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The Exalenz BreathID® Hp Lab System or Exalenz 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 Exalenz BreathID® Hp Lab System or Exalenz BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult 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. The Exalenz 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® Hp Lab System, with the trade name BreathID® Smart, is a noninvasive 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 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:

• A 75mg 13C-urea tablet ●
• A 4.3g package of powdered Citrica (citric acid) ●
• Drinking straw
• Package Insert (Instructions for Use) ●
• 2 Breath Sample Bags (Baseline and Post Ingestion) with 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 BreathID® Smart System measures and computes the ratio between 13CO2 and 12CO2 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.

The provided text describes the regulatory clearance of the BreathID® Smart System as substantially equivalent to the BreathID® Hp Lab System (predicate device). The Special 510(k) submission focuses on a modified configuration of the predicate device, integrating three existing stand-alone components into one. The performance testing section primarily addresses verification and validation of the modified system, rather than a clinical study establishing diagnostic performance against a ground truth for a novel device.

Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria is geared towards demonstrating equivalence to the predicate device in terms of performance characteristics, not a primary diagnostic accuracy study.

Here's the breakdown of the information that can be extracted from the provided text, along with what is not available given the nature of this document (a 510(k) summary for a modified device):

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

The document mentions that all predefined acceptance criteria were met but does not explicitly list the quantitative acceptance criteria for most tests, beyond the cutoff point for detection. The tests described are primarily engineering and analytical validation tests comparing the new device to the predicate, rather than a clinical diagnostic accuracy study.

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

• Sample Size for Comparison Test: 80 measurements were performed on each system (BreathID® Hp Lab System and BreathID® Smart System).
• Data Provenance: The tests used "contrived gases simulating different levels of 13CO2". This indicates these were bench tests using simulated samples, not human patient data. The country of origin of this specific test data is not provided, but the applicant's address is in Israel.

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)

• Not Applicable / Not Provided: For the performance tests described (precision, reproducibility, carry-over, environmental, and comparison using contrived gases), expert interpretation of patient samples was not required to establish ground truth. The "ground truth" for these tests would be the known concentration of the simulated gases.

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

• None: Adjudication methods are typically relevant for clinical studies where multiple experts interpret patient data to establish a definitive diagnosis. The described tests used direct measurement of simulated gas concentrations and engineering validation, which do not involve expert adjudication.

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

• No MRMC Study: This document does not describe an MRMC study. The device measures a chemical ratio in breath; it is not an imaging device or AI-assisted diagnostic tool that would involve human readers.

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

• Not Applicable: The device is a diagnostic system that provides a numerical output (DOB) and a positive/negative determination based on a predefined cut-off. It is inherently a standalone measurement system, but the term "standalone performance" often refers to an AI algorithm's performance without human interaction. This device is an instrument, not an AI algorithm in the traditional sense, though it does have embedded software. The performance testing focuses on the system's ability to accurately measure 13CO2/12CO2 ratios.

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

• Known/Contrived Gas Concentrations: For the described performance tests, the "ground truth" for the test set was created using "contrived gases simulating different levels of 13CO2". This means the expected 13CO2 concentrations were known and controlled by the experimenters.

8. The sample size for the training set

• Not Applicable / Not Provided: The device is an instrument for measuring a specific chemical ratio, not a machine learning or AI model that requires a training set in the conventional sense. Its functionality is based on molecular correlation spectroscopy an established technology.

9. How the ground truth for the training set was established

• Not Applicable: As there's no "training set" in the context of an AI model, there's no ground truth establishment for such a set. The device's operation is based on physical principles of spectrometry and a defined chemical reaction.

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The Exalenz BreathID® Hp System is intended for use to continually and 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 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 System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device.

The device is for use by trained health care professionals. To be administered under a physician's supervision.

The BreathID® Hp 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 13CO2 and 12CO2 concentrations in the patient's exhalation, and a test kit. The IDkit Hp™ One kit consists of:

• A 75mg 13C-urea tablet
• A 4.3g package of powdered Citrica (citric acid)
• One IDcircuit™ nasal cannula
• Drinking straw
• Package Insert (Instructions for Use)
• Quick User Guide

The BreathID® Hp System measures and computes the ratio between 13CO2 and 1202 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 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 Exalenz BreathID® Hp System's acceptance criteria and performance are detailed below, based on the provided document. The primary purpose of this 510(k) submission was to expand the indication for use to include pediatric patients (ages 3-17). The subject device and predicate device are identical in their technological characteristics and use.

