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Transonic Systems' BLF22 and BLF22A tissue perfusion monitors are intended for use in the measurement of microvascular perfusion.

The BLF22 (single-channel) Tissue Perfusion Monitor reports Flow, Mass or Velocity on its front panel digital display. Housed in a small metal case, the Monitor is equipped with a convenient multi-position handle/stand. It also features: rear panel analog outputs for Flow/Mass/Velocity in 0 - 10 Volts DC; and a USB computer interface.

The BLF22A (single-channel + Indicator Tone) Tissue Perfusion Monitor incorporates all the functionality of the BLF22, plus adjustable Low Flow Indicator Tone circuitry. This will sound an audio signal when tissue perfusion flow drops below a preset level.

The provided document is a 510(k) summary for the Transonic Tissue Perfusion Monitors (Models BLF22 and BLF22A). It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically expected for an AI/ML medical device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through bench testing and electrical safety testing.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this document, as they relate to studies for AI/ML device performance validation.

Here's a summary of the information that can be extracted, and an explanation for what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a quantitative manner. The performance testing is described qualitatively as demonstrating "functional requirement specifications" and meeting "all required release specifications."

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

Not applicable. The document describes "bench studies" and "testing" but does not specify a "test set" in the context of an AI/ML model or a sample size of patient data. The testing appears to be hardware-focused, evaluating the device's functional and electrical properties.

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

Not applicable. Ground truth establishment by experts is not described, as the performance testing focused on the device's physical and electrical functioning, not diagnostic accuracy based on expert interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through bench and electrical safety testing, not assessing human reader improvement with AI assistance.

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

Not applicable. This device is a monitor measuring microvascular perfusion, not an AI algorithm, so the concept of "standalone performance" for an algorithm is not relevant here. The device itself is standalone in its function as a measurement tool.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing would be the true physical measurements of flow, mass, and velocity under controlled conditions, and compliance with electrical safety standards. This is inherent in bench testing and refers to accurately calibrated equipment and established safety protocols.

8. The Sample Size for the Training Set

Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

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The intended use of the ELSA system is to provide clinically relevant data to healthcare providers treating neonatal, pediatric, adult patients with arterial and venous lines for routine monitoring of diagnostic parameters: Delivered Flow; Recirculation: Oxygenator Blood Volume and other 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 ELSA system, which is an apparatus based on transit time ultrasound indicator dilution techniques that provides clinically relevant data to healthcare providers treating patients undergoing Extracorporeal Life Support Procedures. The clinically relevant data (such as delivered flow, recirculation, oxygenator blood volume and other related hemodynamic parameters), shall indicate the efficacy of such procedures and quantify the patient's hemodynamic status. These patients could be in the intensive care units (ICU), operating room (OR) or other such environments.

The provided text includes a 510(k) summary for the Transonic ELSA System, outlining its substantial equivalence to predicate devices and detailing bench testing. However, it does not contain the specific acceptance criteria or the full study details to definitively answer all parts of your request.

Here's what can be extracted and what information is missing:

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

The document states: "The ELSA system (HCE101) is deemed to be safe and effective based on the safety testing conducted in accordance with the IEC 60601-1 standard and the electromagnetic compatibility test report." and "Prior to shipment, the finished product will be tested and must meet all required release specifications before distribution."

• Acceptance Criteria (General): Safe and effective; compliance with IEC 60601-1 standard; electromagnetic compatibility test report; meeting all required release specifications (physical testing and visual examination).
• Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity) against defined acceptance criteria are provided in this summary. It states "These tests are established testing procedures that ensure the product's performance parameters conform to the product design specifications," but doesn't list the parameters or their achieved values.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The testing mentioned is "bench testing," meaning it was likely conducted in a laboratory setting. No patient data provenance is mentioned.

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)

• Number of Experts: Not applicable/not specified. The testing described is bench testing, not a clinical study involving experts establishing ground truth from patient data.
• Qualifications of Experts: Not applicable/not specified.

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

• Adjudication Method: Not applicable/not specified. This is typically relevant for clinical studies involving multiple readers, which is not described here.

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

• No MRMC study is mentioned. This device is described as a diagnostic monitor, 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

• The testing described is "bench testing" focusing on safety, electromagnetic compatibility, and conformity to product design specifications. This implies standalone device performance testing, but the specific metrics are not detailed.

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

• For the bench testing, the "ground truth" would likely be instrument calibration standards, reference measurements (e.g., using established flow meters), or predefined physical standards for visual and physical examinations. No patient-derived ground truth (like expert consensus or pathology) is mentioned because this was bench testing, not a clinical study.

