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For use in prothrombin time determinations and prothrombin time-based assays.

Dade® Innovin® is a lyophilized preparation of purified recombinant human tissue factor produced in E. coli combined with synthetic phospholipids, calcium and stabilizers. The reagent initiates clotting via the extrinsic common pathway in a global screening test, the prothrombin time (PT). The obtained clotting time detects single or combined deficiencies of the extrinsic coagulation system indicative of hereditary and acquired coagulation disorders, is a sensitive monitoring test for oral anticoagulation therapy and an assay for specific coagulation factors.

Here's a breakdown of the acceptance criteria and study information for the Dade® Innovin® device, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • The document does not explicitly state the sample size of the test set in terms of the number of patient specimens. It only states that "specimens were tested."
   • The data provenance (e.g., country of origin, retrospective or prospective) is not specified.

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

   • This information is not applicable as the study involves a direct comparison of a new in vitro diagnostic (IVD) device against a predicate IVD device, rather than a clinical interpretation by human experts. The "ground truth" here is the measurement provided by the established predicate device.

3. Adjudication method for the test set:

   • Not applicable for this type of IVD device comparative study. The comparison is quantitative based on direct measurements.

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) reagent, not an AI-powered diagnostic imaging or interpretation tool that would involve human readers.

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

   • Yes, this was a standalone performance study in the context of an IVD. The device (Dade® Innovin®) was tested independently and its results were compared directly to those of the predicate device (Dade® Thromboplastin IS) without human intervention or interpretation as part of the core measurement.

6. The type of ground truth used:

   • The "ground truth" for this comparative study was the results obtained from the predicate device, Dade® Thromboplastin IS (K891169). The goal was to demonstrate substantial equivalence to this legally marketed device.

7. The sample size for the training set:

   • The document does not mention a separate "training set" as this is a traditional IVD device, not a machine learning or AI model. The comparative performance study described serves as the validation of the device's performance against the predicate.

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

   • Not applicable as there is no mention of a "training set" in the context of this traditional IVD product.

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To aid in the detection of platelet dysfunction in citrated human whole blood for use in patients with a suspected disorder of primary hemostasis.

The Dade® PFA-100™ system is an instrument and test reagents in which the process of platelet adhesion and aggregation following a vascular injury is simulated in vitro. Platelet dysfunction detected by the PFA-100 system may be acquired, inherited or induced by platelet inhibiting agents. The PFA-100 system allows for rapid evaluation of platelet function on small samples of anticoagulated whole blood. The single use test cartridge reagents consists of a number of integrated parts including a capillary, a sample reservoir and a biologically active membrane with a central aperture. By application of a constant vacuum, anticoagulated whole blood is aspirated from the sample reservoir through the capillary and the aperture under standardized rheological conditions that expose platelets to high shear stress. The membrane is coated with collagen and one additional agonist. At the beginning of a test, Trigger Solution is dispensed to wet the membrane. Similar to the in vivo mechanism, platelets adhere and aggregate at the aperture thereby gradually diminishing and finally arresting the blood flow. The instrument determines the time from the start of the test until the platelet plug occludes the aperture, and reports that time interval as the Closure Time. Platelet plug formation in the PFA-100 system is dependent on adequate platelet activity and adequate von Willebrand factor status. Therefore, the Closure Time is an indicator of the platelet function in the analyzed whole blood sample.

The Dade PFA-100 Platelet Function Analyzer is intended to aid in the detection of platelet dysfunction in citrated human whole blood for patients with a suspected disorder of primary hemostasis.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state pre-defined acceptance criteria. Instead, it compares the performance of the proposed device (PFA-100) to a predicate device (Chrono-log Aggregometer) to demonstrate substantial equivalence. The reported performance of both devices is presented below:

The study concludes that the Clinical Sensitivity and Specificity of the proposed device are "statistically comparable" to those of the predicate device, indicating that the device meets the implied acceptance of being equivalent to the existing market standard.

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

• Sample Size: A total of 328 specimens were tested.
  • 176 samples were from subjects with normal platelet function.
  • 152 samples were from subjects with platelet dysfunction (von Willebrand disease, aspirin-induced dysfunction, and Glanzmann's thrombasthenia).
• Data Provenance: The document does not explicitly state the country of origin. The study was a clinical study, which typically implies prospective data collection, but it's not explicitly stated if it was fully prospective or included retrospective components. The samples were collected from subjects representing 63% females and 37% males.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.

