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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- NeoPTimal kits provide thromboplastin reagents from rabbit brain extract, for the quantitative determination, in human citrated plasma (3.2% sodium citrate), of Prothrombin Time (PT) on STA-R family, STA Compact family and STA Satellite family instruments. STA- NeoPTimal is a coagulation screening test intended to be used by professional laboratory personnel for the evaluation of the extrinsic coagulation pathway and the monitoring of oral vitamin K antagonist therapy using the International Normalized Ratio (INR).

The in-vitro diagnostic STA® - NeoPTimal kits are available in two sizes and contains:
STA® - NeoPTimal 5: 6 x 5 ml vials of Reagent 1, 6 x 5 ml vials of Reagent 2
STA® - NeoPTimal 10: 12 x 10 ml vials of Reagent 1, 12 x 10 ml vials of Reagent 2
Reagent 1 is STA® - NeoPTimal, lyophilized thromboplastin prepared from rabbit brain extract. The STA® - NeoPTimal reagent contains a specific heparin inhibitor. Any prolongation of the prothrombin time is, therefore, related to a real deficiency of factor II, V, VII, X and/or fibrinogen.
Reagent 2 is a solvent containing calcium.
The test consists of the use of calcium thromboplastin to measure the clotting time of the patient's plasma and to compare it with that of a normal standard. The test measures, as a whole, the activities of the coagulation factor II (prothrombin), factor V (proaccelerin), factor VII (proconvertin), factor X (Stuart factor) and factor I (fibrinogen).
The PT value is expressed in seconds or INR. The result has to be interpreted according to the patient's clinical and biological states. The INR value corresponds to the ratio of the patient's PT to that of the standard PT raised to the ISI (International Sensitivity Index) power of the thromboplastin used:
INR = ( Patient's PT / Mean Normal PT ) * ISI
The ISI value of a given thromboplastin is determined by testing normal plasma and VKA (vitamin K antagonist)-treated patient plasma with that thromboplastin and with the International Reference preparation (RBT) for thromboplastin.

The provided text is a 510(k) summary for a medical device called STA-NeoPTimal, which is a Prothrombin Time (PT) test. The document primarily focuses on the device's performance characteristics, stability, and comparison to a predicate device. It does not describe a study involving human readers or AI assistance. Therefore, I cannot extract information related to MRMC studies, the number of experts for ground truth, or the sample size of a training set for an AI model from this document.

However, I can provide information based on the performance criteria and studies detailed in the document for the STA-NeoPTimal device itself.

Here's the information extracted and organized as requested, with details that are present in the document:

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

The document does not explicitly state "acceptance criteria" values in a table for each performance characteristic but rather describes that "acceptance criteria were met for all samples in the studies." The tables provided show the reported device performance.

Table of Performance Characteristics (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)

• Precision/Reproducibility (Single-site): Each sample type (11 samples for seconds, 7 for INR) was tested with N=240 replicates (2 replicates/day over 20 days) on each of three instruments (STA R Max, STA Compact Max, STA Satellite). Data provenance is "one external site" for single-site testing.
• Precision/Reproducibility (Multi-site): Each sample type (11 samples for seconds, 7 for INR) was tested with N=270 replicates (2 runs/day over 5 days at 3 sites per analyzer). Data provenance is "three external sites" per analyzer.
• Extrinsic Factor Sensitivity: Not explicitly stated, but implies the use of contrived samples with known factor levels.
• Interferences: Four samples were used: 1 normal, 2 VKA patient samples (INR 2.0-3.0 and 3.1-4.5), and 1 Deficient V patient sample.
• Sample Stability (Room Temperature): Four normal samples and eight VKA samples (INR 1.5 to 5.5).
• Sample Stability (Long-term Frozen): 53 samples stored at ≤ -70°C (Normal and VKA patient samples with INR between 1.5 and 5.0).
• Shelf-life Stability: 10 samples (Normal, VKA patient samples with INR 2-4.5, Deficient V, Quality controls).
• In-Use Stability: Six samples (Normal, VKA 2-3, VKA 3-4.5, Deficient V, Two controls).
• Method Comparison: Not explicitly stated, but it was an "external method comparison study" involving "four sites" comparing STA NeoPTimal with Thromborel S.
• Reference Interval: 137 patients. Data provenance is "across three external sites."

The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective, but as performance validation studies for a device, they are typically prospective.

