(209 days)
The LiNA CystoVu HD is intended for use in visualization via LiNA displaying unit of adult male and female urethra and bladder cavity during diagnostic and therapeutic cystoscopy procedures. It is intended for hospital- or medical office environment use and is operated by medical professionals.
The LiNA ScopeVu is intended for visualization from compatible LiNA endoscopes for female and male patients of all ages during diagnostic and therapeutic endoscopy procedures. It is intended for hospital- or medical office environment use and is operated by medical professionals.
The LiNA CystoVu™ HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. Visualization will be achieved by LiNA Scope Vu™ full HD display and light source. The LiNA Cysto Vu™ HD is intended to be used with a reusable LiNA ScopeVu™ to visualize the urethra and the bladder. The LiNA CystoVu™ HD can be operated by the left or right hand. The optical module in the distal tip consists of a camera housing containing camera and LED light sources.
The provided text describes the LiNA CystoVu HD and LiNA ScopeVu, single-use flexible cystoscopes, and their substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study that proves the device meets those criteria with detailed device performance metrics, MRMC comparative effectiveness studies, standalone algorithm performance, or training set details as requested in your prompt.
The document focuses on demonstrating substantial equivalence to a predicate device (Ambu aScope 4 Cysto) through non-clinical performance testing.
Here's a breakdown of what can be extracted from the provided text based on your request, and what is missing:
1. Table of acceptance criteria and the reported device performance
This information is not explicitly provided in the document. The text states: "Non-clinical performance testing was conducted in order to demonstrate that the LiNA CystoVu HD and LiNA ScopeVu perform according to their requirements and specifications." It then lists the types of tests conducted:
| Test Type | Reported Performance/Outcome |
|---|---|
| Functional and Performance Testing (mechanical instrumentation) | Satisfies functional performance requirements including force/bending/tensile stress and stress cracking and irrigation flow testing. |
| Optical Performance Testing (ISO 8600 series) | Complies with ISO 8600 series. |
| Optical Performance (various metrics) | Color performance, geometric distortion, field of view, resolution, depth of field, image intensity uniformity, SNR, dynamic range, image frame frequency, and system delay were compared with the predicate device. (Specific measurements/thresholds are not provided, only that a comparison was done and implied to be acceptable for substantial equivalence) |
| Electrical Safety and EMC Testing | Complies with IEC 60601-1 and IEC 60601-2-18 for safety and IEC 60601-1-2 for EMC. |
| Software Verification and Validation | Conducted as required by IEC 62304 and documented per FDA Guidance. |
| Biocompatibility Testing | All tests indicated patient contact materials were biocompatible (in accordance with ISO 10993 series). |
| Sterilization | Validated in accordance with ISO 11135 to an SAL of 10⁻⁶. |
| Human Factors Testing | Confirmed that the design of the device is safe and effective for intended users, uses, and use environments. |
2. Sample size used for the test set and the data provenance
This information is not provided. The non-clinical performance testing description does not specify sample sizes for individual tests or the provenance of any data used for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The testing described is primarily non-clinical and technical performance testing, not involving expert interpretation of medical images or diagnoses. Human factors testing included "Test participants representing the intended users," but their qualifications for establishing ground truth (in the diagnostic sense) are not relevant or mentioned.
4. Adjudication method for the test set
This information is not provided. Given the nature of the non-clinical performance tests conducted, an adjudication method as typically understood for clinical or image interpretation studies is not applicable or described.
5. 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
This information is not provided. The document makes no mention of AI or an MRMC study. It describes a medical device (endoscope components) and its direct performance, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. There is no mention of an algorithm or standalone performance testing for AI components.
7. The type of ground truth used
For the technical and performance tests, the "ground truth" would be the engineering specifications, relevant ISO/IEC standards, and expected functional outcomes. For biocompatibility, it's the established safety profiles within ISO 10993. For sterilization, it's the validated SAL (Sterility Assurance Level).
The document explicitly states: "Clinical data was not used to support substantial equivalence of the subject device to the predicate device." This means there was no ground truth derived from pathology, expert consensus on clinical cases, or outcomes data in a clinical setting for substantial equivalence.
8. The sample size for the training set
This information is not applicable and not provided. There is no mention of an AI algorithm or a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no mention of an AI algorithm or a training set.
In summary: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence of a medical device (endoscope components) to a predicate device through non-clinical performance testing and technological comparison. It does not involve AI, clinical data for determining substantial equivalence, or detailed studies with the specific metrics the prompt is asking for related to AI performance, expert ground truth, or training sets.
§ 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.