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

No MRMC comparative effectiveness study was explicitly described in the provided text. The study focused on comparing the device's performance to a predicate device, not on the improvement of human readers with AI assistance.

6. Standalone Performance Study:

Yes, a standalone performance study was conducted. The "Clinical Sensitivity" and "Clinical Specificity" values reported for the "Proposed Device PFA-100" represent its standalone performance in detecting platelet dysfunction. The overall agreement with the predicate device also indicates its standalone performance compared to an existing method.

7. Type of Ground Truth Used:

The Platelet Function Status for each sample (used as the ground truth) was based upon "results from a platelet function test panel and clinical history." This suggests a combination of objective clinical laboratory tests and expert clinical judgment.

8. Sample Size for the Training Set:

The document does not mention a separate "training set" or its sample size. The study described appears to be a validation study for the device, comparing its performance to a predicate using the entire collected dataset. This type of device relies on established biological principles and may not involve a machine learning training phase in the traditional sense.

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

As no separate training set is mentioned, this information is not applicable.

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Dade TRU-Liquid Cardiac Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and to assist in the control of accuracy and precision of a laboratory's cardiac marker procedures.

Dade® TRU-Liquid™ Cardiac Control Levels 1,2 and 3. Liquid Tri-Level Cardiac Control. Quality Control Material (Assayed and Unassayed).

This document is a 510(k) summary for a medical device called "Dade® TRU-Liquid™ Cardiac Control." It is a quality control material intended for use in clinical laboratory quality assurance programs to assess the accuracy and precision of cardiac marker procedures. The document states that the device is "substantially equivalent" to a previously cleared predicate device, the "Liquichek Cardiac Markers Control" manufactured by Bio-Rad Laboratories (K961828).

Based on the provided text, the following information can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria (e.g., specific ranges for accuracy, precision, or recovery) or provide detailed performance data for the Dade® TRU-Liquid™ Cardiac Control device.

Instead, the core of the submission is a demonstration of substantial equivalence to a predicate device. This means the device is considered acceptable if it performs comparably to the predicate device for its intended use. The document affirms this substantial equivalence, but it does not present the direct experimental results that led to that conclusion for the new device.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The document refers to the predicate device (K961828) which would have had its own testing, but details on the testing of the Dade® TRU-Liquid™ Cardiac Control itself are absent from this summary.

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

This information is not applicable and not provided. The device is a quality control material, not a diagnostic device requiring expert interpretation of results to establish ground truth. Its "truth" is based on the known concentrations of analytes within the control material, which are then used to assess other diagnostic assays.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used for diagnostic devices where human interpretation or consensus is required for complex cases.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic devices that involve human readers interpreting medical images or data. The Dade® TRU-Liquid™ Cardiac Control is a quality control material for laboratory instruments/assays.

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

No, a standalone performance study (in the context of AI algorithms) was not done. This device is not an AI algorithm. Its performance is evaluated through its stability, homogeneity, and accuracy of assayed values when used to calibrate or check other diagnostic assays.

7. The Type of Ground Truth Used

For a quality control material like this, the "ground truth" would be the assigned or assayed values (known concentrations) of the cardiac markers within the control material itself. These values are typically established through rigorous analytical methods, often by the manufacturer using reference methods or certified reference materials. The purpose of the control is then to ensure that clinical laboratory instruments/assays accurately measure these known concentrations.

8. The Sample Size for the Training Set

This information is not applicable and not provided. A "training set" refers to data used to train machine learning models. This device is not an AI/ML device.

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

This information is not applicable and not provided, as there is no training set for this type of device.

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The Cardiac Troponin-I Calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

The Cardiac Troponin-I (TROP) Calibrator is a five level frozen product with target concentrations of 0, 2, 8, 25, and 55 ng/mL containing cardiac troponin-l in a buffered bovine protein matrix. The kit consists of five vials; two at each level.

This document is a 510(k) premarket notification for a medical device called the "Cardiac Troponin-I (TROP) Calibrator." It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present "acceptance criteria" in the traditional sense of performance metrics for an AI/device, nor does it report "device performance" in terms of accuracy, sensitivity, or specificity. Instead, the focus is on demonstrating substantial equivalence to a predicate device.

The "acceptance criteria" here are implicitly linked to the characteristics of the predicate device, the Stratus® Cardiac Troponin-I Calibrators, which the new device aims to match or be comparable to. The reported "device performance" is a comparison of features and intended use.