1. Table of Acceptance Criteria and Reported Device Performance

The core of the device's performance relies on its ability to accurately detect H. pylori. The clinical study focused on safety and the agreement with a stool antigen test in a pediatric population.

Note: The document states that "These study results met the predefined success criteria for confirming the safety of the 13 C-urea substrate in the pediatric population, and for providing further evidence of BreathID Hp System performance in this population taking into consideration prior supportive clinical performance in the adult population." While specific numerical performance criteria for PPA and NPA in the pediatric study are not listed in the provided sections, the successful outcome statement implies they were deemed acceptable in the context of supporting an expanded indication of use. The device uses a predefined cutoff of 5.0 DOB per mil for positive/negative determination.

2. Sample Size and Data Provenance

• Test Set Sample Size: 53 subjects were enrolled for safety assessment, and 41 subjects completed the full study protocol for evaluable breath and stool test endpoints during the clinical validation.
• Data Provenance: The study was a "multi-center, non-randomized, open label study" conducted at "6 clinical sites that were geographically diverse." The country of origin of the data is not explicitly stated, but the mention of "6 clinical sites" suggests a prospective collection of data.

3. Number and Qualifications of Experts for Ground Truth

• The document does not specify the number of experts used to establish ground truth for the test set.
• The ground truth for the performance assessment was established by comparing the BreathID® Hp System results to an "FDA cleared H. pylori stool antigen test," which was analyzed by a central laboratory. Expert qualifications are not mentioned in this context.

4. Adjudication Method

• The adjudication method for the test set is not explicitly described. For the performance assessment, the BreathID® Hp System results were compared against an "FDA cleared H. pylori stool antigen test" result, implying this served as the comparative standard.

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

• No MRMC comparative effectiveness study was done. This device is an automated diagnostic system, not one that relies on human interpretation that would be assisted by AI.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The "Clinical Validation" section describes a study where the BreathID® Hp System's results were directly compared (algorithm only, without human-in-the-loop performance) to a stool antigen test. The system applies a predefined threshold of 5 DOB to determine a positive or negative result.

7. Type of Ground Truth Used

• The primary ground truth used for assessing device performance was an FDA cleared H. pylori stool antigen test. This is a laboratory-based diagnostic test.

8. Sample Size for the Training Set

• The document does not provide information on the sample size for a training set. The submission focuses on expanding the indications for use for an existing device (predicate device K130524), and the study conducted was for clinical validation in a pediatric population, not for training a new algorithm. It's likely the underlying algorithm was trained on data prior to the predicate device's clearance.

9. How Ground Truth for the Training Set was Established

• The document does not provide this information, as the study described was for clinical validation of an expanded indication rather than for initial algorithm development or training.

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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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The Exalenz BreathID® Hp System is intended for use to continually and non-invasively measure changes in the 1302 / 1202 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 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 System consists of the IDkit:Hp™ and the BreathID® Hp test device.

The device is for use by trained health care professionals. To be administered under a physician's supervision.

The modified BreathID® Hp 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 1302 and 1202 concentrations in the patient's exhalation and a test kit. The test kit consists of:

• IDcircuit™ Oridion Nasal FilterLine™ (nasal cannula) (K980325)
• A 75mq 13C-urea tablet
• A 4.3g package of powdered Citrica (citric acid)
• Drinking straw
• Package Insert (Instructions for Use)

The modified BreathID® Hp System measures and computes the ratio between 1302 and 1202 in the patient's exhalation before and after the ingestion of 13C-urea. The change in the 1302 / 1202 ratio before and after ingestion of 13C-urea is referred to as the Delta over Baseline (DOB).

The basis of the 13C measurement method for both the modified versions of the BreathID® System is a technology called Molecular Correlation Spectroscopy™ (MCS™), MCS™ is based on the concept of optical absorption of specific radiation emitted from CO2 discharge lamps.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria for substantial equivalence in the clinical validation centered on the agreement between the modified BreathID® Hp System and its predicate device (unmodified BreathID® System) for H. pylori diagnosis.

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