8. The sample size for the training set

• Sample Size: Not applicable. The document describes a medical device, not a machine learning or AI model that requires a "training set."

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

• Ground Truth Establishment: Not applicable, as there is no mention of a training set for a machine learning model.

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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 HCM102 system is intended for diagnostic assessment of cardiovascular status and circulatory variables in patients aged 1 month and older. This includes COstatus measurements by indicator dilution for quantifying patient's cardiac and volume status as well as 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 system, cardiac output (CO) value from dilution is used to calibrate the pressure wave form and assess continuous cardiac output. In addition the system also measures 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 HCM102 system, which is an apparatus based on ultrasound dilution and arterial pressure waveform analysis to provide diagnostic assessment of cardiovascular status including COstatus (HCM101) measurements by indicator dilution for quantifying patient's cardiac and volume status as well as 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 system, cardiac output is first measured by COstatus (HCM101) system and this is then automatically transferred to calibrate the arterial pressure waveform to obtain continuous cardiac output (when that mode is selected). Thus cardiac output is determined both intermittently through ultrasound technique and continuously through arterial pressure waveform analysis. 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 FDA 510(k) summary for the Transonic HCM102 System does not contain acceptance criteria or a study proving that the device meets specific performance criteria in a clinical setting.

The document discusses the device's functionality, its similarity to predicate devices, and general safety and effectiveness testing (IEC 60601-1 and EMC, bench, and animal testing). However, it lacks details on specific performance metrics, clinical study design, sample sizes for test or training sets, ground truth establishment, or expert involvement for assessing the device's accuracy or efficacy in measuring cardiovascular parameters in human patients.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence based on technical aspects and general safety standards, not on detailed clinical performance data against pre-defined acceptance criteria.

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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 AureFlo Monitor is intended for use with Transonic Systems' HT300-Series-FT Surgical Flowmeters. These Flowmeters are intended for use with adult and pediatric patients for measurement of blood or liquid volume flow with Transonic perivascular Flowprobes on major and peripheral arteries, veins and ducts; on non-aerated synthetic vessel grafts; where surgery is medically indicated; intraoperatively, rather than in chronic implant; at intraoperative sites which admit and retain ultrasonic couplant; with minimal vessel manipulation or constriction (to avoid vessel spasm); where application does not unnecessarily lengthen surgical procedure. Measurement of blood or perfusate volume flow with sterile tubing Flowsensors on flexible tubing specific to the flowsensor (never on arteries, veins) and for non-aerated media which are transparent to ultrasound.

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 Systems AureFlo Monitoring System. The device is a versatile monitoring system to continuously measure, display, record and document absolute volume flow and other derived parameters. It is used during surgery with Transonic Flowprobes to measure and display blood flow in vessels. It can also be used with Sterile Tubing Flowsensors to measure and display flow of fluids through tubing circuits. AureFlo's flexible integrated system can be set up in a variety of configurations. A stand-alone HT300-Series flowmeter can be upgraded to work with Flow Trace® software. The system can also be set up on any operating room cart with an optional monitor stand: The display panel is an Intel® Pentium M® CPU touch-screen computer/monitor with Microsoft Windows XP®. The computer/monitor's manual can be accessed by selecting "Help" on the Windows Start Screen. FlowTrace® Software works exclusively with HT300-Series-FT Flowmeters to provide a real-time waveform display of volume flow, mean flow and Pulsatile Index (PI). During CABG surgery, connection with an ECG signal allows for an on-screen ECG display, diastolic/systolic shading of coronary graft waveforms and calculation of a D/S (diastolic/systolic) Ratio.

The provided text describes the Transonic Systems AureFlo Monitoring System and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized safety and performance standards. However, it does not contain the level of detail typically found in a study proving a device meets specific, quantitative "acceptance criteria" related to diagnostic accuracy or clinical outcomes.

Instead, the submission primarily highlights:

1. Technological Characteristics Comparison with a Predicate Device: This is used to argue for substantial equivalence.
2. Compliance with Safety and EMC Standards: IEC 60601-1 and CISPR 11.
3. Bench Testing: Internal bench testing by Transonic Systems Inc. to ensure performance parameters conform to design specifications.

Given this context, I will extract and infer information where direct details are absent, making explicit that the acceptance criteria reported here are based on the information provided, which is more about regulatory compliance and engineering specifications than a traditional clinical study with accuracy metrics.

