(91 days)
The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.
The intended use of the device is to illuminate the eye during anterior and posterior vitreoretinal surgery and to provide photocoagulation when used with the appropriate commercially available laser light source and probe.
Acceptance Criteria and Study Details for Synergetics Synerlight FiberOptic Lightsource
The provided document describes the 510(k) summary and FDA clearance letter for the Synergetics Synerlight FiberOptic Lightsource. This submission is for substantial equivalence to a predicate device, K964005.
Based on the provided information, there are no explicit acceptance criteria or detailed study results demonstrating device performance against such criteria in the manner typically expected for AI/ML-based medical devices.
Instead, the submission relies on the concept of substantial equivalence to a predicate device already on the market. This means the device is considered safe and effective because it is as safe and effective as a legally marketed device, and does not raise different questions of safety and effectiveness.
Here’s a breakdown of the information that is available and what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly stated in document) | Reported Device Performance (Explicitly stated in document) |
|---|---|
| Not explicitly stated as quantifiable performance metrics (e.g., sensitivity, specificity, accuracy, illumination intensity targets). | "Testing demonstrated that the subject device is substantially equivalent to the predicate device." |
Explanation: The document does not provide specific, measurable acceptance criteria in terms of clinical or technical performance parameters for the device itself (e.g., minimum lumen output, color temperature range, specific photocoagulation effectiveness). The primary "acceptance criterion" from an FDA 510(k) perspective is demonstrated substantial equivalence to a legally marketed predicate device. The "reported device performance" is a general statement of meeting this substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable/not provided. This type of information is typically associated with studies involving data analysis, such as image analysis for AI devices. The submission for a fiberoptic light source would not involve a "test set" of patient data in this manner.
- Data Provenance: Not applicable/not provided. The submission focuses on the performance characteristics of the hardware device itself, likely through engineering and functional testing, rather than analysis of patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable/not provided. Ground truth establishment with experts is relevant for diagnostic devices that interpret clinical data. For a fiberoptic light source, the "ground truth" would be objective measurement of its physical properties and functionality.
4. Adjudication Method for the Test Set
- Not applicable/not provided. This typically refers to resolving discrepancies in expert interpretations, which is not relevant for a hardware device like a light source.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. MRMC studies are used to assess the impact of a diagnostic tool (often AI-assisted) on human reader performance, usually in interpreting medical images or data. This is not relevant for a light source.
- Effect Size of Human Readers with vs. without AI assistance: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a hardware component and does not operate as a standalone algorithm. Its function is to illuminate, and potentially provide photocoagulation when used with a laser.
7. The Type of Ground Truth Used
- Implicit Ground Truth: For a fiberoptic light source, the "ground truth" would implicitly be based on established engineering standards for light output, spectral characteristics, safety (e.g., heat generation, electrical safety), and compatibility with other surgical equipment. These would be objectively measured and compared to the predicate device.
- The document does not specify the exact technical parameters or standards used for comparison, but states unequivocally that "Testing demonstrated that the subject device is substantially equivalent to the predicate device."
8. The Sample Size for the Training Set
- Not applicable. This device is a hardware product, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set, there is no ground truth for it to be established.
Summary of Approach for This Device:
The Synergetics Synerlight FiberOptic Lightsource gained FDA clearance through the 510(k) pathway by demonstrating substantial equivalence to an existing predicate device (K964005). The "study" mentioned, "Testing demonstrated that the subject device is substantially equivalent to the predicate device," refers to internal engineering and functional testing. This testing would have assessed that the new device has similar technological characteristics (e.g., light output, spectral range, safety features, intended use, materials) or, if different, that those differences do not raise new questions of safety and effectiveness.
The documentation does not contain the detailed performance metrics, clinical study designs, or expert review processes that would be typical for more complex diagnostic or AI-driven devices.
§ 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.