(14 days)
The Vista StereoScope System is intended for the use in endoscopic procedures and all types o video assisted procedures, including general endoscopic and laparoscopic, thoracic, anterior an posterior spinal and as an aid in visualization of cardiac structures
The Vista StereoScope System is a device used to allow observation in body cavities, organs, or canals through manmade or natural orifices. It is designed for use in all types of endoscopic and endoscopic assisted procedures. The system is supplied as a Vista Stereoscope Camera Head, Vista Stereo Endoscope and a 3 D Camera control unit (CCU). The device is designed to work with commercially available light sources and video monitor overhead mounted displays. The modified coupler enables the camera head assembly to be sterilized.
The provided document appears to be an FDA 510(k) clearance letter and summary for a medical device called the "Vista Stereoscope System". This document establishes substantial equivalence to a predicate device, which is a regulatory pathway to market a new device by demonstrating it is as safe and effective as an already legally marketed device.
However, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the way robust medical device studies (like those for AI/ML devices) typically do. Instead, the document focuses on demonstrating substantial equivalence to a predicate device based on intended use, operating principle, basic design, and shelf life.
Here's why the requested information cannot be fully provided from this document:
- No specific acceptance criteria: The document does not define quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or other benchmark thresholds) that the device must meet.
- No detailed study results: It states that "Testing demonstrates that the modifications proposed herein do not adversely effect safety and effectiveness," but it does not provide details of such testing, including sample sizes, ground truth establishment, expert qualifications, or adjudication methods.
- Not an AI/ML device: The "Vista Stereoscope System" appears to be a hardware device (camera head, endoscope, 3D camera control unit) for visualization, not an AI/ML software device that would typically undergo studies to compare its diagnostic performance against a ground truth.
Therefore, many of the requested fields are not applicable or cannot be answered from the provided text.
Here is an attempt to answer the questions based only on the provided text, indicating where information is not available:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified beyond "does not adversely effect safety and effectiveness" compared to predicate. | "Testing demonstrates that the modifications proposed herein do not adversely effect safety and effectiveness." |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method
- Adjudication method: Not specified.
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
- MRMC study done? No, this is not an AI-assisted device. The document is for a stereoscope system, which is a visualization tool, not an AI diagnostic/assistance tool.
- Effect size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable, as this is not an algorithm/AI device.
7. The type of ground truth used
- Type of ground truth: Not specified. Given it's a visualization device, "ground truth" in the diagnostic sense is less relevant than verification of image quality, functionality, and safety compared to the predicate device.
8. The sample size for the training set
- Sample size: Not applicable, as this is not a machine learning/AI device requiring a training set.
9. How the ground truth for the training set was established
- Ground truth establishment: Not applicable, as this is not a machine learning/AI device requiring a training set with established ground truth.
Summary Explanation:
The provided document is an FDA 510(k) clearance for a stereoscope system, which is an endoscopic visualization device. The regulatory pathway used here is "substantial equivalence" to a predicate device (Vista Stereoscope System K990635). This means the manufacturer demonstrated that their device is as safe and effective as the already-marketed predicate, primarily through comparability in intended use, operating principles, basic design, and a general statement about testing demonstrating no adverse effect on safety and effectiveness due to modifications.
This type of submission typically does not involve the detailed clinical performance studies, ground truth establishment, or expert reviews that are common for AI/ML-driven diagnostic devices. Therefore, the specific details requested regarding acceptance criteria, sample sizes, expert qualifications, and adjudication methods for performance studies are not present in this document.
§ 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.