(275 days)
The Synergetics Fiber Optic light Source is indicated for use during anterior and posterior vitreoretinal surgery to illuminate the eye.
The Synergetics lightsource is a stand alone arc-lamp based lightsource that incorporates a standard connector mount used by most endoilluminators. It has a brightness control, accessory filter control and lamp life timer display.
Here's an analysis of the provided text regarding the Synergetics, Inc. Synerlight Fiber Optic Lightsource, focusing on acceptance criteria and the study proving its performance.
It's important to note that this document is a 510(k) submission, which primarily aims to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing novel safety and effectiveness. Therefore, some of the requested information, particularly regarding formal acceptance criteria with specific thresholds, detailed study designs, and human reader performance comparisons, is not explicitly present in the provided text. The "study" described herein is a comparison between the new device and a predicate device.
Acceptance Criteria and Device Performance
The acceptance criteria for the Synergetics Synerlight Fiber Optic Lightsource are implicitly derived from its comparison to the predicate device, the Dutch Ophthalmic, USA Xenon Illumination System (D.O.R.C.). The core acceptance criterion is substantial equivalence in intended use, safety, and effectiveness. The reported device performance is measured against that of the predicate device across various parameters.
Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implicit from Predicate) | Reported Synergetics Synerlight Performance | Device Meets Criteria? |
|---|---|---|---|
| Intended Use | During anterior and posterior vitreoretinal surgery to illuminate the eye. | During anterior and posterior vitreoretinal surgery to illuminate the eye. | Yes |
| Filter Selection Knob | Detented, turns internal filter wheel, allows selection from up to six different accessory filters. | Detented, turns internal filter wheel, allows selection from up to six different accessory filters. | Yes |
| Connector Mount | Standard design, accepts most commercially available endoilluminator light fibers, internal detent for secure fit. | Standard design, accepts most commercially available endoilluminator light fibers, internal detent for secure fit. | Yes |
| Brightness Control | Allows user to adjust light output. | Allows user to adjust light output, small indicator arrow, artwork depicts off/standard/high settings, red LED/audible beep/tactile detent for high power mode. Differences addressed by labeling and warnings. | Yes (with additional safety features) |
| Lamp Type | Arc-lamp based, ILC 75 watt Cermax (xenon lamp). | Arc-lamp based, Welch Allyn 24 watt Hi-Lux (metal-halide lamp). Differences addressed by labeling and warnings, and it's used in other predicate devices. | Yes (with justification) |
| Accessory Filters | Five different accessory filters (e.g., Green, Yellow, Red, Blue, Daylight). | Six different imaging enhancing filters (White light, Triple-band, UV/Blue light, Blue narrow band, Green narrow band, Red narrow band). Synergetics #1 equivalent to D.O.R.C. without filters. Other filters either have no D.O.R.C. equivalent (e.g., UV/Blue safety) or are narrower spectrum. | Yes (with enhanced safety/features) |
| Visible Light Output | Produces "white" 5600°K temperature light. Overall power output: 17.8mW. | Produces "white" 5500°K temperature light. Overall power output: 36.1mW (max), approximately 15.0 mW (standard/small fiber). | Yes (with higher potential, but controlled) |
| UV Light Output | Produces a substantial amount of light below 420nm. | White light filter #1 blocks UV below 420nm. UV/Blue light filter blocks below 495nm. Considerably less UV/Blue light output than D.O.R.C., deemed safer. | Yes (and improved safety) |
| IR Light Output | Unfiltered ILC lamp produces ~60% power in harmful IR range. Internal IR filter crucial. | White light filter #1 blocks IR above 700nm. Less IR output with other filters. Designed to eliminate IR above 700nm. | Yes (and improved safety) |
Study Details (Substantial Equivalence Comparison)
The "study" presented here is a comparison against a predicate device to establish substantial equivalence under the 510(k) pathway, not a traditional clinical trial or performance study with acceptance criteria in the sense of predefined statistical thresholds for device accuracy or efficacy.
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Sample Size used for the test set and the data provenance:
- Test Set: No explicit "test set" in the sense of patient data is used. The comparison is between the Synergetics Synerlight Fiber Optic Lightsource (new device) and the D.O.R.C. Xenon Illumination System (predicate device).
- Data Provenance: The data appears to be a mix of manufacturer specifications (for both devices) and internal testing conducted by Tayman Medical (for D.O.R.C.'s visible light output) and Synergetics (for its own device's power output and IR output). It is a retrospective analysis and comparison of device specifications and internal lab measurements. The country of origin of the data is not specified beyond the manufacturers' locations (USA for Tayman Medical/Synergetics, and USA for D.O.R.C.).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of expert evaluation is not mentioned or relevant for a 510(k) substantial equivalence submission, which relies on objective device specifications and comparative measurements rather than expert clinical judgment on individual cases.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no expert adjudication of imaging or clinical findings. The comparison is based on technical specifications and measured output.
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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 device is a light source for surgery, not an AI or imaging diagnostic tool. An MRMC study is not relevant here.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The device's "standalone" performance is described through its technical specifications and measured outputs as compared to the predicate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is the technical specifications and measured performance of the predicate device, as stated in its own documentation or measured by the applicant, and established industry standards for medical device safety (e.g., phototoxicity concerns regarding UV and IR light). The goal is to show the new device is as safe and effective, or safer/more effective where justified and controlled (e.g., reduced UV/IR output, higher controlled visible light).
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The sample size for the training set:
- Not applicable. This device is not developed using machine learning, so there is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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.