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The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times.

The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times. Hardware modifications addressed in this submission are a direct response to the obsolescing of several major hardware components including the Print Circuit Board, the ADU Controller and the Printer. The HMS software has also been modified to run on Windows CE 5.0: A complete system verification and software verification of all requirements have been performed. The Display Adapter Hantronix PCBA and Power Interconnect PCBA have been incorporated into the Interface PCBA to reduce interconnects and have a more reliable device. The Common Processing Platform has been used to replace the Freescale HC11. A complete ADU software verification of all requirements has been performed. A new Printer has been selected that will work with the new Off the Shelf Computer PCBA. The voltage of the printer has been reduced from 24 V to 7V. The Operators Manual and Device labels have been updated to reference the IEC 61010-1: 2001, 2nd Edition standard.

The provided text describes a 510(k) premarket notification for the Hemostasis Management System Plus (HMS Plus). This submission focuses on hardware and software modifications to an already cleared device (HMS Plus, K101271). As such, the document primarily aims to demonstrate substantial equivalence to the predicate device rather than presenting a novel study to establish performance acceptance criteria.

The information requested regarding acceptance criteria and a study proving the device meets them is not present in the provided text in the typical format of a new clinical or performance study. The text explicitly states: "A complete system verification and software verification of all requirements have been performed." This suggests that the device's performance was verified against its existing, established requirements (those of the predicate device).

However, based on the provided text, I can infer and extract some relevant points:

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

The document explicitly states:

• "Same intended use."
• "Same operating principle."
• "Same technological characteristics."
• "Same performance claims."

This strongly implies that the acceptance criteria for the modified device are identical to those of the predicate HMS Plus (K101271). The "reported device performance" is implicitly stated to be equivalent to the predicate device due to these similarities and the conducted verifications.

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

The document mentions "A complete system verification and software verification of all requirements have been performed." However, it does not specify the sample size, the type of test set (e.g., patient samples, simulated data), or the data provenance (e.g., country of origin, retrospective or prospective) for these verifications.

3. 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 text. The document refers to "system verification and software verification," which typically involves testing against specifications and defined outcomes, rather than expert-established ground truth in the context of diagnostic interpretation.

4. Adjudication method for the test set:

This information is not provided in the text.

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:

This type of study is not applicable to the information provided. The device is an "Automated Heparin Analyzer," which is a laboratory instrument, not an AI-powered diagnostic imaging system requiring human reader interaction for interpretation. The modifications described are hardware and software updates to an existing instrument, not the introduction of AI for human assistance.

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

The device (HMS Plus) is an "Automated Heparin Analyzer." Its operation, as described, is inherently "standalone" in performing the assays and providing results. The submission focuses on verifying that the modified hardware and software components maintain the original standalone performance. The text states: "A complete system verification and software verification of all requirements have been performed." This implies that the standalone performance requirements of the predicate device were met by the modified device.

7. The type of ground truth used:

Given that the device performs "in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times," the "ground truth" for its performance would typically be established by established laboratory methods, reference standards, and control materials with known values, against which the device's measurements are validated. The document explicitly mentions "system verification and software verification of all requirements," implying verification against predefined performance standards and expected analytical results for these assays.

8. The sample size for the training set:

The document does not describe a "training set" in the context of machine learning, as this submission is about hardware/software modifications to an existing, cleared medical device for "Automated Heparin Analyzer." While software was modified to run on Windows CE 5.0, the type of "training" typically associated with AI models is not discussed.

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

As no "training set" for an AI model is described, this information is not applicable.

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For determining in vitro individual responses to heparinization using whole blood on the HMS Plus instrument. For in Vitro Diagnostic Use.

The modification to the current device is to replace old USP heparin with revised USP heparin. The heparin concentrations have been increased by 13.6% for heparinized channels (ch 1 & 2 and ch 3 &4). The source of the heparin remains porcine.

This document is a 510(k) summary for a modified Heparin Dose Response (HDR) Cartridge. It serves as a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The core modification is the replacement of old USP heparin with revised USP heparin, with increased concentrations in specific channels. The document establishes that the "intended use," "operating principle," "technological characteristics," and "performance claims" remain the same as the predicate device.

It contains no information about the acceptance criteria or a study proving the device meets those criteria, as it's a submission for a minor modification rather than a new device or a clinical performance study. Therefore, I cannot generate the requested table and answer to the specific questions regarding acceptance criteria and study details.

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The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times.

The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges.