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

This type of information (sample size, data provenance from specific countries, retrospective/prospective studies) is not applicable to this document. This is a 510(k) submission for a calibrator, which is a reference material used to ensure the accuracy of a diagnostic test. It's not a diagnostic device itself that processes patient data or images. The "test set" in this context would refer to internal validation tests performed by the manufacturer, but details of such tests are not provided in this summary.

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

This information is not applicable. The device is a calibrator, not a diagnostic tool that requires expert-established ground truth from medical images or clinical data. The "ground truth" for a calibrator is its assigned value, which is determined through a rigorous manufacturing and quality control process using established analytical methods, not by expert medical consensus.

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

This information is not applicable. Adjudication methods are typically used in studies involving expert review of diagnostic interpretations, which is not relevant for a calibrator.

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. This document describes a calibrator, not an AI-powered diagnostic device. Therefore, no MRMC study or assessment of AI assistance to human readers would be performed or reported here.

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

This information is not applicable. This device is a biochemical calibrator, not an algorithm, so the concept of standalone algorithmic performance is not relevant.

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

The "ground truth" for the Cardiac Troponin-I (TROP) Calibrator is its assigned concentration value of cardiac troponin-I. This is established through the manufacturer's internal quality control processes, which would involve precise analytical measurements using reference methods and traceable standards. It is a chemical/analytical ground truth, not a medical or expert-based truth like pathology or outcomes data.

8. The sample size for the training set:

This information is not applicable. This device is a calibrator, not a machine learning model, so there is no "training set" in the context of data used to train an algorithm.

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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To determine gram-positive bacterial susceptibility against the antimicrobial agent Sparfloxacin. Organisms with indications for testing* include: Sparfloxacin Gram-Positive Bacteria Staphylococcus aureus

Microdilution Minimum Inhibitory Concentration (MIC) Panels

This document describes the acceptance criteria and the study that proves the MicroScan® Dried Gram-Positive MIC/Combo Panels with Sparfloxacin meet those criteria.

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

   Performance Metric	Acceptance Criteria (implied from predicate)	Reported Device Performance
   Essential Agreement	Substantially equivalent performance compared to NCCLS frozen Sparfloxacin Reference Panels (implied overall >90%)	98.4% overall Essential Agreement
   Reproducibility	Acceptable reproducibility and precision	Acceptable reproducibility and precision across inoculum methods (Turbidity, Prompt) and instruments (autoScan-4, WalkAway Systems)
   Quality Control	Acceptable Quality Control performance	Acceptable Quality Control performance

   Note: The specific numerical acceptance criteria for Essential Agreement were not explicitly stated in the provided text but are implied by the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991), which typically requires high agreement for such devices.

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

   • Sample Size: Not explicitly stated. The study used "fresh and stock Efficacy isolates and stock Challenge strains" for gram-positive external evaluations.
   • Data Provenance: Not explicitly stated, but given this is a US regulatory submission, it is highly likely the data was generated in the US or in compliance with US regulatory standards. The study appears to be prospective in the sense of evaluating the new Sparfloxacin panel against a reference standard in a controlled manner, though the originating isolates (efficacy and challenge strains) could have been collected retrospectively.

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

   • This is not applicable as the "ground truth" was established by a reference method (NCCLS frozen Sparfloxacin Reference Panels), not by individual expert consensus readings of data.

4. Adjudication method for the test set:

   • Not applicable, as the evaluation was a direct comparison to a reference standard, not an expert consensus process.

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 a study for an antimicrobial susceptibility device, not an AI-assisted diagnostic tool involving human readers.

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

   • Yes, this was a standalone performance study of the MicroScan® Dried Gram-Positive MIC/Combo Panels compared to a reference method. Human interpretation of the panel results is inherent to its use, but the study itself is evaluating the device's accuracy against a gold standard, not human performance with or without the device.

7. The type of ground truth used:

   • Reference Method: The "ground truth" was established by the NCCLS frozen Sparfloxacin Reference Panels. This is a recognized standard method for determining antimicrobial susceptibility.

8. The sample size for the training set:

   • Not applicable. This device is a diagnostic panel, not a machine learning algorithm that requires a training set in that context. The "development" of the panel would involve internal optimization, but there isn't a "training set" in the sense of AI/ML.

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

   • Not applicable (see point 8).

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Measurements of creatine kinase MB isoenzyme are used in the diagnosis and treatment of myocardial infaction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

The Dade Stratus® CK-MB Fluorometric Enzyme Immunoassay is an in vitro diagnostic test for the MB isoenzyme of creatine kinase. The assay can be processed on the Stratus® analyzer, the Stratus® II analyzer or the Stratus® IIntellect analyzer.

