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The STA® - Coag Control (N + ABN) PLUS is a kit containing a normal plasma and an abnormal plasma intended for the quality control of the following tests on STA-R® and STA Compact analyzers: prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT).

The STA® - Coag Control (N + ABN) PLUS kit is a set of two control levels. Each kit provides: 12 x 2-ml vials of Reagent 1 (STA® - Coag Control N PLUS), citrated normal human plasma, lyophilized. 12 x 2-ml vials of Reagent 2 (STA® - Coag Control ABN PLUS), citrated abnormal human plasma, lyophilized. STA® - Coag Control (N+ ABN) PLUS Reagents are used as controls for clotting assays (PT, APTT, fibrinogen, and TT) and chromogenic assays (AT) performed on analyzers of the STA® line. Analyzers of the STA® line utilize the chronometric principle (viscosity based detection system) for clotting tests while the chromogenic assays are based on the photometric method (measurement of absorbance of monochromatic light).

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided document:

Device Name: STA® - Coag Control (N + ABN) PLUS

Device Intended Use: For the quality control of prothrombin time (PT), activated partial thromboplastin time (APTT), fibrinogen, thrombin time (TT), and antithrombin (AT) tests on STA-R® and STA Compact analyzers.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes "Precision" as the primary performance characteristic evaluated for this quality control device. The acceptance criteria are implicitly defined by the reported performance, as the study aims to demonstrate that the device performs equivalently to the predicate device and within acceptable analytical limits for precision in a clinical laboratory setting. While explicit numerical acceptance limits are not stated as "acceptance criteria," the study's results (CV%) are presented as demonstrating acceptable precision for a quality control material.

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

• The precision studies were performed according to CLSI guideline EP5-A2.
• Sample Size: The STA® - Coag Control N PLUS and ABN PLUS were tested for 20 days, 2 runs per day, in duplicate. This means for each analyte and control level, there were 20 (days) * 2 (runs/day) * 2 (duplicates/run) = 80 measurements.
• Data Provenance: The document does not specify the country of origin of the data. It is a prospective study, as it describes a specific testing protocol conducted to evaluate the device's performance.

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

This is a study evaluating the performance of a clinical laboratory quality control material, not a diagnostic device requiring expert interpretation of results. Therefore, the concept of "experts" establishing a "ground truth" for interpretation of test results is not applicable in the traditional sense. The "ground truth" for precision is the actual variability observed across repeated measurements, assessed using statistical methods.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretation of data (e.g., medical images) to resolve discrepancies among experts. This study evaluates the quantitative precision of a laboratory control material, which does not involve subjective interpretation or adjudication among multiple reviewers.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this device. This study evaluates the analytical performance (precision) of a quality control material used in in-vitro diagnostic assays, not the performance of an AI system, nor does it involve human readers or cases in the context of interpretation.

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

This is not an AI device or algorithm. The study evaluates the analytical performance of a quality control reagent on an automated analyzer. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.

7. The Type of Ground Truth Used

For this precision study, the "ground truth" is the statistical measure of variability (Coefficient of Variation, CV%) observed from repeated measurements of the control materials. There is no external "gold standard" or "definitive diagnosis" in the way one would refer to pathology for an imaging device. The performance is compared to generally accepted analytical performance standards for laboratory control materials and, implicitly, to the predicate device's expected precision.

8. The Sample Size for the Training Set

This study evaluates the analytical performance of a quality control material; it does not involve machine learning or a "training set" in the context of AI model development. The study is a direct performance evaluation.

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

As noted above, this study does not involve a training set as it is not an AI device.

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The STA Compact Max® is a fully automatic clinical analyzer designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Diagnostica Stago's STA Compact Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA Compact® analyzer (K093167). It performs tests which aid in the diagnosis of Haemostatic disorders and the monitoring of anticoagulant treatment. The device consists of a cuvette, a metal ball, three needles, oscillation amplitude detection, a light source and sensor, and software.

The STA Compact Max® is a modified version of the legally marketed device, STA Compact® (K093167). The modifications primarily involve updates to the onboard computer, operating system, and user interface, as well as minor external design changes. The company claims that these modifications do not alter the fundamental technological characteristics, principles of operation, or performance of the device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) for the STA Compact Max®. Instead, the acceptance criteria are implicitly stated through the claim of "comparable performances" to the predicate device and the assertion that "no new questions were raised regarding the Safety, Effectiveness, Performance, Indication for Use, Technology and the Principles of Operation."

The device performance is described as:

The essential acceptance criterion is that the STA Compact Max® demonstrates "comparable performances" to the predicate device (STA Compact® K093167) despite the internal and external modifications. The study performed aims to demonstrate this equivalence. The specific performance metrics (e.g., precision, accuracy, linearity) that were likely evaluated to establish "comparable performances" are not detailed in the provided summary, but would have been part of the Verification and Validation utilized as part of the Design Controls.

