The Hp Detect™ Stool Antigen ELISA is an in vitro diagnostic qualitative enzyme immunoassay for the detection of Helicobacter pylori (H. pylori) antigens in human stool or feces. The Hp Detect™ Stool Antigen ELISA is intended to aid in the initial diagnosis and post-therapy diagnosis of H. pylori infection. Additionally, the test may be used to assess H. pylori infection status after treatment. Retesting at a minimum of 4 weeks after the completion of treatment may be done to assess H. pylori status. Test results should always be taken into consideration by the physician in conjunction with patient's clinical information (history and symptoms). For Prescription Use Only.

The Hp Detect Stool Antigen ELISA is an enzyme immunoassay which detects the H. pylori antigen in human fecal samples. The Hp Detect Stool Antigen ELISA comes in a kit that contains materials to assay a total of 92 samples. The device consists of a 96-well clear flat bottom polystyrene high bind microplate coated with affinity purified rabbit anti-human H. pvlori polyclonal antibody. The device is provided with detection antibody which is a purified mouse monoclonal antibody specific for H. pylori antigen and has been conjugated to horseradish peroxidase (HRP). The device kit is also provided with sample diluent buffer, wash buffer, substrate solution, stop solution along with negative and positive controls. Negative control is a phosphate buffered protein solution and positive control is composed of purified H. pylori antigen (ATCC strain 43504) from cell lysate. Polyclonal anti-H. pylori captures antibodies that are immobilized on microwells. Patient samples prepared in sample diluent are added to the microwells and incubated for one hour at 37 ± 2℃. If the H. pvlori antigen is present in the sample, it will bind to the immobilized antibody on the plate. Following this incubation, the plate is washed thoroughly. A peroxidase conjugated anti-H. pylori monoclonal antibody is then added to the microwells and incubated for 30 minutes at 37 ± 2℃. If H. pylori antigen is bound to the microwells in the first step, the detection antibody would now bind in this step to form a sandwich complex. Following this incubation, a thorough wash step is performed to remove non-specific and non-binding materials. Substrate is then added and incubated for 10 minutes at 37±2℃ to generate a color in the presence of the enzyme complex. Stop solution is then added to end the reaction. The results are read spectrophotometrically at the following wavelengths: 1. Single Wavelength Measurement at 450 nm 2. Dual Wavelength Measurement 450/620 nm or 450/630 nm

The provided document is an FDA 510(k) Pre-Market Notification for the Biomerica, Inc. Hp Detect Stool Antigen ELISA for the detection of Helicobacter pylori (H. pylori) antigens in human stool or feces. It is a qualitative immunoassay intended to aid in the initial diagnosis and post-therapy diagnosis of H. pylori infection.

Based on the provided text, the device itself has acceptance criteria for its analytical performance (e.g., reproducibility, LoD, specificity, inclusivity) and clinical performance (Positive Percent Agreement - PPA, Negative Percent Agreement - NPA). The study detailed in the document serves to prove that the device meets these internal acceptance criteria set by the manufacturer for FDA clearance.

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

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

The document does not explicitly state pre-defined acceptance criteria values in a formal table for PPA and NPA. However, it presents the achieved performance and concludes that the results are "acceptable." We can infer the implicit acceptance criteria from these reported values. For analytical performance, criteria are implied by the "acceptable" statement for reproducibility, precision, LoD, cross-reactivity, interference, and inclusivity.

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

• Clinical Study - Frozen Specimen:
  • Sample Size: 433 frozen and de-identified fecal samples.
  • Provenance:
    • 355 specimens from Italy.
    • 78 specimens from three geographically different regions of the USA (west, southwest, and southeast).
  • Nature: Retrospective (frozen, de-identified samples). Patients were presenting with dyspepsia, undergoing endoscopy/biopsy, not on certain medications, and no H. pylori treatment within 6 months.
• Clinical Study - Fresh Stool Specimen:
  • Sample Size: 142 fresh, de-identified fecal specimens.
  • Provenance: Collected through multiple biospecimen vendors and clinical laboratories. Locations not specified beyond "collection centers" and "Biomerica (internal site)."
  • Nature: Likely prospective (freshly collected and then immediately tested/shipped). Patients had symptoms of H. pylori infection.
• Post-Therapy Diagnosis:
  • Sample Size: 14 paired (pre- and post-therapy) frozen retrospective specimens.
  • Provenance: Italy.
  • Nature: Retrospective (frozen, paired samples). All subjects initially positive by CRM and completed eradication therapy. Post-therapy samples collected minimum 4 weeks after treatment.

