(30 days)
The basixTOUCH40 Inflation Syringe is used to inflate an angioplasty balloon or other interventional device, and to measure the pressure within the balloon.
The basixTOUCH40TM Inflation Syringe by Merit Medical is a 30mL disposable device with a threaded plunger assembly, a flexible high pressure extension tube. The basixTOUCH40TM is designed to generate positive and negative pressure, and monitor positive pressures over a range of zero to +40ATM/BAR (zero to 588 PSI).
This document is a 510(k) premarket notification for the basixTOUCH40 Inflation Syringe. It describes the device, its intended use, and its substantial equivalence to a predicate device. The information provided outlines performance testing that was conducted, but it does not contain specific acceptance criteria with reported device performance values in a table, nor does it detail a study that proves the device meets specific acceptance criteria in the format requested.
The document states that "The results of the testing demonstrated that the subject basixTOUCH40 Inflation Syringe met the predetermined acceptance criteria applicable to the safety and effectiveness of the device." However, the document does not list those acceptance criteria or the actual performance results of the device against those criteria. It also does not describe a clinical study or a comparative effectiveness study with human readers.
Therefore, for many of the requested points, the information is not present in the provided text.
Based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The document states that "The results of the testing demonstrated that the subject basixTOUCH40 Inflation Syringe met the predetermined acceptance criteria applicable to the safety and effectiveness of the device," but it does not provide the criteria themselves or the specific performance results in detail.
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 present in the provided document. The document mentions "Performance testing" but does not specify sample sizes for these tests or the data provenance.
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/present as the device is a medical instrument (inflation syringe), not an AI diagnostic tool that requires expert-established ground truth on a test set. The performance testing would be engineering or bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/present as the device is a medical instrument and the performance testing described would not involve adjudication of a test set in the way an AI diagnostic tool would.
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/present as the device is a medical instrument (inflation syringe), not an AI diagnostic tool that would be part of a multi-reader multi-case study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/present as the device is a medical instrument and not an algorithm. Bench testing was performed for the device's functional attributes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/present as the device is a medical instrument, not a diagnostic tool requiring such ground truth. The "ground truth" for the performance tests would be defined by engineering specifications and physical measurements.
8. The sample size for the training set
This information is not applicable/present. The device is a physical medical instrument, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/present. The device is a physical medical instrument, not an AI model that requires a training set.
Summary of available information related to performance testing:
- Device: basixTOUCH40 Inflation Syringe
- Purpose: To inflate an angioplasty balloon or other interventional device and to measure the pressure within the balloon.
- Comparison to Predicate: The subject device generates a higher maximum pressure (40 ATM) compared to the predicate (35 ATM). The connection between the gauge and the syringe barrel was modified from a brass-fit to a snap-fit connection.
- Performance Testing Done (Types of tests mentioned):
- Fluid Functional Use
- Vertical Gauge Tensile
- Horizontal Gauge Tensile
- Vacuum Capability
- Gauge Accuracy
- Retainer Cap Bond Torque
- Tip Adapter Securement and Tip Securement
- Outcome of Testing: "The results of the testing demonstrated that the subject basixTOUCH40 Inflation Syringe met the predetermined acceptance criteria applicable to the safety and effectiveness of the device."
- Biocompatibility: Not required due to no patient contact.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.