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

The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It refers to "Validation Studies" and "Risk Assessment" but does not provide details of these studies. Given that this is a Special 510(k) for modifications to an existing device, the focus is on demonstrating that the changes do not adversely affect performance. The validation studies would have focused on verifying that the new hardware and software components perform as expected and do not introduce new risks or alter the previously established performance characteristics of the predicate device.

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. For a coagulation analyzer, "ground truth" would typically be established by comparing results to reference methods, other established analyzers, or clinical outcomes, perhaps interpreted by medical professionals. However, the details of expert involvement are not mentioned in this summary.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable to the STA Compact Max® device. This device is an automated clinical analyzer for in vitro coagulation studies and does not involve human readers interpreting images or data with AI assistance. It performs measurements directly on plasma samples.

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

The STA Compact Max® is an automated device, meaning it operates in a standalone manner without human-in-the-loop performance influencing its measurement results. The results are generated by the instrument's mechanical, optical, and software components. Human interaction is primarily for loading samples, reagents, and interpreting the output. So, in essence, its core function is "algorithm only" in terms of its diagnostic output. However, the document doesn't explicitly describe a separate "standalone study" in the context often associated with AI diagnostic algorithms. Rather, its inherent operation is standalone.

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

The document does not explicitly state the type of ground truth used for the validation studies. However, for coagulation analyzers, ground truth often involves:

• Reference methods: Comparing results to established, highly accurate laboratory reference methods.
• Certified reference materials/standards: Using materials with known analyte concentrations.
• Comparison to predicate device: A primary method in a 510(k) where modifications are made to an existing device. The performance of the modified device would be compared against the predicate device using patient samples and quality control materials.

The study's goal was to demonstrate "comparable performances" to the predicate device, implying that the predicate's performance served as a de-facto 'ground truth' or benchmark for the new device.

8. The Sample Size for the Training Set

This information is not provided and is generally not applicable in the same way it would be for machine learning or AI-based devices. The "training" for this type of device involves engineering design, calibration, and verification/validation processes rather than a data-driven training set for an algorithm to learn from. The software migration and new graphical user interface were likely developed and tested against defined functional requirements rather than a "training set."

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

As explained above, the concept of a "training set" with established ground truth is not directly applicable to this type of automated medical device in the same way it is for AI algorithms. The "ground truth" for the development and testing of the device's components (hardware, firmware, and software) would be based on engineering specifications, physical laws, chemical reactions, and established principles of coagulation measurement, rather than a dataset with labeled medical conditions. The previous STA Compact® (predicate device) and its proven performance would serve as the benchmark for how the new device should function and deliver results.

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The STA® - Liquid Anti-Xa kits are intended for use with STA-R®, STA Compact® and STA Satellite® analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

The STA® - Multi Hep Calibrator is a set of calibrator plasmas intended for use with STA-R®, STA Compact®, and STA Satellite® analyzers, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity.

The STA® - Quality HNF/UFH kit is a set of two plasmas intended for the quality control of unfractionated heparin (UFH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact®, and STA Satellite® analyzers.

The STA® - Quality HBPM/LMWH kit is a set of two plasmas intended for the quality control of low molecular weight heparin (LMWH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact, and STA Satellite® analyzers.

The STA® - Liquid Anti-Xa is a chromogenic assay technique used for determination of the level of UFH and LMWH that have high affinity for antithrombin by measuring their anti-Xa activity. The method is a one-step reaction based on a similar principle: as soon as factor Xa is added to the plasma-substrate mixture, two reactions take place simultaneously, namely, hydrolysis of the substrate by factor Xa and inhibition of factor Xa by the heparin-antithrombin complex. After the necessary period of time for the competitive reaction to reach equilibrium, the quantity of paranitroaniline that is released is inversely proportional to the concentration of heparin present in the test medium.

The STA® - Multi Hep Calibrator reagents are lyophilized human plasmas at five different heparin concentrations. They are used to create the calibration curve on STA-R®, STA Compact®, and STA Satellite® analyzers performing the chromogenic method for heparin (UFH and LMWH) using STA® - Liquid Anti-Xa.

The STA® - Quality HNF/UFH reagents are lyophilized human plasmas at two different UFH concentrations. They are used for the quality control of UFH activity assay by measuring the anti-Xa activity using the chromogenic method STA® - Liquid Anti-Xa performed on STA-R®, STA Compact®, and STA Satellite® analyzers.

The STA® - Quality HBPM/LMWH reagents are lyophilized human plasmas at two different LMWH concentrations. They are used for the quality control of LMWH activity assay by measuring the anti-Xa activity using the chromogenic methods, STA® - Liquid Anti-Xa and STA® - Rotachrom® Heparin, performed on STA-R®, STA Compact, and STA Satellite® analyzers.

The provided document describes the 510(k) summary for several in vitro diagnostic devices for measuring heparin activity. The document focuses on demonstrating substantial equivalence to predicate devices through performance characteristics, rather than establishing acceptance criteria and proving them with a specific study with a defined ground truth, as would be common for AI/ML device submissions.

