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The intended use of the Sysmex® CA-7000 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument uses citrated human plasma to perform coagulation tests.

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The Sysmex® Automated Coagulation Analyzer CA-7000 performed a clinical correlation study and a precision study to demonstrate its performance claims as being similar to predicate devices.

1. Table of acceptance criteria and the reported device performance:

The document describes two types of studies: "Summary of Method Comparison Studies Between CA-6000 or BCS" and "Summary of Precision Studies Sysmex® Automated Coagulation Analyzer CA-7000".

Acceptance Criteria for Method Comparison Studies (Implied via Predicate Equivalence):
The acceptance criteria for the method comparison studies are implicitly defined by demonstrating substantial equivalence to the predicate devices (Sysmex® Automated Coagulation Analyzer CA-6000 and Behring Coagulation System (BCS™ System)). This is primarily evaluated through the Coefficient of Correlation (r), which should be close to 1 (indicating a strong positive linear relationship), and visual inspection of the Regression Equation.

Reported Device Performance (Method Comparison Studies):

Acceptance Criteria for Precision Studies:
The acceptance criteria for precision are not explicitly stated as numerical thresholds (e.g., maximum allowable %CV). However, the intent is to demonstrate acceptable within-run, between-run, and total precision for each assay at different control levels. The reported %CV values should be within generally accepted clinical laboratory standards for these types of assays.

Reported Device Performance (Precision Studies):

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

• Sample Size for Test Set (Clinical Correlation Studies):
  • The sample sizes varied by assay, ranging from 104 (Derived Fibrinogen) to 381 (Thrombin Time). All specific sample sizes are listed in the table above under "Sample Number (n)".
• Data Provenance:
  • The document states: "During those studies, specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay." This suggests a mix of prospective and retrospective samples, likely collected to represent a clinically relevant range.
  • There is no explicit mention of the country of origin for the clinical data. The manufacturing site is Sysmex Corporation, Kobe, Japan, and the distributor is Dade Behring Inc. in the US, but this does not specify the origin of the clinical samples.

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 document. The study compares the new device's readings against predicate devices, implying that the predicate devices' results serve as the reference or "ground truth" for the comparison. There is no mention of independent experts establishing a ground truth for the clinical correlation studies.

4. Adjudication method for the test set:

• This information is not applicable as the ground truth was established by comparing to predicate devices, not by expert consensus requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This information is not applicable. The device is an automated coagulation analyzer, which does not involve "human readers" or "AI assistance" in the context of interpreting medical images or data by human clinicians. It is a laboratory instrument that outputs numerical results.

6. 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 Sysmex® Automated Coagulation Analyzer CA-7000. It is an automated system designed to operate "without human-in-the-loop performance" for the actual coagulation test execution and measurement. The results are generated directly by the analyzer.

7. The type of ground truth used:

• The "ground truth" for the method comparison studies was the results obtained from the predicate devices (Sysmex® Automated Coagulation Analyzer CA-6000 or Behring Coagulation System (BCS™ System)). This is a form of comparative (or reference method) ground truth where an established, cleared device's performance serves as the benchmark.
• For precision studies, the concept of "ground truth" is different; it's about the device's internal consistency and reproducibility, which is assessed inherently by statistical analysis of repeated measurements on control samples.

8. The sample size for the training set:

• This information is not applicable. This device is a traditional laboratory instrument, not an AI/machine learning model that typically requires a "training set" in the common sense of AI development. It operates based on established chemical and optical principles.

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

• This information is not applicable for the same reasons as #8.

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The intended use of the Sysmex® CA-1500 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.

The instrument uses citrated human plasma to perform the following parameters and calculated parameters:

Clotting Analysis Parameters

• Prothrombin Time (PT) .
• Activated Partial Thromboplastin Time (APTT) .
• Fibrinogen (Clauss) .

Chromogenic Analysis Parameters

• Antithrombin III .
  Calculated Parameters

• . PT Ratio

• PT INR

• PT % ●

• Extrinsic Factors (II, V, VII, X) ● Intrinsic Factors (VIII, IX, XI, XII) .

• Derived Fibrinogen ●

• Factor Assays % Activity .

The CA-1500 is substantially equivalent in intended use and technological characteristics to the Sysmex® Automated Coagulation Analyzer CA-6000, Sysmex Corporation, Kobe, Japan, which was cleared by FDA under Document Control Nos. K964139 and K992321; or the Behring Coagulation Timer (BCT), Dade Behring, Marburg, Germany which was cleared by FDA under Document Control No. K955278.

