(348 days)
The VISTA™ Endoscope and accessories are intended for use in providing access to, and visualization of, the thoracic and abdominal cavities, to allow for the performance of various diagnostic and therapeutic surgical procedures.
The VISTA Endoscope is a flexible fiberscope that allows for visualization of the thoracic and abdominal cavities. The device is labeled non-sterile and must be sterilized prior to use. The Endoscope may be used with or without the SCOUTTM Blunt-tipped Guide accessory, which aids in Endoscope advancement and steerability. The Guide also has a fluid channel (cannula) that may be used to deliver saline that may be required for irrigation during an endoscopic procedure. The SCOUTTM Guide is a sterile, single-use device, sterilized by electron beam radiation.
The provided document describes a 510(k) premarket notification for the VISTA™ Endoscope and Accessories. It outlines the device's description, indications for use, and a comparison of its technological characteristics with predicate devices. The "Performance Data" section briefly mentions that "Laboratory and performance tests were executed to ensure that the devices functioned as intended and met design specifications" and "Data demonstrated that the VISTA Endoscope and accessories met all performance testing acceptance criteria." However, it does not provide specific details about the acceptance criteria nor the study design, sample sizes, expert qualifications, or ground truth establishment for those performance tests.
Therefore, I can only provide the information that is present in the document.
1. A table of acceptance criteria and the reported device performance
The document states: "Data demonstrated that the VISTA Endoscope and accessories met all performance testing acceptance criteria."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly listed, but implied by compliance with standards: EN 60601-2-18: 1996, EN60601-1:1990, ISO 10993-1:2003, AAMI TIR12:2004, ISO 11137:2006. | The VISTA Endoscope and accessories met all performance testing acceptance criteria and comply with the listed standards. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Laboratory and performance tests were executed".
- Sample size: Not specified.
- Data provenance: Not specified. It's implied to be laboratory testing, but no details on the origin of the data or whether it was retrospective or prospective are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not specified. The document refers to "performance tests" and "design specifications" but does not mention the involvement of experts to establish a "ground truth" in the context of clinical or diagnostic performance. This is typically a technical performance study, not a clinical diagnostic study with expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not specified. This type of adjudication method is relevant for studies involving human interpretation of data, which is not described here.
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
Not applicable. This document describes a medical device (endoscope), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document describes a medical device (endoscope), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated using the term "ground truth." For the performance tests, the "ground truth" would be the engineering specifications and standards that the device was designed to meet (e.g., optical properties, flexibility, material biocompatibility, sterility).
8. The sample size for the training set
Not applicable. This document describes a medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This document describes a medical device, not a machine learning model.
§ 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.