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Pacific Hemostasis Thromboplastin D is an in vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays (for Factors II, V, VII and X).
Pacific Hemostasis Thromboplastin D is intended for use for performing the one-stage Prothrombin Time test (PT) and PT-based factor assays.

Pacific Hemostasis Thromboplastin D is a lyophilized extract of rabbit brain thromboplastin containing calcium, stabilizer and buffer.

Acceptance Criteria and Study for Pacific Hemostasis Thromboplastin D

This device is a Thromboplastin reagent intended for in vitro diagnostic use to perform Prothrombin Time (PT) testing and quantitative PT-based factor assays, as well as for monitoring oral anticoagulant (OAC) therapy. The study demonstrates substantial equivalence to a predicate device, Dade Thromboplastin C Plus.

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 a numerical sample size for the test set. It mentions "specimens from normal and abnormal patients, as well as samples from patients receiving OAC therapy."

The data provenance is not explicitly stated in terms of country of origin. However, the study was conducted at "two sites" using "multiple instruments," suggesting a multi-site correlation study. It is a retrospective clinical specimen study using collected patient samples.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This study focuses on the analytical performance and equivalence of a laboratory reagent rather than the diagnostic interpretation by experts. The "ground truth" here is the established measurement performance of the predicate device, not an expert's assessment of patient condition.

4. Adjudication Method

Not applicable, as this is an analytical performance study comparing a new reagent to a predicate, not a study involving expert review of diagnostic cases.

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

No, an MRMC comparative effectiveness study was not done. This is not a diagnostic imaging or interpretation device that would involve human readers.

6. Standalone (Algorithm Only) Performance

Yes, the performance is essentially "standalone" as it refers to the analytical performance of the regent itself when used on laboratory instruments, without human interpretive input beyond following the testing protocol. The correlation and precision metrics directly assess the reagent's performance.

7. Type of Ground Truth Used

The ground truth for this study is implicitly established by the performance of the legally marketed predicate device (Dade Thromboplastin C Plus). The acceptance criteria are based on demonstrating analytical equivalence (correlation, bias, precision) to this established gold standard in the PT testing domain.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" as this is an analytical validation study of a reagent, not a machine learning model. The samples described in section 2 ("specimens from normal and abnormal patients, as well as samples from patients receiving OAC therapy") served as the study set for performance evaluation.

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

Not applicable. As noted in section 8, there isn't a "training set" in the context of a machine learning model. The principle of ground truth in this study is the analytical results obtained when testing samples with the predicate device, which is a widely accepted and legally marketed reagent.

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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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Pacific Hemostasis Heparin Control Plasma Level 1, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the slightly abnormal range.

Pacific Hemostasis Heparin Control Level 1 is a lyophilized preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found nonreactive for HBsAG and negative for antibodies to HIV and HCV.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Heparin Control Plasma Level 1:

1. Table of Acceptance Criteria and Reported Device Performance

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Pacific Hemostasis Heparin Control Plasma Level 2, an unassayed control plasma, is intended for use in heparin assay procedures. In addition, it can be used for quality control in monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing. It will yield APTT values in the moderately high abnormal range.

Pacific Hemostasis Heparin Control Level 2 is a lyophilized preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found nonreactive for HBsAG and negative for antibodies to HIV and HCV.

The provided K992279 510(k) Summary describes the "Heparin Control Plasma, Level 2" device. This is an in vitro diagnostic device, specifically a control plasma used for heparin assay procedures and monitoring heparin therapy with Activated Partial Thromboplastin Time (APTT) testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

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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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Pacific Hemostasis Immunodepleted Factor VIII (FVIII) Deficient Plasma is intended for use as a substrate in the quantitative determination of Factor VIII activity in citrated plasma.

Pacific Hemostasis (PH) Immunodepleted Factor VIII Deficient Plasma is a lyophilized preparation of fresh human plasma with added stabilizer. The product is prepared from pooled normal citrated plasma, and then depleted of FVIII by immobilized highly specific antibodies. Factor VIII activity is less than 1%, all other coagulation Factors are within the normal range. Each unit of source material used in the preparation of this product has been tested and found negative for HBsAg (Hepatitus B Surface antigen) and negative for antibodies to HIV and HCV. The product is provided in 1.0mL vials, 10 vials per package.

Acceptance Criteria and Study for Factor VIII Immunodepleted Plasma

This document details the acceptance criteria and the study performed to demonstrate substantial equivalence for the Pacific Hemostasis Immunodepleted Factor VIII Deficient Plasma.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Pacific Hemostasis (PH) Immunodepleted Factor VIII Deficient Plasma were established through comparison to a legally marketed predicate device, the Biopool (BP) Factor VIII Deficient Plasma. The device performance was assessed across several metrics, as summarized in the table below. While specific numerical "acceptance criteria" were not explicitly stated as pass/fail thresholds, the study aimed to demonstrate "indistinguishable" or "equivalent" performance within acceptable analytical variations for in vitro diagnostic devices.