Therefore, many of the requested elements (e.g., test set sample size, data provenance, number of experts for ground truth, adjudication method, MRMC study, training set details) are not applicable or not explicitly detailed in this type of submission.

However, I can extract information related to performance characteristics that serve as "acceptance criteria" for the device, and the studies performed to demonstrate these.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance characteristics of the STA® - Liquid Anti-Xa device (and its associated calibrator and controls) through precision and detection limit/working range studies. The "acceptance criteria" are implied by the ranges and values obtained, showing performance similar or superior to predicate devices or within acceptable analytical limits for IVD assays.

• Sample 1 (mean 0.21 IU/mL): Repeatability CV 6.2%, Within-lab CV 9.9%
• Sample 2 (mean 0.55 IU/mL): Repeatability CV 3.1%, Within-lab CV 6.6%
• Sample 3 (mean 0.97 IU/mL): Repeatability CV 3.4%, Within-lab CV 5.5%
  LMWH Samples:
• Sample 4 (mean 0.86 IU/mL): Repeatability CV 3.1%, Within-lab CV 4.8%
• Sample 5 (mean 1.48 IU/mL): Repeatability CV 3.0%, Within-lab CV 5.1%
• Sample 6 (mean 1.75 IU/mL): Repeatability CV 2.9%, Within-lab CV 5.0% | Performed according to CLSI guideline EP5-A2 over 22 days, 2 runs/day. |
  | Precision (Dedicated Calibration - 3-point UFH) | CV% values within acceptable analytical limits. | UFH Samples:
• Sample 1 (mean 0.22 IU/mL): Repeatability CV 5.6%, Within-lab CV 9.2%
• Sample 2 (mean 0.55 IU/mL): Repeatability CV 3.0%, Within-lab CV 6.1%
• Sample 3 (mean 0.97 IU/mL): Repeatability CV 3.5%, Within-lab CV 5.1% | Similar study design to hybrid calibration. |
  | Precision (Dedicated Calibration - 3-point LMWH) | CV% values within acceptable analytical limits. | LMWH Samples:
• Sample 4 (mean 0.86 IU/mL): Repeatability CV 3.2%, Within-lab CV 5.2%
• Sample 5 (mean 1.48 IU/mL): Repeatability CV 3.1%, Within-lab CV 5.3%
• Sample 6 (mean 1.75 IU/mL): Repeatability CV 2.8%, Within-lab CV 5.1% | Similar study design to hybrid calibration. |
  | Detection Limit (UFH/LMWH 5-point calibration) | Detection threshold should be clinically relevant for heparin monitoring. | 0.10 IU/mL (UFH and LMWH) | Assessed according to CLSI guideline EP17-A. |
  | Linearity Range (UFH/LMWH 5-point calibration) | Linearity range should cover the clinically relevant range for heparin monitoring. | UFH: up to 1.10 IU/mL; LMWH: up to 2.00 anti-Xa IU/mL | Assessed according to CLSI guideline EP6-A. |
  | Detection Limit (UFH 3-point calibration) | Detection threshold should be clinically relevant. | 0.10 IU/mL | Assessed according to CLSI guideline EP17-A. |
  | Linearity Range (UFH 3-point calibration) | Linearity range should cover the clinically relevant range. | up to 1.10 IU/mL | Assessed according to CLSI guideline EP6-A. |
  | Detection Limit (LMWH 3-point calibration) | Detection threshold should be clinically relevant. | 0.10 anti-Xa IU/mL | Assessed according to CLSI guideline EP17-A. |
  | Linearity Range (LMWH 3-point calibration) | Linearity range should cover the clinically relevant range. | up to 2.00 anti-Xa IU/mL | Assessed according to CLSI guideline EP6-A. |
  | Interfering Substances | No significant interference from common endogenous substances at clinically relevant concentrations. | Insensitive to: hemoglobin (up to 1.5 g/l), conjugated bilirubin (up to 288 mg/l), unconjugated bilirubin (up to 138 mg/l), triglycerides (up to 6.9 g/l). | Performed according to CLSI guideline EP7-A2. |

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

• Test set sample size: For precision studies, 6 heparin samples (3 UFH, 3 LMWH) were used for each calibration type (hybrid and dedicated). For the detection limit and linearity studies, specific sample numbers are not provided but are implicit in the CLSI guidelines (EP17-A and EP6-A) which typically involve multiple replicates across different concentrations. For interfering substances, the number of samples is not explicitly stated, but the study tested specific concentrations of key interferents.
• Data provenance: Not explicitly stated, but given this is an in vitro diagnostic device for global markets, the samples would likely be prepared laboratory controls and patient plasma samples (for linearity, detection limit, and interference studies), not geographically defined "countries of origin" in the same way as imaging data. The studies are prospective in the sense that they are designed experiments to validate performance.

