The rest of the test procedure and the manner of signal production is identical to that for a patient sample.

This document describes the safety and effectiveness information for the TAS HMT Controls, which are in vitro coagulation controls intended for use with the TAS Analyzer and HMT cards to assure the proper functioning of the system.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TAS HMT controls are defined by the expected clotting time ranges and acceptable Coefficient of Variation (CV) for both normal and heparin controls, ensuring they indicate the system is functioning properly. The summary provides performance data from both non-clinical and clinical studies.

Interpretation: The reported performance data for both non-clinical and clinical studies consistently falls within or closely aligns with the established ranges and CVs, indicating that the device meets its implicit acceptance criteria for providing accurate and reliable control measurements. The stability and robustness under various conditions also demonstrate that the device performs as intended.

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

• Test Set Description:
  • Non-Clinical Performance Data: The summary mentions "Within day, day to day, operator, lot to lot, vial to vial, drop to drop variation studies," implying a comprehensive internal test set. However, specific numbers for samples, operators, lots, or vials are not provided.
  • Clinical Performance Data: Studies were performed at "two clinical study sites and at CDI." At each clinical site, the controls were tested in duplicate each day for 20 days. This means:
    • Site A: 2 controls (Normal & Heparin) * 2 replicates * 20 days = 80 measurements
    • Site B: 2 controls (Normal & Heparin) * 2 replicates * 20 days = 80 measurements
    • CDI: The testing at CDI also generated similar data, likely following the same duplicate daily for 20 days protocol, leading to another 80 measurements for similar consistency testing.
    • Total clinical measurements contributing to the reported means and CVs for variation would be at least 240.
• Data Provenance: The data is a mix of internal testing ("CDI") and external clinical sites. The specific country of origin is not explicitly stated, but CDI is located in Raleigh, NC, USA. The clinical study sites are referred to as "clinical study sites," suggesting these are real-world, prospective data collection points.

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

This information is not applicable and not provided in the summary. The "ground truth" for this device, a coagulation control, is its expected clotting time measured against a reference standard or specified range. The performance is assessed by direct measurement against these pre-defined targets, not by expert interpretation of complex images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As explained above, the assessment of a coagulation control involves direct measurement against established ranges, not subjective human interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done for the TAS HMT controls. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the goal is to evaluate if an AI system improves human performance. The TAS HMT controls are in vitro diagnostic reagents/controls, not an AI-powered diagnostic system requiring human interpretation.

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

Yes, in essence, standalone performance was assessed. The TAS HMT controls themselves are not an "algorithm," but rather a reagent. The performance described here (clotting times, CVs, stability) is purely the performance of the control material in conjunction with the TAS Analyzer and HMT cards, essentially its "standalone" performance as an independent component of the system, without human interpretive input affecting the clotting time measurement itself. The human-in-the-loop primarily performs the physical steps of the test and interprets whether the numerical result falls within the acceptable range.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for the TAS HMT controls is the expected clotting time range for a "normal" and a "heparin" control sample, derived from the physical-chemical properties of the control material designed to mimic these states. This is an analytical ground truth or defined reference range, not one established by expert consensus, pathology, or outcomes data in the way these terms are typically applied to more subjective diagnostic tests. The predicate device (ACT-trol controls) likely served as an initial benchmark for establishing these expected performance characteristics.

8. The Sample Size for the Training Set

This information is not provided and likely not applicable in the conventional sense for this type of device. The TAS HMT controls are chemical reagents, not a machine learning model that requires a distinct "training set." The development of the control formulation would involve extensive R&D and optimization, but this process doesn't align with the concept of a training set for an algorithm.

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

This is not applicable as there is no "training set" in the context of an algorithm. The development of the TAS HMT controls involved:

• Designing formulations to mimic specific coagulation states (normal and heparinized).
• Using human plasma screened for antibodies and antigens.
• Selecting packaging for user-friendliness.
• Presumably, extensive internal R&D to characterize the clotting times and stability properties of various formulations until the desired performance characteristics were achieved, benchmarked against legally marketed controls (like ACT-trol).

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