Here's a breakdown of the acceptance criteria and study details for the Stratus® CK-MB Fluorometric Enzyme Immunoassay, based on the provided document:

Acceptance Criteria and Device Performance Study

The primary purpose of this submission (K972782) was to expand the sample type for the already cleared Stratus® CK-MB Fluorometric Enzyme Immunoassay from human serum to human heparinized plasma samples. The acceptance criteria for this expansion focused on demonstrating substantial equivalence between the performance of the assay when using serum compared to heparinized plasma.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state pre-defined acceptance criteria in terms of specific ranges for slope, intercept, or correlation coefficient. Instead, it presents the results of a comparison study between serum and heparinized plasma, implying that acceptable performance is demonstrated by a strong correlation and a slope/intercept close to the ideal (slope of 1, intercept of 0) for method comparison.

Note: The "Acceptance Criteria" here are inferred based on typical expectations for method comparison studies to demonstrate substantial equivalence for a new sample type. The document does not explicitly state what ranges were considered acceptable prior to the study.

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

• Sample Size: 160 samples (referred to as "rats" in the table, which is highly likely a typo and should be "runs" or "samples"). Given the context of human serum and plasma, it's virtually certain these were human samples and not from actual rats.
• Data Provenance: The document does not specify the country of origin. The study was conducted as a comparison study between serum and heparinized plasma, supporting the market expansion. It is implied to be a prospective collection for the purpose of this comparison, although not explicitly stated as prospective or retrospective.

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

This type of submission, pertaining to a sample matrix expansion for an in vitro diagnostic (IVD) assay, does not typically involve expert review for ground truth in the way a diagnostic imaging device might. The "ground truth" for the test set is established by the measurements themselves using the existing, cleared assay on serum, and comparing those to measurements on heparinized plasma. The experts involved would be the laboratory personnel performing the assays, whose qualifications are not detailed but are assumed to be standard for a clinical laboratory.

4. Adjudication Method for the Test Set

Not applicable. This is not a study comparing human performance or interpretations, but rather an analytical comparison of an IVD assay's performance on different sample types.

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

No, an MRMC comparative effectiveness study was not done. This study is an analytical performance study comparing the assay's results across different sample matrices, not a study of human reader performance.

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

Yes, in a sense, a "standalone" analytical performance evaluation was performed. The Stratus® CK-MB Fluorometric Enzyme Immunoassay is an automated in vitro diagnostic test. The study evaluates the performance of this assay (the "algorithm/device") directly on different sample types without human interpretive intervention beyond running the test and analyzing the numerical output.

7. The Type of Ground Truth Used

The ground truth used for this comparison study is the measurement obtained from human serum samples using the already cleared Stratus® CK-MB assay. The heparinized plasma samples are then compared against these serum measurements to demonstrate equivalence. Essentially, the "ground truth" is the established measurement performance on the original, cleared sample type.

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" in the context of this submission. This is not a machine learning model, but rather an analytical device. The "training" for such a device involves its initial development and validation, which occurred prior to this 510(k) submission (for the original serum clearance).

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

Not applicable in the context of this submission. For an IVD, the initial "ground truth" during development involves rigorous analytical validation (e.g., accuracy, precision, linearity, interference, limit of detection) against reference methods or known concentrations, and then clinical correlation studies. The details of this prior validation are not part of this specific 510(k) submission which focuses on a sample type expansion.

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Dade TRU-Liquid Bilirubin Control is intended for use as an assayed quality control material in clinical laboratory quality assurance programs and in the monitoring of accuracy and precision.in the clinical laboratory assay of ... .. bilirubin.

Dade® TRU-Liquid™ Bilirubin Control Levels 1,2 and 3. Liquid Tri-Level Bilirubin Control. Quality Control Material (Assayed and Unassayed).

This is a 510(k) summary for a quality control material, not a medical device in the typical sense that would have performance criteria related to patient diagnosis or treatment. The acceptance criteria and "study" described are focused on demonstrating substantial equivalence to a predicate device, which is a different type of evaluation than assessing clinical performance.

Here's an analysis of the provided text in the context of your request:

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

The provided document does not contain a table of acceptance criteria or reported device performance in the way you might expect for a diagnostic or therapeutic device. Instead, the "acceptance criterion" for a 510(k) submission for a quality control material is substantial equivalence to an already legally marketed predicate device.

