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The BreathID® Hp Lab System or the BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach.

The BreathID® Hp Lab System or BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit Hp® kit, and the BreathID® Hp device, Auto Sampler and Lab Application. The BreathID® Smart System consists of the appropriate IDkit Hp® kit and the BreathID® Smart device.

To be administered by trained personnel as ordered by a licensed healthcare practitioner.

The modified BreathID® Smart System, is a non-invasive breath test system for detecting the presence of Helicobacter pylori (H. pylori). The system consists of an electro-optical medical device with embedded software designed to measure and compute the changes in the ratio between 13CO2 and 12CO2 concentrations in the patient's exhalation, an integrated Auto Sampler, integrated software, and a test kit.

The IDkit Hp® Two test kit consists of:

• One 75mg 13C-urea tablet .
• One packet of 4.3g of powdered Citrica (citric acid) .
• One drinking straw ●
• One drinking cup ●
• One Package Insert (Instructions for Use) ●
• One Quick User Guide ●
• Two Breath Sample Bags (one Baseline and one Post Ingestion) ●
• Four bar code labels .
• A large Sample Transport Bag ●

Using bags for breath collection enables off-site and deferred testing as well as testing of multiple breath sample bags sequentially in a batch. The modified BreathID® Smart System measures and computes the ratio between 13CO2and 12CO2 in the patient's exhaled breath before and after the ingestion of 13C-urea. The change in the 13CO2 / 12CO2ratio before and after ingestion of 13C-urea is used to compute the Delta over Baseline (DOB).

The 13C measurement method for both the subject and the cleared (predicate) versions of the BreathID® Smart System is based on Molecular Correlation Spectroscopy™ (MCS) technology. MCS technology is based on the concept of optical absorption of specific radiation emitted from CO2 discharge lamps.

The provided text describes a Special 510(k) submission for a modified BreathID® Smart System where the primary change is an update to the operating system from Windows CE 6 to Windows 10. The original BreathID® Smart System (K220494) is the predicate device.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format with performance results for the modified device compared to a specific benchmark. Instead, it focuses on demonstrating equivalence to the predicate device. The key performance metric mentioned is "Delta over Baseline (DOB)" and a positive/negative determination based on a cutoff of ">5 DOB."

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

• Sample Size: "The comparison test included 80 measurements on each system..." This refers to the comparison between the modified and predicate systems, not necessarily a clinical test set from patients. The exact nature of these "measurements" (e.g., how many unique samples, how many replicates) is not fully detailed, but they involved "contrived gases."
• Data Provenance: The "measurements" used contrived gases. This indicates an in vitro or laboratory-based testing approach, not data from human patients. Therefore, information about country of origin or retrospective/prospective nature for patient data is not applicable to this specific comparison test.

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

This information is not provided. The comparison test utilized "contrived gases simulating different levels of 13CO2," suggesting an engineered ground truth rather than a clinical ground truth established by experts.

4. Adjudication Method for the Test Set:

Not applicable. The test set involved contrived gases and a direct comparison between the modified and predicate devices, not subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The device is a diagnostic testing system (BreathID®) that provides a quantitative output (DOB) and a positive/negative determination. It does not involve human readers interpreting images or data that would be assisted by AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, the testing described appears to be a standalone performance evaluation. The "comparison test" was performed directly between the predicate and modified systems using controlled inputs (contrived gases), without human intervention in the diagnostic decision-making process beyond operating the device. The device itself performs the measurement and computes the DOB.

7. Type of Ground Truth Used:

For the comparison test discussed, the ground truth was based on contrived gases simulating different levels of 13CO2. This allowed for controlled evaluation of the system's ability to measure and compute 13CO2concentrations accurately. For the clinical efficacy of the device as a whole for H. pylori, the text states it uses 13C-urea, which is a known and approved method (NDA 21-314).

8. Sample Size for the Training Set:

This information is not provided. The document describes a Special 510(k) for a modification (OS change) to an already cleared device, not the development of a completely new algorithm requiring a training set. The underlying "MCS technology" is already established.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as a training set for a new algorithm associated with this modification is not mentioned.

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