(333 days)
The Flexilux II Cystoscope is - like the predicate device - used to permit direct viewing of the male urethra, prostate, and bladder for purpose of performing diagnostic and surgical procedures.
The Flexilux II Hysteroscope is - like the predicate device - used to illuminate and visualize the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Cystoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures.
The Hysteroscope is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Flexilux II Hysteroscope and Cystoscope (herein after; Flexilux II Endoscope) are rigid type endoscopes with traditional compact objectives and rod-lens system.
The basic design of the Flexilux II Endoscope is similar to those legally available for sale in the U.S.A... It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical stainless steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
The provided document is a 510(k) Premarket Notification for the Flexilux II Endoscope, which aims to demonstrate substantial equivalence to existing predicate devices. It does not present a study with specific acceptance criteria and performance data in the way typically seen for novel AI/ML devices or new performance claims.
Instead, the documentation focuses on comparing its design, materials, and intended use to already legally marketed predicate devices. The "performance" assessment is based on demonstrating that the new device is functionally identical to the predicates and adheres to relevant industry standards.
Here's an attempt to extract and frame the information you requested, based on the context of this 510(k) submission for a non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim for a traditional medical device, the "acceptance criteria" are not reported as quantitative performance metrics (e.g., sensitivity, specificity, AUC) but rather as compliance with existing standards and identity to predicate devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Same specifications and intended use as predicate devices. | The specifications and intended use of the Flexilux II Endoscope are the same as those of the claimed predicate devices. No significant differences in design or conditions of intended use. (Section: Safety and Performance) |
| Biocompatibility | Constructed of materials of the same specifications as predicate devices. | The Flexilux II Endoscope is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility. (Section: Safety and Performance & Conclusion) |
| Standards Compliance | Conforms to applicable ISO standards and medical electrical equipment standards. | The Flexilux II Endoscope conforms to applicable ISO standards (DIN 58105; IEC 60601-2-18). (Section: Safety and Performance & Conclusion) |
| Labeling | Consistent with legally marketed predicate devices. | Substantial equivalence for this device was based on a comparison of labeling. (Section: Safety and Performance) |
| Physical Design | Similar physical and performance design characteristics to predicate devices. | Substantial equivalence for this device was based on a comparison of physical and performance design characteristics as compared to the predicate devices. (Section: Safety and Performance) |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as there was no explicit "test set" in the context of an AI/ML algorithm evaluation. The assessment was based on comparing the device's design and materials to existing predicate devices and compliance with standards. There's no data provenance in terms of country of origin or retrospective/prospective studies mentioned for performance evaluation.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth, in the context of AI/ML, refers to definitively correct labels for a dataset. Here, the "truth" is established by adherence to manufacturing standards and functional equivalence to known safe and effective devices. There were no experts establishing ground truth for a diagnostic output.
4. Adjudication Method
Not applicable. No diagnostic outputs or images required adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a traditional endoscope, not an AI/ML system, so no MRMC study was performed to assess human reader improvement with AI assistance.
6. Standalone Performance Study (Algorithm Only)
Not applicable. There is no algorithm to evaluate in a standalone manner.
7. Type of Ground Truth Used
The "ground truth" for this submission is implicitly established by:
- Predicate Device Performance: The core argument is that the Flexilux II Endoscope functions equivalently to legally marketed and proven predicate devices.
- Industry Standards: Compliance with relevant ISO and IEC standards (e.g., DIN 58105; IEC 60601-2-18) serves as the "ground truth" for certain physical and safety performance aspects.
- Material Specifications: The use of materials identical to those in predicate devices ensures biocompatibility, relying on the known safety of those materials.
8. Sample Size for the Training Set
Not applicable. There is no AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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.