(100 days)
The LSI Videoscopic Display System produces high quality video images for use in a wide range of medical applications, including surgery, microscopy and endoscopy.
The LSI Videoscopic Display System utilizes advanced video projection technology to display an image on a sterile, disposable screen appropriately positioned within the surgical field.
This submission, K963919, describes a display system rather than an AI device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for AI/ML medical devices, is not directly applicable or available in the provided text.
The information primarily focuses on comparing the technical specifications of the LSI Videoscopic Display System to a predicate conventional video monitor.
However, I can extract the relevant comparative information as presented in the document, which serves as the "acceptance criteria" through a demonstration of substantial equivalence to the predicate device in terms of technical performance.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the LSI Videoscopic Display System are implicitly defined by its substantial equivalence to the Sony Color Video Monitor (PVM-1343MD) across various technical specifications. The "study" for this type of device typically involves a direct comparison of these specifications to demonstrate that the new device performs at least as well as, or better than, the predicate.
| Specification | Acceptance Criteria (Predicate Device: Sony PVM-1343MD) | Reported Device Performance (LSI Videoscopic Display System Model 001) |
|---|---|---|
| Indications For Use | Produces high quality video images for use in a wide range of medical applications, including surgery, microscopy, endoscopy and A/V. | Produces high quality video images for use in a wide range of medical applications, including surgery, microscopy and endoscopy. |
| Diagonal Picture Measure (in.) | 13 | 14 (Slightly larger - meets or exceeds) |
| Resolution | >600 (H) TV lines (2000 Characters (50 characters/line x 25 lines)) | 800 (H) x 600 (V) active pixels (Higher resolution - meets or exceeds) |
| Video Input | 1.0V p-p, 75 ohms | 1.0V p-p, 75 ohms (Matches) |
| Audio Input | Phono jack | Phono jack (Matches) |
| Power Requirements | 110-130 V AC at 50-60 Hz | 120V AC at 60 Hz, 230V AC at 50 Hz (Compatible with common regional power variations, encompassing predicate) |
| Power Consumption | 99W (approx.) | 600 W (approx.) (Higher power consumption, but this is a technical characteristic, not necessarily a performance deficit for a display system) |
| Dimensions (in.) | 13.5 (H) x 13.63 (W) x 16.25 (D) | 8.04 (H) x 12.2 (W) x 16.38 (D) (Different dimensions, but within reasonable variations for a medical device with similar function) |
| Weight (lb.) | 36.4 | 28.5 (Lighter - meets or exceeds) |
| Sterile Disposables | None | Plastic screen for placement in the surgical field. (Additional feature, not a direct comparison point for equivalence in standard functionality, but enhances clinical utility) |
| Image Source | SMPTE C (American standard phosphor) | Texas Instruments Digital Micromirror Projector (Different technology, but the output resolution and image quality are the primary comparison points for equivalence) |
Additional Information Not Applicable to this Device Type (AI/ML Specifics):
Due to the nature of K963919 as a conventional medical device (a display system) and not an AI/ML device, the following points are not relevant or cannot be extracted from the provided text:
- Sample size used for the test set and the data provenance: Not applicable. Performance is based on technical specifications.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Performance is based on technical specifications.
- Adjudication method for the test set: Not applicable.
- 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 is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context would be the measured physical and electrical characteristics of the device.
- The sample size for the training set: Not applicable. This device does not use a training set as it's not an AI/ML model.
- How the ground truth for the training set was established: Not applicable.
§ 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.