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

• Not applicable (N/A) in the context of this IVD device. The "ground truth" for these types of assays is established by the known concentrations of calibrators, controls, and spiked samples, or by reference methods, not by expert interpretation.

4. Adjudication method for the test set:

• N/A. Adjudication is not relevant for analytical performance studies of quantitative IVD assays.

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

• No. This is an in vitro diagnostic device, not an AI/ML-driven interpretive device typically associated with MRMC studies.

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

• Yes, this is a standalone device. The performance characteristics (precision, detection limits, linearity, interference) are determined for the algorithm/device only. Human involvement is in operating the analyzer and interpreting the numerical results, but the analytical performance itself is inherent to the device.

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

• For precision, linearity, and detection limit, the ground truth is established by the known concentrations of the calibrators and control plasmas, or by accepted reference methods for heparin activity (e.g., anti-Xa activity).
• For interfering substances, the ground truth is the addition of specific interfering agents at known concentrations to samples, and then assessing if the device's measurement of heparin is accurately maintained.

8. The sample size for the training set:

• Not applicable (N/A) in the AI/ML sense. This is a traditional IVD device using established chromogenic assay principles, not an AI/ML system that requires a "training set" to learn. The method relies on biochemical reactions and quantitative measurement.

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

• N/A for the same reason as point 8.

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The STA® - Hybrid Hep Calibrator is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity using the chromogenic method, STA® - Rotachrom® Heparin.

The STA® Hybrid Hep Calibrator is a set of lyophilized human plasmas used to create the calibration curve on the STA® line of IVD instruments performing the chromogenic method for heparin (UFH and LMWH) assays. Each STA® Hybrid Hep Calibrator available contains: 4 x 1-ml vials of Reagent 1: STA® Hybrid Hep Calibrator O lyophilized human plasma free of heparin. 4 x 1-ml vials of Reagent 2: STA® Hybrid Hep Calibrator 3 lyophilized human plasma containing a well-defined quantity of UFH. 4 x 1-ml vials of Reagent 3: STA® Hybrid Hep Calibrator 6 lyophilized human plasma containing a well-defined quantity of UFH that is greater than that of Reagent 2. 4 x 1-ml vials of Reagent 4: STA® - Hybrid Hep Calibrator 9 lyophilized human plasma containing a well-defined quantity of LMWH. 4 x 1-ml vials of Reagent 5: STA® Hybrid Hep Calibrator 18 lyophilized human plasma containing a well-defined quantity of LMWH that is greater than that of Reagent 4.

The provided text describes a 510(k) summary for the STA® - Hybrid Hep Calibrator, a medical device. This submission seeks to bundle two previously cleared devices (STA® - Hepanorm® H and STA® - Calibrator HBPM/LMWH Kit) into a single kit. The document focuses on demonstrating substantial equivalence to these predicate devices for regulatory purposes.

Therefore, the document does not contain information about:

• Specific acceptance criteria for device performance (e.g., accuracy, precision) as typically defined in a clinical study.
• A formal study that proves the device meets specific acceptance criteria in terms of measured performance metrics.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness studies, standalone performance, or grand truth types.
• Training set sample sizes or how their ground truth was established, as this is a calibrator device and not an AI/ML diagnostic system.

The document states that the STA® - Hybrid Hep Calibrator and its predicate devices are "identical products regarding indication/intended use, formulation or materials of construction and design, technology, and safety." The primary difference is the bundling of two existing calibrators into one kit. The substantial equivalence argument relies on the fact that no new questions of safety, effectiveness, or technology are raised due to this bundling.

Essentially, the "study" proving the device meets acceptance criteria is implied by its substantial equivalence to previously cleared devices. The acceptance criteria, in this regulatory context, are primarily that the bundled calibrator performs equivalently to the two separate predicate calibrators, which have already been deemed safe and effective.

Summary of available information related to device performance and regulatory acceptance:

Information not available in the provided text:

• Sample sized used for the test set and the data provenance: Not applicable in this context as this is a calibrator, not a diagnostic algorithm. Performance is assessed through equivalence to existing calibrators.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a calibrator device, not an algorithm.
• The type of ground truth used: For calibrators, ground truth typically refers to the accurately assigned values of the analytes (UFH and LMWH in this case) within the calibrator plasmas. The text states the plasmas contain "well-defined quantity of UFH" and "well-defined quantity of LMWH", implying these values are established and verified during manufacturing of the calibrator materials.
• The sample size for the training set: Not applicable as this is not an AI/ML device.
• How the ground truth for the training set was established: Not applicable.

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The STA Compact® Automated Multi-Parametric Analyzer is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA Compact Automated Multi-Parametric Analyzer is designed as a fully automatic system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, support for instrument maintenance, and work load optimization. The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators, and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents. The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. chronometric) measurements and photometric assays (at specific wavelengths) on plasma samples. The STA Compact® is the modified version of the Company's STA Compact® (K961579), legally marketed Predicate Device. The modification of the device involves replacement of components for reliability of operation or obsolescence reasons, change in the device application software to provide operator/user use enhancements and modification of the data post-processing to increase results reliability.

