(78 days)
The Endoscopic Light Source XL202/L3 is intended to be used with fiber optic endoscopes to provide illumination of body cavities, hollow organs and canals during endoscopic procedures.
The device is classified as Cardiac Floating (CF) which allows the use in endoscopic cardiac procedures when used in conjunction with the proper instrumentation.
The Endoscopic Light Source XL202/L3 uses a 180 W xenon lamp to provide illumination during endoscopic surgery through a fiber optic cable, which is connected to the device. Furthermore, the light source can be equipped with an additional 150 W halogen lamp for diagnostic applications in endoscopy. The 150 W halogen lamp also function as a backup up lamp to avoid interrupting a procedure in case of a malfunction of the xenon lamp. The color temperature of the xenon lamp and halogen lamp is approximately 6000 % and 3400 % respectively, the lamp life approximately 500 hours and 50 h respectively.
The provided text is for a 510(k) summary for an Endoscopic Light Source. This type of document is for a medical device that provides illumination and is not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies and performance will not be applicable.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Device Performance Study for Endoscopic Light Source XL202/L3
The 510(k) summary for the Endoscopic Light Source XL202/L3 does not describe a study involving specific acceptance criteria and performance metrics in the way one would for an AI/ML algorithm or a new diagnostic device requiring clinical performance evaluation. Instead, the "performance data" section focuses on compliance with established electrical safety and general medical device standards, and the demonstration of "substantial equivalence" to predicate devices.
The underlying principle for the approval of this device is substantial equivalence, meaning it performs as safely and effectively as other legally marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 601-1 | Complies |
| Electromagnetic Compatibility (EMC) | IEC 601-1-2 | Complies |
| General Medical Device Directive | Medical Device Directive 93/42/EEC | Conforms |
| Underwriters Laboratories Standard | UL2601-1 | Meets requirements |
| Intended Use Equivalence | Provide illumination of body cavities, hollow organs and canals during endoscopic procedures. | Similar in design and technological characteristics to predicate devices; intended use is identical. |
| Safety and Effectiveness | No new questions of safety and effectiveness compared to predicates. | Differences between the XL202/L3 and predicate devices are minor and raise no new questions of safety and effectiveness. |
| Illumination Source (Xenon) | 180W Xenon lamp | 180W xenon lamp, color temperature approx. 6000K, lamp life approx. 500 hours. |
| Illumination Source (Halogen - Backup) | 150W Halogen lamp | 150W halogen lamp, color temperature approx. 3400K, lamp life approx. 50 hours. Also functions as backup. |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable as the document describes a traditional medical device (light source) without a test set of data in the context of an AI/ML or diagnostic performance study. The "testing" referred to is compliance testing against established engineering and safety standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable. Ground truth is not established in the clinical or diagnostic sense for a light source. Device functionality is assessed against engineering specifications and safety standards.
4. Adjudication Method for the Test Set:
This information is not applicable. There is no "test set" in the context of clinical or diagnostic performance that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable. The device is an endoscopic light source, not a diagnostic or AI-assisted interpretation tool. Therefore, a study to measure human reader improvement with or without AI assistance is irrelevant.
6. Standalone (Algorithm Only) Performance Study:
This information is not applicable. This is a hardware device (light source), not an algorithm.
7. Type of Ground Truth Used:
This information is not applicable in the context of clinical or diagnostic ground truth. For this type of device, the "ground truth" is defined by compliance with established engineering standards (e.g., light output specifications, electrical safety parameters) and the device's ability to perform its intended function (providing illumination) as reliably as predicate devices.
8. Sample Size for the Training Set:
This information is not applicable. There is no "training set" for a hardware medical device like a light source.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As there is no training set, there is no ground truth establishment for it.
In summary: The provided 510(k) summary focuses on demonstrating that the Endoscopic Light Source XL202/L3 meets safety and performance standards equivalent to existing, legally marketed predicate devices through compliance testing and comparison of technical specifications. It is not an AI/ML-driven device or a device requiring a clinical performance study with a test set, ground truth, or expert adjudication.
§ 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.