Acceptance Criteria and Device Performance Study for the Transonic Systems AureFlo Monitoring System

The Transonic Systems AureFlo Monitoring System obtained 510(k) clearance (K112657) by demonstrating substantial equivalence to a predicate device (K040228 Medi-Stim VeriQ System) and compliance with relevant safety and electromagnetic compatibility standards. The primary "acceptance criteria" for this premarket notification appear to be related to safety, electromagnetic compatibility, and the device's ability to meet its internal design specifications through bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not specify a sample size for a "test set" in the context of a clinical performance study involving patient data. The evaluation primarily relies on:

• Compliance testing: For standards like IEC 60601-1 and CISPR 11. These tests typically involve simulating use conditions or testing components and the complete system in controlled environments, not a specific "patient test set."
• Bench testing: Internal validation by Transonic Systems Inc. against design specifications. The document does not provide details on the sample size (e.g., number of devices tested, number of measurements taken for different flow conditions) for this bench testing, nor does it refer to data provenance in terms of country of origin or retrospective/prospective nature. It is implied that this testing was conducted in a laboratory setting by the manufacturer.

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

Given that the document describes regulatory compliance testing and internal bench testing rather than a clinical study requiring an expert-adjudicated "ground truth," this information is not applicable and not provided. The "ground truth" for the performance/bench testing would be derived from calibrated measurement devices or known physical properties being assessed (e.g., known flow rates, electrical signals). For substantial equivalence, the "ground truth" is established by comparing the device's technological characteristics and intended use to those of the predicate device, which is a regulatory, not an expert-driven clinical, assessment.

4. Adjudication Method for the Test Set

As there is no clinical "test set" and thus no expert-driven adjudication described, this information is not applicable and not provided. Compliance with safety and EMC standards and internal bench testing have their own established protocols for verification and validation, which do not involve expert adjudication in the manner of medical image interpretation studies (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance?

No, an MRMC comparative effectiveness study involving human readers or AI assistance was not done or described in this 510(k) submission. The AureFlo Monitoring System is a blood flow measurement device, not an AI-powered diagnostic or interpretive tool that would typically undergo such a study.

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

No, a standalone algorithm performance study (without human-in-the-loop) was not done or described. This device is a measurement system, not a software algorithm providing diagnostic interpretations. Its "performance" is inherently tied to its physical interaction with blood vessels or tubing and its ability to accurately measure flow, which is then displayed to a human operator.

7. The Type of Ground Truth Used

For the safety, EMC, and bench testing, the "ground truth" would be established by:

• Reference Standards: For electrical safety (IEC 60601-1) and EMC (CISPR 11), the ground truth is the published standard itself and the ability of the device to meet its requirements when tested by an accredited lab (TUV Rheinland of North America, Inc.).
• Calibrated Measurement Equipment: For bench testing of flow measurement capabilities, the ground truth would be precise measurements from highly accurate and calibrated flow meters or known, controlled flow conditions used to verify the AureFlo system's output. The document doesn't explicitly state "calibrated equipment" but it is implicitly understood in "ensur[ing] the product's performance parameters conform to the product design specifications."

No pathology, expert consensus, or outcomes data are mentioned as ground truth for this type of device and submission.

8. The Sample Size for the Training Set

Not Applicable. The Transonic Systems AureFlo Monitoring System is a hardware-based measurement device with associated software, not a machine learning or AI algorithm that requires a "training set" of data in the typical sense. It operates based on ultrasonic transit-time principles.

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

Not Applicable. As there is no "training set" for a machine learning algorithm, there is no ground truth established for it. The device's operational principles are physics-based, not learned from data.

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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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The Transonic AngioFlow meter and catheter are indicated for use during angioplasty procedures to verify the flow before, during, and after treatment. The system is intended for the measurement of blood flow within a vascular bed utilizing a catheter-based sensor. This sensor system uses thermal changes induced by a bolus injection of normal saline and thermal-dilution principles to calculate blood flow.

The Transonic Angio Flow Meter and Catheter which is intended for the measurement of blood flow within a vascular bed utilizing a catheter-based sensor. This sensor system uses thermal changes induced by a bolus injection of normal saline and thermal-dilution principles to calculate blood flow in hemodialysis grafts.

The provided text is a 510(k) summary for the Transonic Angio Flow Meter and Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for a new device. Therefore, much of the requested information regarding acceptance criteria, specific performance studies, sample sizes, ground truth establishment, and expert qualifications is not explicitly available in the provided text.

Based on the available information, here's what can be extracted and what cannot:

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

This information is not explicitly available in the provided text. The document states:

• "All finished products are tested and must meet all required release specifications."
• "The array of testing required for release includes, but is not limited to; physical testing, visual examination (in process and finished product)."
• "The physical testing is defined by Quality Control Test Procedure documents. The physical testing measures values and parameters which conform to the product design specifications."