Here's an analysis of the provided text regarding the Sysmex® Automated Coagulation Analyzer CA-1500, focusing on acceptance criteria and the supporting study:

The provided document is a 510(k) Summary of Safety and Effectiveness Information for the Sysmex® Automated Coagulation Analyzer CA-1500, submitted to the FDA in 1999. It focuses on demonstrating substantial equivalence to predicate devices, primarily through method comparison and precision studies.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds (e.g., "r > 0.95"). Instead, it reports the performance metrics achieved in comparison and precision studies, implying these demonstrate "similarity" or acceptable performance when compared to predicate devices. The key performance indicators used are the Coefficient of Correlation (r) for method comparison and various Coefficient of Variation (%CV) for precision.

Below is a table summarizing the reported device performance from the provided study, which serves as the de-facto demonstration of meeting acceptance for substantial equivalence:

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

The "test set" in this context refers to the samples used in the clinical correlation (method comparison) studies and precision studies.

• Clinical Correlation (Method Comparison) Studies:

  • Sample sizes ranged from 66 to 165 samples, depending on the specific test.
  • Data Provenance: The specimens were evaluated from "apparently healthy individuals and from patients with different pathological conditions." The country of origin is not explicitly stated, but Dade Behring Inc. is based in Miami, FL, and Sysmex Corporation in Kobe, Japan. Given the submission is to the FDA, it is most likely that at least some, if not all, of the clinical correlation studies were performed using data from the US, or globally applicable data following international standards. The studies appear to be prospective in the sense that they were conducted for the purpose of this submission (as clinical correlation studies comparing the new device to predicates).

• Precision Studies:

  • For all precision studies, the sample size (N) was 40. Note: For precision, N refers to the number of replicates or measurements taken, not necessarily unique patient samples.
  • Data Provenance: The study utilized "Control Level" samples, specifically "CPN" (Control Plasma Normal) and either "Path. Pool" (Pathological Pool) or "CPP" (Control Plasma Pathological). These are likely commercially prepared quality control materials or pooled patient samples designed for assay validation. The provenance (country, retrospective/prospective) for these specific control materials is not detailed.

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

This type of submission (510(k) for an automated coagulation analyzer) does not involve human expert interpretation of images or clinical findings to establish a "ground truth" in the way medical imaging AI devices do.

Instead, the "ground truth" for the test set is established by the predicate devices (Sysmex® Automated Coagulation Analyzer CA-6000 and Behring Coagulation Timer (BCT)), which are legally marketed and accepted devices for performing these coagulation tests. The new device's results are compared to the predicate device's results.

Therefore, there were no human experts establishing ground truth in the typical sense for this device. The 'gold standard' is the measurement provided by the established predicate device and associated reference methods/standards for coagulation assays.

4. Adjudication Method for the Test Set

As explained above, there isn't an "adjudication method" involving human experts in the context of this device. The comparison is between the quantitative results of the proposed device and the predicate device. If discrepancies were observed, standard laboratory procedures for investigating outliers or re-running samples would be employed, but not a panel of experts adjudicating a "truth."

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 for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance (e.g., accuracy, efficiency) is measured. This submission is for an automated laboratory analyzer, which produces quantitative results directly, not interpretations by human readers in the same way.

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

Yes, the provided studies are for standalone performance. The Sysmex® Automated Coagulation Analyzer CA-1500 is an in vitro diagnostic (IVD) device designed to perform coagulation tests automatically. The method comparison and precision studies directly evaluate the performance of this analyzer (the "algorithm/device only") without human intervention during the measurement process, beyond loading samples and reagents. The results presented (correlation coefficients, %CV) represent the inherent analytical performance of the device itself.

7. The Type of Ground Truth Used

The "ground truth" for the method comparison studies was established by the measurements obtained from the legally marketed predicate devices (Sysmex® CA-6000 and Behring Coagulation Timer (BCT)). For precision studies, the ground truth refers to the expected or consensus values for the control materials used. This is a form of reference method/predicate device comparison rather than pathology, expert consensus, or outcomes data in the traditional sense.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI models, as this is a traditional IVD device. The device's operation is based on established electrochemical/optical principles and pre-programmed algorithms for signal processing and calculation, not on a machine learning model that requires a distinct training phase with labeled data.