The provided text describes a special 510(k) submission for a modified medical device, the STA Compact® Automated Multi-Parametric Analyzer. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets a specific set of new acceptance criteria through a standalone study with detailed performance metrics.

The core of the submission revolves around the modification of an already legally marketed device. Therefore, the "acceptance criteria" discussed are largely centered on demonstrating that the modifications do not introduce new risks or alter the fundamental performance, operation, or safety profile of the device, rather than establishing entirely new performance benchmarks.

Here's an attempt to extract and infer the requested information, acknowledging that a direct "acceptance criteria table" with specific numerical targets and direct "device performance" results for new criteria is not explicitly present in the provided text. The "study" referenced is a "Validation Study" conducted as part of the Risk Assessment to demonstrate substantial equivalence.

Acceptance Criteria and Device Performance for Modified STA Compact® Automated Multi-Parametric Analyzer (K093167)

The provided document describes a special 510(k) submission for modifications to the STA Compact® Automated Multi-Parametric Analyzer. The primary goal of this submission is to demonstrate substantial equivalence to its predicate device (STA Compact® K961579), rather than establishing new, independent acceptance criteria against specific numerical performance targets for an entirely new device. The "acceptance criteria" here are therefore interpreted as demonstrating that the modified device's performance is comparable to the predicate and that the modifications do not negatively impact safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated in the provided text. The document refers to "Validation Studies" and "Risk Assessment" but does not give specific numbers of samples or cases used in these studies.
• Data Provenance: Not explicitly stated. Given it's a modification to an existing device, it's likely internal validation data, potentially using both retrospective and prospectively generated samples. The country of origin is not mentioned.

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

This information is not provided in the document. For an IVD device like this, ground truth would typically come from existing diagnostic methods or certified reference materials, not necessarily expert consensus on complex image or clinical data.

4. Adjudication Method for the Test Set

This information is not provided in the document. It is unlikely to be relevant in the traditional sense of human adjudication for an automated IVD instrument performing coagulation tests, where ground truth is typically established by laboratory reference methods.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned and is not applicable to this type of device. The STA Compact is an automated in vitro diagnostic (IVD) instrument; it does not involve human "readers" interpreting output in the way an AI-assisted diagnostic imaging device would. The "AI" component described is specifically for hook effect detection and re-dilution, which is an enhancement to the instrument's automated analytical capabilities, not an assistance tool for human interpretation.

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

Yes, the device operates in a standalone (algorithm only) manner for its primary function. The modifications, particularly the hook effect detection, are enhancements to its automated analytical capabilities without human intervention during the testing process itself. The document implicitly supports standalone performance by describing it as a "fully automatic clinical instrument."

7. The Type of Ground Truth Used

The ground truth for performance validation of an automated coagulation analyzer would typically be established using:

• Reference laboratory methods: Established and validated laboratory techniques for measuring coagulation parameters.
• Reference materials/calibrators: Certified reference materials or calibrator values.
• Clinical correlation: Comparison to established clinical diagnoses or patient outcomes, especially for demonstrating the utility of results in aiding diagnosis of coagulation abnormalities or monitoring anticoagulant therapy.
  The document does not explicitly state the specific type of ground truth used for the validation studies, but these are standard for IVD devices.

8. The Sample Size for the Training Set

This information is not provided in the document. For an IVD instrument with embedded software algorithms and data post-processing, "training set" might refer to data used during software development and algorithm refinement. The document focuses on the validation studies for the final modified device.

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

This information is not provided in the document. Similar to point 7, ground truth for training (if applicable) would likely follow standard IVD validation practices, but the specifics are not detailed.

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The STA® - Liatest® Free PS kits are intended for use with analyzers of the STA® line suitable with these reagents for the antigenic assay of free Protein S in plasma by the immuno-turbidimetric method.

The STA® - Liatest® Free PS test kit is comprised of a suspension of latex microparticles coated with two (2) different mouse monoclonal anti-human free protein S antibodies stabilized with bovine albumin. Also in the test kit is an HEPES buffer. Testing is carried out in citrated human plasma via the immunoturbidimetric method utilizing external calibrator plasmas for the STA® - Liatest Free PS (the predicate device is pre-calibrated, not utilizing external calibrator plasmas).

Here's an analysis of the provided text regarding the STA® - Liatest® Free PS device, focusing on acceptance criteria and study information.

It's important to note that the provided documents are a 510(k) Summary and an FDA clearance letter. These typically focus on demonstrating substantial equivalence to a predicate device rather than detailing specific de novo clinical study results, acceptance criteria, and performance for this specific device modification as if it were a new device. The provided text does not include detailed acceptance criteria or a dedicated study proving performance against such criteria in the way a clinical trial might for a novel device. Instead, it highlights the device's technological characteristics and argues for substantial equivalence to a previously cleared predicate device.

