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The 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 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 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 systems consist of an electro-optical medical device designed to measure and compute the changes in the ratio between 1302 and 1202 concentrations in the patient's exhalation, software, and a test kit.

The IDkit Hp® One test kit consists of:

• . One Package Insert
• One Tablet of 13C-enriched urea,75mg .
• One packet of 4.3g of Powder Citrica (citric acid). .
• One IDcircuit™ nasal cannula ●
• . One straw for stirring and drinking

Using a nasal cannula for breath collection directly from the patient's nostrils enables point of care testing. The BreathID® Hp continually 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 "3C-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.

This document is a Special 510(k) submission for a labeling modification to an already cleared medical device, the BreathID® Hp System. A Special 510(k) is used when a modification to a cleared device does not affect its intended use, fundamental scientific technology, or safety/effectiveness profiles. This means the core performance characteristics of the device itself are not being re-evaluated in this submission, but rather the interpretation and communication of its results under specific circumstances (patients on PPIs).

Therefore, the submission does not contain information about the original acceptance criteria and the study that proved the device met those criteria. It focuses solely on the rationale for the labeling change.

Here's what can be extracted from the document:

1. Context of the Submission:

• Trade/Device Name: BreathID® Hp System
• Regulation Number: 21 CFR 866.3110 (Campylobacter Fetus Serological Reagents - note: this seems like a misclassification in the document for an H. pylori urea breath test, as H. pylori is a specific bacterial infection, not related to Campylobacter Fetus. This might be a generic regulation listed or an artifact. The actual product code aligns with urea breath tests.)
• Regulation Name: Test, urea (breath or blood)
• Regulatory Class: Class I, reserved
• Product Code: MSQ, JJQ
• Predicate Device: BreathID® Hp System (K173772)
• Purpose of this 510(k): To obtain marketing clearance for a labeling modification of the BreathID® Hp System (K173772). This modification is solely to the package insert which is included in the IDkit Hp® One, the test kit used as part of this cleared 510(k) device, while the Intended Use and Indication for Use remain unchanged. The modified labeling informs clinicians that for patients taking proton pump inhibitors (PPIs), a positive result could be considered as indicative of the presence of urease enzyme associated with H. pylori.

2. What is Unchanged from the Cleared Device (K173772):

• Intended Use / Indication for Use: "The 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 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 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."
• Device Description: The system consists of an electro-optical medical device designed to measure and compute changes in the 13CO2 and 12CO2 ratio, software, and a test kit (IDkit Hp® One).
• Measurement Method: 13C measurement based on Molecular Correlation Spectroscopy™ (MCS) technology.
• Test Kit and Ingested Drug: The IDkit Hp® One test kit (13C urea tablet and citric acid powder approved in NDA-21-314), the procedure for ingestion of test substrate, and the breath collection method remain unchanged.
• Technological Characteristics: Remain unchanged.
• Performance Testing: "Performance characteristics remain unchanged." This explicitly states that no new performance testing (like sensitivity/specificity studies) was conducted for this submission because the underlying technology and operation are identical.

3. What is Changed (Labeling Modification):

The modification addresses the interpretation of results for patients using Proton Pump Inhibitors (PPIs), which were previously a known cause of false negative results. The new labeling clarifies that:

• Old Warning Removed: "Antimicrobials, proton pump inhibitors, and bismuth preparations are known to suppress H. pylori. Ingesting these medications within two weeks prior to performing the breath test mav produce false negative test results."
• New Statements Added/Revised:
  • False negative results may still be caused by PPIs within two weeks prior to testing.
  • If a negative result is obtained from a patient ingesting a PPI within two weeks, it may be a false-negative and the test should be repeated two weeks after discontinuing PPIs.
  • Crucially: "A positive result for a patient on a PPI could be considered as indicative of the presence of urease associated with H. pylori." (This is the core change, allowing interpretation of positive results even with PPI use, whereas previously any use of PPIs within the window could make results unreliable).

Addressing your specific questions based on the provided text:

Since this is a Special 510(k) for a labeling change on a previously cleared device, the document does not contain the details of the original performance studies. The submission explicitly states "Performance characteristics remain unchanged," indicating no new studies were performed to demonstrate that the device meets new acceptance criteria. Instead, it reinterprets existing performance for a specific clinical scenario.

Therefore, most of your questions cannot be answered from this specific document.

Here's what can be inferred or directly stated, and what cannot:

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

   • Cannot be provided from this document. This information would be in the original 510(k) submission for K173772. This current document states that performance characteristics remain unchanged, meaning the device still meets the original acceptance criteria.

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

   • Cannot be provided from this document. This would be in the original K173772 submission. No new clinical studies were conducted for this labeling change.

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):

   • Cannot be provided from this document. This would be in the original K173772 submission.

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

   • Cannot be provided from this document. This would be in the original K173772 submission.

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:

   • Not applicable. This device is a diagnostic test (urea breath test, non-imaging) and does not involve "human readers" or "AI assistance" in the typical sense of imaging analysis for which MRMC studies are performed. Its output is interpretable directly as positive or negative based on the device's measurement.