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

As there is no mention of a "training set" for an AI model, this question is not applicable to the provided document. The device's operational parameters and algorithms would have been developed and validated internally by the manufacturer through engineering design, laboratory testing, and adherence to performance specifications, rather than through an AI training paradigm.

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The intended use of the Sysmex® CA-6000 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.

The instrument uses citrated human plasma to perform the following parameters and calculated parameters:

Clotting Analysis Parameters

• Prothrombin Time (PT) .
• Activated Partial Thromboplastin Time (APTT) .
• Fibrinogen (Clauss) .
• Thrombin Time .
• Extrinsic Factors (II, V, VII, X) ●
• Intrinsic Factors (VIII, IX, XI, XII) ●
• Batroxobin .
• . Protein C

Chromogenic Analysis Parameters

• Antithrombin III .
• . Plasminogen
• Factor VIII .

Calculated Parameters

• PT Ratio .
• PT INR .
• Protein C .
• Heparin ●
• a2-Antiplasmin .
• Derived Fibrinogen .
• Factor Assays % Activity .

The Sysmex® CA-6000 is intended for use as an automated citrated human plasma coagulation analyzer.

Here's a breakdown of the acceptance criteria and study information for the Sysmex® Automated Coagulation Analyzer CA-6000 based on the provided text:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The acceptance criteria for this device are implicitly tied to its substantial equivalence to a predicate device, the Behring Coagulation Timer (BCT). This means the performance of the CA-6000 is deemed acceptable if it demonstrates similar performance to the BCT.

Note: The document focuses primarily on correlation with the predicate device and precision, rather than specific numeric thresholds for accuracy. The "acceptance criteria" here are implied to be achieving strong correlation and acceptable precision, demonstrating similar performance to the established predicate.

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

• Sample Size:
  • Factor VIII Chromogenic Assay: n = 92
  • α2-Antiplasmin Chromogenic Assay: n = 128
  • Precision Studies: 40 samples for each control level (CPN and CPP) for both Factor VIII and α2-Antiplasmin.
• Data Provenance: Retrospective and prospective. The studies "evaluated specimens from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay." The location of these individuals and patients is not explicitly stated (e.g., country of origin), but given the applicant is Dade Behring Inc. Miami, FL, and Sysmex Corp. Japan, it's likely a mix, potentially with US-based clinical samples. The "in-house correlation studies" suggest internal testing.

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

This information is not provided in the document. For diagnostic devices like this, patient samples with known clinical conditions (pathological conditions) serve as the "ground truth" for evaluating accuracy and correlation. However, the specific process for establishing these "known clinical conditions" or whether expert review was involved is not detailed.

4. Adjudication Method for the Test Set

This information is not provided. As the study focuses on quantitative correlation with a predicate device and precision, inter-rater adjudication of results is not typically a direct component. The predicate device's results serve as the reference for comparison.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) changes with and without AI assistance. The Sysmex CA-6000 is an automated analyzer, not an AI-assisted diagnostic tool for human readers. Its primary function is to perform tests and output quantitative results, rather than to aid human interpretation of complex images or data in an MRMC setting.

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

Yes, the provided studies essentially represent standalone performance. The Sysmex® CA-6000 is an "Automated Coagulation Analyzer." The studies described (method comparison and precision) evaluate the device's performance in generating results directly from samples, independent of human interpretation or intervention in the measurement process itself. The "algorithm" here refers to the device's internal methods for assay execution and result calculation.

7. Type of Ground Truth Used

The ground truth used for the method comparison studies was derived from the predicate device's measurements (Behring Coagulation Timer - BCT) and from patient specimens with "different pathological conditions" and "apparently healthy individuals". The BCT's results served as the reference for determining the CA-6000's correlation. For the precision studies, the "ground truth" is the inherent variability of the assay on control materials and patient samples under repeated measurements.

8. Sample Size for the Training Set

The document does not provide information on a "training set". This type of device (automated analyzer) is typically developed and validated using engineering principles, analytical studies, and comparison to existing, cleared devices, rather than machine learning models that require distinct training sets.

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

Since no training set is mentioned or applicable in the context of this device's development as described, this information is not applicable.

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The intended use of the Sysmex® CA-500 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.

The instrument uses citrated human plasma to perform the following parameters and calculated parameters:

Clotting Analysis Parameters

• Prothrombin Time (PT) ●
• Activated Partial Thromboplastin Time (APTT) .
• Fibrinogen (Clauss) .

