(49 days)
The Ophthalmic Technologies i-Scope™ is intended to be used for visualization of intra-ocular structures, as a means to introduce micro instruments into the eye, or as a means to introduce laser fibers into the eye for photocoagulation.
The Ophthalmic Technologies i-Scope™ is a rigid ophthalmic fiber-optic microendoscope. The i-Scope has an imaging fiber bundle with 10,000 pixels, an illumination fiber, and a working channel for an optional laser fiber or microinstruments. The laser fiber is disposable and can be replaced between cases. The fiber is not manufactured by Ophthalmic Technologies. The image fiber bundle terminal is connected to an orientation ring, video adapter and video camera. The illuminating bundle fiber can be connected to the OTI "XE-LITE" Xenon Light Source, or other light sources which have been cleared by the FDA. The laser fiber is disposable and can be replaced between cases.
The K971679 510(k) submission for the Ophthalmic Technologies i-scope does not contain a study that establishes acceptance criteria for its device performance in the way a diagnostic AI device would. Instead, this submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance and material comparisons, as clinical tests were not required. The device is an ophthalmic endoscope, not an AI-based diagnostic tool.
Therefore, many of the requested categories for AI device studies are not applicable or cannot be extracted from this document.
Here's an attempt to address the request with the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance | Study Type |
|---|---|---|
| Resolution comparable to predicate devices | Resolution with test pattern presented | Non-Clinical Test |
| Light output comparable to predicate devices | Light output compared to other devices presented | Non-Clinical Test |
| Materials used are safe and similar to predicate devices | All materials used have been used in predicate devices | Non-Clinical Test |
| Intended use aligns with predicate devices (visualization of intra-ocular structures, introduction of micro-instruments, introduction of laser fibers) | Device description and intended use provided | Device Description |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission does not describe a clinical test set with human or patient data for evaluating performance against predefined acceptance criteria. The "tests" mentioned are non-clinical, likely involving physical measurements or comparisons.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of diagnostic performance, is not established or reported in this submission for the evaluation of the device.
4. Adjudication method for the test set
- Not Applicable. No test set requiring adjudication in the context of diagnostic performance is described.
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, a MRMC comparative effectiveness study was not done. This device is an ophthalmic endoscope, not an AI diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The OTI i-scope is a physical medical device (endoscope), not an algorithm. Standalone algorithm performance is irrelevant.
7. The type of ground truth used
- Not Applicable. For the non-clinical tests (resolution, light output), the "ground truth" would be the known physical properties or established measurement standards, rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
- Not Applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This device is not an AI algorithm and therefore has no training set or associated ground truth.
§ 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.