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)

The document states that the ground truth for the clinical studies (frozen and fresh specimens) was established by comparison with an "FDA cleared device" (predicate device). For the frozen specimen study, discrepant results were further analyzed by "chart review and determined to have a RUT or history result."

For the post-therapy study, the ground truth was a "composite reference method (CRM) consisting of histology and Rapid Urease Test."

The document does not specify the number of experts or their qualifications (e.g., pathologists, gastroenterologists) involved in establishing the ground truth via histology, RUT, or chart review. It implies laboratory testing capabilities for the predicate device.

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

The document describes adjudication for discrepant results in the frozen specimen clinical study:

• Discrepant results were "further analyzed by chart review and determined to have a RUT or history result."
  This suggests a form of adjudication after the initial comparison, using additional clinical information or laboratory results (RUT or histology) as a reference. This is not a multi-reader adjudication method but rather a method for determining the "true" status of discrepant samples.

There is no mention of multi-reader adjudication for the Hp Detect Stool Antigen ELISA results themselves. The device's results are read spectrophotometrically based on defined cut-offs.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an in-vitro diagnostic (ELISA), not an AI-powered diagnostic imaging tool that would typically involve human readers and MRMC studies. The device provides a quantitative or qualitative output (positive/negative) that is read spectrophotometrically, not interpreted by human readers in the same way as medical images.

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

This refers to the performance of the device itself (the "algorithm" in this context being the ELISA assay) without human interpretation variables beyond the initial lab procedure. Yes, the performance characteristics (analytical and clinical studies) directly report the standalone performance of the Hp Detect Stool Antigen ELISA device against comparator methods or reference standards. The results (PPA, NPA, sensitivity, specificity) represent the device's accuracy in detecting H. pylori antigens.

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

The ground truth for the test sets was primarily established through:

• Comparison to an FDA cleared predicate device for the frozen and fresh specimen clinical studies.
• Composite Reference Method (CRM) consisting of histology and Rapid Urease Test (RUT) for the initial H. pylori status and post-therapy evaluation.
• Chart review combined with RUT or histology results for resolving discrepant cases in the frozen specimen study.

This is a form of "laboratory reference standard" and "clinical/pathology confirmation."

8. The sample size for the training set

The document describes the analytical and clinical performance studies, which are validation studies or test sets. It does not provide information on the sample size used for the training set of the Hp Detect Stool Antigen ELISA device. As an ELISA assay, it is a biochemical test, not a machine learning model that typically undergoes data-driven training. The "training" for such a device involves assay development, optimization, and establishment of reagents and procedures, rather than a machine learning training set of data.

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

As the Hp Detect Stool Antigen ELISA is a biochemical immunoassay (not an AI/ML device), the concept of a "training set" and establishing ground truth for it in the machine learning sense is not applicable. The "ground truth" for developing and optimizing such a device would implicitly rely on well-characterized H. pylori positive and negative samples, purified antigens, and potentially clinical samples with known infection status (established through methods like culture, PCR, histology, RUT) to guide the reagent selection, assay design, and cut-off determination. The document details the methodology for setting assay cut-off based on a panel of 227 specimens (83 positive, 144 negative by predicate device), which could be considered part of the "development" or "optimization" phase for establishing the device's operational parameters, but not a "training set" in the context of deep learning.

