(52 days)
The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous).
This device integrates 3-D studies from computerized tomography (CT) and magnetic resonance (MR), and medical super-computers with image processing, analysis, and display functions already cleared by the FDA, with a non-mechanical 3-dimensional digitizer in order to provide pre-operative surgical planning and real-time intra-operative localization with accuracy similar to that of framestereotaxy without the limitations of frame-application.
The provided text describes the ViewPoint device and asserts its substantial equivalence to three predicate devices: ISG Viewing Wand, SNT StealthStation, and Picker ViStar. However, it does not include information about acceptance criteria or a study demonstrating that the ViewPoint device meets such criteria. The document is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed device rather than providing new clinical study data with acceptance criteria for the new device.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
This information is not provided in the document. The substantial equivalence chart compares technical specifications and intended uses, but not performance against pre-defined acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document does not describe a test set or clinical study for the ViewPoint device itself.
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)
This information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not provided. The ViewPoint device is an "Image assisted surgery device" and while it assists physicians, the document does not describe an MRMC study comparing human performance with and without its assistance, nor does it quantify an effect size. The AI aspect is also not explicitly detailed beyond "image processing, analysis, and display functions."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not provided. The document describes the device's technical specifications and its intended use, but not the development or training of any AI components.
9. How the ground truth for the training set was established
This information is not provided.
Summary of available information:
The document focuses on demonstrating substantial equivalence of the ViewPoint device to existing devices based on:
- Intended Use: The ViewPoint's intended use is for pre-surgical planning and intra-cranial surgical localization for space-occupying lesions or malformations. This is compared to the intended uses of the predicate devices.
- Technological Characteristics: A detailed comparison of various technical parameters such as:
- Type of Digitizer (ultrasonic pulses vs. electrogoniometer or optical cameras)
- Registration Technique (scanned fiducials vs. Laitinen Stereo-adapter or surface fitting)
- Type of Sterilization (ETO sterilizable wand)
- Computer hardware (DEC 3000 Model 700, RAM, Image Storage, Monitor)
- Networking capabilities (Ethernet, DICOM v3.0)
- Graphical Interface (4 viewports, 512x512 resolution)
- Image Manipulation & Reformatting Capabilities (Multiplanar Reformatting, Surface Rendering)
The document explicitly states: "The ViewPoint is substantially equivalent to the Viewing Wand (K911783), the StealthStation (K954276) and the ViStar workstation (K905070) in safety and effectiveness." This statement, along with the detailed comparison chart, is the "study" (or rather, the justification) provided to demonstrate that the device meets regulatory requirements through the 510(k) pathway, which does not typically require new clinical trial data for substantial equivalence.
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SUMMARY OF SAFETY AND EFFECTIVENESS
MAY 1 6 1996
1. General Information
Classification: Class II Image Processing System (Accessory) Common/Usual Name: Image assisted surgery device ViewPoint™ Proprietary Name: Establishment Registration: Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143 FDA Owner Number: #1580240 FDA Registration Number: #1525965
Performance Standards:
No Applicable Standards.
2. Intended Uses:
The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous).
3. Device Description:
This device integrates 3-D studies from computerized tomography (CT) and magnetic resonance (MR), and medical super-computers with image processing, analysis, and display functions already cleared by the FDA, with a non-mechanical 3-dimensional digitizer in order to provide pre-operative surgical planning and real-time intra-operative localization with accuracy similar to that of framestereotaxy without the limitations of frame-application.
4. Safety and Effectiveness
i
The ViewPoint is substantially equivalent to the Viewing Wand (K911783), the StealthStation (K954276) and the ViStar workstation (K905070) in safety and effectiveness. The following chart has been compiled to demonstrate ViewPoint's substantial equivalence to these devices.
