(49 days)
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.
§ 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).