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

   • Partially applicable/inferred. For a diagnostic test like this, the device itself provides the measurement. The "standalone" performance would be its sensitivity and specificity against a "true" H. pylori status. This data would have been part of the original K173772 clearance. The current submission implies that the device's measurement capabilities remain the same.

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

   • Cannot be provided from this document but can be inferred. For H. pylori breath tests, the ground truth is typically established by other diagnostic methods for H. pylori, such as biopsy with histology, rapid urease test (RUT), or culture, or a combination (composite reference standard). This information would be in the original K173772 submission.

8. The sample size for the training set:

   • Not applicable. This product is a diagnostic device, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's parameters are likely calibrated and validated, but not "trained" on data in the same way.

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

   • Not applicable. See point 8.

In summary, this document is an administrative update for a minor change in labeling interpretation, not a re-clearance or new performance study for the device itself. To get the requested information about device performance and the original studies, one would need to access the original 510(k) submission document (K173772).

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

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

• Sample Size (Clinical Test Set): 79 valid subjects (PP analysis set).
• Data Provenance: The document states "A single center, non-randomized, comparative study was conducted..." indicating it was a prospective study. The country of origin is not explicitly stated, but the applicant's address is in Modiin, Israel and the FDA letter indicates the submission date. There is also a reference to "Asian-Pacific" ethnicity, which could suggest a diverse study population, but does not explicitly state the location of the clinical trial.

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

The clinical study primarily focused on demonstrating equivalence between the modified device and the predicate device. The "ground truth" for H. pylori infection in the clinical study was established by "local clinical practice" and "serum blood tests". The document mentions that if a serum blood test was performed, "these blood tests were the only means used to diagnose the presence of H. pylori." No specific number or qualifications of experts involved in interpreting these blood tests or overall clinical diagnosis are provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1) for establishing the ground truth diagnoses. The diagnosis was based on standard clinical practice, primarily serum blood tests where performed. The breath tests (both modified and unmodified) were "masked from the treating physician and did not have an impact on the patient's treatment," implying that the ground truth was independently established.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly described. The study compared the performance of two devices (modified vs. unmodified BreathID® System) rather than human readers with and without AI assistance. The device itself is a measurement instrument, not an AI to assist human readers in image interpretation, for example.

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

While the device provides an objective measurement (DOB), the clinical validation compares its diagnostic output to the predicate device, also a standalone diagnostic, and ultimately to clinical diagnoses. The device itself is "algorithm only" in the sense that it processes breath samples and outputs a DOB value without human interpretive assistance for that value. The clinical study was designed to show that this standalone capability of the modified device is equivalent to the predicate device's standalone capability.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

For the clinical validation, the ground truth for H. pylori infection was established through local clinical practice, primarily serum blood tests. In cases where no blood test was performed, patient follow-up and symptom progression were mentioned, but the primary reference for diagnosis was serum blood tests.

For the analytical studies (Comparative, Precision, Reproducibility Validations), the "ground truth" or reference was based on three H. pylori samples with known expected DOB values (high, low, and moderate positive), as defined by FDA Draft Guidance. This refers to controlled samples with established concentrations, not patient-derived clinical ground truth.

8. The Sample Size for the Training Set

The document does not explicitly mention a training set or its sample size. The submission focuses on demonstrating substantial equivalence of a modified device to a predicate, and therefore the described studies are primarily validation and verification tests. It's possible the original BreathID® System (K011668) had training data, but it is not discussed for this 510(k) submission.

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

Since no explicit training set is mentioned, the method for establishing its ground truth is also not described.

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The Crit-Line Anemia Management software is a database application used to record, track and trend patient data as pertains to the management of anemia, and provide a dosage recommendation.

The CLAM software is a database application that records, tracks, trends, and analyzes patient data (Hematocrit, Oxygen Saturation, and Hemoglobin) along with current ESA dose in order to effectively manage anemia. During dialysis treatment, the CLAM downloads initial, real-time Hematocrit (HCT), Oxygen Saturation (SaO2), and Hemoglobin (Hb) data from the Crit Line blood monitor. The CLAM software trends this patient data along with current Erythropoiesis Stimulating Agent (ESA) dosage to determine the patient's Hb levels, the need (if any) for ESA dosing, and to track patient's response to treatment. The CLAM software uses a proprietary algorithm to calculate a recommendation for ESA dosage based on patient data trends and current ESA dose in order to establish and maintain predetermined patient Hb levels. The CLAM proprietary algorithm used to determine ESA dosing for anemia treatment is based on the current manual algorithm. In addition, the CLAM software generates and prints patient reports for review and record keeping. The CLAM software resides on a host computer separate from the Crit Line units and acquires real-time data from the clinic's Crit Line monitors via wireless radio signal or by a serial cable.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Crit Line Anemia Management (CLAM) software:

The provided 510(k) summary focuses primarily on establishing substantial equivalence to predicate devices and describes a performance comparison of its ESA dosage recommendation algorithm to manual calculations. It does not provide explicit "acceptance criteria" in the typical quantitative sense (e.g., target specificity, sensitivity, or accuracy thresholds) for the device's performance, nor does it conduct a comprehensive clinical study to prove these against a definitive ground truth. Instead, the study aims to show agreement with current manual practice.

