(23 days)
EXALT Model D Single Use Duodenoscope: The EXALT Model D Single-Use Duodenoscope is intended for use with a Boston Scientific endoscopic video imaging system, for endoscopy and endoscopic surgery within the duodenum. EXALT Controller: The EXALT Controller is intended for use with a Boston Scientific endoscope for endoscopic diagnosis, treatment, and video observation.
The EXALT Model D Single-Use Duodenoscope is a sterile, single-use, flexible duodenoscope used to examine the duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery. When connected to an EXALT Controller, the EXALT Model D Single-Use Duodenoscope provides imaging and illumination, 4-way steerable navigation, lens wash, insufflation, suction, facilitates image capture initiation, and allows the delivery of various ancillary devices. The EXALT Controller is an endoscopic video imaging system that receives video signals from the EXALT Model D Single-Use Duodenoscope, processes the video signals, outputs video images to a video monitor, and outputs electrical signals that interface with external image capture systems. The EXALT Controller also controls the light transmitted by the tip of the EXALT Model D Single-Use Duodenoscope to illuminate the area of interest within the anatomy.
This document does not contain the specific acceptance criteria or details of a study structured to prove a device meets those criteria in the manner one would find for an AI/ML medical device. Instead, it is an FDA 510(k) clearance letter for a hardware (medical device) product, specifically an endoscope and its controller.
Therefore, many of the requested points, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and sample size/ground truth for training sets, are not applicable to the information provided. These elements are typically part of a submission for software as a medical device (SaMD) or AI/ML-driven devices.
However, based on the provided text, I can extract and infer information relevant to the device's performance demonstration for its 510(k) clearance, framed in the context of substantial equivalence to predicate devices:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices seeking 510(k) clearance, the "acceptance criteria" are generally demonstrating substantial equivalence to a legally marketed predicate device across various characteristics. The "reported device performance" refers to how the new device matches or performs comparably to the predicate device in those characteristics.
| Characteristic | Acceptance Criteria (Substantial Equivalence to Predicate) | Reported Device Performance (EXALT Model D / Controller) |
|---|---|---|
| Intended Use | Must be the same as the predicate devices. | Same intended use: "endoscopy and endoscopic surgery within the duodenum" (Duodenoscope); "endoscopic diagnosis, treatment, and video observation" (Controller). |
| Technological Characteristics | Similar mechanical and optical characteristics (working length, diameters, articulation angles, flow rates, resolution, direction of view, field of view). Similar video formats, outputs, and illumination technology. | "Share similar mechanical and optical characteristics, including working length, diameters, articulation angles, flow rates, resolution, direction of view, and field of view." (Duodenoscope) |
| "Share similar video formats and outputs and illumination technology" (Controller). Key difference: LEDs in duodenoscope, not controller (unlike predicate). | ||
| Performance Data (Bench) | Must demonstrate comparable performance to predicate in specified areas. | Successful performance testing completed for: Working Length, Insertion Portion Diameter, Articulation Angles, Flow Rates, Reliability, Resolution, Direction of View, Field of View, Light Output. |
| Biocompatibility | Must meet ISO 10993-1 standards. | Evaluated in accordance with ISO 10993-1. |
| Electrical Safety / EMC | Must meet AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18 standards. | Evaluated in accordance with AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-2, and IEC 60601-2-18. |
| Procedural Performance (Clinical) | Must confirm performance in relevant clinical procedures. | Clinical testing performed to confirm procedural performance in endoscopic cholangiopancreatography (ERCP) procedures. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "clinical testing" for procedural performance but does not specify the sample size (i.e., number of patients or procedures) used for this clinical study.
- Data Provenance: The document does not explicitly state the country of origin or whether the clinical data was retrospective or prospective. It only states "Clinical testing was performed to confirm procedural performance...".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This point is not applicable. For hardware devices like endoscopes, "ground truth" as conceptualized for AI/ML performance (e.g., expert consensus on image interpretation) is not typically established in the same way. The procedural performance evaluation would likely involve assessments by practicing physicians/endoscopists, but their role is to assess the device's functionality and efficacy during the procedure, not to create an image-based "ground truth" dataset for an algorithm.
4. Adjudication Method for the Test Set
This point is not applicable. As there's no specific "test set" in the AI/ML sense (e.g., images requiring interpretation), there's no mention of an adjudication method.
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
This point is not applicable. MRMC studies are typically for evaluating the impact of AI on human reader performance, which is not relevant for this hardware device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This point is not applicable. The EXALT Model D Duodenoscope and EXALT Controller are hardware devices, not standalone algorithms.
7. The Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as applied to AI/ML image analysis is not relevant here. For a medical device like an endoscope, the "truth" is its functional performance during procedures, its ability to provide clear imaging, enable tool delivery, and adhere to safety standards (biocompatibility, electrical safety). The clinical testing assessed "procedural performance," which means observing the device's operation in real use cases, rather than establishing a diagnostic ground truth from images.
8. The Sample Size for the Training Set
This point is not applicable. Hardware devices like endoscopes do not have "training sets" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
This point is not applicable, as there is no training set for a machine learning algorithm.
§ 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.