This 510(k) summary (K101271) describes a modification to the Medtronic Hemostasis Management System Plus (HMS Plus), an automated heparin analyzer. The modification involves a software change related to the dispense volume used during quality control tests.

Therefore, the study supporting this submission is not a typical clinical performance study demonstrating diagnostic accuracy, but rather a verification and validation study to ensure the modified software continues to meet its pre-established performance criteria. Since the document states "Same performance claims," the acceptance criteria and performance are implicitly based on ensuring the device functions as intended after the software change and maintains the performance established for the prior version (K894317/A3).

Based on the provided information, I can deduce the following:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the test set in terms of patient samples or data. Given that this is a software modification involving a change in dispense volume for a quality control test, the test set would primarily involve:

• Internal validation/verification test runs: This would involve a sufficient number of QC tests to demonstrate the accurate and consistent dispensing of the new 220 uL volume and ensure the overall system functionality remains within specifications.
• Data provenance: The data would likely be prospective from internal testing conducted at Medtronic. Given the nature of the device (heparin analyzer), the testing would occur in controlled laboratory settings. Country of origin is likely USA (Minneapolis, MN is where Medtronic Perfusion Systems is located).

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

For a software modification that changes a dispense volume in a QC test, the "ground truth" would be established by:

• Engineering specifications and measurement standards: The new dispense volume (220 uL) is a precise engineering parameter. The ground truth is the accurate measurement of this volume using calibrated instruments.
• Quality Control (QC) protocols: The ground truth for the device's overall performance after the change would be its ability to pass established QC criteria using reference materials.

Therefore, it's unlikely a panel of external "experts" (like radiologists) was used to establish ground truth in the traditional sense. Instead, qualified engineers, metrologists, and quality control personnel at Medtronic, with expertise in instrument calibration, fluid dynamics, and medical device testing, would have been responsible for verifying the change and confirming that the device met its specifications. Their qualifications would include relevant degrees in engineering, science, or related fields, and experience in medical device development and quality assurance.

4. Adjudication Method for the Test Set

Adjudication, in the context of expert review, is not applicable here. The "adjudication" for this type of submission would be:

• Verification and validation testing: Did the device perform as expected according to predetermined test protocols and specifications?
• Compliance with internal quality procedures: Was the change implemented and tested according to Medtronic's quality management system?
• Regulatory review: The FDA's review and approval of the 510(k) submission serves as the ultimate "adjudication" that the device is substantially equivalent and safe/effective for its intended use after the modification.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the diagnostic performance of imaging devices or algorithms that require human interpretation, often evaluating the impact of AI on human reader performance. This submission is for a software modification to an automated heparin analyzer, where human interpretation of results in a diagnostic setting is not the primary focus of the change.

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

The device itself is an automated analyzer, meaning it operates in a standalone manner to generate results. The "study" (i.e., verification and validation testing) would inherently involve evaluating the algorithm's performance in generating results based on the new dispense volume, without direct human intervention in the result generation process. So, in essence, the evaluation of the software change was a "standalone" assessment of its functionality and impact on the automated process. There's no "human-in-the-loop" aspect to the core function of an automated analyzer's measurements.

7. The Type of Ground Truth Used

The ground truth used would be based on:

• Engineering specifications and metrology: For the dispense volume change, the ground truth is the precisely measured volume using validated and calibrated metrology instruments.
• Reference materials and calibrated controls: For overall device performance, the ground truth would be established using reference materials (e.g., known heparin concentrations) and calibrated quality control solutions. The device's results would be compared against these known values.
• Predicate device performance data: Since the performance claims are stated as "same," the original performance data for the predicate HMS Plus (K894317/A3) serves as a benchmark for the expected performance (ground truth) of the modified device.

8. The Sample Size for the Training Set

There is no mention of a training set in this document. This is not an AI/ML device in the sense of predictive modeling that requires a separate training set. The software modification is a deterministic change to a dispense volume rather than an algorithm trained on data.

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

As there is no training set for this type of software change, this question is not applicable.

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The Heparin Dose Response (HDR) controls are used to verify the performance of the HDR cartridges and the HMS Plus instrument.

The HDR Control set is an in vitro diagnostic device. The primary function is to identify if each pair of heparinized channels of the HDR cartridge has normal or abnormal function by measuring if the clotting time ratios between heparinized and unheparinized channels are within or outside a specified range. HDR control 1 is used to verify that channels 1,2, 5 and 6 of the HDR cartridge are functioning correctly. HDR control 2 is used to verify that channels 3, 4, 5 and 6 of the HDR cartridge are functioning correctly.