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The Premier HpSA Flex enzyme immunoasay (EIA) is an in vitro qualitative procedure for the detection of Helicobacter pylori antigens in human stool. The test is intended for use with unpreserved stool specimens or preserved stool specimens in transport media. Test results are intended to aid in the diagnosis of H. pylori infection and to monitor response during and post- therapy in patients. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least four weeks following completion of therapy.

Meridian Bioscience has modified its FDA-cleared PREMIER Platinum HpSA® PLUS assay (K182559), a qualitative, in vitro diagnostic test for the detection of Helicobacter pylori antigens present in unpreserved human stool specimens. This modification, to be marketed under new device trade name Premier HpSA® Flex upon FDA clearance, is the addition of a new specimen type claim to the intended use of the previously cleared device (K182559) whereby specimens may be preserved in Cary-Blair or Culture and Sensitivity (C&S) transport media.

The Premier HpSA Flex test is a microwell-based enzyme immunoassay that detects H. pylori antigens present in human stool specimens, either unpreserved in transport media. The test uilizes a plurality (mixture) of monoclonal anti-H. pylori capture antibodies adsorbed to microwells. Diluted patient samples and an enzyme conjugate reagent are added to the microwells and incubated for one hour at room temperature. A wash is performed to remove unbound material. Substrate is added and incubated for 10 minutes at room temperature. Color develops in the presence of bound enzyme. Stop solution is added and the results are interpreted visually or spectrophotometrically.

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

Acceptance Criteria and Device Performance

The core of this submission is about adding a new specimen type claim (preserved stool in Cary-Blair or C&S transport media) to an already FDA-cleared device. Therefore, the "acceptance criteria" revolve around demonstrating that the device performs equivalently with these new specimen types as it did with the original unpreserved stool and that the performance remains robust.

Here's a summary of the performance characteristics presented as implicit acceptance criteria and the reported device performance:

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Analytical Sensitivity (LoD): Not explicitly stated how many samples per lot were used in the LoD study, but it mentions "Three lots" and "positive results >= 95% of the time."
   • Precision/Reproducibility: 360 samples (10 panels x 12 blinded samples x 3 laboratories). The samples were "contrived stool samples" with H. pylori antigen spiked in. Data provenance is implied to be domestic (USA) due to the submission context, and it's a prospective study looking at controlled, contrived samples.
   • Preserved Specimen Storage Stability: Not explicitly stated how many samples were used, but the study was designed to validate stability claims.
   • Freeze/Thaw Stability: Not explicitly stated how many samples were used.
   • Analytical Specificity/Interference: Not explicitly stated how many samples were used, but testing was performed in the presence of various substances.
   • Analytical Specificity/Cross-reactivity: Not explicitly stated how many samples were used, but each organism was tested with a true negative and a contrived low positive sample at specified concentrations.
   • Method Comparison (Clinical Performance): 200 archived stool specimens were enrolled, of which 182 were evaluable and used for the comparison. Data provenance is of archived specimens from patients, suggesting retrospective data. The specific country of origin is not mentioned.

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

   • This device is an in-vitro diagnostic (IVD) for detecting antigens, not an imaging device requiring expert interpretation for ground truth.
   • For the Precision/Reproducibility study, "expected assay result" was used as ground truth for contrived samples. This implies the ground truth was based on the known concentration of spiked antigen.
   • For the Method Comparison study, the comparison was against an "FDA-cleared comparator device" and "Standard of Care (SoC) testing using an FDA-cleared commercial assay." The "ground truth" for clinical performance appears to be established by the results of these existing FDA-cleared methods. No human expert consensus was used to define the ground truth for individual samples.

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

   • No human adjudication method was mentioned or implied, as the device is an IVD detecting antigens, and ground truth was established either by known concentrations in contrived samples or by results from existing FDA-cleared assays.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was conducted. This type of study is typically performed for AI-assisted diagnostic imaging devices where human interpretation directly impacts results. This device is an immunoassay (IVD).

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

   • Yes, the performance data provided (LoD, Reproducibility, Interference, Cross-reactivity, Method Comparison) represent the standalone performance of the Premier HpSA Flex assay. It's an automated or semi-automated EIA, not an algorithm requiring human interaction for its direct output.