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 as the device is an in-vitro diagnostic test for Prothrombin Time, and the "ground truth" (or reference values) is established through laboratory methods and reference standards, not expert interpretation of qualitative data like images.

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

Not applicable for this type of in-vitro diagnostic device performance study.

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. The document describes a laboratory diagnostic device, not an AI-assisted diagnostic tool that would involve human readers interpreting results.

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

The device is a standalone in-vitro diagnostic reagent kit used on automated instruments (STA-R family, STA Compact family, STA Satellite family). Its performance is evaluated directly (algorithm-like in terms of automated measurement) without direct human interpretation in the loop of the measurement itself, though human professionals use the results.

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

The "ground truth" for this in-vitro diagnostic device is established by:

• Reference Intervals: Determined using a population of 137 patients according to CLSI guideline EP28-A3c.
• Comparison to Predicate Device: Performance is compared to an existing, legally marketed predicate device (Thromborel® S) using a method comparison study.
• Known Concentrations/Levels: For intrinsic validity testing like Extrinsic Factor Sensitivity and Interference studies, controlled samples with known concentrations of factors or interfering substances are used.
• Standardized Prothrombin Time Measurement: The core measurement (PT) itself is a standardized laboratory test.

8. The sample size for the training set

Not applicable. This document describes a new in-vitro diagnostic reagent, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable.

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The STA® - Liatest® D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (3.2% sodium citrate) for use on STA-R®, STA Compact® and STA Satellite® analyzers by professional laboratory personnel. The STA® - Liates® D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT.

STA® - Liatest® D-Di kit contains: 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 two different mouse monoclonal anti-human D-dimer antibodies (8D2 and 2.1.16) stabilized with bovine albumin.

The test principle is based on the change in turbidity of a microparticle suspension that is measured by photometry. A suspension of latex microparticles, coated by covalent bonding with monoclonal antibodies specific for D-dimer is mixed with the test plasma for which the D-dimer level is to be assayed. An antigen-antibody reaction takes place, leading to an agglutination of the latex microparticles which causes an increase in turbidity of the reaction medium. This increase in turbidity is reflected by an increase in absorbance, the latter being measured photometrically. The increase in absorbance is a function of the D-dimer level present in the test sample.

This document describes the acceptance criteria and study proving the performance of the STA® - Liatest® D-Di kit, an immuno-turbidimetric assay for the quantitative determination of D-dimer.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the STA® - Liatest® D-Di kit were based on achieving specific Negative Predictive Value (NPV) and Sensitivity targets for the exclusion of Pulmonary Embolism (PE) and Deep Venous Thrombosis (DVT) in outpatients with low to moderate pretest probability (PTP).

Note: The document explicitly states that the results "meet both confirmatory hypotheses relating to NPV and Sensitivity." While the predicate device's PE and DVT results are listed in the "Similarities Chart," the detailed performance data for the new device (STA® - Liatest® D-Di) in the clinical performance section is specifically for DVT exclusion. The indications for use state "to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT)", but the detailed study results presented focus on DVT.

2. Sample Size and Data Provenance

• Test Set Sample Size: 980 samples of patients with a low or moderate PTP were included in the primary efficacy analyses. This consisted of 79 suspects of DVT and PE, and 901 suspects of DVT only. Of the 980 samples, 85 were DVT positive and 895 were DVT negative.
• Data Provenance: The data was collected from a prospective, multi-center clinical study conducted at 16 sites across the United States, Europe, and Canada. The patients were consecutive, ambulatory outpatients presenting at emergency units or outpatient clinics suspected of having venous thromboembolism (VTE).

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the "number of experts" or their "qualifications" in the context of establishing ground truth in the traditional sense of human readers adjudicating medical images. Instead, the ground truth was established through a clinical protocol:

• Patients with positive D-dimer results were considered for an imaging procedure (e.g., ultrasound, CT angiography).
• Patients with negative D-dimer results were assigned to a three-month follow-up to confirm the absence of DVT/PE.
• The "Reference" column in the results tables (Tables 1, 2) is a combination of "imaging or 3-month follow-up."

Therefore, the establishment of ground truth was based on clinical diagnostic pathways and follow-up, rather than expert interpretation of a specific dataset for the purpose of algorithm validation in the way one might see for an imaging AI. The "experts" in this context would be the clinicians and radiologists involved in the standard of care diagnostic work-up.

