(100 days)
The ENDOLIGHT LED Light Source Projector is intended to illuminate the surgical site during minimally invasive surgical procedures by producing light that is transmitted from the light source through fiber optic cable and a scope.
The ENDOLIGHT LED Light Source is a fiber optic light source utilizing a single, solid state, high power, white light emitting diode (LED) to produce visible light that used to illuminate surgical sites during minimally invasive surgical procedures. The light from the ENDOLIGHT LED Light Source is transmitted through an optical cable and a scope. ENDOLIGHT LED 1.1 and 1.2 are comprised of light source and power supply cord. The units consist of aforementioned LED, cooling fan, light port, and protective housing. ENDOLIGHT LED 1.1 and 1.2 are portable and are very similar in design, format, and functionality to other LED light sources including the predicate devices. This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.
The provided text describes a 510(k) premarket notification for the ENDOLIGHT LED Light Source. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study that proves the device meets specific performance thresholds in a clinical or AI-assisted context.
Therefore, many of the requested categories cannot be answered from the provided document. This document describes a medical device rather than an AI/ML powered device.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document does not present a table of specific quantitative acceptance criteria alongside reported performance data. Instead, it states that "Design verification testing demonstrates that the devices function as intended" and lists adherence to voluntary safety and performance standards.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Functionality | Device functions as intended. | "Design verification testing demonstrates that the devices function as intended..." |
| Safety - Electromagnetic Compatibility | Conforms to IEC 60601-1-2 Edition 3:2007-03. | "The ENDOLIGHT LED 1.1 and 1.2 conform to the following Safety Standards: IEC 60601-1-2..." |
| Safety - General Requirements | Conforms to IEC 60601-1, Medical Electrical Equipment Part 1. | "The ENDOLIGHT LED 1.1 and 1.2 conform to the following Safety Standards: IEC 60601-1..." |
| Safety - Endoscopic Equipment | Conforms to IEC 60601-2-18:1996, Amendment 1 2000. | "The ENDOLIGHT LED 1.1 and 1.2 conform to the following Safety Standards: IEC 60601-2-18..." |
| Safety & Effectiveness (General) | No new issues of safety and effectiveness raised. | "...performance did not raise any new issues of safety and effectiveness..." |
| User Training | Formal user training not required. | "...formal user training is not required." |
2. Sample Size Used for the Test Set and the Data Provenance:
Not applicable. The document describes a traditional medical device (LED light source), not an AI/ML-powered device that would typically involve test sets of data for performance evaluation. The "testing" mentioned refers to design verification and adherence to electrical safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. Ground truth and expert consensus are relevant for AI/ML-powered diagnostic or interpretive devices, which this is not. The "ground truth" for this device would be its physical properties and adherence to engineering and safety standards.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of an adjudication method as it relates to evaluating data for an AI/ML-powered device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This is not an AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an AI/ML algorithm. The device stands alone as a light source.
7. The Type of Ground Truth Used:
For this device, the "ground truth" for its performance is established by engineering specifications, international safety standards (e.g., IEC standards for medical electrical equipment), and functional design verification tests. The document explicitly states "Design verification testing demonstrates that the devices function as intended" and lists conformity to specific IEC safety standards.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML-powered device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
In summary: The provided document is for a traditional medical device (an LED light source) and outlines its substantial equivalence to predicate devices based on technological characteristics and adherence to established safety standards. It does not involve AI/ML technology, and therefore, many of the requested categories related to AI/ML performance evaluation (such as test sets, ground truth establishment by experts, adjudication, and clinical effectiveness studies with AI) are not applicable.
§ 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.