(99 days)
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:
- Technological Characteristics Comparison with a Predicate Device: This is used to argue for substantial equivalence.
- Compliance with Safety and EMC Standards: IEC 60601-1 and CISPR 11.
- 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
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance (as stated in the document) |
|---|---|---|
| Safety | IEC 60601-1 (Medical Electrical Equipment standard) | "The AureFlo Monitoring System is deemed to be safe and effective based on the safety testing completed by TUV Rheinland of North America, Inc., in accordance with the IEC 60601-1 Medical Electrical Equipment standard." |
| Electromagnetic Compatibility (EMC) | CISPR 11 standard | "This system also tested to and found to be in compliance for electromagnetic compatibility in accordance with the CISPR 11 standard." |
| Performance (Bench) | Conformance to product design specifications, as defined by Quality Control Test Procedure documents. | "bench testing was conducted by Transonic Systems Inc. and the validation report can be found in Section 18 of this 510(k) submission. ... The array of testing required for release includes, but are not limited to; physical testing and visual examination (in-process and finished product). ... These tests are established testing procedures that ensure the product's performance parameters conform to the product design specifications." |
| Technological Equivalence | Key characteristics comparable to the predicate device (Medi-Stim VeriQ System) | Detailed comparison table provided in the submission (see "Technological Characteristics Compared to Predicate Device" section for specifics like technology, channels, measured parameters, user interface, etc.). This comparison supports the claim of substantial equivalence. |
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.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).