(127 days)
The Fuse Gastroscopy System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The Fuse Gastroscopy System is indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). The Fuse Gastroscopy System consists of camera heads, endoscopes, video system, light source and other ancillary equipment.
The Fuse Gastroscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the upper digestive tract. The purpose of this submission is to propose new biopsy channel supplier and also to present several design changes that enhance device usability and robustness. The indications for use, fundamental technology and operation principals of the legally marketed device were not changed. The system labeled for healthcare facilities/hospitals enables physicians to view a high-resolution wide field of view of up to 245° (measured diagonally), or 210° (measured horizontally)
The provided text describes a 510(k) premarket notification for the "Fuse® Gastroscopy System" by EndoChoice Inc. This document focuses on demonstrating substantial equivalence to a predicate device (Fuse PeerScope HG, K131422) after making modifications to the existing device. It does not contain information about a study proving the device meets specific acceptance criteria in the context of diagnostic performance or a comparative effectiveness study with human readers.
The performance testing described here is focused on engineering verification and validation of design changes, ensuring safety and effectiveness after modifications, rather than establishing diagnostic performance acceptance criteria for a new AI or image analysis algorithm.
Therefore, many of the requested sections about acceptance criteria, diagnostic performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, and standalone algorithm performance cannot be extracted from this document.
Here's a breakdown of what can be extracted or inferred based on the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance:
This information is not explicitly provided in terms of diagnostic performance metrics like sensitivity, specificity, or AUC against specific acceptance criteria. The performance testing section states: "All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device." This refers to internal engineering/safety testing, not diagnostic accuracy.
2. Sample sized used for the test set and the data provenance:
Not applicable. The document discusses performance testing for mechanical, electrical, and reprocessing aspects, not a clinical diagnostic test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for diagnostic performance is not mentioned as this is not a diagnostic performance study.
4. Adjudication method for the test set:
Not applicable.
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, an MRMC comparative effectiveness study was not done. The device is a gastroscopy system (an endoscope), not an AI or image analysis system intended to assist human readers in diagnosis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable, as it's not a diagnostic performance study.
8. The sample size for the training set:
Not applicable, as it's not an AI or algorithm-based device requiring training data.
9. How the ground truth for the training set was established:
Not applicable.
Summary of available information:
The document describes the modifications made to an existing medical device (Fuse® Gastroscopy System) and the engineering-focused performance testing conducted to ensure these modifications did not negatively impact the device's safety and effectiveness.
- Acceptance Criteria & Performance (General): The general acceptance criterion was that "All test results passed," demonstrating the device is "safe and effective in comparison with the predicate device." This relates to bench tests (functional, performance, software), laboratory safety/EMC compatibility, biocompatibility, and reprocessing testing. Specific numerical acceptance criteria for these tests are not provided in this summary.
- Study Type: This was a series of engineering verification and validation tests rather than a clinical diagnostic study. It aimed to demonstrate that design modifications (e.g., new biopsy channel supplier, angulation knob brake, umbilical cord plug, locking lever, 90-degree umbilical cord orientation, updated reprocessing methods) maintained the device's safety and effectiveness compared to the predicate.
- Sample Size/Data Provenance for these engineering tests: Not explicitly stated, though implicitly the tests would have involved a number of manufactured devices or components. Data provenance is "within EndoChoice's laboratory or by accredited third parties."
- Ground Truth for these engineering tests: Established by predefined engineering specifications, regulatory standards (listed in the document), and comparison to the performance of the predicate device. For example, reprocessing testing would have had objective criteria for efficacy.
§ 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.