(188 days)
The Entero-Test® HP is an in-vitro diagnostic device to be used for the collection of fluid/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. The device consists of a nylon thread, 90cm in length, coiled inside a #00 gelatin pharmaceutical capsule.
The Entero-Test® HP is collection device encased in a gelatin capsule. It can be used to collect fluids/mucous in the upper gastrointestinal tract of adults. A pH stick and a color chart are included in each package for the purpose of identifying the pH of the fluids/mucous.
Here's an analysis of the acceptance criteria and study details based on the provided text for the Entero-Test® HP device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Effectiveness in collecting fluids/mucous containing Helicobacter pylori from the upper gastrointestinal tract of adults. | The Entero-Test® HP is effective in collecting fluids/mucous containing Helicobacter pylori. |
| Recovery rate of Helicobacter pylori when compared to Biopsy results. | The comparative results of studies in the U.S. and China show a recovery rate of 74% vs. 80% respectively. Both are "in excess of seventy percent (70%)" when compared to Biopsy test results. |
| Safety: No adverse reactions or serious injuries. | "No adverse reactions or serious injuries were reported from both sites." |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the exact sample sizes for the clinical tests conducted in the U.S. and China. It only refers to "the studies" and "both study sites."
The data provenance is stated as: U.S. and China (indicating different geographical locations for the studies). The studies were conducted to compare the device's performance to an established "gold standard," implying they were prospective in nature for data collection related to device performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states that Biopsy is considered the "gold standard" for determining the presence of Helicobacter pylori. While biopsy interpretation typically involves pathologists, the document does not specify the number or qualifications of experts consulted for interpreting the biopsy results that served as the ground truth.
4. Adjudication method for the test set
The document does not mention any specific adjudication method used for establishing the ground truth (biopsy results) for the test set.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device described (Entero-Test® HP) is a specimen collection device, not an AI-powered diagnostic tool requiring human reader interpretation in the context of AI assistance. The study compared the device's collection effectiveness against a gold standard (biopsy).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Entero-Test® HP is a physical specimen collection device. Its "performance" refers to its ability to collect a sample, not an algorithm's classification or diagnostic ability. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device. The study evaluated the device's effectiveness in collecting a good sample.
7. The type of ground truth used
The type of ground truth used was Biopsy results, explicitly stated as the "gold standard" for determining the presence of Helicobacter pylori.
8. The sample size for the training set
The document does not mention a training set as this device is a specimen collection tool, not a machine learning algorithm that requires training data. The studies described are performance validation studies.
9. How the ground truth for the training set was established
As there is no training set for this type of device, this question is not applicable.
§ 866.2900 Microbiological specimen collection and transport device.
(a)
Identification. A microbiological specimen collection and transport device is a specimen collecting chamber intended for medical purposes to preserve the viability or integrity of microorganisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device may be labeled or otherwise represented as sterile. The device aids in the diagnosis of disease caused by pathogenic microorganisms.(b)
Classification. Class I (general controls). The device, when solely intended for use in the collection of concentrated parasites from specimens and transport, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.