FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The D.O.R.C. SOLUX Light Source uses a halogen lamp and an internal focusing system to focus the light into the end of the optical fiber. Accessories to the Illumination Unit include adapters and color filters.

AI/ML Overview

This 510(k) summary (K973757) describes the D.O.R.C. SOLUX Light Source, an ophthalmic light source intended for intraocular illumination in vitreoretinal surgery. The submission establishes substantial equivalence to existing predicate devices (Grieshaber Light Source and Escalon VitLite I) primarily based on operational and technological characteristics, rather than clinical performance studies with acceptance criteria in the typical sense of AI/software devices.

Here's an analysis based on the provided document, addressing your specific points:

#	Information Requested	Details from K973757
1	Table of acceptance criteria and reported device performance	Acceptance Criteria (Implied by Predicate Comparison): The device (SOLUX Light Source) must have technological and operational characteristics similar to legally marketed predicate devices, particularly in areas like intended use (intraocular illumination for vitreoretinal surgery), lamp type (Halogen), variable intensity, UV filtration, and ability to adapt to multiple accessories. While specific numerical "acceptance criteria" are not explicitly stated for each characteristic in the way one would for a diagnostic accuracy study, the implicitly accepted performance is that which is "substantially equivalent" to the predicate devices.

Reported Device Performance (SOLUX Light Source):

Indication: Endoillumination for vitreoretinal surgery (YES)
Lamp Type: Halogen
Lamp Rating: 100 watts
Light Output (lumens): High: 3800, Low: 3200
Color Temperature (degrees K): High: 3220, Low: 3160
Variable Intensity: Yes
Wavelength Range (nm): 400-800
UV filtration: Yes
Additional color filtration: Green, Yellow, Red, Blue, Daylight (all Yes)
Adapts to multiple accessories: Yes |
| 2 | Sample size for the test set and data provenance | This is a conventional medical device (light source), not a software/AI device. Therefore, there is no "test set" or "data provenance" in the context of diagnostic performance evaluation. The substantial equivalence is based on engineering specifications and comparison to predicate devices, not on data from patient cases. |
| 3 | Number of experts to establish ground truth for test set and qualifications | Not applicable. No test set for ground truth establishment. |
| 4 | Adjudication method for the test set | Not applicable. No test set. |
| 5 | MRMC comparative effectiveness study | Not applicable. This is a light source, not a diagnostic AI system where human readers would improve with AI assistance. |
| 6 | Standalone (algorithm only) performance study | Not applicable. This is a hardware device, not an algorithm. Standalone performance for such a device would refer to its electrical, optical, and mechanical specifications as an engineering product, which were implicitly demonstrated or compared to predicates to establish substantial equivalence. |
| 7 | Type of ground truth used | Not applicable. The "ground truth" for this type of device is its physical specifications and functionality, which are compared against known capabilities of predicate devices. There is no diagnostic "ground truth" from pathology, expert consensus, or outcomes data in this context. |
| 8 | Sample size for the training set | Not applicable. This is not an AI/ML device. There is no "training set." |
| 9 | How the ground truth for the training set was established | Not applicable. No training set. |

Summary of the Study and Acceptance Criteria:

The "study" in this context is a 510(k) premarket notification which aims to demonstrate substantial equivalence to legally marketed predicate devices. The primary method is a comparison of technological and operational characteristics.

Acceptance Criteria (Implied): The D.O.R.C. SOLUX Light Source is accepted if its technical specifications and intended use are similar enough to the predicate devices (Grieshaber Light Source and Escalon VitLite I) that it can be considered equally safe and effective. The comparison table (page 1) serves as the core of this demonstration. For instance, having "YES" for "Indication: Endoillumination for vitreoretinal surgery" for all devices shows alignment in intended use. The fact that its lamp type is Halogen, like the Grieshaber, and its wavelength range (400-800 nm) encompasses that of the Escalon VitLite (450-700 nm), along with features like UV and color filtration, contribute to this claim of equivalence.
Proof of Meeting Criteria: The provided table titled "Comparison of SOLUX Light Source to Predicate Devices" directly shows how the D.O.R.C. SOLUX Light Source's characteristics align with or are similar to the predicate devices across various attributes like lamp type, variable intensity, filtration, and intended use. The FDA's letter (page 2-3) confirming "substantial equivalence" is the official recognition that the device meets these implied acceptance criteria based on the information provided in the 510(k) submission.

This 510(k) is characteristic of traditional medical device clearances based on engineering comparisons rather than clinical performance data typical of AI/ML-powered diagnostic devices.

Summary

Regulation Number and Section

§ 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.