Chromogenic Analysis Parameters

• Antithrombin III ●
• Protein C t

Calculated Parameters

• PT Ratio .
• PT INR ●
• Batroxobin .
• Protein C ●
• Heparin .
• Derived Fibrinogen .

The Sysmex® CA-500 is intended for use as an automated citrated human plasma coagulation analyzer.

{
  "acceptance_criteria_and_study": {
    "1._table_of_acceptance_criteria_and_reported_device_performance": {
      "Method Comparison Studies": {
        "Predicate Device": "Behring Coagulation Timer (BCT) or Behring Fibrintimer A (BFA)",
        "Acceptance Criteria (Implicit)": "Coefficient of Correlation (r) > 0.95 for method comparison to predicate device",
        "Reported Device Performance": {
          "Batroxobin (vs. BCT)": "r = 0.984",
          "Protein C, Chromogenic (vs. BCT)": "r = 0.963",
          "Heparin, Chromogenic (vs. BCT)": "r = 0.977",
          "Protein C, Coagulometric (vs. BFA)": "r = 0.974"
        }
      },
      "Precision Studies": {
        "Acceptance Criteria (Implicit)": "Low %CV (Coefficient of Variation) for within-run, between-run, and total precision.",
        "Reported Device Performance": {
          "Batroxobin Time (CPN)": "Within-Run %CV = 1.0, Between-Run %CV = 1.2, Total %CV = 1.5",
          "Batroxobin Time (Pool Plasma 2)": "Within-Run %CV = 1.9, Between-Run %CV = 0.7, Total %CV = 1.9",
          "Protein C Coagulometric (CPN)": "Within-Run %CV = 4.8, Between-Run %CV = 3.6, Total %CV = 5.8",
          "Protein C Coagulometric (CPP)": "Within-Run %CV = 9.0, Between-Run %CV = 6.2, Total %CV = 10.4",
          "Protein C Chromogenic (CPN)": "Within-Run %CV = 1.6, Between-Run %CV = 1.0, Total %CV = 1.8",
          "Protein C Chromogenic (CPP)": "Within-Run %CV = 3.6, Between-Run %CV = 1.4, Total %CV = 3.6",
          "Heparin (Ci-Trol Hep Hi)": "Within-Run %CV = 4.0, Between-Run %CV = 5.2, Total %CV = 6.4",
          "Heparin (Ci-Trol Hep Lo)": "Within-Run %CV = 5.6, Between-Run %CV = 4.7, Total %CV = 7.1"
        }
      }
    },
    "2._sample_size_used_for_the_test_set_and_the_data_provenance": {
      "Method Comparison Studies": {
        "Batroxobin": "183 samples",
        "Protein C, Chromogenic": "114 samples",
        "Heparin, Chromogenic": "53 samples",
        "Protein C, Coagulometric": "Not explicitly stated for BFA comparison, but implied to be similar numbers for other tests (e.g., 114 range for Protein C tests with BCT)",
        "Data Provenance": "Specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay. Country of origin not specified, but likely within Dade Behring's operational regions (e.g., USA, Europe). Retrospective or prospective not specified, but typically prospective for method comparison studies."
      },
      "Precision Studies": {
        "Batroxobin Time (CPN/Pool Plasma 2)": "40 samples per level",
        "Protein C Coagulometric (CPN/CPP)": "40 samples per level",
        "Protein C Chromogenic (CPN/CPP)": "40 samples per level",
        "Heparin (Ci-Trol Hep Hi/Lo)": "32 samples per level",
        "Data Provenance": "Control materials (CPN, CPP, Ci-Trol Hep Hi/Lo) and pooled plasma. Country of origin not specified. Prospective testing."
      }
    },
    "3._number_of_experts_used_to_establish_the_ground_truth_for_the_test_set_and_the_qualifications_of_those_experts": "Not applicable. This device is an automated coagulation analyzer, and its performance is evaluated against established laboratory methods (predicate devices) and internal quality control samples, not against expert human interpretation of clinical data or images.",
    "4._adjudication_method_for_the_test_set": "Not applicable. Ground truth for performance studies of automated laboratory analyzers is typically established by the results from a legally marketed predicate device or by standard reference materials, not through expert adjudication.",
    "5._if_a_multi_reader_multi_case_(MRMC)_comparative_effectiveness_study_was_done,_If_so,_what_was_the_effect_size_of_how_much_human_readers_improve_with_AI_vs_without_AI_assistance": "Not applicable. This is an automated laboratory analyzer, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.",
    "6._if_a_standalone_(i.e._algorithm_only_without_human-in-the-loop_performance)_was_done": "Yes. The studies presented (method comparison and precision) evaluate the standalone performance of the Sysmex® Automated Coagulation Analyzer CA-500 against predicate devices and internal controls. There is no human-in-the-loop component for the analytical performance itself.",
    "7._the_type_of_ground_truth_used": "The ground truth for the test set (method comparison) was established by the measurements obtained from legally marketed predicate devices (Behring Coagulation Timer (BCT) and Behring Fibrintimer A (BFA)). For precision studies, it was based on the expected values of control materials and pooled plasmas.",
    "8._the_sample_size_for_the_training_set": "Not applicable. This is an automated laboratory analyzer, not a machine learning or AI-based device that typically requires a 'training set'. Its operational parameters are likely calibrated during manufacturing and validated through performance testing.",
    "9._how_the_ground_truth_for_the_training_set_was_established": "Not applicable for the same reasons as above. The device's internal algorithms are based on established coagulation measurement principles, not learned from a training dataset."
  }
}