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

   • For analytical performance studies (LoD, Precision, Interference, Cross-Reactivity), the ground truth was known concentrations of H. pylori antigen in contrived samples or known presence/absence of interfering/cross-reacting substances/organisms.
   • For the method comparison (clinical performance), the ground truth was established by results from an FDA-cleared comparator device and Standard of Care (SoC) testing using an FDA-cleared commercial assay.

7. The sample size for the training set:

   • This is a traditional in-vitro diagnostic device (immunoassay), not a machine learning/AI algorithm that requires a "training set" in the conventional sense. The device's components and parameters are developed through standard chemistry and assay development processes, not through iterative training on a dataset.

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

   • As stated above, there is no "training set" for an immunoassay in the context of AI/ML. The "ground truth" for the development of the assay itself would align with standard analytical validation methods, ensuring the assay accurately detects the target analyte (H. pylori antigens) at various concentrations and in the presence of relevant interferents, against known standards.

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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.

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Curian Campy, for use with the Curian Analyzer, is a rapid, qualitative fluorescent immunoassay for the detection of a Campylobacter-specific antigen in human fecal specimens. Curian Campy is intended to detect C. jejuni, C. coli, C. upsaliensis, and C. lari in human stool from patients with signs and symptoms of gastroenteritis. The test is intended for use with unpreserved fecal specimens or preserved fecal specimens in transport media. Test results are to be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures. Curian Campy is intended to aid in the diagnosis of Campylobacter infection.

The Curian® Campy assay is a qualitative in vitro diagnostic test for the detection of Campylobacter-specific antigens in human stool samples collected from individuals with signs and symptoms of gastroenteritis. Curian Campy is intended to detect C. jejuni, C. coli, C. upsaliensis, and C. lari in unpreserved or preserved stool in Cary-Blair or C&S transport media. The Curian® Campy assay utilizes fluorescence technology with the cleared Curian® Analyzer (K192817) to detect Campylobacter-specific antigens in human stool.

Here's a breakdown of the acceptance criteria and study details for the Curian Campy device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate section with predefined thresholds. However, based on the presentation of clinical performance data, the implicit acceptance criteria for sensitivity and specificity are demonstrated by the confidence intervals achieved in the clinical studies. For analytical performance, 100% agreement for certain categories and no observed interference/cross-reactivity are the implicit acceptance criteria.

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

• Prospective Clinical Study:
  • Sample Size: 1,474 specimens
  • Data Provenance: Prospective, collected from July 2020 to December 2020 at five clinical study sites across geographically distinct regions throughout the United States.
• Archived Clinical Study:
  • Sample Size: 290 archived samples
  • Data Provenance: Retrospective. The samples had prior culture and speciation results and were retrospectively tested.
• Contrived Study:
  • Sample Size: 210 specimens (150 positive, 60 negative).
  • Data Provenance: Contrived samples (spiked with Campylobacter species).
• Reproducibility Study:
  • Sample Size: 320 samples (160 unpreserved stool, 160 preserved stool in C&S media).
  • Data Provenance: Contrived samples, tested across three sites (one internal, two external).
• Prozone / Hook Effect Study:
  • Sample Size: 14 dilutions (n=7 for preserved, n=7 for unpreserved) tested in replicates of 5.
  • Data Provenance: Contrived samples.
• Cross-Reactivity/Microbial Interference Study:
  • Sample Size: Not explicitly stated as a number, but involves testing various bacteria, fungi, and viral strains (spiked into stool, some clinical Norovirus samples).
  • Data Provenance: Primarily contrived samples, with 5 clinical Norovirus stool specimens.
• Interfering Substances Study:
  • Sample Size: Not explicitly stated, but involves testing C. jejuni low positive contrived samples in the presence of 27 different chemical and biological substances.
  • Data Provenance: Contrived samples.
• Assay Reactivity/Inclusivity Study:
  • Sample Size: Not explicitly stated, but involves testing multiple strains of C. jejuni, C. coli, C. upsaliensis, and C. lari.
  • Data Provenance: Laboratory strains.
• Brush Bridging Study:
  • Sample Size: 53 non-pipettable clinical stool specimens (5 positive, 48 negative) from the prospective and archived clinical studies, plus a panel of contrived samples (25 at 3x LoD, 25 at 5x LoD, 25 negative).
  • Data Provenance: Clinical (from prior studies) and contrived.

