(90 days)
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.
| Acceptance Criteria / Performance Metric | Reported Device Performance (Initial Diagnosis) | Reported Device Performance (Post-Treatment) |
|---|---|---|
| Accuracy (Sensitivity) | 100% [95% CI (90.60; 100.00)] | 92.3% [95% CI (66.69; 98.63)] |
| Accuracy (Specificity) | 97.9% [95% CI (93.97; 99.28)] | 100% [95% CI (93.47; 100.00)] |
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.
§ 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).