Therefore, the answers below are derived from the information available and will reflect the nature of a 510(k) submission, which often relies on comparison to a predicate rather than extensive new performance studies for minor modifications.

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not present specific, quantitative acceptance criteria (e.g., minimum sensitivity, specificity, accuracy targets) for the modified STA® - Liatest® Free PS device, nor do they report detailed performance results against such criteria. The primary "performance" being assessed here is its equivalence to the predicate device.

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

The documents do not mention a specific "test set" and sample size for performance evaluation in the context of a new clinical study for this modified device. The determination of substantial equivalence relies on comparing the modified device's characteristics to those of the predicate device.

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified, as a new study with a specific data set for the modified device's performance is not detailed.

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

This information is not provided. Given that this is a 510(k) for a modification (calibration method) to an in-vitro diagnostic device, and not a de novo submission requiring extensive new clinical validation of diagnostic accuracy, expert consensus for ground truth on a new test set would not typically be a primary focus. The focus is on ensuring the calibration change does not negatively impact the performance established by the predicate.

4. Adjudication Method for the Test Set

Not applicable, as no new test set requiring expert adjudication for ground truth is described in the provided text.

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

Not applicable. This device is an in-vitro diagnostic (IVD) kit for measuring Protein S in plasma using an automated analyzer (STA® line). It is not an AI-assisted diagnostic tool that involves human readers interpreting images or results, nor is it a device that would undergo an MRMC study.

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

This refers to an IVD device's standalone performance, which is inherent in its operation. The device is a "kit" that works with analyzers of the STA® line. Its performance would be based on its ability to accurately measure free Protein S. While the document asserts substantial equivalence, it doesn't detail a standalone performance study with specific metrics (e.g., precision, accuracy, linearity) for this specific modification's impact. Such studies would typically be part of the product development and validation for the modified device, but their results are summarized as "no new questions in safety, effectiveness, or technology" rather than presented in detail in the 510(k) summary.

7. The Type of Ground Truth Used

For an IVD device like this, "ground truth" typically refers to:

• Accurate analyte concentrations: Established through reference methods, certified calibrators, or internal validation processes.
• Clinical outcomes: Correlating measurements with patient disease status (e.g., deficiency vs. normal).

The document implies that the ground truth for establishing the performance of the predicate device (which the modified device is compared to) would have involved such methods. For the modified device, the "ground truth" for demonstrating equivalence would revolve around showing that the new calibration method yields results consistent with the predicate device and accurately reflects the concentration of Free Protein S. The mention of "external calibrator plasmas" for the modified device suggests that its calibration curve is established against known concentrations using these calibrators.

8. The Sample Size for the Training Set

The concept of a "training set" is primarily relevant for machine learning or AI-driven devices. This IVD kit does not involve a machine learning algorithm that is "trained" on a dataset in the conventional sense. Its "training" involves the use of calibrators to establish a standard curve for quantitative measurement, but this is a different paradigm from AI training. Therefore, a "training set sample size" as commonly understood in AI/ML is not applicable.

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

As explained above, there is no "training set" in the AI/ML sense. For the calibration process, the "ground truth" is established by the Diagnostica Stago's STA® - Free PS Calibrator which are presumably plasmas with known, verified concentrations of free Protein S. The process of how those calibrator values were established (e.g., against a recognized reference method or material) is not detailed in these documents but would be part of the manufacturer's quality system and product development.

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STA-R Evolution® Expert Series Hemostasis System is a fully automatic clinical instrument designed to perform tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA-R Evolution® Expert Series Hemostasis System is designed as a fully automatic system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, support for instrument maintenance, and work load optimization. The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators, and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents. The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. chronometric) measurements and photometric assays (at specific wavelengths) on plasma samples.

The provided text describes modifications to an existing device, the STA-R Evolution® Expert Series Hemostasis System, and asserts its substantial equivalence to a predicate device. However, it does not provide a specific study with acceptance criteria, reported device performance, sample sizes, expert details, or ground truth methodologies that would typically be found in a detailed validation report.

Instead, the document focuses on regulatory approval (510(k) submission) by demonstrating that the modified device has:

• The same Indications for Use.
• The same Technology.
• The same Principles of Operation.
• "Comparable Performances" to the predicate device.

The modifications are stated to "Presult in better performance" due to new hardware/mechanical components, software updates for user enhancements, data post-processing for increased reliability, and bug corrections. It also mentions a "new option of Reverse Sequence Drilling Mode (referred to as PTB)" to increase results reliability when using capped tubes.

The document explicitly states: "Nevertheless, there are no new questions regarding the Safety, Effectiveness, Technology, Principles of Operation and Performance as evidenced by Risk Assessment and Validation Studies (including all the changes mentioned above." This implies that validation studies were performed, but the details of those studies (e.g., acceptance criteria, specific performance metrics, sample sizes, ground truth) are not included in this summary.

Therefore, I cannot provide the requested table and details because the information is not present in the provided text. The document acts as a summary for a 510(k) submission, confirming the existence of validation studies without detailing their results or methodology.