The document states:
"The proposed Dade® TRU-Liquid™ Bilirubin Control is substantially equivalent to the ChemTrak Liquid Bilirubin Control manufactured by Medical Analysis Systems, previously cleared under Document Control No., K833097, on 1/11/84."

Acceptance Criteria for Substantial Equivalence (Inferred):
The acceptance criteria for a quality control material like this would typically involve demonstrating that its characteristics (e.g., stability, commutability, assigned values, matrix effects) are comparable to the predicate device and that it performs its intended function (monitoring accuracy and precision of bilirubin assays) without raising new questions of safety or effectiveness. Specific numerical criteria are not provided in this summary.

Reported Device Performance:
The document does not provide numerical performance data for the Dade® TRU-Liquid™ Bilirubin Control itself. The "performance" assessment is implied through the claim of substantial equivalence.

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 explicitly stated in the provided 510(k) summary. For a quality control material demonstrating substantial equivalence, the "test set" would refer to the data collected to compare its characteristics with the predicate. This might involve running both controls on various bilirubin assay systems multiple times. However, the details of such a comparison study (sample size, data provenance) are not included in this high-level summary.

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 is not applicable to a quality control material in the same way it would be for an imaging or diagnostic device. "Ground truth" for a quality control material primarily relates to its assigned values, stability, and matrix characteristics, which are determined through laboratory testing and analytical methods, not typically by expert consensus of human readers.

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

This is not applicable, as there are no human readers or subjective interpretations involved in establishing the "ground truth" for a quality control material.

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 a quality control material for laboratory tests, 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

This is not applicable. The device is a quality control material, not an algorithm.

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

For a quality control material, the "ground truth" for its characteristics (e.g., assigned values for bilirubin, stability) would be established through analytical testing and reference methods in a laboratory setting. This involves precise measurements, calibration against primary standards (if available), and thorough characterization of the material itself. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable. Quality control materials do not typically have "training sets" in the context of machine learning or AI. Their characteristics are determined through analytical validation.

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

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

In summary:

The provided document is a 510(k) summary for a quality control material (Dade® TRU-Liquid™ Bilirubin Control). The primary "study" involved in its clearance is demonstrating substantial equivalence to a predicate device (ChemTrak Liquid Bilirubin Control). The information requested regarding AI performance, human reader studies, and training/test sets is not relevant to this type of device or its regulatory clearance process as described in this document.

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For quantitative determination of cholesterol or HDL cholesterol in plasma or serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein metabolism disorders'.

The Paramax® Cholesterol Reagent and DuPont aca Cholesterol Reagent are based on colormetic methodology.

The Paramax® Cholesterol Reagent demonstrated substantial equivalence to the DuPont aca Cholesterol Reagent through a correlation study.

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Cholesterol: 48 specimens
• HDL Cholesterol: 100 specimens
• Data Provenance: Not specified, but generally, such studies are retrospective using a collection of patient samples. The country of origin is not mentioned.

3. Number of Experts and Qualifications:

Not applicable. This study involves the comparison of reagent performance on quantitative measurements, not expert interpretation of diagnostic images or data.

4. Adjudication Method:

Not applicable. This is a quantitative comparison of two chemical assays, not a subjective interpretation requiring adjudication.

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

Not applicable. This is a comparison of two diagnostic reagents, not an AI-assisted human reader study.

6. Standalone Performance:

The provided information describes a comparative study between the Paramax® Cholesterol Reagent and a predicate device. While there isn't a separate "standalone" performance section explicitly detailing the Paramax®'s absolute accuracy against a gold standard in isolation, the comparison to a legally marketed predicate device is considered its standalone performance in a regulatory context for demonstrating substantial equivalence. The predicate device's performance would have been established independently.

7. Type of Ground Truth:

The ground truth is established by the measurements obtained from the predicate device, the DuPont aca Cholesterol Reagent. In essence, the predicate device serves as the reference standard against which the new device is compared. This type of ground truth can be considered a "reference method" comparison or "device-to-device" comparison.

8. Sample Size for the Training Set:

Not applicable. This is a validation study comparing two established methodologies/reagents, not a machine learning model requiring a training set.

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

Not applicable, as there is no training set for this type of validation study.

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To determine antimicrobial agent susceptibility

Microdilution Minimum Inhibitory Concentration (MIC) Panels, specifically MicroScan™ Dried Gram-Negative MIC/Combo Panels

Here's an analysis of the provided text regarding the acceptance criteria and study for the Dade MicroScan Inc. MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The text mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used, but the specific number is not provided.
• Data Provenance: The study involved "external evaluations." The country of origin is not specified, but the manufacturer is based in the US (West Sacramento, CA). The data is retrospective in the sense that existing "isolates" and "strains" were used, but the testing itself would be prospective.

