(53 days)
The BreathID™ System is used to diagnose and monitor Helicobacter pylori infection by measuring changes in the 1302/1202 ratio in a patient's breath following the ingestion of 13C urea.
The Oridion BreathID™ system continually and non-invasively measures changes in the 130% 200 exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori infection in the stomach. The Oridion BreathID™ System is to be used as an aid for initial diagnosis and post treatment monitoring of Helicobacter pylori infection.
The BreathID™ system is a non-invasive breath test system for detecting urease associated with Helicobacter pylori. The system consists of:
- A medical device (BreathID™ system) to measure and compute the ratio between 1202 and 13CO2 in the patient's exhalation.
- A Test Kit.
Test Device: The BreathID™ system is based on Oridion's proprietary CO2 measurement technology. The device will be used to measure and compute changes in the ratio between 1202 and 1302 in the patient's exhalation. The Oridion BreathID test device measurement is made by continuous sampling of the breath.
Test Kit: Part of the BreathID™ system is the Test Kit (IDkit™). The Test Kit is used to perform the test for the presence of Helicobacter pylori. The drug in the Test Kit is 13 - Urea. The nasal cannula device used in the kit is an Oridion Nasal Filterline.
The Test Kit consists of:
- Oridion Nasal FilterLine™
- A packaged tablet of 13C-urea
- A package of powdered Citrica
- A drinking straw
- Package insert
Here's a breakdown of the acceptance criteria and the study details for the BreathID™ System, based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria are not explicitly stated as distinct numerical targets in the document. However, the reported device performance and the determination of the cut-off point imply the clinical thresholds for satisfactory performance.
| Acceptance Criteria (Implied) | Reported Device Performance (BreathID™ System) |
|---|---|
| Pre-treatment | |
| Sensitivity (vs. Endoscopic) | 100% |
| Specificity (vs. Endoscopic) | 99.2% |
| Relative Sensitivity (vs. CLOtest®) | 100% |
| Relative Specificity (vs. CLOtest®) | 99.2% |
| Sensitivity (vs. Histology) | 95.8% |
| Specificity (vs. Histology) | 97.7% |
| Post-treatment | |
| Sensitivity (vs. Endoscopic) | 100% |
| Specificity (vs. Endoscopic) | 100% |
| Relative Sensitivity (vs. CLOtest®) | 100% |
| Relative Specificity (vs. CLOtest®) | 100% |
| Sensitivity (vs. Histology) | 100% |
| Specificity (vs. Histology) | 95.2% |
| Relative Sensitivity (vs. Meretek) | 93.3% |
| Relative Specificity (vs. Meretek) | 100% |
Note: The cut-off point (threshold) for the BreathID™ System test was determined to be 5 DOB (Delta Over Baseline). This threshold was confirmed to optimize sensitivity (100% pre-therapy, 95.5% post-therapy) and specificity (99.2% pre-therapy, 100% post-therapy).
Study Details
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Sample sizes used for the test set and the data provenance:
- Pivotal Study:
- Pre-therapy: 315 subjects
- Post-therapy: 77 subjects
- Reference Studies: One additional study included 36 Helicobacter pylori positive patients and 247 negative patients.
- Data Provenance: Not explicitly stated regarding country of origin, but the manufacturer is based in Jerusalem, Israel. The study dates (September 1999 - June 2000) indicate it was a prospective study.
- Pivotal Study:
-
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.
- Ground truth definitions are provided based on endoscopic results, CLOtest®, and histology. These procedures are typically performed and interpreted by medical professionals, implicitly including gastroenterologists/endoscopists and pathologists, but specific expert involvement or their numbers are not detailed.
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Adjudication method for the test set:
- The document does not specify an adjudication method. The ground truth was established by comparing BreathID™ system results to various diagnostic methods (CLOtest®, histology, endoscopic results), which serve as accepted clinical standards.
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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 BreathID™ System is a diagnostic device that directly measures a physiological change (13CO2/12CO2 ratio), not an imaging-based AI system that assists human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance metrics reported (Sensitivity, Specificity, Relative Sensitivity, Relative Specificity) are for the BreathID™ System in standalone mode. The device measures and computes the ratio without human interpretation influencing the diagnostic outcome provided by the device. The system is for "use by trained operators under the supervision of physicians, nurses or other healthcare professionals," but this refers to the operation of the device and supervision of patient care, not to the interpretation of the device's diagnostic output for a positive/negative H. pylori infection.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established using a combination of pathology (histology) and clinical diagnostic tests (CLOtest® and endoscopic results).
- Specifically:
- Helicobacter pylori positive: defined as positive CLOtest® AND positive histology.
- Helicobacter pylori negative: defined as negative CLOtest® AND negative histology.
- Endoscopic results were also used as a comparator.
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The sample size for the training set:
- The document does not explicitly state a separate training set size. The reported study appears to be the pivotal clinical validation study. It's possible that the cut-off point (5 DOB) was determined using a portion of the data or in prior internal studies, but this is not detailed in the provided text. The text mentions "The threshold level of 5 DOB was confirmed to be the optimal Cut-off point (COP) for the BreathID System in a multi-center study," suggesting a validation of this threshold within the clinical study data rather than just pre-defined.
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How the ground truth for the training set was established:
- As a separate training set is not explicitly mentioned, the method for establishing ground truth for any potential internal training/optimization would likely be similar to the pivotal study: using established clinical diagnostic methods like CLOtest® and histology. However, the document does not provide details on a specific training set or its ground truth establishment.
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).