However, the specific "required release specifications" or "product design specifications" (i.e., the acceptance criteria) and the "reported device performance" against these criteria are not detailed. The document primarily focuses on the process of testing rather than the results of specific performance tests.

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

This information is not available in the provided text. The document does not describe a clinical or performance study with a dedicated test set or data provenance. The testing mentioned refers to manufacturing quality control and adherence to design specifications.

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 applicable/available. Since no specific clinical or performance study with a test set is described where ground truth was established, there's no mention of experts or their qualifications for this purpose.

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

This information is not applicable/available. As no specific test set or study is described, there is no mention of 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 applicable/available. The device is a "Thermodilution Meter and Catheter" used for measuring blood flow, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this type of device and is not mentioned.

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

This information is not applicable/available. The device is a measurement instrument, not an algorithm. Its operation inherently involves a human operator.

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

This information is not available. Given the nature of the device (blood flow meter), any "ground truth" for its performance would likely relate to accuracy and precision of flow measurements compared to a gold standard measurement method or known flow rates in a controlled environment. However, the document does not specify how this was established or type of data used.

8. The sample size for the training set:

This information is not applicable/available. The device is a hardware instrument, not an AI or machine learning algorithm that requires a "training set."

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

This information is not applicable/available, for the same reason as point 8.

Summary based on the document:

The 510(k) summary provided indicates that the Transonic Angio Flow Meter and Catheter demonstrates substantial equivalence to its predicate device (K010253, also Transonic Angio Flow Meter and Catheter) based on:

• Similar intended use, device description, and indications for use.
• Similar materials, form, and intended use to the previous version, with no new issues of safety or effectiveness raised by modifications.
• Biocompatibility of patient-contacting materials conforming to EN Standard 30993 and/or USP class VI.
• The meter component meeting applicable electrical safety requirements in accordance with the IEC 601 series of standards.
• Finished products undergoing testing to meet required release specifications, including physical testing (conforming to product design specifications) and visual examination.

The document does not provide specific acceptance criteria in quantitative terms (e.g., "accuracy must be within X%"), nor does it present detailed study results with sample sizes, data provenance, ground truth establishment, or expert involvement as would be expected for a complex diagnostic or AI-driven device. It relies on the assertion of manufacturing quality control and compliance with established standards and the similarity to a legally marketed predicate device.

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The Transonic Syringe Warmer (Model SYR1000) is indicated for use with the Transonic HD01 (HD01PMS and HD02) systems to make Cardiac output measurements. The Transonic Syringe Warmer (Model SYR1000) is an accessory to our HD01-CO Hemodialysis Monitor for Cardiac Output (K980906) which are currently marketed as the HD01046 and HD02 systems. The HD01-CO Hemodialysis Monitor for Cardiac Output (HD01P05 and HD02 systems) requires the user to make a 30cc injection of approximately body temperature saline into the hemodialysis blood circuit for the CO measurement. The syringe warmer provides the user a convenient source of the 30cc injection of approximately body temperature saline for this injection.

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 Syringe Warmer as an accessory to our HD01-CO Hemodialysis Monitor for Cardiac Output (K980906). The HD01-CO Hemodialysis Monitor for Cardiac Output requires the user to make a 30cc injection of ~ body temperature saline into the hemodialysis blood circuit for the CO measurement. The syringe warmer will provide the user a convenient source of the 30cc injection of ~ body temperature saline for this injection.

The provided text describes a 510(k) premarket notification for the Transonic Syringe Warmer, an accessory device. The information primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed acceptance criteria, specific study designs, or performance metrics in a quantitative manner typical for AI/ML device submissions.

Based on the provided text, I can infer the general nature of the "acceptance criteria" and "study" as implied by the FDA's "Safety and Effectiveness" section, but there are no specific numerical thresholds or detailed study results. The submission relies on demonstrating the device is similar to a predicate device and meets general quality control requirements.

Here's an analysis based on the provided text, attempting to address your points as much as possible, while noting where information is absent for this type of submission:

Acceptance Criteria and Study for the Transonic Syringe Warmer

The Transonic Syringe Warmer is an accessory device intended to warm a 30cc syringe of saline to approximately body temperature for injection into a hemodialysis blood circuit. The acceptance criteria and supporting "study" described are focused on demonstrating the device's safety and effectiveness and its substantial equivalence to a predicate device, rather than a quantifiable performance study against specific metrics for AI/ML devices.

