Search Results
Found 1 results
510(k) Data Aggregation
(162 days)
INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST
The Instant-View H. Pylori Rapid Test is a rapid lateral flow, qualitative immunoassay. It is intended for use at point of care facilities to detect the presence of IgG antibodies specific to Helicobacter pylori (H. pylori) in human blood or serum. It provides an aid in the diagnosis of infection by H. pylori. This test has been evaluated for use with serum specimens of adults, 19 years and older.
A one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with H. Pylori antigens, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with H. Pylori antigens, and the C line is coated with goat anti-H. Pylori antibodies.
Here's a breakdown of the acceptance criteria and study information for the Instant-View H. pylori Rapid Test based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sensitivity | High sensitivity to detect H. pylori IgG antibodies | 95% (137/144) |
| Specificity | High specificity to correctly identify absence of H. pylori IgG antibodies | 93% (141/152) |
| Overall Accuracy | High overall accuracy | 94% (278/296) |
| Reproducibility | High intra-assay, inter-assay, and inter-site agreement | Intra-assay: 99.4%-100%; Inter-assay: 99.8%-100%; Inter-site: 99.9% |
| Interference/Cross-Reactivity | No significant interference or cross-reactivity with common substances or closely related microorganisms | No cross-reaction with Campylobacter fetus, C. jejuni, C. coli, or E. coli. No interference with common serum components (lipids, hemoglobin, bilirubin) or other analytes. |
| Equivalency across Formats | All device formats (Cassette, Dip Strip, Serum, Whole Blood/Serum) are equivalent in performance | Studies demonstrated all formats are equivalent. |
Study Information
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: 296 clinically confirmed serum specimens (144 positive, 152 negative).
- Data Provenance: Not explicitly stated (e.g., country of origin). The study states "clinically confirmed serum specimens," implying these were from real patient cases. It is retrospective in the sense that the clinical confirmation (ground truth) was already established for these specimens before testing with the Instant-View device.
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):
- The text states "clinically confirmed serum specimens" to establish the ground truth. It does not specify the number or qualifications of experts involved in this clinical confirmation. It implies that standard clinical diagnostic methods were used to determine positive/negative status for H. pylori, but details on the "who" and "how" are not provided.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The text does not describe an adjudication method for establishing the ground truth. It simply refers to "clinically confirmed" specimens.
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. This device is a rapid diagnostic immunoassay and does not involve "readers" in the context of imaging or clinical interpretation by multiple experts that would necessitate an MRMC comparative effectiveness study to assess human-AI interaction. Its performance is evaluated objectively against clinical confirmation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. The reported sensitivity, specificity, and accuracy are for the device's performance alone when interpreting the sample. There is no human interpretation or intervention in the result generation of the test itself, only in applying the test and reading the final visual line. Therefore, this represents the standalone performance of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- "Clinically confirmed" positive and negative H. pylori status for serum specimens. This typically refers to confirmation by established laboratory methods (e.g., endoscopy with biopsy and histology, urea breath tests, stool antigen tests, or other validated serological tests) which serves as the "truth" against which the new device is compared. Specific details are not provided.
8. The sample size for the training set:
- The document does not explicitly mention a separate training set for the diagnostic performance evaluation (sensitivity and specificity). For immunoassay devices like this, the 'training' often refers to the internal development and optimization of the assay during the manufacturing process, rather than a distinct dataset used to train an algorithm in the AI sense. The 296 specimens are explicitly referred to as the validation/test set.
9. How the ground truth for the training set was established:
- As no explicit training set in the context of an algorithm is mentioned for the performance study, this question is not applicable based on the provided text. For the development of the assay itself, internal R&D processes would involve known positive and negative samples, but these are not typically detailed in 510(k) summaries as "training sets."
Ask a specific question about this device
Page 1 of 1