(271 days)
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.
| Acceptance Criteria Category | Specific Tests/Evaluations Performed | Reported Device Performance (Summary) |
|---|---|---|
| Reprocessing | Reprocessing instruction and method validation | Conducted and documentation provided as recommended by FDA guidance. (Implied: met validation standards for cleaning, disinfection, and sterilization) |
| Biocompatibility | Cytotoxicity Study, Intracutaneous Study, Guinea Pig Maximization Sensitization Test | Conducted in accordance with ISO 10993-1. (Implied: device materials are biocompatible) |
| Electrical Safety & EMC | Electrical safety (ANSI AAMI ES 60601-1, IEC 60601-2-18), EMC (IEC 60601-1-2) | Conducted (Implied: device meets electrical safety and electromagnetic compatibility standards) |
| Bench Performance | Thermal safety, Composite Durability, Photobiological safety, Noise and Dynamic Range, Color Performance, Image Intensity Uniformity, Distortion, Field of View, Direction of View, Depth of Field, Video Latency, Resolution | Conducted to ensure the device performs as intended and meets design specifications. (Implied: meets internal engineering specifications for these parameters) |
| Risk Management | Risk management in accordance with ISO 14971:2019 | Design verification tests and their acceptance criteria were identified and performed as a result of this risk management. (Implied: Risks are acceptably mitigated) |
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.