The HDR controls are single use, non-sterile, point of care, in-vitro diagnostic plasma controls for use with the HMS Plus instrument.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Heparin Dose Response Controls, based on the K051040 submission.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the Heparin Dose Response Controls. It describes the device's function and states that "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device."

However, we can infer the type of acceptance criteria based on the device description:

Important Note: The K051040 submission for the Heparin Dose Response Control is for a "control set" for an instrument, not a diagnostic device that outputs patient results directly. Therefore, the "performance" here refers to its ability to verify the proper functioning of the main diagnostic system (HDR cartridges and HMS Plus instrument), rather than a diagnostic accuracy metric like sensitivity or specificity for a disease. The typical acceptance criteria for such controls would involve demonstrating that they consistently produce the expected "normal" or "abnormal" results when tested on the system, indicating the system's operational integrity.

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

• Test Set Sample Size: Not explicitly stated. The submission mentions "Validation testing," but does not provide a sample size for this testing.
• Data Provenance: Not explicitly stated. The document doesn't specify the country of origin of the data or whether it was retrospective or prospective.

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 document. As "controls," the ground truth is established by the known properties of the control material itself (i.e., whether it should yield a "normal" or "abnormal" result based on its formulation) when run on a properly functioning system. It does not involve expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

• Not applicable and not provided. Ground truth for control materials doesn't typically involve expert adjudication, as their expected behavior is pre-defined.

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

• No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic control, not an AI-powered diagnostic tool for human interpretation. Therefore, the concept of human readers improving with or without AI assistance does not apply.

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

• Yes, in spirit, a "standalone" assessment of the control's performance was done. The device itself is a "control" that produces a result (within or outside a specified range) when run on the HMS Plus instrument. Its performance is evaluated intrinsically through "Validation testing" to ensure it correctly identifies the function of the HDR cartridge channels. There is no "human-in-the-loop" for the control's function itself, only for the subsequent interpretation of the HMS Plus instrument's results when using the control.

7. The Type of Ground Truth Used

• The ground truth for this device is based on known chemical/physical properties of the control material and its intended interaction with the HMS Plus instrument and HDR cartridges. The controls are designed to yield specific clotting time ratios that indicate "normal" or "abnormal" function of the system. This is a form of design-based or reference-based ground truth, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Not applicable and not provided. This device is not an AI/machine learning algorithm, so there is no concept of a "training set" in the context of this 510(k) submission.

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

• Not applicable and not provided, as there is no training set for this type of IVD control device.

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The Heparin Dose Response (HDR) controls are used to verify the performance of the HDR cartridges and the HMS Plus instrument.

The HDR Control set is an in vitro diagnostic device. The primary function is to identify if each pair of heparinized channels of the HDR cartridge has normal or abnormal function by measuring if the clotting time ratios between heparinized and unheparinized channels are within or outside a specified range. HDR control 1 is used to verify that channels 1,2, 5 and 6 of the HDR cartridge are functioning correctly. HDR control 2 is used to verify that channels 3, 4, 5 and 6 of the HDR cartridge are functioning correctly. The HDR Control set is similar in design and use (vial size and reconstitution method) to the existing liquid controls being used in the HMS platform. The HDR controls are single use, non-sterile, point of care, in-vitro diagnostic plasma controls for use with the HMS Plus instrument.

This 510(k) summary does not contain detailed information about acceptance criteria and specific study results in the format requested. It is a high-level summary confirming substantial equivalence to a predicate device.

However, based on the provided text, here's what can be extracted and inferred:

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

The document states, "The primary function is to identify if each pair of heparinized channels of the HDR cartridge has normal or abnormal function by measuring if the clotting time ratios between heparinized and unheparinized channels are within or outside a specified range." This implies that the acceptance criteria are related to these clotting time ratios falling within or outside a predefined "normal" or "abnormal" range.

The phrase "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device" suggests that the device did meet these established criteria. However, the specific numerical acceptance criteria and the actual reported performance values are not provided in this summary.

Inferred Table:

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

This information is not provided in the summary. The summary refers to "Validation testing" but does not detail the size or nature of the test set, nor the data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not provided in the summary. The HDR Controls are an in vitro diagnostic device for verifying instrument performance, so "expert ground truth" in the clinical imaging sense is not directly applicable. The "ground truth" would likely be established by the expected chemical/biochemical reactions within the controls themselves, verified through analytical methods.

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

This information is not provided in the summary.

