(84 days)
The 5mm x 300mm Images Endoscope (REF. 7205XXX) is indicated for use in endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization of the surgical site during decission, ligation and harvesting of vessels.
The Smith & Nephew Images 5mm x 300mm Endoscope transfers light to the surgical site via glass fiber optics and allows visualization of the surgical site through a series of optical lenses and prisms. The endoscope allows it to gain access to the surgical site.
This is a 510(k) summary for an endoscope, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device's performance, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, are not applicable to this document.
The document describes a medical device, the Smith & Nephew Images 5mm x 300mm Endoscope, and asserts its substantial equivalence to a predicate device (Karl Storz Endoscopy Telescope). The basis for clearance is this substantial equivalence, not a performance study against specific acceptance criteria for AI algorithms.
However, I can extract the following information that is somewhat related to "acceptance criteria" in a general sense within the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance (as defined by 510(k) substantial equivalence):
| Acceptance Criteria (for 510(k)) | Reported Device Performance (Smith & Nephew Images 5mm x 300mm Endoscope) |
|---|---|
| Substantial Equivalence in Design: | Substantially equivalent in design to the Karl Storz Endoscopy 5mm x 300mm Telescope. |
| Substantial Equivalence in Materials: | Substantially equivalent in materials to the Karl Storz Endoscopy 5mm x 300mm Telescope. |
| Substantial Equivalence in Function: | Substantially equivalent in function to the Karl Storz Endoscopy 5mm x 300mm Telescope. Transfers light and allows visualization of the surgical site. |
| Substantial Equivalence in Intended Use: | Substantially equivalent in intended use to the Karl Storz Endoscopy 5mm x 300mm Telescope. Indicated for endoscopic surgery of superficial vessels and fascia of the lower extremities to provide illumination and visualization for decission, ligation, and harvesting of vessels. |
| Raises no new questions of safety and effectiveness: | Does not raise new questions of safety and effectiveness compared to the predicate. |
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device with a "test set" in the analytical sense for algorithm performance. Substantial equivalence is demonstrated through comparison of specifications and intended use.
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 an AI algorithm is not relevant here.
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: Not applicable. This is an endoscope, not an AI assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used: For a 510(k) of this nature, the "ground truth" for demonstrating substantial equivalence is generally established by comparison to an existing legally marketed predicate device's established safety and effectiveness profile, often through engineering specifications, material composition, functional tests (if applicable to the device type, e.g., sterility, biocompatibility), and clinical indications. The document mainly focuses on comparative characteristics rather than specific "ground truth" data for performance in a diagnostic sense.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
§ 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.