(36 days)
The device is intended for use in all types of endoscopic and endoscopic assisted procedures.
The Vista Single Chip Camera System is intended for use with optical endoscopes to provide a video image of the target area.
The Vista Single Chip Video Camera 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 product is a video camera. The system will be supplied as a Vista Single Chip Video Camera Head and a Camera Control Unit (CCU). The device is designed to work with commercially available light sources, V&C mount endoscope couplers and video monitors or head mounted displays.
The provided text describes a 510(k) submission for the Vista Single Chip Video Camera System. It outlines the device's intended use, predicate devices, and compliance with safety standards. However, it does not contain the detailed performance data, acceptance criteria, or study descriptions needed to fully answer your request regarding acceptance criteria and a study proving device conformance.
The "PERFORMANCE DATA" section only lists the standards the device was designed to comply with (IEC 601-1, IEC 601-1-2, UL544) and mentions "Optical Test Data" without providing any details about the tests, their results, or acceptance criteria.
Therefore, for most of your questions, the answer will be that the information is not provided in the given text.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. | Not specified in the provided text. |
| (The document only states the device was designed and will be tested in compliance with standards like IEC 601-1, IEC 601-1-2, and UL544, and mentions "Optical Test Data" without details.) | (No specific performance metrics or thresholds are provided.) |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not provided.
- Data Provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not provided. This type of device (a video camera) typically relies on objective performance measurements rather than expert consensus on medical image interpretation for its primary safety and effectiveness evaluation for 510(k) purposes.
- Qualifications of Experts: Not applicable/not provided.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC Study: No, an MRMC study was not described or implied. This type of study is more relevant for diagnostic AI algorithms rather than a medical imaging device itself.
- Effect Size of Human Readers Improvement: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not described in the text. The "Optical Test Data" mentioned could refer to some form of standalone performance, but no details are given. The device is a video camera, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated. For a video camera, "ground truth" would likely relate to objective optical and electrical performance characteristics measured against engineering specifications, rather than medical interpretations.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This device is a hardware video camera, not an AI algorithm that undergoes "training."
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. The concept of a "training set" and "ground truth" for training does not apply to this type of device.
§ 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.