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:

This is not applicable. The device is an in vitro diagnostic control for instrument performance, not an AI-assisted diagnostic tool for human readers.

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

The device described is an "in vitro diagnostic device" (HDR Control set) designed to verify the performance of the "HMS Plus instrument" and "HDR cartridges." This implies a standalone performance evaluation where the control's ability to trigger expected responses from the instrument/cartridge is assessed. The "algorithm" here would be the expected chemical reaction and the instrument's detection capabilities. The summary states, "The primary function is to identify if each pair of heparinized channels of the HDR cartridge has normal or abnormal function by measuring if the clotting time ratios between heparinized and unheparinized channels are within or outside a specified range." This heavily suggests a standalone performance evaluation of the control and the instrument's interaction with it.

However, the specific details of this "standalone" study (e.g., how many controls were tested, how many times, under what conditions) are not provided in this summary.

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

For an in vitro diagnostic control device, the ground truth would be established by the inherent, expected chemical and physical properties of the control material itself, which are designed to produce a specific, known response when tested by the HMS Plus instrument and HDR cartridges. This "ground truth" is typically ensured by rigorous manufacturing, analytical testing of the control material, and established scientific principles of coagulation. It's not "expert consensus" or "pathology" in the typical clinical sense, but rather a known, engineered outcome.

8. The sample size for the training set:

This is not applicable in the context of an in vitro diagnostic control device for instrument verification. There is no AI model being "trained" in the conventional sense. The "training" would be the initial development and optimization of the control formulation to consistently produce the desired clotting time ratios.

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

As mentioned above, there isn't a "training set" in the AI sense. The "ground truth" for the control materials would be established during their design, formulation, and manufacturing processes, where the concentrations of active ingredients are precisely controlled to ensure they yield specific, predictable results (i.e., normal or abnormal clotting time ratios) when interacting with the HMS Plus instrument and HDR cartridges according to established biochemical principles and validated analytical methods.

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The heparin dose response cartridge is intended for determining in vitro individual responses to heparinization using whole blood on the HMS or HMS Plus instruments.

The Heparin Dose Response (HDR) cartridge is an in vitro diagnostic test. The HDR cartridge uses fresh whole blood for determining in vitro individual responses to heparinization based on a target activated clotting time (ACT). The cartridge is for use in the HMS or HMS Plus (Hemostasis Management System) instruments.

The provided text describes a 510(k) premarket notification for a medical device, the Heparin Dose Response (HDR) Cartridge. This document is a summary of the notification and a letter from the FDA.

Here's an analysis of the acceptance criteria and the study as requested, based solely on the provided text.

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It broadly states that "Functional testing such as stability, accuracy and precision were used to establish the performance characteristic of the modifications of this device from the previously marketed device."

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

The document does not specify the sample size used for the test set, nor does it provide information on the data provenance (country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts to establish ground truth for a test set. This device is an in vitro diagnostic test for determining responses to heparinization, suggesting that the "ground truth" would likely be derived from laboratory measurements or established clinical reference methods, not expert consensus on image interpretation or similar.

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

The document does not describe any adjudication method for a test set, as it does not rely on expert interpretation for its validation.

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

No such study (MRMC or AI-assisted performance) is mentioned. This device is an in vitro diagnostic tool, not an AI-assisted diagnostic imaging device for human readers.

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

This refers to a standalone performance of the device itself (the HDR cartridge and HMS/HMS Plus instruments). The summary states: "Functional testing such as stability, accuracy and precision were used to establish the performance characteristic of the modifications of this device from the previously marketed device." This implies standalone performance testing was conducted for these specific characteristics. However, detailed results or specific methodology for these tests are not provided.

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

For an in vitro diagnostic test determining individual responses to heparinization, the "ground truth" would typically refer to:

• Reference laboratory methods: Established and validated laboratory techniques for measuring heparin response or activated clotting time, which the device's measurements are compared against.
• Clinical outcomes (potentially secondary): While not explicitly stated as "ground truth" for direct performance evaluation, the ultimate clinical utility would tie into patient outcomes related to heparinization.
  The document refers to "accuracy," implying a comparison to a known or reference value, but does not specify the exact nature of this reference or "ground truth."

8. The sample size for the training set

The document does not mention a training set. This is a 510(k) for an in vitro diagnostic device, not an AI-based system that typically uses training and test sets in the same manner. Its validation focuses on functional performance like stability, accuracy, and precision against a predicate device.

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

Not applicable, as no training set is mentioned or relevant to the reported validation approach.

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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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