(204 days)
BioSign" H. pylori WB qualitatively detects anti-H. pylori antibody in human whole blood, serum or plassua specimens. The test is intended for use in the diagnosis of Helicobacter pylori infection in parients with symptoms of gastrointestinal disorders.
Not Found
This document, a 510(k) clearance letter for the BioSign™ H. pylori WB device, primarily focuses on regulatory approval based on substantial equivalence to a predicate device. It does not contain detailed information about specific acceptance criteria, a dedicated study proving device performance against those criteria, or the methodology typically associated with such a study (like sample sizes, expert qualifications, or ground truth establishment).
Therefore, based only on the provided text, I cannot fill out the requested table or answer most of the questions about a device performance study. The letter states that the device "qualitatively detects anti-H. pylori antibody in human whole blood, serum or plasma specimens" and is "intended for use in the diagnosis of Helicobacter pylori infection in patients with symptoms of gastrointestinal disorders." This is the core 'performance' described.
If a study report or clinical data were included as an attachment to this 510(k) submission (which is common), that document would contain the requested information. However, this letter itself does not provide it.
Here's what can be inferred or stated from the provided text:
- Device Name: BioSign™ H. pylori WB New One Step anti-H. pylori antibody test
- Intended Use: Qualitatively detects anti-H. pylori antibody in human whole blood, serum or plasma specimens. Intended for use in the diagnosis of Helicobacter pylori infection in patients with symptoms of gastrointestinal disorders.
- Regulatory Status: Substantially Equivalent to legally marketed predicate devices.
Attempting to answer based on the lack of specific information in the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. Often includes sensitivity, specificity, and accuracy targets. | Detects anti-H. pylori antibody |
2. Sample sized used for the test set and the data provenance
* Sample Size (test set): Not mentioned in this document.
* Data Provenance: Not mentioned in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* Number of Experts: Not mentioned in this document.
* Qualifications: Not mentioned in this document.
4. Adjudication method for the test set
* Adjudication Method: Not mentioned in this document.
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
* MRMC Study: Not mentioned in this document. This device appears to be an in vitro diagnostic test, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human improvement with AI would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Standalone Performance: This device is a rapid diagnostic test (implied by "One Step" and "WB" likely meaning "Whole Blood"). Its performance itself is the standalone performance. The document doesn't provide specific standalone performance metrics (e.g., sensitivity, specificity) but rather confirms its regulatory clearance.
7. The type of ground truth used
* Ground Truth Type: Not mentioned in this document. For an H. pylori test, ground truth would typically be established by culture, histology, urea breath test (UBT), or an alternative validated H. pylori test.
8. The sample size for the training set
* Sample Size (training set): Not mentioned in this document. For a rapid diagnostic test like this, the concept of a "training set" in the machine learning sense is not directly applicable. If a training phase was involved in optimizing the assay, details are not provided.
9. How the ground truth for the training set was established
* Ground Truth Establishment (training set): Not mentioned in this document.
Summary of what's provided: The document is a regulatory clearance letter acknowledging substantial equivalence. It confirms the device's intended use and regulatory pathway but does not delve into the detailed performance study data that would have been part of the underlying submission.
§ 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).