• R² = 0.98-0.99 (indicating strong correlation between the two products' standard curves). |
  | Recovery of FVIII activity in controls | FVIII activity levels in 6 control plasmas | - Equivalent recovery for both PH and BP.
• Correlation coefficient = 0.98 (strong positive linear relationship between results obtained with PH and BP).
• Regression line equation: y = 0.9911x + 0.8692 (indicating close agreement, with a slope near 1 and y-intercept near 0, suggesting minimal systematic bias).
• Individual control mean percentages of FVIII recovery were closely matched (e.g., PH 114.7% vs. BP 117.0%, PH 18.0% vs. BP 18.1%). |
  | Instrument compatibility | FVIII activity recovery across multiple instruments | - Tested on Amelung KC 4 A™, MLA®-700, MLA®-1000C™, and ACL-3000PLUS.
• Combined instrument data yielded a correlation coefficient of 0.99.
• Regression line equation: y = 1.037x + 0.5603. |
  | Reconstituted stability | Performance with fresh vs. 8-hour aged plasma | - Standard curves prepared with fresh or 8-hour aged deficient plasma were indistinguishable for both products.
• No clinically significant differences observed in FVIII activity recovered in control plasmas between fresh and aged deficient plasmas for both PH and BP. |

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

• Sample Size:
  • Day-to-day precision: Tested over a 10-day period. The number of control plasmas measured was not explicitly stated in this context but implied to be multiple over this period.
  • Recovery of FVIII activity: Six control plasmas were tested. The "n (days of testing)" for each control plasma ranged from 8 to 10 days.
  • Instrument compatibility: Not explicitly stated as to the number of samples, but implied to be sufficient for generating standard curves and recovering FVIII activity in control plasmas on each of the four instruments.
  • Reconstituted stability: Not explicitly stated, but involved comparison of fresh vs. 8-hour aged deficient plasma performance.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the context of a 510(k) submission for a new device, it is highly likely that the data was generated prospectively as part of the device's validation studies.

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

This type of in vitro diagnostic device (deficient plasma for Factor VIII activity measurement) does not typically rely on "experts" in the sense of clinical reviewers (e.g., radiologists) establishing a "ground truth" for a diagnostic image or patient case.

Instead, the "ground truth" for the test set is inherent in the known Factor VIII activity levels of the control plasmas used. These control plasmas are analytically characterized materials with established target values. The "experts" involved would be the laboratory personnel performing the testing, who would be qualified clinical laboratory scientists or technicians proficient in coagulation assays. Their qualifications are not specified in the provided text.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving subjective assessments or where consensus is needed among multiple readers. For this in vitro diagnostic device, where quantitative measurements are performed against known controls, an adjudication method in this sense is not applicable or described. The results are obtained directly from laboratory measurements and statistical comparisons.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of AI on human reader performance, particularly in medical imaging. The Factor VIII Deficient Plasma is an in vitro diagnostic reagent, not an AI-powered diagnostic system that assists human readers.

6. Standalone Performance (Algorithm Only)

This product is a laboratory reagent, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study was not performed or is not applicable. The performance evaluation focuses on the reagent's analytical characteristics when used in conjunction with standard laboratory instruments and assays.

7. Type of Ground Truth Used

The ground truth used was analytically established values from characterized control plasmas with known Factor VIII activity levels. This is the standard method for validating in vitro diagnostic assays. The "pooled normal plasma" (PNP) and various "Control 1" through "Control 5" with different FVIII activity percentages serve as the ground truth against which the device's ability to recover FVIII activity is measured.

8. Sample Size for the Training Set

This product is an in vitro diagnostic reagent, not a machine learning model or AI device that requires a "training set." Therefore, a sample size for a training set is not applicable and not provided.

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

As noted above, a "training set" is not applicable for this type of device. The ground truth for the performance evaluation (test set) was established by using pre-characterized control plasmas with known Factor VIII activity levels, which is a standard analytical validation approach for IVD reagents.

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Pacific Hemostasis Coagulation Control Level 1 is intended for use as a control to monitor the performance of routine coagulation assays, i.e. Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT and Fibrinogen values in the normal range.

Pacific Hemostasis Coagulation Control Level 1 (Normal) is a lyophilized preparation of citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Coagulation Control Level 1 (Normal) device:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Coagulation Control (Level 1, Normal) and its performance is assessed based on precision (between-run and within-run) for Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) assays, and the expected range for Fibrinogen. The acceptance criteria are implicitly derived from the "substantially equivalent" claim to the predicate device (Dade Ci-Trol Coagulation Control Level 1). The study demonstrates that the Pacific Hemostasis device falls within similar precision limits and expected Fibrinogen ranges as the predicate.

