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The UBiT-IR300 Infrared Spectrometry System is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The system consists of the UBiT-IR300 Infrared Spectrophotometer, the UBiT-AS10 Autosampler, and Otsuka Breath Collection Bags.

The UBiT-IR300 Infrared Spectrometry System is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The UBiT-IR300 System is suitable for use in both clinical laboratory and point-of-care settings.

The UBiT-IR300 Infrared Spectrometry System is a compact analyzer designed for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori. The UBiT-IR300 measures absorption of breath gas by calculating the ratios of 13CO2/12CO2 for a reference breath gas and a sample breath gas. The difference between the ratios for the reference and sample breath gases is calculated to obtain the final measurement result, which is reported as △'3CO2 and expressed as delta per mil (%) or Delta Over Baseline (DOB).

The System consists of the following components:

• UBiT-IR300 Infrared Spectrophotometer -
• UBiT-AS10 Autosampler -
• Otsuka Breath Collection Bags -

The UBiT-IR300 Infrared Spectrometry System is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The device was compared against the traditional Gas Isotope Ratio Mass Spectrometry (GIRMS) method.

Here's the breakdown of the acceptance criteria and study details:

Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are not explicitly stated as numerical thresholds in the provided text. However, for a device seeking 510(k) clearance by demonstrating substantial equivalence, the expectation is that its performance is comparable to or non-inferior to the predicate device. The presented results clearly indicate a very high level of agreement and correlation, suggesting these metrics met the implicit requirements for substantial equivalence.

Study Details

1. Sample Size used for the Test Set and Data Provenance:

   • Sample Size: 320 evaluable subjects.
     • 257 subjects from combined Physician Office Laboratory (POL) sites.
     • 63 subjects from one clinical laboratory site.
   • Data Provenance: The study was a multi-center, prospective study. The country of origin is not explicitly stated, but given the sponsor (Otsuka Pharmaceutical Co., Ltd., Japan) and the contact person's US number, it's likely a US-based or international study with US participant sites. The data is prospective as subjects were recruited and underwent the urea breath test for the study.

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

   • The ground truth in this study was established using the traditional Gas Isotope Ratio Mass Spectrometry (GIRMS) method. The study design directly compares the UBiT-IR300's results to the GIRMS method.
   • Therefore, the "experts" in this context are the established and recognized methodology of GIRMS for 13CO2 enrichment measurement. There's no mention of a separate panel of human experts in the traditional sense (e.g., radiologists) establishing ground truth, as it's a direct analytical comparison.

3. Adjudication Method for the Test Set:

   • Not applicable in the conventional sense. The "adjudication" is inherent in the comparison of the UBiT-IR300 results against the GIRMS method, which serves as the reference standard. Agreement and correlation were calculated based on this direct comparison.

4. 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:

   • No, this was not an MRMC study. This study evaluated the performance of an analytical device (UBiT-IR300) directly against a reference analytical method (GIRMS) for measuring 13CO2 enrichment, not human reader performance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, this study represents a standalone performance evaluation of the UBiT-IR300 Infrared Spectrometry System. It measures the device's ability to accurately measure 13CO2 enrichment independently, with its results then compared to the established GIRMS method.

6. The type of ground truth used:

   • The ground truth was established by the traditional Gas Isotope Ratio Mass Spectrometry (GIRMS) method. This is an established and accepted analytical method for measuring 13CO2 enrichment in breath.

7. The sample size for the training set:

   • The provided summary does not explicitly mention a separate "training set" for the device's development. This is typical for an analytical instrument where performance is often based on the device's physical and algorithmic design, rather than a machine learning model that requires a distinct training phase on clinical data. The clinical study described served as a validation/test set.

8. How the ground truth for the training set was established:

   • As no explicit training set is mentioned in the summary, this question is not directly applicable. If a training phase existed during device development, the ground truth would likely have been established through controlled experiments and calibrations using known standards for 13CO2 enrichment, analogous to the GIRMS method used for the clinical validation.

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