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The BreathID Hp Lab System or 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 BreathD Hp Lab System consists of the appropriate IDkit Ho 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 BreathID® Hp Lab System and the BreathID® Smart System are two non-invasive breath test systems for detecting the presence of Helicobacter pylori (H. pylori) based on the same technology. The systems consist of an electro-optical medical device designed to measure and compute the changes in the ratio between 13CO2 and 12CO2 concentrations in the patient's exhalation, an Auto Sampler, software, and a test kit.

The IDkit Hp™ Two test kit consists of:

• One 75mg 13C-urea tablet .
• One packet of 4.3g 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 ●
• One 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 BreathID® Hp Lab System and the BreathID® Smart System measure and compute the ratio between 13CO2 in the patient's exhaled breath before and after the ingestion of 13C-urea. The change in the 13CO2 / 12CO2 ratio before and after ingestion of 13C-urea is used to compute the Delta over Baseline (DOB).

The 13C measurement method 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.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary.

It's important to note that this 510(k) is a Special 510(k) for a labeling modification only. This means the device itself, its technology, and its core performance characteristics (as established in previous clearances K173777 and K193610) remain unchanged. The modification specifically addresses the interpretation of positive results for patients taking proton pump inhibitors (PPIs). Therefore, a detailed "study that proves the device meets the acceptance criteria" in terms of new performance evaluation is generally not part of a Special 510(k) for a labeling change in the way it would be for a de novo device or a significant technology change.

The document states: "Performance characteristics remain unchanged." This implies that the performance data supporting the original clearances (K173777 and K193610) is what demonstrates the device meets its acceptance criteria. No new performance testing was conducted for this specific 510(k).

Acceptance Criteria and Reported Device Performance

Given that this 510(k) is for a labeling modification related to PPIs and states performance characteristics remain unchanged, the document does not present new acceptance criteria or device performance data for this submission. The original devices were cleared based on their ability to non-invasively measure changes in the ¹³CO₂/¹²CO₂ ratio indicative of urease production associated with H. pylori.

The core intent of the device is to diagnose H. pylori infection. Therefore, for a diagnostic device like this, common performance metrics would typically include:

• Sensitivity: The ability to correctly identify patients with H. pylori.
• Specificity: The ability to correctly identify patients without H. pylori.
• Accuracy: The overall correctness of the test.

However, the provided text does not contain any specific numerical acceptance criteria or reported device performance values for sensitivity, specificity, or accuracy for either the original devices or for this labeling change. These would have been documented in the original 510(k) submissions (K173777 and K193610).

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document's purpose):

Study Information (Relevant to the original device clearances, as no new performance study was done for this labeling change)

Since this is a Special 510(k) for a labeling modification, no new clinical performance study was conducted or described in this document. The document explicitly states, "Performance characteristics remain unchanged." Therefore, the following points cannot be answered from the provided text for this 510(k) submission, but would have been part of the original K173777 and K193610 submissions.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not provided in this document. This information would be in the original 510(k)s (K173777, K193610).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not provided in this document. This information would be in the original 510(k)s (K173777, K193610).

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not provided in this document. This information would be in the original 510(k)s (K173777, K193610).

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:

   • Not applicable. This device is a diagnostic breath test system, not an AI-assisted diagnostic imaging or interpretation tool for human readers. It provides a direct numerical output (Delta over Baseline) based on a chemical reaction.

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

   • Yes, implicitly. The device itself (the BreathID Hp Lab System or BreathID Smart System) provides a standalone measurement (Delta over Baseline) that is then interpreted by a healthcare practitioner. The performance characteristics remaining unchanged implies that the standalone performance that was established for K173777 and K193610 continues to apply. However, specific standalone performance metrics are not given in this document.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not provided in this document. For H. pylori breath tests, ground truth is typically established by other diagnostic methods for H. pylori, often invasive (e.g., biopsy with histology or rapid urease test during endoscopy) or non-invasive (e.g., stool antigen test, serology), sometimes with a composite reference standard. This information would be in the original 510(k)s (K173777, K193610).

7. The sample size for the training set:

   • Not applicable / Not provided. For this type of chemical diagnostic device that measures changes in isotope ratios, there isn't typically a "training set" in the machine learning sense. The device's operation is based on established physical and chemical principles, not on a trained algorithm from a large dataset. The underlying algorithms for calculating the Delta over Baseline are fixed.

