(42 days)
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.
| Acceptance Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|
| Precision Tests: Within laboratory precision/repeatability | Not explicitly stated, but "All the pre-defined acceptance criteria were met" for accurate and repeatable results over time. |
| Reproducibility Test: Between devices | Not explicitly stated, but "All the pre-defined acceptance criteria were met" for accurate and repeatable results over time. |
| Sample Carry-Over Test: No sample carry-over effect | "The carry-over test was designed to demonstrate that the system has no sample carry-over effect." (Implies acceptance criteria met) |
| Environmental Tests: Performance within specified transportation, storage, and operating conditions (temperature, altitude, vibrations, drop tests) | "The BreathID® Smart system was functionality tested several times during the Environmental test and found within the acceptance criteria." |
| Comparison to Predicate (Interchangeability): BreathID® Smart System performance is statistically comparable to BreathID® Hp Lab System | "A comparison test... statistically shows that both systems may be used interchangeably." |
| Electrical Safety and Electromagnetic Compatibility (EMC) | Not explicitly stated, but implies compliance as "All the pre-defined acceptance criteria were met." |
| H. pylori Detection Cut-off Point: 5.0 DOB per mil (post dose minus pre dose) | Not a performance metric of this study, but the same cut-off point as the predicate device. |
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.
§ 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).