Notes on Acceptance Criteria: The document directly states that "For both controls a CV of less than 2.0% was obtained for PT and APTT between-run testing" and "The average CV's obtained for within-run precision were less than 1.5% for PT testing, and less than 1.0% for APTT testing of both products." These statements are presented as observed performance but implicitly serve as the benchmark for substantial equivalence.

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

• Test Set Sample Size:
  • Between-run Precision: 20 duplicate measurements over a 10-day period. This means 20 measurements for PT and 20 for APTT for both the Pacific Hemostasis product and the Dade product.
  • Within-run Precision: 3 runs of 20 duplicate measurements. The average %CV is reported. This implies 60 original measurements for PT and 60 for APTT for both products to calculate the average.
  • Fibrinogen: The sample size for Fibrinogen is not explicitly stated in terms of number of measurements, but a single representative value (287 mg/dL for Pacific Hemostasis and 268 mg/dL for Dade) is given.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, the applicant (Pacific Hemostasis) is based in Huntersville, NC, USA. The study is a prospective performance study conducted specifically for this premarket notification.

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

This type of study for a coagulation control material does not typically involve human experts establishing a "ground truth" in the way a medical image diagnosis aid would. The "ground truth" here is the performance characteristics of a known, legally marketed predicate device (Dade Ci-Trol Coagulation Control Level 1) and the established normal ranges for PT, APTT, and Fibrinogen in a laboratory setting.

4. Adjudication Method for the Test Set

Not applicable. This is a laboratory performance study of a control material, not a clinical study requiring adjudication of diagnoses or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This study is focused on the device's analytical performance (precision and expected range) compared to a predicate device, not on human reader performance with or without AI assistance.

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

Yes, this is essentially a standalone performance study of the coagulation control material. The device itself (the control plasma) is being evaluated for its inherent analytical characteristics (precision and consistency), not as an algorithm or with human interaction once the test is set up.

7. The Type of Ground Truth Used

The "ground truth" is established by:

• The known, validated performance characteristics of the legally marketed predicate device (Dade Ci-Trol Coagulation Control Level 1).
• Clinically accepted normal ranges for PT, APTT, and Fibrinogen assays, which the control is designed to fall within.

8. The Sample Size for the Training Set

Not applicable. This is a premarket notification for a control material, not a machine learning model that requires a training set. The "development" of the product would have involved internal testing and formulation, but not in the context of a "training set" for an algorithm.

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

Not applicable, as there is no training set mentioned or implied for this device.

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Pacific Hemostasis Coagulation Control Level 2 is intended for use as a control to monitor the performance of Prothrombin Time (PT) and Activated Partial Time (APTT) testing. It will yield PT and APTT values in the moderately abnormal range.

Pacific Hemostasis Coagulation Control Level 2 (Abnormal) is a lyophilized preparation of citrated plasma obtained from healthy donors, which has been adjusted to yield prolonged Prothrombin Time and Activated Partial Time values. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.

Here's an analysis of the provided text regarding the Coagulation Control Level 2 (Abnormal) device, structured according to your requested information:

Acceptance Criteria and Study for Coagulation Control Level 2 (Abnormal)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Pacific Hemostasis Coagulation Control Level 2 (Abnormal)" device were implicitly established through comparison to a legally marketed predicate device, the "Dade Ci-Trol Coagulation Control Level II" (K771346). The primary metric for substantial equivalence was precision (both between-run and within-run), as measured by the Coefficient of Variation (CV%) and standard deviation (SD) of Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) values.

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Pacific Hemostasis Coagulation Control Level 3 is intended for use as a control to monitor the performance of Prothrombin Time (PT) and Activated Partial Time (APTT) testing. It will yield PT and APTT values in the markedly abnormal range.

Pacific Hemostasis Coagulation Control Level 3 (Abnormal) is a lyophilized preparation of citrated plasma obtained from healthy donors, which has been adjusted to yield prolonged Prothrombin Time and Activated Partial Thromboplastin Time values. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Coagulation Control Level 3 (Abnormal) device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it compares the performance of the new device (Pacific Hemostasis Coagulation Control Level 3) directly against a legally marketed predicate device (Dade Ci-Trol Coagulation Control Level III) to establish substantial equivalence. The implication is that if the new device performs similarly to the predicate device within reasonable bounds, it meets the "acceptance criteria" for substantial equivalence.

Based on the "Summary of Performance Data for Substantial Equivalence Comparisons," the implicit acceptance criteria are that the new device should demonstrate comparable precision (CV%) to the predicate device for both Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) measurements.

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