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The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
The technological characteristics are the same for all STA R Max® Family and STA Compact Max® family analyzers, including STA R Max 30 and STA Compact Max 30, which is based on two measurement principles: Chronometric measurement principle and Photometry measurement principle.
The analyzers use Diagnostica Stago reagents in addition to open adaptation of other available 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 measures) and photometric assays on plasma samples.
Changes include a redesigned PSR module to replace the Hamilton syringes and Valcor pump of the fluidic circuit and the addition of the HIL module for estimating interferences (Hemoglobin, Icterus, Lipemia).

The provided text describes the performance data for laboratory instruments (STA R Max 3® and STA Compact Max 3®) used for in vitro coagulation studies, not for an AI/ML-driven medical device for which the acceptance criteria would typically focus on diagnostic accuracy metrics like sensitivity, specificity, or AUC as evaluated by expert readers.

Therefore, the requested information regarding acceptance criteria and study design elements specific to AI/ML devices (e.g., sample size for test set with provenance, number of experts for ground truth, adjudication methods, MRMC study, standalone performance, training set details) is largely not applicable to the content of this FDA 510(k) summary, as it pertains to traditional in vitro diagnostic instruments and their analytical performance.

The document focuses on:

• Method Comparison: Comparing the new devices' measurements against predicate devices using standard regression analysis (Passing & Bablok, Deming) and correlation coefficients (Spearman's r).
• Precision/Reproducibility: Assessing the variability of measurements within a run, between runs, between days, and between instruments/sites using standard deviation (SD) and coefficient of variation (CV%).
• Interference Testing (HIL): Testing the impact of hemoglobin, icterus, and lipemia on results.

Below is a reinterpretation of the request based on the provided document, focusing on the analytical performance acceptance criteria and study details for these in vitro diagnostic instruments.

Acceptance Criteria and Device Performance for Coagulation Analyzers (STA R Max 3® and STA Compact Max 3®)

The provided document details the analytical performance of the STA R Max 3® and STA Compact Max 3® coagulation analyzers, demonstrating their substantial equivalence to predicate devices (STA R Max® and STA Compact Max®). The acceptance criteria are implicit in the presented method comparison and precision data, aiming to show comparable performance to the legally marketed predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an in vitro diagnostic (IVD) device (a laboratory instrument) and not an AI/ML-driven diagnostic algorithm, the "acceptance criteria" are defined differently than for radiological AI tools. Here, they relate to statistical comparability (method comparison) and measurement reproducibility (precision). The specific quantitative "acceptance criteria" values (e.g., maximum allowable bias, maximum CV%) are not explicitly stated as discrete numbers in the document's summary tables, but rather are implied by the presentation of regression analysis results (slopes, intercepts, correlation coefficients) and precision statistics (SD, CV%). The expectation is that these values demonstrate strong agreement with the predicate devices and sufficient reproducibility for clinical use.

Performance Data Summary (Representing "Met Acceptance Criteria")

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

• Sample Size:
  • Method Comparison: For each assay and each instrument (STA R Max 3 and STA Compact Max 3), samples were "selected in order to cover the entire measuring range." The exact number of samples (patients) for each method comparison is not explicitly stated as a single number but would be consistent with CLSI EP09c recommendations. For example, the precision data tables indicate 80 replicates per sample per analyzer for single-site precision (e.g., 240 N for "All instruments combined" across 3 analyzers), and 90 N per sample for multi-site precision (across 3 sites) for a total of 270 replicates per sample per parameter across all sites and analyzers.
  • HIL Method Comparison: Not explicitly stated, but samples were "spiked plasma" to create various concentrations across designated indices.
• Data Provenance: The method comparison studies were conducted at "three external sites." Precision studies were conducted at "one external site" (single-site precision) and "three external sites" (multi-site precision). The country of origin is not specified but is implicitly within a region where FDA regulatory standards are applicable.
• Retrospective or Prospective: Not explicitly stated, but given the nature of instrument validation studies, they are typically purpose-generated (prospective) for the study rather than utilizing historical patient data. Spiked plasma for HIL analysis indicates prospective sample preparation.

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

• Not applicable in the context of this IVD device. For an in vitro diagnostic instrument like a coagulation analyzer, "ground truth" is established by the analytical method itself, often by comparison to a well-established reference method or the predicate device that has established analytical accuracy. There are no human "experts" establishing a diagnostic ground truth from images or clinical data in the way an AI/ML diagnostic device would require. The "truth" is the measured concentration or clotting time.

4. Adjudication Method for the Test Set

• Not applicable. As there are no human interpretations or classifications that require adjudication for this type of IVD instrument validation.

