(63 days)
The PyloriTek VP Test Kit includes materials for detection of urease activity in gastric biopsy specimens for the presumptive identification of Helicobacter pylori. The test is for use on symptomatic patients by healthcare professionals.
Helicobacter pylori grows on the gastric mucosa and colonies can be collected with biopsies taken during gastrointestinal endoscopy. H. pylori produces urease which is a useful marker for gastric infections. Pyloritek VP Test Kit detects urease activity in gastric biopsy specimens.
Serim PyloriTek VP Test Kit has the following components:
Reagent strips which contain, in separate dry reagent matrices, the substrate urea (Substrate Pad) and a pH indicator (Reaction Pad). The Reaction Pad containing the pH indicator is covered by a semi-permeable membrane which allows passage of gaseous ammonia but prevents passage of gastric tissue fluid or Hydration Reagent from the Substrate Pad.
Hydration Reagent which contains a buffer that is dispensed on the Substrate Pad prior to performing the test.
Reaction Chamber which is a plastic device that holds developing strips and provides solid contact between the gastric biopsy, the Substrate Pad and the Indicator Pad. This arrangement ensures that ammonia gas generated is directed through the semi-permeable membrane to the pH indicator.
PyloriTek VP Positive Control Paper is provided separately to be used as a quality control material with the PyloriTek VP Test Kit. This control is a 0.2 x 3.25 inch strip of paper containing dry urease, buffer and stabilizer. PyloriTek VP Positive Control is run on PyloriTek VP Test Strips separate from biopsy specimens.
The provided text describes a 510(k) summary for the Serim™ PyloriTek® VP Test Kit. Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as a predefined target for sensitivity and specificity. Instead, it presents the performance of the PyloriTek VP Test Kit in comparison to its predicate device.
| Metric | Reported Device Performance (PyloriTek VP Test Kit) |
|---|---|
| Sensitivity | 100% |
| Specificity | 98.5% |
2. Sample size used for the test set and the data provenance
- Sample Size: Replicate biopsy specimens from 84 patients.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "replicate biopsy specimens," implying a comparison between the two test kits on the same patient samples. It's a retrospective comparison against a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The text only states that a comparison was made between the PyloriTek VP Test Kit and the predicate PyloriTek Test Kit. It does not elaborate on how the true H. pylori status of the 84 patients was confirmed, which would typically involve a gold standard interpreted by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the 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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a rapid urease test for the detection of H. pylori, not an AI-powered diagnostic system that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a chemical assay (rapid urease test) and not an algorithm or AI system. Its performance is inherent to the chemical reaction and the human interpretation of color change, not an automated algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implies that the ground truth for the comparison was established by the predicate device, the PyloriTek Test Kit (K953632), as the new device's performance is reported in relation to it. However, the ultimate ground truth for the predicate device itself (e.g., biopsy culture, histology) is not explicitly stated for this study. The phrase "Replicate biopsy specimens from 84 patients were tested for H. pyloriTek VP and PyloriTek Test Kits" indicates a direct comparison of the two tests on the same samples.
8. The sample size for the training set
This information is not applicable/not provided. The PyloriTek VP Test Kit is a chemical assay, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable/not provided as there is no training set for this type of device.
§ 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).