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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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