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

   • Not applicable. See point 8.

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The Exalenz BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 1300/14CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach.

The Exalenz BreathID® Hp Lab 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 Exalenz BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device. Auto Sampler and Lab Application.

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

The BreathID® Hp Lab 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 ratio between 13002 and 1202 concentrations in the patient's exhalation, an Auto Sampler, a Lab Application, and a test kit. The IDkit Hp™ Two kit consists of:

• A 75mg 13C-urea tablet
• A 4.3g package of powdered Citrica (citric acid) ●
• Drinking straw
• Package Insert (Instructions for Use) ●
• Quick User Guide
• 2 Breath Sample Bags (Baseline and Post Ingestion) with bar code labels and a large Sample Transport Bag

Using bags for breath collection along with the Auto Sampler enables off site and deferred testing as well as testing of multiple breath sample bags sequentially in a batch. The BreathID® Hp Lab System measures and compute the ratio between 13CO2 and 12 CQ2 in the patient's exhaled breath before and after the ingestion of 13C-urea. The change in the 13CO2 / 12CO2 ratio 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® Hp Lab systems 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.

This document describes the 510(k) summary for the Exalenz BreathID® Hp Lab System, specifically focusing on expanding its indications for use to include pediatric patients aged 3-17 years old. The device is identical to its predicate, and the submission primarily addresses the expansion of the patient population.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance Study

The primary purpose of this 510(k) submission was to expand the indications for use to include pediatric patients. Therefore, the "acceptance criteria" presented below are based on the secondary endpoint of the clinical validation study conducted for this pediatric population expansion, as the device itself is stated to be identical to a previously cleared one for adults. The study aimed to assess performance in pediatrics, supported by existing adult data.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only provides performance metrics (Positive Percent Agreement and Negative Percent Agreement) against a stool antigen test for the pediatric study. It does not explicitly state pre-defined "acceptance criteria" numerical thresholds for these performance metrics for the pediatric population within this document. Instead, it states that "These study results met the predefined success criteria for confirming the safety... and for providing further evidence of BreathID Hp Lab System performance..." implying that the reported values were acceptable.

Note on "Cut-off Point": The document mentions a "Cut-off Point" of "5.0 DOB per mil (post dose minus pre dose)" for determining positive/negative H. pylori infection. This is a classification threshold for the device's output, not a performance acceptance criterion in the same vein as PPA/NPA.

2. Sample Sizes and Data Provenance

• Test Set Sample Size:
  • Screened: 54 subjects
  • Enrolled (Full Analysis - FA set) for Safety Assessment: 53 subjects
  • Completed full study protocol with evaluable breath and stool test endpoints: 42 subjects (This is the effective test set size for performance assessment.)
• Data Provenance: The study was prospective and conducted at 6 clinical sites that were geographically diverse (no specific countries mentioned, but given the FDA submission, it's likely U.S. or international sites adhering to relevant regulations).

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state how many experts were used or their specific qualifications for establishing the ground truth for the test set. The ground truth was established by a central laboratory analyzing stool specimens with an FDA cleared H. pylori stool antigen test. While this implies expert analysis is involved in running and interpreting such a test, specific details about the individuals (e.g., number, board certification, years of experience) are not provided.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was established using an FDA-cleared stool antigen test at a central laboratory, which is a definitive clinical test, not based on expert consensus requiring adjudication.

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

No, an MRMC comparative effectiveness study was not conducted. This device is a diagnostic test (breath test) with a determined cut-off for positive/negative results, not an imaging analysis system typically evaluated with MRMC studies for human reader improvement with AI assistance. The study compared the device's results to a established clinical ground truth (stool antigen test).

6. Standalone Performance Study (Algorithm Only)

Yes, the performance metrics (Positive Percent Agreement and Negative Percent Agreement) are presented as standalone performance of the BreathID® Hp Lab System, classifying patients as positive or negative based on its 5 DOB cut-off, compared to the stool antigen test. There is no human-in-the-loop component mentioned in its operation or the reported performance.

7. Type of Ground Truth Used

The type of ground truth used was an FDA cleared H. pylori stool antigen test, analyzed by a central laboratory. This is a laboratory/clinical test result considered a definitive diagnostic marker for H. pylori infection.

