(57 days)
HP-ONE is for in-vitro diagnostic use only. It is intended to detect the urease enzyme of Helicobacter pylori and provide a presumptive diagnosis of H. pylori gastritis.
HP-ONE detects the urease enzyme for the presumptive identification of Helicobacter pylori in gastric mucosal biopsies. It is intended for in-vitro diagnostic use only. A gastric mucosal endoscopic biopsy is placed in the HP-ONE tray well and a reagent containing urea, hydrogen peroxide, a pH dye indicator, and an acidic buffer is placed over the biopsy specimen. A bubbling reaction occurs as catalase breaks down the peroxide. If H. pylori is present, the urease in H. pylori converts the urea to ammonia which raises the pH and changes the color of the reagent, indicating a positive test.
This document describes the HP-ONE device, its intended use, and performance characteristics. However, it does not explicitly state "acceptance criteria" as a separate predefined standard. Instead, the "acceptance criteria" are implicitly met by the reported performance characteristics that were considered sufficient for substantial equivalence to a predicate device.
Here's the information requested, organized based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Relative Sensitivity | Performance comparable to HP-Fast (predicate device). Specific numerical criteria are not stated, but the achieved sensitivity was deemed acceptable for substantial equivalence. | 92.3% |
| Relative Specificity | Performance comparable to HP-Fast (predicate device). Specific numerical criteria are not stated, but the achieved specificity was deemed acceptable for substantial equivalence. | 100% |
| Positive Predictive Value | Not explicitly stated as acceptance criteria. | 100% |
| Negative Predictive Value | Not explicitly stated as acceptance criteria. | 91.23% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 117 patients
- Data Provenance: The text does not specify the country of origin of the data. It states, "In the clinical study of 117 patients with possible peptic ulcer disease..." This suggests the data was from a clinical study, but whether it was retrospective or prospective is not explicitly stated. Given it's a study for regulatory submission, it is typically a prospective or carefully selected retrospective cohort.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth was established by histological criteria (presence of H. pylori organisms upon staining). The text does not specify the number or qualifications of the experts (e.g., pathologists) who performed the histological assessments.
4. Adjudication Method for the Test Set
The text does not describe an adjudication method for the test set. The ground truth was based on histological diagnosis.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states, "HP-ONE agreed with the positive histological diagnosis in 60 cases (92.3%) and agreed with the negative diagnosis in all 52 (100%) of the cases." This indicates a standalone performance evaluation against a reference standard, not a comparative effectiveness study involving human readers with and without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes. The study presented is a standalone performance evaluation of the HP-ONE device against histological diagnosis as the ground truth. HP-ONE itself is a diagnostic test kit that produces a result; it's not an "algorithm" in the typical sense of AI, but rather a chemical reaction-based diagnostic tool. The performance metrics (92.3% sensitivity, 100% specificity) reflect the device's inherent capability.
7. Type of Ground Truth Used
The ground truth used was histological criteria (presence of H. pylori organisms upon staining).
8. Sample Size for the Training Set
The document does not describe a separate "training set." The clinical study of 117 patients appears to be the primary dataset reported for performance evaluation. For a chemical diagnostic test like HP-ONE, the "training" typically refers to the R&D and optimization process for the reagent formulation, not an algorithmic training process with a distinct dataset.
9. How the Ground Truth for the Training Set Was Established
Since no separate training set is described in the provided text, this question is not applicable. The device's formulation would have been developed and optimized based on scientific principles and internal testing, but without a formally described "training set" with established ground truth in the context of this 510(k) summary.
§ 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).