(90 days)
The Fiber Optic Endoillumination Probe is indicated for intraocular illumination in vitreoretinal surgery.
The Fiber Optic Endoillumination Probe provides intraocular illumination. The light is transmitted from the source to the inside of the eye through a flexible optical fiber, which has been threaded through an illumination probe.
This 510(k) summary (K980636) for the Fiber Optic Endoillumination Probe does not describe a study with acceptance criteria and reported device performance. Instead, it demonstrates substantial equivalence to a predicate device (Infinitech, Inc. Fiber Optic Probe, K870942) based on operational and technological characteristics.
Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text.
Here's a breakdown of what can be extracted and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided.
The submission relies on a comparison table to establish substantial equivalence, not to report performance against specific acceptance criteria. The "Comparison Criteria" act as attributes that are matched for equivalence rather than performance metrics with thresholds.
| Comparison Criteria | Acceptance Criteria (Implied for Equivalence) | Reported Device Performance (Dutch Ophthalmic, USA Fiber Optic Endoillumination Probe) |
|---|---|---|
| Device Type: Fiber Optic Probe | Must be "Yes" (a Fiber Optic Probe) | Yes |
| Indication: Intraocular illumination in vitreoretinal surgery | Must be "Yes" (for intraocular illumination in vitreoretinal surgery) | Yes |
| Patient Contact Materials: PMMA and fluoropolymer fiber and medical grade Surgical stainless steel | Must be "Yes" (matching materials) | Yes |
| Sterilization Method: Validated ETO | Must be "Validated ETO" (or equivalent, typically requiring validation data) | Validated ETO |
| Packaging: Validated Heat Sealed Tyvek | Must be "Validated Heat Sealed Tyvek" (or equivalent, typically requiring validation data) | Validated Heat Sealed Tyvek |
Note: The predicate device details for "Sterilization Method" and "Packaging" are "Not Known," indicating that Dutch Ophthalmic's methods were assessed for safety and effectiveness on their own merits and found acceptable, rather than directly comparing to a known predicate value.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This submission does not detail an experimental test set with sample sizes. It's a regulatory submission for substantial equivalence based on descriptive and technological characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. No test set or ground truth established by experts is described.
4. Adjudication method for the test set
Not applicable/Not provided. No test set or adjudication method 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. This is not an AI-enabled device. It's a fiber optic endoillumination probe. Therefore, no MRMC study or AI-related effectiveness is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable/Not provided. No ground truth is described as the device is for illumination, not diagnosis or measurement requiring ground truthful comparison.
8. The sample size for the training set
Not applicable/Not provided. This is not an AI/machine learning device, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable/Not provided. As there's no training set, there's no ground truth established for one.
§ 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.