Search Results

This instrument is intended to be used with an Olympus video system center, light source, documentation equipment. monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

The EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GIF-1TH190 is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).

The GIF-1TH190 consists of three parts: the control section, the insertion section, and the connector section. The basic principle including user interface and operation for the procedure of the GIF-1TH190 is identical to that of the primary predicate device (K112680) and reference device (K131902).

This document describes the EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 and its substantial equivalence to a predicate device. It appears to be part of a 510(k) submission to the FDA. The information provided heavily focuses on bench testing and comparison to predicate devices rather than clinical studies with defined acceptance criteria for diagnostic performance metrics like sensitivity or specificity.

Here's an analysis based on the provided text, addressing your specific points:

1. A table of acceptance criteria and the reported device performance

The document does not present a single table of "acceptance criteria" alongside specific reported "device performance" in the way one might expect for a diagnostic AI device (e.g., statistical thresholds for sensitivity/specificity). Instead, the "performance data" section details various engineering and safety tests. The acceptance criteria for these tests are generally implied to be meeting design specifications and regulatory standards.

2. Sample size used for the test set and the data provenance

The document explicitly states:

• "No animal study was performed to demonstrate substantial equivalence."
• "No clinical study was performed to demonstrate substantial equivalence."

This indicates that there was no formal test set in the sense of patient data or clinical samples used to evaluate diagnostic performance. The "tests" mentioned are primarily engineering bench tests on the device itself or material and reprocessing validation studies. Therefore, sample size and data provenance are not applicable in the context of clinical/diagnostic performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Since no clinical or diagnostic performance study was conducted on patient data, there was no "ground truth" to be established by experts in this context. The evaluation relies on technical comparisons and non-clinical validations.

4. Adjudication method for the test set

Not applicable, as no clinical or diagnostic performance test set was used that would require adjudication.

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

Not applicable. This device is a gastrointestinal videoscope, not an AI-powered diagnostic system or an assistance tool for human readers. It's a hardware device designed for direct human operation for visualization.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware device for direct visualization by a human, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No "ground truth" for diagnostic purposes was established as no clinical or diagnostic performance study was conducted. The "ground truth" for the various engineering tests would be the established industry standards, regulatory requirements, and internal design specifications.

8. The sample size for the training set

Not applicable, as this is a hardware device and not an AI/machine learning algorithm.

9. How the ground truth for the training set was established

Not applicable, as this is a hardware device and not an AI/machine learning algorithm.

Summary Conclusion from the Document:

The document focuses on demonstrating substantial equivalence of the EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 to a legally marketed predicate device (EVIS EXERA III GIF-H190 and referenced PENTAX Video Upper G.I. Scopes EG-3490K) primarily through:

• Comparison of technological characteristics: Highlighting similarities and justifying differences through non-clinical testing.
• Non-clinical performance testing: Including reprocessing validation, biocompatibility, electrical safety/EMC, and various bench performance tests (e.g., optical properties, mechanical durability).
• Risk management: Assurance that potential risks have been identified and mitigated.

The submission did not involve clinical studies, animal studies, or expert evaluations of diagnostic performance, as is typical for traditional hardware medical devices demonstrating substantial equivalence to a well-established predicate. The acceptance criteria are therefore tied to meeting established engineering specifications, regulatory standards, and demonstrating that any differences from the predicate device do not raise new questions of safety or effectiveness.

Ask a specific question about this device