4. Adjudication Method for the Test Set

Not applicable in the typical sense of expert adjudication of AI outputs. The ground truth was established by standard clinical practice: a positive D-dimer result led to imaging, and a negative D-dimer result led to a 3-month clinical follow-up for confirmation.

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

No MRMC study was done, as this is an in-vitro diagnostic (D-dimer assay), not an imaging AI diagnostic device intended to assist human readers. The study evaluates the standalone performance of the assay in a clinical pathway.

6. Standalone Performance (Algorithm Only without Human-in-the Loop)

Yes, this study represents a standalone (algorithm only) performance evaluation. The STA® - Liatest® D-Di kit itself is the "algorithm" or diagnostic tool, and its performance (sensitivity and NPV) is reported based on its direct results in conjunction with a clinical pretest probability assessment model. Its output (D-dimer level) is then used to guide clinical decisions (imaging vs. observation).

7. Type of Ground Truth Used

The ground truth was established by clinical outcomes data and definitive diagnostic imaging (e.g., ultrasound for DVT, CT angiography for PE) or clinical follow-up confirming the absence of the condition. Specifically, the "Reference" for the test set was determined by "imaging or 3-month follow-up."

8. Sample Size for the Training Set

The document does not specify a separate "training set" or its sample size. This is common for traditional in-vitro diagnostic assays, where product development and analytical validation are often not described in terms of "training sets" like machine learning models. The study described is primarily a clinical validation study demonstrating performance on a test set.

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

As no specific "training set" (in the context of machine learning) is discussed for this in-vitro diagnostic device, this point is not applicable. The development and analytical validation of such assays typically involve laboratory studies (e.g., linearity, precision, interference) and internal developmental studies that establish the assay's performance characteristics, rather than a "ground truth" derived from a clinical dataset used for training, as would be the case for an AI/ML device.

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The STA R Max® 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.

Diagnostica Stago's STA R Max® is a fully automatic clinical laboratory designed as a modification to the company's previously cleared STA-R Evolution® Expert Series analyzer (K093001). 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 provided text is a 510(k) summary for the STA R Max® device. This document focuses on demonstrating substantial equivalence to a predicate device (STA-R Evolution® Expert Series) for regulatory approval, rather than detailing a study that proves the device meets specific acceptance criteria based on performance metrics.

Therefore, much of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance studies, and ground truth establishment cannot be found in this document.

The document does describe the device's intended use, principle of operation, and how it is substantially equivalent to its predicate.

Here's a breakdown of the available information:

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

This information is not provided in the document. The document primarily focuses on demonstrating substantial equivalence to a predicate device by comparing characteristics, not on presenting specific performance data against predefined acceptance criteria for the subject device.

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 provided in the document. The document does not describe a clinical or performance study with a test set.

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 provided in the document. The document does not describe the establishment of a ground truth for a test set.

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

This information is not provided in the document. The document does not describe the use of a test set or an adjudication method.

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 provided in the document. The STA R Max® is an automated clinical instrument for coagulation studies, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with human readers assisting AI is not relevant to this device's function.

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

The document describes the STA R Max® as a "fully automatic clinical instrument" which performs tests and reports results. This implies a standalone (algorithm only) performance, however, specific performance metrics or a dedicated standalone study are not detailed. The document relies on similarity to the predicate device, not on new standalone performance studies of the subject device.

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

This information is not provided in the document. The document does not detail how specific ground truth was established for performance evaluation of the subject device. The clearance is based on substantial equivalence.

8. The sample size for the training set

This information is not provided in the document. The document does not describe a training set in the context of machine learning or AI.

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

This information is not provided in the document. The document does not describe a training set or its ground truth.

Summary of available information related to the device and its regulatory submission:

• Device Name: STA R Max®
• Regulation Number: 21 CFR 864.5425
• Regulation Name: Multipurpose system for in vitro coagulation studies
• Regulatory Class: Class II
• Product Code: JPA
• Indications for Use: The STA R Max® 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.
• Predicate Device: STA-R Evolution® Expert Series (K093001)

Key points from the "Substantial Equivalence Comparison" (Table 1):

The document argues for substantial equivalence based on the following:

• Identical Indications for Use/Intended Use.
• Identical Target Population (to aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy in patients).
• Identical Anatomical Sites (in vitro testing of human plasma).
• Identical Point of use (Hospital Laboratory or other Health Care Laboratory).
• Identical Chronometric Method of Coagulation Detection (Mechanical measurement of the oscillation of the metal ball in the cuvette).
• Identical Photometric Method of Coagulation Detection (Light absorption technique provided by a filtered light source (405μm, 540μm)).
• Identical Electrical Safety standards.
• Identical Disposables.

