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The Transonic COstatus system is indicated for use in patients 1 month or older with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.

The proposed device is a variation of the COstatus system (K080116) which can measure the same parameters in patients 2 years and above. The COstatus system uses a peristaltic pump to circulate a small volumes blood passed the sensors rather than using a hemodialysis circuit. The system can thereby be used on any patient with arterial and venous access lines. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.

This document is a 510(k) summary for the Transonic COstatus System for Infants. It describes the device, its intended use, and its substantial equivalence to previously cleared devices. It states that the device is safe and effective based on safety testing, and animal and clinical validation studies. However, this document does not contain explicit acceptance criteria tables or detailed results of specific studies with performance metrics, sample sizes, ground truth establishment, or multi-reader multi-case study information.

The document discusses the following:

1. Table of acceptance criteria and reported device performance:
The document states that "Prior to shipment, the finished products are tested and must meet all required release specifications before distribution." and that "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures that ensure the products performance parameters conform to the product design specifications." However, it does not provide any specific acceptance criteria (e.g., accuracy thresholds, precision limits) or quantitative performance results (e.g., mean absolute error, correlation coefficients) for cardiac output measurement.

2. Sample sized used for the test set and the data provenance:
The document mentions "animal and clinical validation studies were also performed to establish equivalence of cardiac output measured by COstatus with those made by standard clinical methods such as thermodilution, etc." However, it does not specify the sample size (number of animals or patients) or the data provenance (e.g., country of origin, retrospective/prospective nature) for these studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document refers to "standard clinical methods such as thermodilution" for comparison. This implies that the ground truth would be established by these methods. However, it does not mention any "experts" in the context of establishing ground truth for the test set, nor does it specify the number or qualifications of any such experts.

4. Adjudication method:
Given that expert consensus is not explicitly mentioned for ground truth, no adjudication method is described.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:
The COstatus system measures physiological parameters and is not an imaging device typically evaluated with MRMC studies comparing human reader performance. Therefore, no MRMC comparative effectiveness study is mentioned or implied.

6. Standalone performance:
The COstatus system is designed to directly measure physiological parameters. Its performance, as implied by "animal and clinical validation studies," would be its standalone performance against a ground truth method. The document states that "equivalence of cardiac output measured by COstatus with those made by standard clinical methods such as thermodilution" was established. This implicitly refers to standalone performance, but no quantitative results are provided.

7. Type of ground truth used:
The ground truth used was "standard clinical methods such as thermodilution."

8. Sample size for the training set:
The document makes no mention of a training set. The COstatus system is a device based on "indicator dilution techniques," which usually implies a direct measurement principle rather than a machine learning model that requires a training set.

9. How the ground truth for the training set was established:
As no training set is mentioned, this information is not applicable or provided.

In summary, this 510(k) document provides high-level information about the safety and effectiveness of the Transonic COstatus System for Infants, but lacks the specific detailed study results and acceptance criteria typically found in more comprehensive device performance reports. The focus is on demonstrating substantial equivalence to predicate devices and adherence to safety standards.

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The Transonic COSTATUS System is indicated for use in patients greater than or equal to 2 years old (child, adolescent, adult) with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic COstatus System which is an apparatus using an indicator dilution technique for the measurement fluid volumes. The system is a variation of the HD01 system which can measure CO during a Hemodialysis treatment. The COstatus system uses a peristaltic pump to draw a small volume of blood passed the sensors rather than using a Hemodialysis circuit. The system can thereby be used on any patient with arterial and venous access lines.

This 510(k) submission (K080116) for the Transonic COstatus System surprisingly does not include any explicit acceptance criteria or a detailed study section demonstrating the device's performance against such criteria. Instead, the submission relies heavily on a claim of substantial equivalence to predicate devices (K023960 and K980906) and general statements about internal testing and manufacturing processes.

Therefore, many of the requested sections about specific study design parameters cannot be filled as the information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not mentioned. No specific test set for performance evaluation is described.
• Data Provenance: Not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable, as there's no mention of a clinical or expert-validated test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as no test set requiring ground truth adjudication is described.

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

• MRMC Study: No. The document does not describe any MRMC comparative effectiveness study, nor does it mention evaluating human reader improvement with or without AI assistance. The device is a diagnostic computer for cardiovascular status, not an AI-assisted diagnostic imaging or interpretation tool in this context.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study: No specific standalone performance study comparing the algorithm's output to a ground truth with quantitative metrics is described. The device is described as an "apparatus using an indicator dilution technique" to measure fluid volumes, implying a direct measurement system rather than a complex algorithm whose standalone performance would typically be evaluated in isolation.

7. Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated or described. The document refers to "product design specifications" for performance parameters, but not how these were validated externally or against an established ground truth.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The device is not described as an AI/ML product that undergoes a "training" phase.

9. How Ground Truth for Training Set Was Established

• Method for Establishing Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML model.

Summary of the Study:

Based on the provided text, the submission for the Transonic COstatus System does not describe a traditional clinical performance study with explicit acceptance criteria, a defined test set, or a ground truth established by experts. Instead, the entire submission hinges on demonstrating substantial equivalence to two predicate devices:

• K023960: LiDCOplus Hemodynamic Monitor
• K980906: Transonic Hemodialysis Monitor, Cardiac Output (Measurement)

The primary "study" or evidence presented for safety and effectiveness is through this comparison, highlighting:

• Similar Materials, Form, and Intended Use: The COstatus System is stated to be similar to the HD01 (K980906) in these aspects.
• Mechanism of Action: Both the COstatus and the HD01 use an indicator dilution technique. The COstatus differs from the HD01 by using a peristaltic pump instead of a hemodialysis circuit, allowing for use on any patient with arterial and venous lines.
• Comparison to LiDCOplus (K023960): The COstatus also uses a peristaltic pump like the LiDCOplus, but uses saline as an indicator instead of lithium chloride. Crucially, the COstatus runs as a closed loop, returning drawn blood to the patient, unlike the LiDCOplus which does not.
• Conclusion on Differences: The submission states that these differences "do not raise any new issues of safety or effectiveness regarding the Transonic COstatus System."
• Internal Testing: The document mentions that "All finished products are tested and must meet all required release specifications before distribution," including "physical testing" and "visual examination" to ensure performance parameters conform to "product design specifications." However, these specifications and specific results are not detailed.

In essence, the "study" proving the device meets criteria is primarily the argument for substantial equivalence based on engineering design comparison and internal product quality control, rather than a clinical trial with performance metrics.

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