(149 days)
The Fuse 1C System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. The system is indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients.
The Fuse™ IC Colonoscopy System is a GI platform for diagnostic visualization and therapeutic intervention of the lower digestive tract. The system enables physicians to view high resolution wide field of view of up to 300°. The Fuse 1C is a modification of the legally marketed (K130718) PeerScope system Model H (the predicate device). The device has been modified to include a water bottle, cap, and tubing that are specified for use only with the Fuse1C.
The Fuse IC Colonoscopy System consists of the following components:
- The Fuse 1C colonoscope is a flexible, adult size video colonoscope labeled for . repeatable clinical usage within health care facilities. The colonoscope design and materials have not been modified, aside from a change in market name.
- The main control unit (FuseBox™) performs image processing and relays video . signals from the video colonoscope to external display monitors. The FuseBox also offers pneumatic controls and interfaces with various external accessories.
- Ancillary components and accessories for use in reprocessing and irrigation. A . change in water bottle/cap/tubing is the difference between the predicate device and · the Fuse 1C device submitted herein for review.
The provided text describes the 510(k) summary for the Fuse 1C Colonoscopy System. However, it does not contain information about the acceptance criteria or a study proving the device meets specific performance metrics. The document focuses on demonstrating substantial equivalence to a predicate device based on design, intended use, materials, labeling, and non-clinical testing of an accessory.
Therefore, I cannot populate the requested table or answer most of the questions about a specific performance study.
Here's a breakdown of what can be extracted and why other parts cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | The document states "All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device." However, specific numerical performance criteria or results are not provided. |
Reasoning: The document states that "Non-clinical testing has been performed on the device," including benchtop functional performance testing, laboratory validation of cleaning, high-level disinfection, and sterilization instructions, and biocompatibility testing. It concludes that "All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device." However, it does not specify what the acceptance criteria were for each test, nor does it provide the quantitative results that "passed." This is typical for a 510(k) summary focused on substantial equivalence rather than original clinical efficacy trials.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified.
Reasoning: The document refers to "non-clinical testing" and "benchtop functional performance testing." These are laboratory-based tests, not human studies, so concepts like "sample size for the test set" and "data provenance" (in the context of patient data) do not directly apply in the way they would for a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable/specified.
- Qualifications of experts: Not applicable/specified.
Reasoning: Since the testing described is non-clinical (benchtop and laboratory validation), there would not be "experts" establishing ground truth in the sense of clinical diagnoses or interpretations. The "ground truth" would be established by the testing protocols and objective measurements in the laboratory.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable.
Reasoning: As above, this applies to clinical studies involving human interpretation, not to non-clinical bench or lab tests.
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
- MRMC study: No, an MRMC comparative effectiveness study was not done or reported in this document.
- Effect size: Not applicable.
Reasoning: This document is for a colonoscopy system, not an AI-assisted diagnostic tool. The focus is on the device's technical specifications and safety/effectiveness for visualization and intervention, not on comparing reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable.
Reasoning: This is a colonoscopy system, which is inherently a human-in-the-loop device. There is no "algorithm only" performance to evaluate in this context.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of ground truth: For the non-clinical tests, the "ground truth" would be defined by established engineering specifications, safety standards (e.g., ISO 10993-1 for biocompatibility), and validated laboratory assay results for cleaning, disinfection, and sterilization.
Reasoning: The ground truth for benchtop and laboratory validation is based on objective, measurable criteria defined by regulatory standards and engineering specifications rather than human expert consensus on clinical findings.
8. The sample size for the training set
- Sample size for training set: Not applicable.
Reasoning: This document does not describe the development of an algorithm or AI model that would require a "training set."
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable.
Reasoning: As above, this document does not describe an AI model or algorithm development.
Summary of the document's content:
The document is a 510(k) summary for the Fuse 1C Colonoscopy System, which is a modification of a previously cleared device (Predicate Device: PeerScope System Model H, K130718). The primary modification is a change in the specified accessory: the water bottle, cap, and tubing set.
The manufacturer, EndoChoice, Inc., claims substantial equivalence to the predicate device due to identical intended use, design, materials (for the core colonoscope), and labeling (with updated instructions for the new accessory).
Non-clinical testing performed on the accessory water bottle, cap, and tubing included:
- Benchtop functional performance testing
- Laboratory validation testing of cleaning instructions
- Laboratory validation testing of high-level disinfection instructions
- Laboratory validation testing of sterilization instructions
- Biocompatibility testing in conformance with ISO 10993-1
All these tests "passed," indicating that the accessory, and thus the modified system, is considered safe and effective in comparison with the predicate device. The document does not provide specific performance metrics or acceptance criteria beyond this general statement of passing tests.
§ 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.