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

• This type of study does not typically utilize human experts in the same way as an imaging or diagnostic AI study to establish ground truth.
• Ground Truth Establishment: The ground truth for antimicrobial susceptibility is established by the NCCLS Frozen Levofloxacin Reference Panels. These reference panels are standardized laboratory methods, not subjective expert interpretations. Therefore, the concept of "number of experts" and "qualifications of experts" does not directly apply here.

4. Adjudication Method for the Test Set:

• Adjudication methods like 2+1 or 3+1 are primarily relevant for human interpretation tasks where disagreements between experts need resolution.
• In this study, the comparison is made against a reference standard (NCCLS Frozen Levofloxacin Reference Panel). The "adjudication" is essentially a direct comparison of the MIC results from the MicroScan™ panel to the established MICs from the reference panel. There's no human adjudication process described.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret data, and the goal is to assess the impact of an AI tool on human performance (e.g., radiologists reading medical images).
• This submission describes a direct comparison of one in vitro diagnostic (IVD) device (MicroScan™ panel) against a reference standard (NCCLS Frozen Levofloxacin Reference Panel) to determine "substantially equivalent performance" in antimicrobial susceptibility testing. It does not involve human readers interpreting data that is then improved by AI.

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

• Yes, in the context of IVD performance, this is a standalone performance study. The MicroScan™ Dried Gram-Negative MIC/Combo Panels are an automated or semi-automated system designed to produce an MIC result. The "algorithm" here is the chemical and optical detection system within the MicroScan™ device itself, and its performance is evaluated independently against a reference method. There isn't a human actively "in the loop" interpreting the final MIC result from the MicroScan device in the same way a radiologist interprets an image generated by an AI tool.

7. The Type of Ground Truth Used:

• Reference Standard / Standardized Laboratory Method: The ground truth was established by the NCCLS Frozen Levofloxacin Reference Panels. NCCLS (National Committee for Clinical Laboratory Standards, now CLSI - Clinical and Laboratory Standards Institute) provides widely accepted, standardized methods for antimicrobial susceptibility testing. These reference panels are considered the gold standard for determining true MIC values.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided. This document describes a premarket notification for a specific product, not the development or training of a machine learning model. The MicroScan™ panels are a chemical/biological system. They are "developed" through R&D, but not "trained" in the machine learning sense with a distinct training set. The "external evaluations" represent verification and validation, not model training.

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

• Not Applicable. See point 8.

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The Paramax® Salicylate Reagent is intended for use as quantitative determination of salicylate in plasma and serum.

The Paramax® Salicylate Reagent is based on colormetric methodology.

{
  "acceptance_criteria_and_performance": {
    "table": [
      {
        "criterion": "Correlation with predicate device",
        "acceptance_level": "High correlation coefficient",
        "reported_performance": "Correlation coefficient = 0.999"
      },
      {
        "criterion": "Regression equation",
        "acceptance_level": "Regression equation indicating substantial equivalence",
        "reported_performance": "Paramax® value = (1.16 x aca value) - 1.8 mg/dL"
      }
    ],
    "study_summary": "The study demonstrated substantial equivalence between the Paramax® Salicylate Reagent and the DuPont aca Salicylate Reagent based on the high correlation coefficient (0.999) and a regression equation of Paramax® value = (1.16 x aca value) - 1.8 mg/dL."
  },
  "sample_size_test_set": 49,
  "data_provenance": "Not specified (likely clinical samples, but country/retrospective/prospective not mentioned in snippet).",
  "number_of_experts_ground_truth": "Not applicable; the ground truth for this comparison study was established by the predicate device (DuPont aca Salicylate Reagent).",
  "qualifications_of_experts": "Not applicable",
  "adjudication_method": "Not applicable",
  "mrmc_comparative_effectiveness_study": "No, this was a device-to-device correlation study, not an MRMC study involving human readers.",
  "standalone_performance_study": "Yes, the study evaluated the standalone performance of the Paramax® Salicylate Reagent by comparing its results to a predicate device's results on the same samples.",
  "type_of_ground_truth": "Predicate device's results (DuPont aca Salicylate Reagent). The predicate device's measurements are considered the reference for establishing substantial equivalence.",
  "sample_size_training_set": "Not applicable; this is a device validation study, not a machine learning model training.",
  "how_ground_truth_for_training_set_established": "Not applicable"
}

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