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

• Ground Truth for Clinical Studies (Prospective and Archived): The ground truth was established by "standard of care Campylobacter culture and speciation" which is a laboratory method. There is no mention of human experts directly establishing the ground truth for classification of individual samples.
• Ground Truth for Contrived Studies (Reproducibility, Analytical Sensitivity, Prozone, Cross-Reactivity, Interfering Substances, Assay Reactivity): The ground truth was established by creating samples with known concentrations of organisms or by confirming the absence of organisms. This suggests laboratory verification rather than expert clinical assessment.

4. Adjudication Method for the Test Set

• Prospective Clinical Study: For specimens with discordant results between the Curian Campy assay and the reference method (culture and speciation), further evaluation was done using "FDA-cleared commercial nucleic acid amplification test (NAAT)". This acts as a form of adjudication for discordant results, though it's not a human consensus process.
• Archived Study, Contrived Studies, Analytical Performance Studies: No adjudication method is explicitly described for these studies other than the initial ground truth determination.

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 comparative effectiveness study was done.
• This device is an in-vitro diagnostic assay (Curian Campy) read by an automated analyzer (Curian Analyzer), not an AI assisting human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

• Yes, the performance data presented for the Curian Campy assay is standalone. The device (Curian Campy assay with the Curian Analyzer) provides a qualitative result (positive/negative) automatically. The interpretation of results is "automated by Curian Analyzer," and the clinical studies directly evaluate this automated output against a reference standard.

7. The Type of Ground Truth Used

• Clinical Studies (Prospective and Archived): The primary ground truth was culture and speciation for Campylobacter. For discordant results in the prospective study, an FDA-cleared commercial nucleic acid amplification test (NAAT) was used for further evaluation.
• Analytical Performance Studies (Reproducibility, Analytical Sensitivity, Prozone, Cross-Reactivity, Interfering Substances, Assay Reactivity, Contrived Study): The ground truth was based on known concentrations of spiked organisms or known negative samples, verified by laboratory methods.

8. The Sample Size for the Training Set

• The document does not describe algorithmic training. This device appears to be a fluorescence immunoassay interpreted by an analyzer, not a machine learning or AI algorithm that requires a separate training set. The descriptions of "analytical performance" and "clinical performance" are for evaluating the performance of the device itself, not for training an AI model.

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

• As there is no mention of an AI algorithm requiring a training set, this question is not applicable to the information provided.

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Sofia 2 Campylobacter FIA employs immunofluorescence for the rapid qualitative detection of a Campylobacter-specific antigen in human fecal specimens. Sofia 2 Campylobacter FIA is designed to detect C. jejuni, C. coli, C. lari and C. upsalients with signs and symptoms of gastroenteritis. The test is intended for use with preserved fecal specimens in transport media and unpreserved fecal specimens. Test results should be considered in conjunction with clinical findings and patient history.

The Sofia 2 Campylobacter FIA employs immunofluorescence technology that is used with Sofia 2 for the rapid qualitative detection of Campylobacter jejuni, Campylobacter lari, and Campylobacter upsaliensis specific antigens in fecal samples.