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

Based on the document, the acceptance criteria are implicitly tied to "release specifications" and "product design specifications." The "reported device performance" is essentially that the device functions as intended to warm saline.

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

The document does not specify a "test set" in the context of a typical AI/ML study with data points. Instead, it refers to "all finished products" being tested.

• Sample Size: "All finished products" are tested. This implies a 100% inspection or testing of manufactured units.
• Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed by the manufacturer, Transonic Systems Inc. (located in Ithaca, NY, USA).
• Retrospective/Prospective: Not applicable. These are manufacturing quality control tests, not clinical studies.

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

This information is not applicable to the type of device and submission described. There is no mention of experts establishing ground truth for a test set, as this is a hardware device undergoing manufacturing quality control rather than a diagnostic AI/ML algorithm.

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

Not applicable. There is no "test set" requiring adjudication in the context of clinical or diagnostic performance. The testing described is internal quality control.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices, not for a syringe warmer. There is no AI component mentioned in this device.

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

No, a standalone algorithm-only performance study was not done. This device is a hardware accessory and does not contain an AI algorithm.

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

The "ground truth" for this device's performance is based on its adherence to manufacturing specifications and its ability to perform its stated function (warming saline to ~body temperature). This would be validated through engineering measurements and quality control checks, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. This device does not use machine learning or have a "training set."

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

Not applicable. This device does not use machine learning or have a "training set."

Summary of the "Study" Described:

The "study" demonstrating the Transonic Syringe Warmer meets its acceptance criteria is best described as a comprehensive quality control and manufacturing testing process rather than a clinical trial or AI performance study.

• Process: "All finished products are tested and must meet all required release specifications before distribution."
• Testing Types: "physical testing, visual examination (in process and finished product)."
• Methodology: "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."
• Documentation: "The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control cGMP's."

The submission primarily relies on demonstrating substantial equivalence to a predicate device (Vista Dental Anesthetic Syringe Warmer) and asserting that the modified intended use (warming saline for hemodialysis monitoring) "does not raise any new issues of safety or effectiveness." This approach underscores that the primary evidence for this particular 510(k) submission is related to manufacturing quality and equivalence, not advanced performance metrics or clinical study data.

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The Transonic Flow-QC Set is indicated for use as part of an extracorporeal blood circuit for hemodialysis when the Transonic HD01 System will be use to make access flow, recirculation, and/or cardiac output measurements during the patient's hemodialysis treatment.

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 Flow-QC® Sets which are Hemodialysis extension sets for connection into standard Hemodialysis circuits. These sets provide tubing segments of consistent material and wall thickness to which our HD01 Hemodialysis system can be calibrated. They also provide an injection port for making cardiac output measurements with the HD01 system.

The provided text is a 510(k) Summary for the Transonic Flow-QC® Sets, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a medical device with an algorithm.

Therefore, the information requested regarding acceptance criteria, device performance, study characteristics (sample sizes, ground truth, experts, adjudication), and multi-reader multi-case (MRMC) or standalone studies is not explicitly available in the provided document. This document emphasizes material testing, compliance with standards, and comparison to a predicate device, which is a common approach for certain classes of medical devices.

Here's a breakdown based on the provided text, indicating where information is missing:

Acceptance Criteria and Device Performance

Study Details

Below is a response to each specific point, indicating that the information is not present in the provided 510(k) summary for the Transonic Flow-QC® Sets. This type of 510(k) submission, particularly for accessories, often relies on material compliance and comparison to a predicate rather than extensive clinical performance studies as would be seen for a diagnostic algorithm.

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

   • Information Not Provided. The document describes manufacturing quality control and material testing, not a clinical performance study with a "test set" in the context of an algorithm.

2. 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):

   • Information Not Provided. No "ground truth" establishment by experts is mentioned, as this is not a diagnostic device or an algorithm requiring such validation.

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

   • Information Not Provided. No adjudication method is mentioned, as there is no "test set" in the context of a diagnostic performance study.

4. 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:

   • Information Not Provided. No MRMC study was performed or is relevant, as this device is a hemodialysis accessory, not an AI-assisted diagnostic tool.

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

   • Information Not Provided. This device does not involve an algorithm, hence no standalone performance study was conducted or is applicable.

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

   • Information Not Provided. "Ground truth" in the context of diagnostic accuracy is not addressed. The "truth" for this device relates to manufacturing specifications and material compliance.

7. The sample size for the training set:

   • Information Not Provided. There is no "training set" as this device does not involve machine learning or an algorithm.

8. How the ground truth for the training set was established:

   • Information Not Provided. Not applicable, as there is no training set.

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