(88 days)
The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are intended to attach to standard commercially available endoscopes for visualization of body cavities, hollow organs, and canals.
The Genzyme Surgical Products Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are designed to provide a picture of the surgical field during endoscopic procedures. The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras take the image that would be normally seen by the naked eye, and displays it on a color monitor. The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras provide imaging through standard, commercially available, legally marketed endoscopes.
The Digital RGB and the 3-Chip Digital RGB Endoscopic Cameras both consist of a Camera head, camera control box, and camera cable, camera cable connector soaking cap and coupler accessories. A coupler couples the camera head to the commercially available endoscope.
The provided 510(k) summary for the Genzyme Surgical Products Digital RGB and 3-Chip Digital RGB Endoscopic Cameras is a premarket notification for a medical device. These documents primarily focus on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting detailed "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the way a clinical trial or performance standard for algorithms would.
In this context, "acceptance criteria" would relate to regulatory compliance and equivalence to predicate devices, and the "study" would be the testing performed to demonstrate that compliance.
Here's an analysis based on the provided text, addressing your points as much as possible within the limitations of a 510(k) summary:
1. A table of acceptance criteria and the reported device performance
The 510(k) summary does not explicitly state acceptance criteria in terms of performance metrics (like sensitivity, specificity, resolution, etc.) for image quality or clinical utility. Instead, the acceptance criteria are implicitly that the device performs similarly to the predicate devices and meets relevant safety and electromagnetic compatibility (EMC) standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Provide a picture of the surgical field during endoscopic procedures, display on a color monitor, attach to standard endoscopes. | "The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are designed to provide a picture of the surgical field during endoscopic procedures. The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras take the image that would be normally seen by the naked eye, and displays it on a color monitor. The Digital RGB and the 3-Chip Digital RGB Endoscopic Cameras both consist of a Camera head, camera control box, and camera cable, camera cable connector soaking cap and coupler accessories. A coupler couples the camera head to the commercially available endoscope." |
| Intended Use Equivalence: Visualization of body cavities, hollow organs, and canals. | "The Genzyme Surgical Products Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are intended to attach to standard commercially available endoscopes for visualization of body cavities, hollow organs, and canals." (Identical to predicate devices' intended use) |
| Technological Characteristics Equivalence: Similar components and image processing capabilities (contrast enhancement, edge correction). | "The Genzyme Surgical Products Camera components and the predicate devices are designed to be attached to commercially available endoscopes. The endoscopic image in the proposed and predicate devices can be displayed on any standard operating monitor or stored. A VCR/Video Printer can be used to produce hard copies of images obtained using both the proposed and predicate devices. Both the Digital RGB and the 3-Chip Digital RGB Endoscopic Cameras and the Karl Storz EndoVision Digivideo System provide contrast enhancement and edge correction and are used in conjunction with cameras attached to rigid or flexible endoscopes." |
| Safety and EMC Standards Compliance: Meet relevant electrical safety and electromagnetic compatibility standards. | "The devices were tested to EN 55011:03.1991 and EN 60601-1-2:05.1993." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The "testing" mentioned refers to compliance with electrical safety and EMC standards, not a clinical performance study involving patient data or images. For a device like an endoscopic camera from this era, clinical performance was largely assumed by its equivalence in function and image output to existing devices.
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)
This information is not applicable and therefore not provided. The testing described (EMC and electrical safety) does not involve clinical "ground truth" established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods are typically used in clinical studies involving interpretation, which is not the type of testing described here.
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 MRMC study was done. This device is a basic endoscopic camera for direct visualization, not an AI-powered image analysis tool. Therefore, discussions of "improving human readers with AI" are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is hardware for image capture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
No clinical "ground truth" was used. The testing was for compliance with electrical safety and electromagnetic compatibility standards.
8. The sample size for the training set
This information is not applicable and therefore not provided. This device is an imaging hardware component, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. As per point 8, there is no AI algorithm or training set discussed in this 510(k).
In summary of the 510(k) context:
This 510(k) notification is primarily focused on demonstrating that the new endoscopic camera is substantially equivalent to legally marketed predicate devices. This means showing that it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The "performance testing" referred to (EN 55011 & EN 60601-1-2) relates to electrical safety and electromagnetic compatibility, which are standard engineering tests for medical devices, rather than clinical efficacy studies often associated with AI or novel diagnostic tools. Therefore, many of the questions you asked, which are highly relevant for AI/algorithm-based devices, are not applicable to this type of medical device submission.
§ 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.