The patient's sample is placed in the Specimen Tube containing the Specimen Solution to dilute, making the antigenic components more accessible to the specific antibodies. An aliquot of the diluted sample is dispensed through a filter to remove particulates, making them more compatible for testing, into the Test Cassette sample well. From the sample well, the sample migrates through a test strip containing various unique chemical environments. If Campylobacter jejuni, Campylobacter coli, Campylobacter lari, or Campylobacter upsaliensis specific antigens are present, they will be bound by antibodies coupled to fluorescent microparticles that migrate through the test strip. The fluorescent microparticles containing bound proteins will be captured by antibodies at a defined location on the test strip where they are detected by Sofia 2. If Campylobacter jejuni, Campylobacter coli, Campylobacter lari, or Campylobacter upsaliensis specific antigens are not present, the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia 2.

The Test Cassette is placed inside of Sofia 2 for automatically timed development (WALK AWAY Mode), or pre-incubated on the bench top prior to loading into Sofia 2 (READ NOW Mode), where Sofia 2 will scan, measure, and interpret the immunofluorescent signal using method-specific algorithms. Sofia 2 will display the test results (Positive, Negative, or Invalid) on the screen.

The fluorescence signal obtained with this assay is invisible to the unaided eye. The test results can only be obtained with the proper use of Sofia 2.

The Sofia 2 Campylobacter FIA is a device for the rapid qualitative detection of Campylobacter-specific antigens. It is designed to detect C. jejuni, C. coli, C. lari, and C. upsaliensis from patients with signs and symptoms of gastroenteritis in human fecal specimens (preserved or unpreserved).

Here's an analysis of the acceptance criteria and the study data provided:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided information, the key performance metrics are Sensitivity and Specificity from the Prospective Clinical Study.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size for Clinical Study: 811 total specimens.
  • 191 fresh, neat specimens
  • 620 fresh specimens in transport media
• Data Provenance: Prospective Clinical Study (likely multi-center, though specific countries are not mentioned). All specimens were "fresh".
• Test Set Sample Size for Archived Study: 70 frozen, characterized specimens.
  • 35 culture-negative specimens preserved in transport media.
  • 35 positive specimens (11 in transport media, 24 neat fecal specimens).
• Data Provenance for Archived Study: Archived, frozen specimens, characterized at a central laboratory.

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

The document does not specify the number of experts or their qualifications for establishing the ground truth.

4. Adjudication method for the test set

• For the Prospective Clinical Study: The primary comparison was against culture and identification. For discordant specimens (Sofia Positive/Culture Negative), species-specific RT-PCR and bi-directional sequence analysis were used for confirmation. In this case, 6 discordant specimens were identified as positive for Campylobacter (3 C. jejuni, 2 C. upsaliensis, and 1 C. coli) by this additional molecular testing. This suggests a form of discordant analysis/adjudication.
• For the Archived Clinical Study: Ground truth was established by culture and further characterized by RT-PCR and bi-directional sequencing. All 35 positive specimens were confirmed by all methods, and all 35 negative specimens yielded 100% correlation with all test methods.

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

This is not applicable as the Sofia 2 Campylobacter FIA is an automated IVD device. It does not involve human readers interpreting results with or without AI assistance in the context of diagnostic imaging, for example. The Sofia 2 instrument scans, measures, and interprets the immunofluorescent signal using method-specific algorithms and displays the result.

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

Yes, the device operates in a standalone manner. The Sofia 2 instrument itself provides the final "Positive, Negative, or Invalid" result after processing the test cassette. This performance directly reflects the algorithm's output. The performance data (Sensitivity, Specificity) from the clinical studies represents this standalone performance.

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

• Prospective Clinical Study: Culture and identification was the primary reference method. For discordant results (Sofia Positive/Culture Negative), species-specific RT-PCR and bi-directional sequence analysis were used as a confirmatory ground truth.
• Archived Clinical Study: Culture for initial characterization, and further confirmed by RT-PCR and bi-directional sequencing.

8. The sample size for the training set

The document does not explicitly state the sample size used for the training set of the device's algorithms. The provided data focuses on the validation of the finalized device.

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

The document does not provide details on how the ground truth for the training set was established. It focuses on the analytical and clinical validation of the device.

