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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 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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