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The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.

The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.

The Sonoclot Analyzer System generates a qualitative graph, known a the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.

The Sonoclot Coaqulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.

The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.

The Sonoclot Analyzer System generates a qualitative graph, known as the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.

Sonoclot Viewer is a data collection, storage, and retrieval program for use with Sonoclot Analyzers. Sonoclot Viewer collects serial data from one or more Sonoclot Analyzers. This data is compressed, processed for certain performance results, displayed, and stored as data files.

Sonoclot Viewer enables users to assign patient, operator, and reagent information to a test, manage patient test results and analyzer/reagent quality control data, communicate with the hospital information system, and create reports to meet billing or regulatory compliance requirements.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets them because the provided text does not contain this information. The text is a 510(k) summary for the Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a study proving their fulfillment.

Instead, the document highlights:

• Device Name & Classification
• Legally Marketed Predicate Devices
• Device Description Summary
• Intended Use/Indications for Use
• Comparison of Indications for Use and Technology
• Non-Clinical and/or Clinical Test Summary & Conclusions for Software Reengineering

The "Non-Clinical and/or Clinical Test Summary & Conclusions" section mentions validation of reengineered software (Sonoclot Viewer) against the predicate software (Signature Viewer) to ensure equivalent calculated results. However, it does not define specific acceptance criteria for performance metrics (like accuracy, precision, sensitivity, specificity, etc.) nor does it describe a study design with sample sizes, expert involvement, or ground truth establishment in the way requested for a typical AI/device performance study.

Without this specific information regarding acceptance criteria and a detailed study report, I cannot fulfill your request.

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The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.

The aiACT Kit is intended only for high dose heparin anticoagulation management (ACT ≥ 400 seconds on Sonoclot Analyzer) as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment.

The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood.

The aiACT Kit is a yellow plastic lidded cuvette containing contact activator and magnetic stir bar.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the aiACT Kit.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the aiACT Kit as specific thresholds for regulatory approval. However, it presents "Normal Ranges" for the aiACT test. While this isn't framed as a pass/fail criteria, it serves as a performance benchmark against healthy individuals without heparin.

Note: The document only provides the normal range itself as the "reported device performance." It doesn't present a separate study cohort demonstrating the aiACT kit's performance relative to these ranges from an external dataset. It's implied that the observed normal range is the performance of the device in a normal, unheparinized population.

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

The document does not explicitly state the sample size used to establish the "Normal Range" for the aiACT Kit. It only refers to a "Normal Population, No Heparin" for "Native Whole Blood."

• Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated (e.g., country of origin). It can be inferred that it is retrospective or prospective data collected to establish the normal range, but the methodology is not detailed.

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

This section is not applicable as the document does not describe the use of experts to establish a "ground truth" for the test set in the context of diagnostic accuracy. The ground truth, in this case, is simply the observed range of ACT/Onset and Clot Rate results from a presumably healthy, unheparinized population. There's no mention of a diagnostic task requiring expert interpretation.

4. Adjudication Method for the Test Set

This section is not applicable as the document does not describe a scenario requiring adjudication, such as conflicting expert interpretations or complex diagnostic judgments. The "ground truth" is based on direct measurement of clotting parameters in a normal population.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This section is not applicable. The document describes a comparison of the aiACT Kit with the SonACT Kit, but it is a comparison of technological characteristics and expected performance, not an MRMC study assessing human reader improvement with or without AI assistance. The aiACT Kit is an in vitro diagnostic test, not an AI-assisted diagnostic tool for Human Readers.

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

Yes, implicit in the document, a standalone performance of the device (aiACT Kit with Sonoclot Analyzer) was assessed. The "Normal Range" values (ACT/Onset and Clot RATE) are the direct output of the device itself without human interpretation in a diagnostic loop.

7. The Type of Ground Truth Used

The ground truth used for establishing the normal ranges is based on direct physiological measurement of Activated Clotting Time (ACT/Onset) and Clot Rate from a "Normal Population" with "Native Whole Blood" (i.e., not heparanized). It's an empirical observation of typical values in a healthy state.

8. The Sample Size for the Training Set

The document does not explicitly mention a training set or its sample size. This is common for in vitro diagnostic devices where "training" in the machine learning sense is not typically applicable for establishing performance characteristics like normal ranges. The normal ranges are typically derived from a studied population.

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

As no explicit "training set" is mentioned in the context of machine learning, this question doesn't entirely apply. However, if we consider the data used to define the "Normal Range" as the equivalent of data used to establish expected performance, the ground truth (the observed ACT/Onset and Clot RATE values) was established by direct measurement using the aiACT Kit on native whole blood samples from a "Normal Population" without heparin. The methodology of this measurement (e.g., number of subjects, how "normal" was defined, protocol for measurement) is not detailed in this summary.