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STA® - Free PS Calibrator kit is a set of calibrator plasmas intended for use with analyzers of the STA® line suitable to these reagents for the calibration of free protein S assays by the immuno-turbidimetric method, STA® - Liatest® Free PS.

The STA® - Free PS Calibrator kit is a set of lyophilized human plasmas used to create the calibration curve on an IVD instrument performing the immunoturbidimetric method for free protein S assays, STA® - Liatest® Free PS. Such IVD instruments being the STA® product line of medical device analyzers such as STA-R® and STA Compact®.

In the lyophilized state and uncompromised primary packaging, the product calibrator plasmas remain stable for a period of 18 months from the date of manufacture when stored at 2 - 8°C. In the reconstituted state, STA® - Free PS Calibrator have demonstrated to be stable for 4 hours on board STA-R® and STA Compact®.

The provided text describes the 510(k) premarket notification for the STA® - Free PS Calibrator. While it details the device's intended use, technological characteristics, and substantial equivalence to a predicate device, it does not include a specific study or detailed data proving the device meets acceptance criteria.

The text states, "performance data enclosed in this notice further demonstrates suitability for the intended use," but this data is not present in the provided excerpts. As such, I cannot create a table of acceptance criteria and reported device performance, nor can I provide details on sample sizes, ground truth establishment, or specific study types.

However, based on the available information, I can address some of the requested points if such a study were described:

1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not present in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present in the provided text.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This is a calibrator for an in-vitro diagnostic test, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be applicable to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a calibrator, not an algorithm. Therefore, a standalone performance study in the context of "algorithm only" is not applicable. However, the text mentions "performance data enclosed in this notice further demonstrates suitability for the intended use," which would imply standalone performance data for the calibrator itself, likely focusing on its ability to establish a correct calibration curve and maintain stability. The specifics of this performance data are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a calibrator, the "ground truth" typically involves reference values or certified reference materials against which the calibrator's assigned values are validated. The text does not explicitly state how the ground truth for the performance data (mentioned but not included) was established, but it would involve comparing the calibrator's output to known, highly accurate reference standards.
8. The sample size for the training set: This is a calibrator device, not a machine learning algorithm that requires a "training set" in the conventional sense. Performance evaluation would involve evaluating the calibrator's characteristics (e.g., linearity, stability, accuracy of assigned values) using multiple lots, instruments, and potentially comparison to established reference methods or predicate devices. The relevant "sample size" for such an evaluation is not provided.
9. How the ground truth for the training set was established: As mentioned in point 8, a "training set" in the AI/ML context is not applicable. For a calibrator, its "ground truth" (i.e., its assigned values and performance characteristics) would be established through a rigorous process of metrological traceability, often involving primary reference materials or international standards for free protein S. The text does not detail this process for the STA® - Free PS Calibrator.

In summary, while the document confirms the device's intended use and the FDA's substantial equivalence determination, it does not provide the specific performance data or a detailed study description that would allow for the complete fulfillment of your request regarding acceptance criteria and their proof.

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The STA Satellite™ Automated Multi-Parametric AnalyzerSatellite® Automated Multi-Parametric Analyzer is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA Satellite® Automated Multi-Parametric Analyzer is designed as a fully automatic bench-top system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, system supervision, support for instrument maintenance, and work load optimization. The STA Satellite® is the bench-top version of the company's STA-R®, legally marketed predicate device.

The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators, and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents.

The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. Chronometricchronometric) measurements and photometric assays (at specific wave lengths) on plasma samples. The principle of the chronometric method consists in measuring the variation of the oscillation amplitude of the ball (in the cuvette). A decrease in oscillation amplitude corresponds to an increase in the viscosity of the media (i.e. ., coagulation). The principle of the photometric measurements on the instrument is based on measured absorbance (also referred to as Optical Density, or OD) of monochromatic light of predetermined wavelength passing through the cuvette as a (clotting) reaction takes place.

The provided text describes a 510(k) summary for the STA Satellite® Automated Multi-Parametric Analyzer, a modified version of the STA-R® device, intended for in vitro coagulation studies.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: The document states that "Test samples were analyzed in duplicate on the STA -Satellite and the STA-R." However, the number of test samples or the total number of subjects from which these samples were derived is not specified in the provided text.
• Data Provenance:
  • Country of Origin: The validation study was performed at "an internal site and two external sites." The direct country of origin for these sites is not explicitly stated. However, the submitter, Diagnostica Stago, Inc., is based in Parsippany, New Jersey, USA. The predicate device manufacturer, Diagnostica Stago SAS, is likely based in France given the "CE Marked" status of the device and its commercialization in France since September 2004. It's plausible that one or more sites were in the USA, and potentially one in France, but this is an inference, not a direct statement.
  • Retrospective or Prospective: The text does not explicitly state whether the study was retrospective or prospective. The phrasing "Test samples were analyzed" suggests a prospective collection and analysis for the validation study.