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Curian HpSA, for use with the Curian Analyzer, is a rapid, qualitative, fluorescent immunoassay for the detection of Helicobacter pylori antigen in human stool. Test results are intended to aid in the diagnosis of H, pylori infection and to demonstrate loss of H. pyloriantigen following treatment. Accepted medical practice recommends that testing by any current method, to confirm eradication, be done at least following completion of therapy. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.

The Curian™ HpSA® assay is a qualitative in vitro diagnostic test for the detection of Helicobacter pylori in human stool. The Curian™ HpSA® assay utilizes fluorescence technology with the newly developed Curian™ Analyzer to detect H. pylori antigen. The Curian™ Analyzer has been designed to disposition sample results from lateral flow immunoassays.

Here's a breakdown of the acceptance criteria and study information for the Curian™ HpSA® and Curian™ Analyzer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical performance study aiming for substantial equivalence to an FDA-cleared predicate device. The predicate device had a demonstrated sensitivity and specificity ≥ 95%, with a lower bound of the two-sided 95% confidence interval (CI) greater than 89% against a composite reference method. Therefore, the new device's agreement with this predicate is the key performance metric assessed.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: 542 evaluable specimens.
• Data Provenance: The specimens were from the intended use population, collected in a multi-center method comparison study conducted at three sites in the USA. The study appears to be prospective in nature, as it "evaluated" the device for detecting H. pylori stool antigen in human stool.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

This information is not explicitly provided in the document for the test set. The clinical study compares the new device to an "FDA-cleared H. pylori stool antigen EIA" which was itself previously evaluated against a composite reference method. The document does not describe the establishment of the ground truth for this specific study's test set, nor the number or qualifications of experts involved in that.

4. Adjudication Method (Test Set)

The primary comparison is between the new device and an FDA-cleared comparator EIA. However, in cases of discordance, PCR was used for adjudication:

• "2/3 Curian HpSA false negatives were dispositioned as negative by PCR"
• "8/14 Curian HpSA false positives were dispositioned as positive by PCR"

This suggests a form of supplementary adjudication using a molecular method for discordant results between the new device and the comparator EIA.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes the performance of a diagnostic assay (Curian™ HpSA®) in a standalone clinical comparison against another assay, not the improvement of human readers with AI assistance.

6. Standalone Performance

Yes, a standalone performance study was done. The document explicitly describes the "Comparison of Curian™ HpSA® assay to an FDA-cleared H. pylori Stool Antigen EIA" focusing on the device's accuracy in detecting H. pylori antigen in human stool samples. The device itself (the Curian™ Analyzer) interprets the results from the lateral flow immunoassay.

7. Type of Ground Truth Used (Test Set)

The "ground truth" for the current study is effectively the results from an FDA-cleared H. pylori stool antigen EIA. This predicate EIA was, in turn, previously established against a "composite reference method (i.e., culture, histology, and RUT) for initial H. pylori diagnosis." So, indirectly, the ultimate ground truth is a composite reference method.

8. Sample Size for Training Set

The document does not provide information on the sample size used for the training set. This is an in vitro diagnostic device, and details about its internal algorithm training (if any is applicable beyond general assay development) are not disclosed in this 510(k) summary.

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

The document does not provide information on how the ground truth for the training set was established, as details about training sets are not included in this summary.

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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 provided text is a 510(k) clearance letter from the FDA for a device called "CAMPYLOBACTER CHEK." This letter primarily addresses the regulatory status and marketing approval of the device, rather than the detailed technical performance data or a description of the study that proves the device meets acceptance criteria.

The information requested in the prompt, specifically regarding acceptance criteria, device performance, sample sizes for training and test sets, expert ground truth establishment, adjudication methods, MRMC studies, and detailed ground truth types, are typically found in the device's 510(k) summary or the pivotal study report, which are not included in the provided document.

Therefore,Based on the provided document, I cannot answer the questions regarding the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter, which confirms regulatory approval but does not contain the detailed performance study information required to answer your questions. This type of information would typically be found in the 510(k) summary document or the underlying scientific study report submitted to the FDA, which is not part of this letter.

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