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The intended use of the Sysmex® CA-500 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.

The instrument uses citrated human plasma to perform the following parameters and calculated parameters:

Clotting Analysis Parameters

• Prothrombin Time (PT) ●

• Activated Partial Thromboplastin Time (APTT) .

• Fibrinogen (Clauss) .

• Batroxobin .

• Protein C .
  Heparin

.

• · Thrombin Time
• Extrinsic Factors (II, V, VII, X) .
• Intrinsic Factors (VIII, IX, XI, XII) .

Chromogenic Analysis Parameters

• Antithrombin III .
• . Protein C

Calculated Parameters

• PT Ratio ●
• . PT INR
• . Derived Fibrinogen
• Factor Assays % Activity .

The Sysmex® CA-500 is intended for use as an automated blood plasma coagulation analyzer.

The Sysmex® Automated Coagulation Analyzer CA-500 is intended for use as an automated blood plasma coagulation analyzer. The device's performance was compared to a predicate device, the Behring Coagulation Timer (BCT).

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes "in-house correlation studies" to demonstrate that the performance claims of the proposed device are similar to the predicate device. The acceptance criteria can be inferred from the reported performance, which shows high correlation coefficients (r ≥ 0.960) between the CA-500 and the BCT for the measured coagulation factors.

Note: The specific numerical acceptance criteria (e.g., r > 0.95) are not explicitly stated in the provided text but are inferred from the reported strong correlations.

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

• Sample Size (Test Set):
  • Coagulation Factor VII: 80 specimens
  • Coagulation Factor VIII: 94 specimens
• Data Provenance: The specimens were evaluated from "apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay." The country of origin is not specified but the manufacturing site is Kobe, Japan, and the distributor is Dade Behring Inc. in Newark, DE, USA. The studies are described as "in-house correlation studies," suggesting they were conducted by the manufacturer or a contracted entity. The data is prospective, as samples were "evaluated" during these studies.

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

The document does not mention the use of experts to establish ground truth in the context of the correlation studies. The ground truth for the device's performance is established by comparison to a predicate device, the Behring Coagulation Timer (BCT), rather than an independent expert consensus on patient conditions.

4. Adjudication Method for the Test Set:

Not applicable. The study is a method comparison study between the proposed device and a predicate device, not an assessment requiring expert adjudication of results.

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

No, an MRMC comparative effectiveness study was not done. The study focuses on the analytical performance of the device 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, the study describes the standalone performance of the Sysmex® Automated Coagulation Analyzer CA-500 in comparison to the predicate device. It evaluates the device's ability to measure coagulation factors.

7. The Type of Ground Truth Used:

The "ground truth" for this study is the measurements obtained from the predicate device, the Behring Coagulation Timer (BCT). The study assesses the correlation and agreement of the Sysmex CA-500 with a previously cleared device, not against absolute pathological or outcomes data independent of a measurement instrument.

8. The Sample Size for the Training Set:

The document does not mention a "training set" as this is not an AI/machine learning device that would typically undergo a training phase. It is an automated coagulation analyzer being evaluated for substantial equivalence to a predicate device based on its analytical performance.

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

Not applicable, as there is no mention of a training set for this device in the provided text.

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