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The Transonic HCM103 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in patients aged 1 month and older. The measurements include continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation, systemic vascular resistance and related index parameters) by continuous arterial pressure waveform analysis. In this stand-alone system, cardiac output (CO) value is entered from such devices as COstatus (HCM101) system or equivalent to calibrate the pressure wave form for measurement of continuous cardiac output. In addition the system also provides heart rate, systolic, diastolic pressures, mean arterial pressure and indexed 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 HCM103 system, which is an apparatus based on arterial pressure waveform analysis to provide diagnostic assessment of cardiovascular status including continuous cardiac output and associated hemodynamic parameters (such as stroke volume variation; pulse pressure variation). In this stand-alone system, calibration value is entered from such devices as COstatus (HCM101) system or equivalent. In addition the system also measures heart rate, systolic, and diastolic pressures and derives mean arterial pressure. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.

The provided document is a 510(k) summary for the Transonic HCM103 System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria or a detailed study proving the device meets those criteria, especially in terms of clinical performance metrics like sensitivity, specificity, accuracy, or diagnostic effectiveness.

Here's an analysis based on the information provided in the document, highlighting what is missing for a complete answer to your request:

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

   • Not provided. The document states: "Bench studies confirmed the accuracy of the HCM103 system based on arterial pressure waveform analysis to accurately measure continuous cardiac output, stroke volume variation, pulse pressure variation, systemic vascular resistance index and other related parameters." However, it does not provide specific numerical acceptance criteria (e.g., "accuracy of +/- 10%") or the reported device performance against such criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not provided. The document states "Bench studies confirmed the accuracy..." but does not mention any clinical test set, sample size, or data provenance. It explicitly states, "Animal and clinical testing was not required to support substantial equivalence."

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)

   • Not applicable / Not provided. Since clinical testing was not required and no clinical test set is described, there's no mention of experts establishing ground truth for such a set.

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

   • Not applicable / Not provided. See point 3.

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 HCM103 system is a diagnostic computer for cardiovascular status and circulatory variables. It's not an AI-assisted diagnostic tool that human readers would use to interpret images or data in a comparative effectiveness study. The document describes it as a "stand-alone system" where a CO value is "entered from such devices as COstatus (HCM101) system or equivalent to calibrate the pressure wave form."

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

   • Yes, implicitly. The document describes the HCM103 system as performing measurements "by continuous arterial pressure waveform analysis" and deriving parameters. This is a standalone algorithm. The "Performance Testing" section focuses on "Bench studies confirmed the accuracy" and "software testing and electrical safety testing." There's no human-in-the-loop performance described beyond the entering of a calibration CO value.

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

   • Not explicitly stated for the "bench studies." For a device measuring physiological parameters, the "ground truth" in bench studies would typically come from highly accurate reference instruments or simulated physiological models with known parameters. The document only mentions "Bench studies confirmed the accuracy," implying comparison to some form of established "true" values within a bench setting.

8. The sample size for the training set

   • Not provided. The document does not describe the development or training of any machine learning model or algorithm. It refers to its analytic approach as "arterial pressure waveform analysis." If an algorithm was developed, details on its training data are not included.

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

   • Not provided. See point 8.

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting detailed clinical performance data against specific acceptance criteria. For the Transonic HCM103 System, the FDA determined that "Animal and clinical testing was not required to support substantial equivalence." The performance testing mentioned ("Bench studies confirmed the accuracy...") is described broadly and without specific metrics or the methodology required to answer most of your detailed questions.

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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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