8. Sample Size for the Training Set

The document does not specify a sample size for a training set. The purpose of this 510(k) was to expand the indication for an already cleared and identical device. The "clinical validation" described is essentially a performance evaluation in the new (pediatric) population, not a de novo algorithm development or training. The device's underlying technology and cutoff (5.0 DOB) were already established and validated in adult populations (as per the predicate device K162150).

9. How Ground Truth for the Training Set Was Established

As there is no clear mention of a "training set" in the context of this 510(k) submission, the establishment of ground truth for a training set is not applicable here. The device's core functionality and diagnostic characteristics were presumably established during the development and clearance of the predicate device (K162150) for adults.

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The Exalenz BreathID® Hp Lab 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 Exalenz BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. The Exalenz BreathID® Hp Lab System consists of the IDkit:Hp™ kits, and the BreathID® Hp device, Auto Sampler and Lab Application.

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

The BreathID® Hp Lab 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 ratio between 1302 and 12CO2 concentrations in the patient's exhalation, an Auto Sampler, a Lab Application, and a test kit. The IDkit Hp" Two kit consists of:

• A 75mg 13C-urea tablet .
• A 4.3g package of powdered Citrica (citric acid) ●
• . Drinking straw
• Package Insert (Instructions for Use) ●
• . Quick User Guide
• 2 Breath Collection Bags (Baseline and Post Ingestion) with bar code labels and a . Transport Bag

Using bags for breath collection along with the Auto Sampler enables off site and deferred testing as well as testing of multiple breath sample bags sequentially in a batch.

The BreathID® Hp Lab System measures and computes the ratio between 1302 and 12 CO2 in the patient's exhaled breath before and after the ingestion of 13C-urea. The change in the 13CO2 / 12CO2 ratio before and after ingestion of 13C-urea is used to compute the Delta over Baseline (DOB).

The 13C measurement method for both the current and the cleared versions of the BreathID® Hp systems 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.

Here's a breakdown of the acceptance criteria and study details for the BreathID® Hp Lab System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents the clinical validation results as a demonstration of the device's efficacy, specifically its sensitivity and specificity for initial diagnosis and post-treatment monitoring of H. pylori infection. The acceptance criteria are implicitly defined by these performance targets.

2. Sample Sizes and Data Provenance

The document does not explicitly state the country of origin for the clinical study data, but it was a "multi-center" study. It was a prospective clinical validation study.

• Test Set Sample Size:
  • Initial Diagnosis Cohort: 179 adult patients
  • Post-Treatment Cohort: 68 adult patients

3. Number of Experts and Qualifications for Ground Truth

The document specifies "composite biopsy results (histology and RUT)" as the ground truth. It does not provide information on the number of experts used to establish this ground truth or their qualifications (e.g., number of pathologists, years of experience, etc.).

4. Adjudication Method for the Test Set

The document mentions "composite biopsy results (histology and RUT)" were used. This implies a combination of diagnostic methods to establish the ground truth, but it does not detail a specific adjudication method (e.g., 2+1 reader consensus for histology, or how histology and RUT results were combined if discordant).

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

No, an MRMC comparative effectiveness study involving human readers with/without AI assistance was not mentioned. The study focused on the standalone performance of the BreathID® Hp Lab System against a clinical gold standard.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The clinical validation section details the sensitivity and specificity of the BreathID® Hp Lab System (the algorithm/device only) in diagnosing and monitoring H. pylori infection.

7. Type of Ground Truth Used

The ground truth used for the clinical validation study was expert consensus / pathology / clinical outcomes data, specifically "composite biopsy results (histology and RUT)".

8. Sample Size for the Training Set

The document does not specify the sample size for any training set. As this is a medical device for H. pylori detection and not, for example, a novel image-based diagnostic, it's possible the device uses pre-established thresholds (like the 5.0 DOB cut-off) rather than a machine learning model that requires a distinct training phase in the typical sense. The underlying technology (Molecular Correlation Spectroscopy) is described as an optical absorption method, and the system computes a ratio, suggesting a more direct measurement rather than a trained classification model.

9. How Ground Truth for the Training Set Was Established

Since a training set sample size is not mentioned, the method for establishing its ground truth is also not provided.

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