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The gbACT+ Kit is an in-vitro diagnostic product designed for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The gbACT+ test is an activated whole blood clotting time test. It may also be used with citrated whole blood or plasma. The gbACT+ Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management at low to moderate heparin levels (1 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening.

The gbACT+ Kit is an in-vitro diagnostic product designed for use with the Sonoclot Coagulation & Platelet Function Analyzer System. Each kit contains glass bead cuvettes, probes and instructions for use. Current package sizes of 100 (#800-0412) and 24 (#800-0411) tests are available. The lidded pink cuvettes contain a controlled amount of the glass bead activator and a magnetic stir bar. A mason box is used for the kit package.

The provided text describes the gbACT+ Kit and claims substantial equivalence to the predicate device, the SonACT Kit. However, it does not include detailed "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way typically expected for a modern medical device submission with specific performance metrics and statistical analysis.

Instead, the submission primarily focuses on technological characteristic comparison and typical results for both the new device (gbACT+) and the predicate device (SonACT). The implicit acceptance criteria seems to be that the gbACT+ Kit produces "normal ranges" of results that are comparable or acceptable within the context of activated whole blood clotting time tests, and that its performance characteristics are similar to the predicate device.

Here's an attempt to extract and present the information based on the provided text, acknowledging its limitations regarding explicit acceptance criteria and detailed study methodology:

1. Table of acceptance criteria and the reported device performance

Since explicit "acceptance criteria" (e.g., "sensitivity must be >X%, specificity >Y%") are not provided, I'll infer them from the "Normal Range" values presented for both devices and their intended use. The performance reported for the gbACT+ is its "Normal Range" in comparison to the predicate.

Interpretation of "Acceptance": The "acceptance" is implicitly demonstrated by presenting typical results within normal ranges for the new device and comparing them side-by-side with the predicate's typical results, indicating that the new device functions similarly and produces relevant clinical information. The FDA's 510(k) clearance implies that these comparisons were deemed sufficient for substantial equivalence.

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

• Sample Size: Not explicitly stated. The document refers to "Normal Population, No Heparin" for "Native Whole Blood" and provides "Typical Results and Examples" (Normal A, Normal B). This suggests a small, unspecified number of subjects were tested to generate these "typical" values, rather than a large formal clinical trial with a defined sample size.
• Data Provenance: Not explicitly stated. Likely collected in the USA, as the company address is in Wheat Ridge, CO, USA. The data appears to be prospective in the sense that testing was performed to establish normal ranges for the device, but the methodology of this testing is not detailed.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Ground Truth Establishment: The "Normal Range" values are presented as established values, but the method by which they were established (e.g., consensus, previous studies, clinical guidelines) or who established them is not detailed.

4. Adjudication method for the test set

• Adjudication method: Not described or mentioned.

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

• MRMC Study: Not applicable. This device is an in-vitro diagnostic kit for coagulation testing, not an imaging device or AI-assisted diagnostic tool that would involve multiple human readers interpreting results.

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

• The gbACT+ Kit is an in-vitro diagnostic product used with the Sonoclot Coagulation & Platelet Function Analyzer System. The analyzer itself performs the measurement and provides quantitative and qualitative results. The "performance" described here is of the kit (reagent cuvettes), not an AI algorithm. So, while it's a "standalone" test in the sense that the analyzer produces objective measurements, it is not an "algorithm-only" performance in the context of AI. The performance is of the device system (kit + analyzer) without human interpretive input for the primary measurements.

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

• The ground truth for the "normal ranges" is implicitly defined by established clinical norms or reference values for activated whole blood clotting time parameters. It does not explicitly mention pathology, expert consensus, or outcomes data as the direct ground truth for these specific ranges, but rather refers to a "Normal Population, No Heparin."

8. The sample size for the training set

• Not applicable. The gbACT+ Kit is a reagent kit, not a machine learning model that requires a training set.

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

• Not applicable, as there is no training set for this type of device.

Summary of Limitations in the Provided Text:

The provided 510(k) summary is from 1998/1999 and reflects the regulatory expectations of that era. For a modern AI/ML device, the level of detail regarding acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement would be significantly more extensive and rigorous. This document focuses on demonstrating substantial equivalence to a predicate device primarily through comparative tables of technological characteristics and typical performance ranges, rather than detailed statistical evidence meeting pre-defined acceptance criteria from a formal clinical study.

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