Search Results

The Aero Jet Ventilation Catheter is indicated to be used as a device for ventilating the patient by the administration of oxygen and air, a technique referred to as jet ventilation.

The Aero Jet Ventilation Catheter is a sterile, single-use, prescription medical device that consists of a three lumen PTFE extrusion, a PEBAX centering feature at the distal end, three (3) MABS female luer connectors, silicone extrusion to connect the connectors to the main shaft, and four (4) polyolefin color coded marker bands for identification of connectors and depth marking. A removable stainless-steel stylet is included to support the device during insertion. It has a nominal insertion length of 23 cm and nominal OD of 3.85 mm. It is inserted orally and placed subglottic. It provides jet ventilation and allows for monitoring of pressure and EtCO2.

This document is a 510(k) clearance letter for a medical device called the "Aero Jet Ventilation Catheter." 510(k) clearances are for demonstrating substantial equivalence to a predicate device, not for proving new claims of safety and effectiveness through clinical trials with strict acceptance criteria based on new performance metrics.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the way described in the prompt (e.g., related to AI/algorithm performance, MRMC studies, specific effect sizes, ground truth establishment, or sample sizes for test/training sets in the context of diagnostic/AI performance).

The "performance testing summary" in the document refers to standard engineering and biocompatibility tests to show the device functions as intended and is safe, similar to the predicate device. It is not a study to establish performance against specific clinical or diagnostic metrics with human readers or AI in the way implied by the prompt's detailed questions.

Based on the provided text, I cannot complete the table or answer the questions as they pertain to a study proving device performance against acceptance criteria in a clinical/diagnostic context (like an AI study). The 510(k) process for this device relies on demonstrating equivalence to an existing device, primarily through engineering and bench testing, not through comparative clinical studies as you've outlined for diagnostic/AI devices.

Here's what I can extract from the document regarding "acceptance criteria" in the context of a 510(k) submission for this type of medical device:

The acceptance criteria for a 510(k) submission for a device like the Aero Jet Ventilation Catheter are implicitly tied to demonstrating substantial equivalence to a predicate device. This typically involves showing:

• Same Indications for Use: The new device is intended for the same uses as the predicate.
• Same Technological Characteristics: The new device has similar design, materials, and operating principles.
• Differences Do Not Raise New Questions of Safety/Effectiveness: If there are differences, testing must show they do not negatively impact safety or effectiveness.

The "studies" performed are primarily non-clinical functional and performance testing alongside biocompatibility testing. These tests are designed to show that the device performs its intended mechanical functions reliably and safely, and interacts biocompatibly with the body, similar to the predicate.

Therefore, the table and answers below reflect the type of "acceptance criteria" and "proof" found in this specific 510(k) document, which differs significantly from criteria for AI/diagnostic performance studies.

Acceptance Criteria & Device Performance (Based on K243579)

Since this is a 510(k) for a physical medical catheter, the "acceptance criteria" are not focused on diagnostic accuracy or AI performance, but rather on physical and functional characteristics to demonstrate substantial equivalence to a predicate device. The "performance" is implicitly tied to meeting these engineering and biocompatibility standards.

Table of Acceptance Criteria and the Reported Device Performance

Since the request focuses on information typically found in studies for AI/diagnostic devices, and this 510(k) is for a physical catheter, most of the specific numbered questions are not applicable (N/A) to the provided document.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Sample Size: Not explicitly stated for each bench test. For engineering/bench tests, "sample size" refers to the number of devices or components tested. These are laboratory tests, not clinical data sets.
* Data Provenance: N/A (These are laboratory bench tests of manufactured devices, not clinical data from patients/regions). The tests are performed on samples of the manufactured device.
* Retrospective/Prospective: N/A (Refers to clinical data collection, not bench testing).

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)
* N/A. This applies to clinical interpretation or AI ground truth. For a physical device, "ground truth" is established by engineering specifications, validated test methods (e.g., ISO standards), and physical measurements. Expertise would lie with engineers, material scientists, and quality control professionals who design and conduct the tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* N/A. This applies to human reader disagreements in clinical studies. Bench testing results are typically objectively measured against pre-defined engineering tolerances and test protocols.

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
* N/A. No MRMC study was done, as this is a physical medical device, not an AI or diagnostic imaging device. The document explicitly states: "No animal or clinical studies were conducted for this submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* N/A. No algorithm or AI component is listed for this physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* N/A. As a physical device, "ground truth" for the performance tests (e.g., tensile strength, flow rate, dimensions, laser resistance) is based on:
* Engineering Specifications: Designed values and tolerances.
* International Standards (e.g., ISO): Predetermined test methods and acceptable limits (e.g., for biocompatibility, connector integrity, laser resistance).
* Physical Measurements: Direct measurements of device properties.

8. The sample size for the training set
* N/A. This refers to training data for an algorithm. This device does not use a "training set."

9. How the ground truth for the training set was established
* N/A. This refers to ground truth for training an algorithm. Not applicable to this physical device.

Ask a specific question about this device