(109 days)
The Fuse® Colonoscopy System is intended for diagnostic visualization of the digestive tract. The system also provides access for therapeutic interventions using standard endoscopy tools. Fuse® Colonoscopes, in conjunction with the FuseBox™ processor, are indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) for adult patients. The Fuse® Colonoscopy System consists of EndoChoice camera heads, endoscopes, video system, light source and other ancillary equipment.
The Fuse Colonoscopy System is a GI platform indicated for diagnostic visualization and therapeutic intervention of the lower digestive tract in adult patients. The purpose of this submission is to expand the product sizes available for the legally marketed unmodified version Fuse 1C System (K132839) by adding two additional lengths: 133cm and 150cm to the current 168cm Fuse 1C colonoscope.
This 510(k) submission also presents several design changes to the system. 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 330°
The provided text is a 510(k) summary for the "Fuse® Colonoscopy System," which is a medical device, not an AI algorithm. Therefore, the questions related to AI algorithm performance (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set) are not applicable.
The document describes modifications to an existing device (Fuse™ 1C System, K132839) and aims to prove substantial equivalence to the predicate device, not to prove the device meets acceptance criteria for an AI algorithm.
However, I can extract and present the information available regarding the device's performance testing and acceptance, which focuses on safety and effectiveness in comparison to its predicate.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance (as pertains to device modification):
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for an AI's performance metrics (e.g., AUC > 0.9). Instead, it focuses on demonstrating that the modified device's design outputs meet its design input requirements and that it performs "as well as the predicate" in terms of safety and effectiveness.
| Category | Acceptance Criteria (Implicit for safety/effectiveness vs. Predicate) | Reported Device Performance |
|---|---|---|
| Colonoscope Working Length | Industry-accepted standard for working lengths. Safety and effectiveness maintained despite adding shorter lengths (133cm, 150cm). | Both designs (original and modified with additional lengths) utilize industry-accepted standard for working lengths. |
| Angulation Knob Brake | Industry-accepted standard for handle brake. Safety and effectiveness maintained despite adding R/L angulation. | Both designs utilize industry-accepted standard for handle brake. |
| Umbilical Cord Plug / Socket | Industry-accepted standard for usability. Safety and effectiveness maintained with integrated design. | Both designs utilize industry-accepted standard for usability. |
| Post-procedure Reprocessing Method | Industry-accepted standard for reprocessing compliance. Safety and effectiveness maintained with automated reprocessing option. | Both designs utilize industry-accepted standard for reprocessing compliance. |
| Insertion Tube Coating | Similar properties to predicate device's coating (TPU). Biocompatibility and performance maintained. | Both materials are TPU, having similar properties. |
| Adhesives | Similar properties to predicate device's adhesives (Epoxy resin). Biocompatibility and performance maintained. | Both materials are epoxy resins, having similar properties. |
| Software | Enhanced features do not negatively impact safety or effectiveness, and may improve performance. | Version 1.1.7 (modified) provides enhanced features over Version 1.0 (predicate). Specific performance metrics are not detailed but passed testing. |
| General Performance (Safety & Effectiveness) | The modified device must be as safe and effective as the predicate device for its intended use. Design outputs must meet design inputs. | "All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device." |
2. Sample size used for the test set and the data provenance:
- Not applicable for an AI algorithm.
- For the device, the performance testing involved "benchtop functional, performance, and software testing," "Laboratory Safety / EMC compatibility re-testing," "Laboratory AER validation," and "Laboratory Biocompatibility testing." The sample sizes for these engineering and lab tests are not specified in this summary, but would typically involve a defined number of units or samples as per particular test standards.
- Data Provenance: Testing was performed "within EndoChoice's laboratory and by accredited third parties." The origin of input "data" in the sense of patient data is not relevant here as it's a hardware/software device validation, not an AI model trained on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This relates to AI algorithm validation where expert consensus establishes ground truth for classification tasks. The Fuse® Colonoscopy System is a visualization and intervention tool, not an AI diagnostic system.
4. Adjudication method for the test set:
- Not applicable. This relates to AI algorithm validation using expert review.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is typically done for diagnostic tools (human readers interpreting images) where AI assistance is being evaluated. The Fuse® Colonoscopy System is an imaging system itself, not an AI assistant to image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to AI algorithm performance. The device itself is "standalone" in the sense that its performance characteristics (e.g., optical quality, mechanical function, electrical safety) are evaluated intrinsically, but it requires a human user (physician) for its clinical application.
7. The type of ground truth used:
- For the engineering and laboratory tests performed, "ground truth" implies meeting the specified engineering requirements and international standards. For example, for biocompatibility, the ground truth is adherence to ISO 10993; for electrical safety, it's adherence to IEC 60601-1.
- It's not "expert consensus, pathology, or outcomes data" in the context of validating an AI diagnostic algorithm.
8. The sample size for the training set:
- Not applicable. This refers to AI algorithms. The device does contain software (Version 1.1.7), but this appears to be for system control and image processing, not a machine learning model that requires a "training set" in the AI sense.
9. How the ground truth for the training set was established:
- Not applicable. This refers to AI algorithms.
In summary, the provided document focuses on demonstrating substantial equivalence of a modified medical device to a legally marketed predicate device, rather than the validation of an AI algorithm against specific performance criteria. The evaluation is centered on engineering bench tests, laboratory validations, and compliance with recognized standards, ensuring the modifications do not negatively impact the device's safety and 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.