(125 days)
The Vista Head Mounted Display System is designed to display video images while mounted on the users head.
The Head Mounted Display (HMD) System is a binocular field display, occupying a large portion of the normal straight ahead field of view. This display is intended to be used as a component of a visualization system for use in endoscopic surgery. Traditional video-endoscopic surgery images are displayed on a TV monitor. This requires the surgeon to maintain contact with the traditional monitor and remain in position with it at all times. Having to turn away from the monitor causes the surgeon to lose sight of what is being accessed. The HMD system enables the surgeon to see the surgical site as well as the general operating field with the lateral and 45 degree look down vision, without having to look away, thus providing the means to present the endoscopic picture in a more natural and acceptable look down location with respect to the patient. This also provides a safe back up, the physician can resort to either direct visualization or utilize the back up 2D video monitor. The HMD takes a standard signal and displays it on two small electronic image display devices called liquid crystal display (LCD). It can be connected to any standard video generating equipment.
The HMD consists of an image generating array, evepiece, and electronics. The image generating array is an active matrix liquid crystal display (LCD). These elements are mounted on a lightweight and compact headgear which fits comfortably on the user's head. The remaining electronics are housed separately in a controller station. The HMD communicates with the controller by a lightweight, durable, flexible cable. The HMD can be driven by both monocular and stereo endoscopes.
The HMD Controller will accept NTSC, PAL with CVBS, or S Video (Y,C) video input. Interfaces to external and remote data sets, power supplies and drivers for the LCD and backlight are included in the controller. A maximum of four (4) HMDs and two (2) standard video monitors can be driven simultaneously with the single controller.
The provided text describes a medical device, the "Head Mounted Display (HMD)", and its intended use, but it does not include information about acceptance criteria or a study proving that the device meets such criteria.
Therefore, I cannot populate the table or answer most of the questions you've posed. The 510(k) summary focuses on device description, intended use, and comparison to predicate devices for regulatory clearance, not on performance studies with defined acceptance criteria.
Here's what I can extract based on the provided text, and what remains unanswered:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No acceptance criteria are mentioned in the provided text. | No performance metrics against acceptance criteria are mentioned in the provided text. |
2. Sample size used for the test set and the data provenance:
- Not provided. The document does not mention any test set, sample sizes, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. The document does not mention any expert review or ground truth establishment for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. No test set or adjudication method is mentioned.
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:
- No. The Head Mounted Display is a hardware component for visualization. It is not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a hardware device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided. No performance studies or ground truth establishment are described.
8. The sample size for the training set:
- Not applicable/Not provided. The device is hardware; there is no mention of a training set for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. There is no mention of a training set or its ground truth.
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961800
SEP 1 1 1996
510(K) SUMMARY July 31, 1996
COMPANY NAME AND ADDRESS
Vista Medical Technologies 5451 Avenida Encinas, Suite A Carlsbad, CA. 92008
CONTACT PERSON Debbie Iampietro Director of Regulatory Affairs and Quality Assurance
(508) 366-8882 Telephone Fax: (508) 366-8858
DEVICE TRADE NAME
Head Mounted Display
COMMON NAME
Stereo Viewing Monitor Display for Endoscopic Visualization
PREDICATE DEVICE
- Device Name: 3DSCOPE™ Three Dimensional Medical Video 1. System Classification: Camera, Television, Endoscopic, without audio Manufacturer: American Surgical Technologies 300 Billerica Rd Chelmsford, MA 01824 510(k) #: K923160 Device Name: Crystal Eyes View/Record and Playback Controllers 2. with Eyewear and Emitters Classification: Endoscope and Accessories, Class II per 21 CFR 876.1500
Manufacturer: Oktas 134 Flanders Rd. Westborough, MA 01581 K944254 510(k) #:
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DEVICE DESCRIPTION
The Head Mounted Display (HMD) System is a binocular field display, occupying a large portion of the normal straight ahead field of view. This display is intended to be used as a component of a visualization system for use in endoscopic surgery. Traditional video-endoscopic surgery images are displayed on a TV monitor. This requires the surgeon to maintain contact with the traditional monitor and remain in position with it at all times. Having to turn away from the monitor causes the surgeon to lose sight of what is being accessed. The HMD system enables the surgeon to see the surgical site as well as the general operating field with the lateral and 45 degree look down vision, without having to look away, thus providing the means to present the endoscopic picture in a more natural and acceptable look down location with respect to the patient. This also provides a safe back up, the physician can resort to either direct visualization or utilize the back up 2D video monitor. The HMD takes a standard signal and displays it on two small electronic image display devices called liquid crystal display (LCD). It can be connected to any standard video generating equipment.
The HMD consists of an image generating array, evepiece, and electronics. The image generating array is an active matrix liquid crystal display (LCD). These elements are mounted on a lightweight and compact headgear which fits comfortably on the user's head. The remaining electronics are housed separately in a controller station. The HMD communicates with the controller by a lightweight, durable, flexible cable. The HMD can be driven by both monocular and stereo endoscopes.
The HMD Controller will accept NTSC, PAL with CVBS, or S Video (Y,C) video input. Interfaces to external and remote data sets, power supplies and drivers for the LCD and backlight are included in the controller. A maximum of four (4) HMDs and two (2) standard video monitors can be driven simultaneously with the single controller.
INTENDED USE
The Vista Head Mounted Display System is designed to display video images while mounted on the users head.
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DEVICE COMPARISON
The HMD system is similar to the display component of the 3DSCOPE™, Three Dimensional Medical Video System which received clearance from FDA in December 1992, (K923160). The 3DSCOPE™ Stereo Display is a high resolution, high speed, multi-synch RGB full color video display monitor. The liquid crystal screen switches its circular polarization from left to right in precise synchronization (120 Hz) with the left and right images that appear on the Stereo Display. When the left image appears on the Stereo Display, the liquid crystal shutter switches to the left polarized state.
The HMD system accepts mono or binocular input from the endoscope and passes the input to the LCD matrix. The small number of elements, compactness and low weight enable this technology to be incorporated into a head mounted display. Most endoscopes are optical and attached to the video system which can feed the video electronic imager rather than an optical image from the endoscope itself to the HMD.
Corrective eyewear may be worn with this device as the HMD provides large eye relief.
§ 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.