However, based on the information provided, we can infer the implicit "acceptance criteria" as the calculated ESA dosage recommendation being "exactly the same" as manually calculated doses.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 62 dialysis patients
• Data Provenance:
  • Country of Origin: New England (United States, as per typical use of "New England" in this context)
  • Retrospective or Prospective: Retrospective data using "the last two weeks of a patient's Hb values" being recorded for analysis.

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

• The ground truth was established by "manually calculated ESA dosage calculations," implying that medical personnel (e.g., clinicians, nurses, physicians as described in Intended User Population) performed these calculations.
• The document does not specify the number of experts, their specific roles (e.g., physician, nurse), or their qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method. The comparison was directly between the CLAM software's calculation and the "manually calculated dose," which presumably represents the established practice. There's no mention of a consensus process among multiple manual calculators or a tie-breaking mechanism.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not explicitly done. The study's focus was on the agreement between the CLAM software's recommendation and manual calculations, not on comparing human reader performance with and without AI assistance or quantifying an "effect size" of improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, a standalone performance evaluation was done. The "performance test" directly compared the CLAM software's calculated ESA dosage recommendations (algorithm only) to manually calculated recommendations. The CLAM software generated its recommendation based on inputted patient data (Hb values and current ESA dose), independently of human input for that specific calculation step.

7. The Type of Ground Truth Used

• Expert Consensus / Expert Determination (via manual calculation): The ground truth for this specific performance test was the "manually calculated ESA dosage calculations." This represents a determination made by medical professionals based on established protocols. It is not pathology, imaging, or direct outcomes data, but rather a calculation based on clinical parameters and existing practice.

8. The Sample Size for the Training Set

• The document does not explicitly state the sample size used for training the CLAM software's proprietary algorithm. It mentions the algorithm is "based on the current manual algorithm" but provides no details on how it was developed or trained on specific datasets.

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

• The document does not specify how ground truth for any potential training set was established. It states the CLAM algorithm "is based on the current manual algorithm," which implies that the logic and principles of existing manual ESA dosing protocols formed the basis of the algorithm's design. It does not detail if or how a separate, labeled dataset with established ground truth was used to train or refine the algorithm.

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The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The POC-AS10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer.

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

The POC-AS10 Auto sampler is an optional accessory to the POCone Infrared Spectrophotometer. The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The POC-AS10 Auto sampler expands the number of breath collection bags that can be set up and analyzed by the POCone Infrared Spectrophotometer. By connecting the POC-AS10 Auto sampler to the POCone Infrared Spectrophotometer, up to ten pairs of breath collection bags (20 bags total) can be set up at one time.

The provided text describes a 510(k) premarket notification for the POC-AS10 Auto sampler, an accessory to the POCone Infrared Spectrophotometer. It focuses on device description, intended use, and substantial equivalence to a predicate device. However, it does not contain detailed information regarding acceptance criteria or a comprehensive study report with specific performance metrics for the device itself.

The "Performance Testing" section states: "The nonclinical testing consisted of reproducibility and carry-over studies using standard gas samples. The testing demonstrated that the POC-AS10 Auto sampler accessory to the POCone Infrared Spectrophotometer successfully fulfilled prospectively defined verification and validation activities."

This statement confirms that testing was done and deemed successful against "prospectively defined verification and validation activities," but it does not explicitly list those acceptance criteria or the quantitative results of the studies. Therefore, I cannot populate the table or provide detailed answers to many of your questions based solely on the provided text.

Here's a breakdown of what can and cannot be answered:

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

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 (Test Set): Not specified. The document only mentions "reproducibility and carry-over studies using standard gas samples."
• Data Provenance: Not specified.
• Retrospective/Prospective: The verification and validation activities were "prospectively defined," implying the studies themselves were likely prospective in nature, but this is not explicitly stated for the data collection.

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 specified. The testing involved "standard gas samples," implying a technical or engineering validation rather than clinical ground truth established by medical experts for patient data.

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

• Not applicable/Not specified. Adjudication methods are typically relevant for human interpretation of data, which is not the primary focus of the performance testing described for this auto sampler accessory.

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, an MRMC comparative effectiveness study was not done. This device is an auto sampler accessory for an infrared spectrophotometer, not an AI diagnostic tool involving human readers.

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

• The "nonclinical testing consisted of reproducibility and carry-over studies using standard gas samples" which can be considered a form of standalone performance testing for the accessory's mechanical and analytical function. However, it's not an "algorithm-only" test in the AI sense, but rather a system performance test.

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

• For the reproducibility and carry-over studies, the "ground truth" would be the known concentration/composition of the "standard gas samples" used. This is a technical standard, not a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

• Not applicable/Not specified. This document describes an accessory to a spectrophotometer, not a system that is "trained" in the machine learning sense.

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

• Not applicable. This device is not an AI/ML system requiring a training set with established ground truth.

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