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AIM is a bite block intended for use in patients 18 years and older who require supplemental oxygen and CO2 monitoring during procedures where the patient is expected to be minimally or moderately sedated. AIM is not indicated for use during procedures that are expected to require deep sedation.

AIM is a single-use, non-sterile bite block with integrated oxygen (O2) delivery and expired gas sampling tubing for patients undergoing procedures where supplemental oxygen and expired gas sampling is required expired. When paired with an oxygen supply and a capnography monitor, AIM can be left in place after the procedure to deliver oxygen and monitor CO2 levels.

AIM consists of a bite block, an attached oxygen delivery line and an attached CO2 sampling line. It delivers oxygen and samples exhaled CO2 in the oropharynx.

The provided text describes a 510(k) summary for a medical device named AIM, which is a bite block with integrated oxygen delivery and expired gas sampling tubing. The summary compares AIM to a predicate device, DualGuard™ (K140473), to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study proving the device meets these criteria, based on the provided document:

Acceptance Criteria and Device Performance Study for AIM

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes performance tests by comparing the AIM device to its predicate, DualGuard™. The acceptance criteria appear to be equivalent or better performance than the predicate device.

Note: The primary acceptance criterion for many of the performance and mechanical tests is "Comparison to predicate," implying that the AIM device must perform equivalently or better than the legally marketed predicate device.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size: The document does not specify the exact sample sizes (number of devices tested) for the performance, mechanical, or aging tests. It mentions "All AIM samples passed the non-clinical tests, and all samples passed the performance tests..." which suggests that all units tested within the sample passed, but the size of "all samples" is not quantified.
• Data Provenance: The study appears to be retrospective in the sense that it's a submission for regulatory clearance based on historical testing. The data originates from simulated conditions (e.g., "simulated oxygen delivery," "simulated EtCO2 values," "simulated respiratory conditions"). The geographic origin of the data/testing is not explicitly stated, but as it's an FDA submission, the testing would typically be conducted under recognized standards, often implicitly in the US or by labs adhering to US-acceptable standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This device is not an AI/ML device that generates diagnostic outputs requiring expert interpretation for ground truth. The acceptance criteria relate to physical performance (FiO2, EtCO2, mechanical properties) measured by instrumentation under simulated conditions, compared against a predicate device. There is no mention of human expert adjudication for ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. As noted above, the ground truth is based on physical measurements and comparisons to a predicate device, not human interpretation or consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is typically performed for AI-assisted diagnostic devices where human readers interpret medical images or data. The AIM device is a physical medical device for oxygen delivery and CO2 monitoring, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, in a sense, the performance tests for FiO2, EtCO2, and CO2 waveforms were evaluative of the device's standalone performance under simulated conditions, without direct human intervention as part of the measurement process itself. The "algorithm" here refers to the physical design and function of the device rather than a computational algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests (FiO2, EtCO2, CO2 Waveforms) was established by:

• Instrumental measurement under simulated conditions: The values of FiO2 and EtCO2, and the characteristics of CO2 waveforms, were presumably measured by calibrated instruments under controlled, simulated physiological conditions.
• Comparative equivalence to a legally marketed predicate device: The performance of the AIM device was directly compared to the performance of the DualGuard™ predicate device under the same simulated conditions. The predicate device's performance effectively served as a reference or "ground truth" for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. The AIM device is a physical medical device, not an AI/ML model that requires a training set of data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

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