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

This information is not provided in the text. The study focuses on method comparison between two instruments rather than an expert-adjudicated ground truth for patient diagnoses.

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

This information is not applicable and therefore not provided, as the study is a method comparison and does not involve adjudication of expert interpretations for a ground truth.

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:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an automated instrument for performing coagulation tests, not an AI or imaging diagnostic tool that would involve human readers interpreting results with or without AI assistance.
• Effect Size: Therefore, there is no information on the effect size of human reader improvement with AI assistance.

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

Yes, the study described is a standalone performance study of the instrument itself. The device is an "Automated Multi-Parametric Analyzer," meaning it performs the analysis automatically. The "Performance Data" section describes a comparison of the STA Satellite® instrument's results to those of the STA-R® predicate device, indicating the algorithm/instrument's performance in isolation.

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

The "ground truth" in this study is the results obtained from the predicate device, STA-R®. The study's objective was to demonstrate substantial equivalence by showing that the STA Satellite® produces statistically similar results to the legally marketed STA-R®. This is a method comparison study, where the established method (predicate device) serves as the reference.

8. The sample size for the training set:

This information is not provided in the text. The document describes a validation study comparing the new device to a predicate, not the internal development or "training" of a machine learning algorithm. If there was any internal development or calibration, the details are not included here.

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

This information is not provided as there is no mention of a training set or ground truth in the context of training for this medical device's performance validation. The study focuses on direct comparison to a predicate device's measured results.

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The STA-R® Evolution (or STA-R®) Automated Multi-Parametric Analyzer is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasmas, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA-R® Automated Multi-Parametric Analyzer is designed as a fully automatic system. Samples and test reagents are loaded into the instrument where sample handling, reagent delivery, analysis, and reporting of results are performed automatically. A central processing unit controls instrument functions such as, management of patient results, quality control, system supervision, support for instrument maintenance, and work load optimization. The STA-R® Evolution is the modified or updated version of the company's STA-R®, legally marketed predicate device. The modification of the device involves the upgrade of the instrument's operating system from Windows NT to the Windows XP platform. Slight modifications to the application software were made to accommodate the new operating system along with operator/user enhancements but without logic configuration changes.

The instrument utilizes Diagnostica Stago reagents in addition to open adaptation of other currently available reagents. Barcoding of test reagents, calibrators, and controls facilitate their use on the system and permits reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents.

The instrument performs multiple test methodologies in random access as selected by the user. These include clotting time or clot-based tests (i.e. chronometric) measurements and photometric assays (at specific wave lengths) on plasma samples. The Technological Characteristics and Principles of Operation for the aforementioned analyses are the same between the subject submission device and the predicate device.

This document describes a Special 510(k) Notice for a modification to the STA-R® Automated Multi-Parametric Analyzer, updating its operating system from Windows NT to Windows XP. The information provided is for a regulatory submission and does not contain detailed acceptance criteria, study data tables, or specific performance metrics as requested.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that a "validation study" was performed and that the device "demonstrate[s] that the STA-R® Evolution is as safe and effective as the predicate device." However, no specific acceptance criteria (e.g., sensitivity, specificity, accuracy, precision thresholds) or corresponding reported device performance metrics are provided in the text. This is a deficiency in the provided information for the requested table.

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

The document mentions a "validation study" but does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data).

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 or any details about their qualifications. This is expected for an IVD device where ground truth is typically based on laboratory-derived measurements rather than expert human interpretation of images or clinical data.

4. Adjudication Method for the Test Set:

The document does not mention any adjudication method for establishing ground truth, as it's not applicable to the type of device (automated instrument) and its validation as described.

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

A MRMC study was not performed and is not relevant for this type of IVD device. The device is an automated instrument, not an AI intended to assist human readers with interpretation.

6. Standalone Performance Study:

Yes, a standalone study was inherently performed. The "validation study" mentioned would assess the performance of the STA-R® Evolution instrument itself. The purpose of the validation was to demonstrate that the upgraded operating system and minor software changes without logic configuration changes did not negatively impact the instrument's performance compared to its predicate.

7. Type of Ground Truth Used:

While not explicitly stated for the "validation study," for an IVD coagulometer, the ground truth would typically be established through laboratory reference methods or comparison to established, validated predicate devices using well-characterized calibrators and controls. The instrument performs "clotting time or clot-based tests (i.e. chronometric) measurements and photometric assays (at specific wave lengths) on plasma samples." Therefore, the ground truth would involve highly accurate and precise measurements obtained via these established laboratory techniques.

8. Sample Size for the Training Set:

The document does not mention a training set sample size. The device is described as an upgrade of an existing instrument's operating system and application software, not a de novo algorithm developed using a training set in the typical machine learning sense. The "logic configuration changes" were explicitly not made.

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

This information is not applicable as the document does not describe a training set for a new algorithm. The modification was primarily an operating system upgrade and minor software enhancements without changes to the core analytical logic.

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