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

• Not applicable. This study pertains to the analytical performance of a laboratory instrument, not an AI-assisted diagnostic tool that aids human readers.

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

• Yes, in the context of an IVD analyzer. The "standalone" performance here refers to the analytical performance of the instrument itself when measuring samples. The entire document describes this "standalone" performance through method comparison and precision studies. The device measures various coagulation parameters directly from plasma samples.

7. The Type of Ground Truth Used

• Analytical Ground Truth: The ground truth for this device's performance is established by:
  • Comparison to a Legally Marketed Predicate Device: The performance of the new devices (STA R Max 3 and STA Compact Max 3) is compared directly to the established performance of their previous versions (STA R Max and STA Compact Max) using patient samples. This is the primary method for demonstrating substantial equivalence.
  • Reference Methods (for HIL): For the HIL interferences, the device's readings were compared against "reference methods, cobas® 8000 modular analyzer (Hemolysis, Icterus, and Lipemia) and spectrophotometer (Lipemia)."
  • Theoretical/Expected Values (for HIL spiking): For HIL, "spiked plasmas were prepared" to provide known concentrations of interfering substances, and the results "matched the index determination for the subject devices and the theoretical index."
  • Repeated Measurements (for Precision): For precision, repeated measurements demonstrating low variability around a mean value for different samples serve as the internal "ground truth" for reproducibility.

8. The Sample Size for the Training Set

• Not applicable for this type of conventional IVD instrument. These are not AI/ML devices that undergo "training" on a data set. Their "training" or calibration involves standard laboratory procedures and calibration materials according to manufacturer protocols.

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

• Not applicable. As stated above, there is no "training set" in the AI/ML sense for this traditional laboratory instrument.

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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® Control [N]+[P] kit is intended for use as control plasmas (Normal and Abnormal levels) for von Willebrand Factor (vWF) and D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579).

The STA®-Liatest® Control [N]+[P] kit provides two citrated human plasmas intended for use as normal and abnormal controls for von Willebrand Factor (vWF) and D-dimer antigen assays by the immino-turbidimetric method performed on STA® analyzers (Diagnostic Stago, France: STA® full-size model and STA® Compact model).

Each STA®-Liatest® Control [N]+[P] kit provides 12 x 1-ml vials of freeze-dried human plasma containing vWF and D-dimer at normal levels (STA®-Liatest® Control [N]) and 12 x 1-ml vials of freeze-dried human plasma containing vWF and D-dimer at abnormal levels (STA®-Liatest® Control [P]).

Both the normal and abnormal plasmas in the freeze-dried state are stable for 24 months after the date of manufacture, when stored at 2°-8°C; after reconstitution with water, both plasmas are stable for 8 hours on board STA® analyzers.

The provided text does not contain typical acceptance criteria and study results in the format expected for medical device performance evaluation. This document is a 510(k) Premarket Notification for a control kit (STA®-Liatest® Control [N]+[P] Kit), which is used to ensure the proper functioning of other assays, specifically for von Willebrand Factor (vWF) and D-dimer antigen.

For a control kit, "acceptance criteria" usually relate to the stability and consistency of the control material itself, rather than performance metrics like sensitivity, specificity, or AI accuracy that would be expected for a diagnostic device. The provided text describes the product, its intended use, and its stability.

Here's the breakdown of what can be extracted or inferred, and what is missing based on your requested format:

What can be inferred from the provided text:

• Device: STA®-Liatest® Control [N]+[P] Kit
• Intended Use: Normal and abnormal controls for vWF and D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers.
• Purpose of the "Study" mentioned (implicitly): To demonstrate the stability of the control plasmas.

What is present regarding "Acceptance Criteria" (interpreted for a control kit):

Missing Information (as per your request, because this is for a control kit, not a diagnostic device with AI):

The following points are not applicable or not provided in the context of this 510(k) submission for a control kit:

1. Sample size for the test set and data provenance: Not explicitly stated for performance validation. The "study" here is likely internal manufacturing/stability testing, not a clinical trial with a "test set" of patients.
2. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for a control kit. Ground truth for a control kit refers to the known concentrations of its analytes, established during manufacturing.
3. Adjudication method for the test set: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This kit controls human readers of an assay, it is not an AI algorithm assisting human readers.
5. Standalone (algorithm-only) performance: Not applicable, as this is a physical control substance, not an algorithm.
6. Type of ground truth used: For a control, the "ground truth" would be the assayed values of vWF and D-dimer established during manufacturing, possibly against a reference standard. The text doesn't specify how these were established.
7. Sample size for the training set: Not applicable. Control kits don't have "training sets."
8. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a regulatory approval for a control kit, not a performance study of a diagnostic device with AI. Therefore, most of your requested detailed study information is not available and not relevant to this specific type of device. The document primarily focuses on the product description and its stability claims.

