(103 days)
A-View® is intended for use in conjunction with TEE investigation of the upper mediastinum in anesthetized patients. They allow visibility of the distal ascending aorta by TEE and permit the condition of the ascending aorta to be evaluated before surgery. A-View® is limited for use in adult patients.
The A-View® is a catheter with an inflatable balloon that is inserted through an endotracheal tube of an anesthetized patient. Once inserted the balloon is inflated with saline. This inflated balloon is placed near the aortic arch so that when the clinician is performing a TEE (transesophageal echocardiography) procedure the saline filled balloon provides better contrast for an image.
The provided text describes the 510(k) premarket notification for the A-View® device, which is a diagnostic ultrasonic transducer. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets acceptance criteria through clinical performance testing. Therefore, much of the requested information regarding clinical studies, ground truth, expert adjudication, and comparative effectiveness studies is not included in this type of submission.
However, based on the non-clinical performance testing conducted, I can extract information related to acceptance criteria and performance for certain device characteristics.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document details bench tests conducted and states that the A-View® met all performance requirements and specifications, supporting substantial equivalence to the predicate device. Specific acceptance criteria are not explicitly quantifiable values in the provided text (e.g., "leakage less than X ml/hr"), but rather a general statement of meeting requirements.
| Acceptance Criteria (Implied) | Reported Device Performance (A-View®) |
|---|---|
| Functional Performance: | Met all performance requirements and specifications (equivalent to predicate) |
| Leakage | Met requirements |
| Balloon inflation | Met requirements |
| Bond strength | Met requirements |
| Flexibility of tubing | Met requirements |
| Kink test | Met requirements |
| Torque | Met requirements |
| Tensile strength | Met requirements |
| Drop test | Met requirements |
| Real-time aged device | Met requirements |
| Biocompatibility: | Compliant with ISO 10993 standards (equivalent to predicate) |
| Cytotoxicity | Met requirements |
| Sensitization | Met requirements |
| Intracutaneous reactivity | Met requirements |
| Acute Systemic Toxicity | Met requirements (even though not required for this classification) |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data. It discusses bench tests for device performance. Sample sizes for these non-clinical tests (e.g., number of devices tested for leakage) are not provided. There is no mention of country of origin for any clinical data because none was presented. The testing described is non-clinical/bench testing, not retrospective or prospective 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. No clinical "test set" with ground truth established by experts is mentioned or described in this 510(k) summary. The device performance was assessed via bench testing, not expert interpretation of clinical data.
4. Adjudication method for the test set
This information is not applicable as there was no clinical "test set" requiring expert adjudication.
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. The A-View® device is a physical diagnostic ultrasonic transducer, not an AI-powered diagnostic tool. No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the A-View® device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance testing (bench tests), the "ground truth" would be established by the engineering and quality standards set for each test (e.g., a specific pressure maintained for a leak test, a measured force for a tensile test). These are objective physical measurements rather than clinical ground truth types like pathology or expert consensus.
8. The sample size for the training set
This information is not applicable. The A-View® is a physical medical device, 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 for the same reason as above (not an AI/ML algorithm).
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.