Differences highlighted in the table, but deemed not to affect substantial equivalence:

• Dimensions, Integrated PC specifications (processor, memory, hard disk), Weight, Connections, Disk drive, Computer table, Touch Screen: These are considered minor differences stemming from obsolescence of computer peripherals, ergonomic enhancements, and new graphical interface/communication protocol, with "no impact on performance, principle of operation, or fundamental technology."

Conclusion drawn from the document: The STA R Max® is substantially equivalent to the STA-R Evolution® Expert Series (K093001) predicate device because they share the same intended use, fundamental technology, principles of operation, and comparable performance characteristics. The modifications are primarily software (GUI, communication protocol), new peripherals, and external design changes for ergonomics. The document states that "no new questions of safety and effectiveness were raised" through risk assessment and verification/validation activities.

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The STA® - Liatest® D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2% sodium citrate) for use on STA-R®, STA Compact® and STA Satellite® analyzers by professional laboratory personnel. The STA® - Liates® D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and as an aid in the diagnosis of deep venous thrombosis (DVT) in outpatients suspected of PE or DVT.

STA® - Liatest® D-Di kit contains: 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 two different mouse monoclonal anti-human D-dimer antibodies (8D2 and 2.1.16) stabilized with bovine albumin.

The test principle is based on the change in turbidity of a microparticle suspension that is measured by photometry. A suspension of latex microparticles, coated by covalent bonding with monoclonal antibodies specific for D-dimer is mixed with the test plasma for which the D-dimer level is to be assayed. An antigen-antibody reaction takes place, leading to an agglutination of the latex microparticles which causes an increase in turbidity of the reaction medium. This increase in turbidity is reflected by an increase in absorbance, the latter being measured photometrically. The increase in absorbance is a function of the D-dimer level present in the test sample.

Here's a breakdown of the acceptance criteria and the study details for the STA® - Liatest® D-Di device, based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the STA® - Liatest® D-Di device are implicitly tied to its ability to
safely rule out Pulmonary Embolism (PE) in patients with low or moderate pretest probability (PTP).
The key performance metric for exclusion of PE is the Negative Predictive Value (NPV).

Study Details

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

   • Total Test Set Sample Size: 1130 samples of patients with a low or moderate PTP.
     • Prospective Study Population: 1060 samples.
     • US Banked Samples (retrospective): 70 samples.
   • Data Provenance: The study involved multiple centers across the United States, Europe, and Canada for the prospective data. The banked samples were from the US. The overall study is a mix of prospective and retrospective data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not specify the number or qualifications of experts used to establish the ground truth. The ground truth was established through a combination of imaging procedures for positive PE cases and a 3-month follow-up for negative PE cases.

3. Adjudication method for the test set:
   The document does not explicitly describe a specific adjudication method for the test set results. Diagnosis of PE was based on imaging or clinical follow-up. For patients with suspected PE, those with positive D-dimer results were considered for an imaging procedure. Patients with negative D-dimer results were considered not to have PE and were assigned to a three-month follow-up. This implies a diagnostic pathway rather than a direct adjudication process by a panel of experts on each case.

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 assay (D-dimer test) and not an AI-assisted diagnostic imaging device that would typically involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Yes, a standalone performance study was done for the STA® - Liatest® D-Di device. The reported sensitivity, specificity, NPV, and PPV are for the device's performance alone in determining D-dimer levels and, in conjunction with PTP, for PE exclusion. While the device is "intended for use in conjunction with a clinical pretest probability (PTP) assessment model," the performance metrics presented specifically reflect the diagnostic accuracy of the D-dimer assay within that pathway.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth was established through a combination of imaging procedures (for positive PE cases) and outcomes data (3-month follow-up for negative PE cases).

7. The sample size for the training set:
   The document does not specify a separate training set sample size. The study focuses on demonstrating the performance of the device in a clinical setting based on a defined test set. For an in-vitro diagnostic like this, the "training" (e.g., assay optimization, establishing parameters) is typically internal to the manufacturer's development process and not part of the clinical performance study reported for regulatory submission in the same way an AI model's training set would be.

8. How the ground truth for the training set was established:
   As no separate "training set" is described in the context of this regulatory submission, how its ground truth was established is not provided. The ground truth for the test set was established as described in point 6.

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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.

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® - 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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