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The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579) to perform quantitative determinations of D-dimer antigen levels in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.

The STA®-Liatest® D-Di test kit is intended for use with STA® analyzers to perform quantitative assays of D-dimer antigen in citrated plasma by the immuno-turbidimetric method based on the measurement of light absorbance produced by a suspension of microlatex particles coated with specific mouse anti-human D-dimer monoclonal antibodies.

Each STA®-Liatest® D-Di test kit provides: 6 x 5-ml vials of ready-for-use Tris buffer and 6 x 6-ml vials of a suspension of microlatex particles coated with mouse anti-human D-dimer monoclonal antibodies.

Reagents in intact vials remain stable for 18 months after the date of manufacture, when stored at 2°-8°C. After opening of the vials, kit reagents (with STA®-Reducers and perforated caps installed on the vials) are stable for 15 days on board STA® analyzers.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific performance metrics. Instead, it describes a 510(k) premarket notification for a medical device, the STA®-Liatest® D-Di Test Kit, which indicates it has been found "substantially equivalent" to a predicate device. This substantial equivalence determination generally means that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.

Here's a breakdown of the requested information based on the provided text, and where the information is not available:

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

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

• Sample size: Not specified.
• Data provenance: Not specified.

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)

• Not applicable/Not specified. The substantial equivalence claim is made against a predicate device, not by establishing ground truth based on expert consensus for the new device's performance.

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

• Not applicable/Not specified. The document does not describe a test set or an adjudication process for such a set.

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 device is an in-vitro diagnostic test kit (an immuno-turbidimetric method), not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study.

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

• Not applicable. This is an automated laboratory test kit; its performance is inherently "standalone" in the sense that the analyzer performs the measurement. However, it's not an "algorithm only" in the context of AI.

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

• The ground truth for chemical assays like D-dimer is typically established through reference methods or validated standards. The document states the new device is "substantially equivalent" to the ASSERACHROM® D-Di kit, which is a "microtiter ELISA-based procedure." This implies the predicate device's established performance serves as the benchmark. The inherent ground truth for D-dimer measurements relates to the actual concentration of D-dimer antigen in the plasma, which would be determined by a highly accurate and precise analytical method. The document does not specify details on how the accuracy of either device was independently validated against a gold standard.

8. The sample size for the training set

• Not applicable/Not specified. This device is a reagent kit and analyzer system, not a machine learning algorithm that requires a "training set" in the conventional sense of AI development.

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

• Not applicable/Not specified. As mentioned above, there is no "training set" in the context of an AI algorithm for this device.

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The STA® D-Di Calibrator kit is intended for use as a calibration plasma for D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579).

The STA® D-Di Calibrator is a citrated human plasma containing D-dimer at a known level, intended for use as a calibration plasma for the assay of D-dimer antigen by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model and STA® Compact model). Each STA® D-Di Calibrator kit provides 6 x 1-ml vials of citrated human plasma in lyophilized form. The D-dimer value of each lot is indicated in the Assay Value insert supplied with each kit. The freeze-dried reagent in intact vials is stable for 24 months after the date of manufacture, when stored at 2°-8°C; the reconstituted plasma remains stable for 4 hours on board STA® analyzers.

The provided text primarily focuses on the regulatory approval of the STA® D-Di Calibrator Kit and its intended use as a calibration plasma. It does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics such as sensitivity, specificity, or accuracy.

The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a predicate device. This type of submission generally relies on demonstrating equivalence rather than providing detailed performance studies against specific acceptance criteria for a new device's efficacy or diagnostic accuracy.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The provided text only offers the following relevant details:

• Device Name: STA® D-Di Calibrator Kit
• Intended Use: To be used as a calibration plasma for the assay of D-dimer antigen by the immuno-turbidimetric method performed on STA® analyzers (STA® full-size model and STA® Compact model).
• Regulatory Status: 510(k) cleared (K964718), found substantially equivalent to predicate devices.
• Product Description: Citrated human plasma containing D-dimer at a known level, supplied in 6 x 1-ml vials in lyophilized form.
• Stability: Freeze-dried reagent is stable for 24 months at 2°-8°C. Reconstituted plasma is stable for 4 hours on board STA® analyzers.

To obtain the information requested, a detailed performance study report or design validation document would be necessary, which is not present in the provided text.

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