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510(k) Data Aggregation
(83 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Positive Percent Agreement: ≥ 95% | 100% [95% Cl (81.6, 100)] |
| Negative Percent Agreement: ≥ 95% | 97% [95% Cl (89.0, 99.1)] |
| Comparative Validation (Analytical): | |
| Pearson's Correlation Coefficient (r) | r = 0.9944 (95% Cl: [0.9904, 0.9966]) |
| p-value | p < 0.0001 |
| Deming Slope [95% CI] | 1.06 [1.029, 1.095] |
| Deming Intercept [95% CI] | -0.05 [-0.302, 0.197] |
| Precision Validation (Analytical): | |
| Repeatability (DOB: 4.3‰) | 12.0% CV |
| Between-Days Precision (DOB: 4.3‰) | 12.9% CV |
| Repeatability (DOB: 5.9‰) | 8.2% CV |
| Between-Days Precision (DOB: 5.9‰) | 11.8% CV |
| Repeatability (DOB: 15.5‰) | 4.4% CV |
| Between-Days Precision (DOB: 15.5‰) | 4.7% CV |
| Reproducibility Validation (Analytical): | |
| Reproducibility (DOB: 4.5‰) | 10.9% CV |
| Between-Days Reproducibility (DOB: 4.5‰) | 11.0% CV |
| Between-Operators Reproducibility (DOB: 4.5‰) | 10.9% CV |
| Reproducibility (DOB: 5.9‰) | 9.2% CV |
| Between-Days Reproducibility (DOB: 5.9‰) | 10.6% CV |
| Between-Operators Reproducibility (DOB: 5.9‰) | 11.4% CV |
| Reproducibility (DOB: 15.5‰) | 3.4% CV |
| Between-Days Reproducibility (DOB: 15.5‰) | 3.4% CV |
| Between-Operators Reproducibility (DOB: 15.5‰) | 3.4% CV |
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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