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SUBSTANTIAL EQUIVALENCE CHART
| Parameter | ISG Viewing Wand(K911783) | SNT StealthStation(K954276) | Picker ViStar(K905070) | ViewPoint |
|---|---|---|---|---|
| Type of Digitizer | A six-jointed, sixdegree of freedomelectrogoniometer ismounted to the ORtable t-rail or headholder and is used forposition and anglemeasurement. Theangular position ofeach joint ismeasured usingproprietary potentio-meter type sensors. | A manual surgicalinstrument that hasbeen modified toincorporate lowvoltage LEDs ontothe handle is used asa probe. The locationof the probe istracked by threeoptical cameras and iscompared to thelocation of thereference system. | NA | Ultrasonic pulsesemitted from twolocations on hand-held wand aredetected by 4microphones in adetector array whichis mounted to theOR table. |
| RegistrationTechnique | Scanned Fiducials,Surface fitting,anatomical features. | Laitinen Stereo-adapter non-invasivestereotactic frame | NA | Scanned Fiducials |
| Type of Sterilization | Instrumented Arm:cleaned and draped.Probes: autoclaved orgas sterilized | Reference arc andOptical probe areauto-claved. | NA | Wand is ETOsterilizable. |
| Parameter | ISG Viewing Wand(K911783) | SNT StealthStation(K954276) | Picker ViStar(K905070) | ViewPoint |
| Computer | Hewlett PackardApollo Series 700,Unix System 5Operating System, X-Windows/MOTIF | Silicon Graphics Indyworkstation with aminimal configurationof a UNIX/X-windows operatingsystem. | Stardent 3000supercomputer usingparallel RISCarchitecture. | DEC 3000 Model700 superscalar RISCmicroprocessor with64 bit word. UNIXSystem with X-windows/MOTIF. |
| RAM Memory | 64 MBytes. | 64 MBytes. | 64 MBytes.Expandable to 128MBytes. | 128 MBytes.Expandable to 256MBytes. |
| Image StorageCapabilities | 1.0 GByte diskstorage. DAT driveand QIC tape. | 500 MBytes of harddisk space and a DATarchive/backupdevice | 760 MBytes diskstorage, 1/4" cartridgetape drive, magnetictape drive. Optionaloptical disk drive. | 2.1 GBytes of diskstorage. Optional 1.3GByte optical diskdrive. 1/2" 9-tracktape system. |
| Monitor | 19 inch, 1280 x 1024high resolution colormonitor, 72 Hz, non-interlaced | High-resolutionmonitor capable ofdisplaying 256 greylevels | 19 inch, 1280 x 1024high resolution colormonitor, 60 Hz, non-interlaced. | 20 inch, 1280 x 1024high resolution colormonitor, 72 Hz, non-interlaced. |
| Networking | Ethernet networkingcapabilities. | Supports the DICOMv3.0 imaging /networking protocol. | Ethernet TCP/IP. | Networking softwarefor direct link to MRand CT systems.Supports the DICOMv3.0 imaging /networking protocol. |
| Parameter | ISG Viewing Wand(K911783) | SNT StealthStation(K954276) | Picker ViStar(K905070) | ViewPoint |
| Graphical Interface | 4 viewports withcontrol panel.Standard viewports:coronal view, sagittalview, axial view and3D view. | 4 viewports withcontrol panel.Standard viewports:coronal view, sagittalview, axial view andnavigational view.Probe positionindicated by cross-hairs. | 1 to 256 individualviewports, image sizesfrom 64 x 64 to 1024x 1024 pixels, abilityto window, level,zoom, pan, applyfilters and draw. | 4 viewports with 512x 512 resolution.Control panel withstatus informationand menu selections.Ability for graphicaloverlays. Layout ofviewports depends onmode of operation. |
| Image Manipulation& ReformattingCapabilities | MultiplanarReformatting, SurfaceRendering. Able toshow diagnosticimages at the locationof the articulatedarm. | MultiplanarReformatting, SurfaceRendering. Able toshow diagnosticimages at anyLaitinen coordinate insurgical space asidentified by theprobe. | MultiplanarReformatting, AngiographicRendering, SurfaceRendering, Cubeview,Cine Display. | MultiplanarReformatting,Surface Rendering.Able to showdiagnostic images atthe location of theprobe tip. |
| Parameter | ISG Viewing Wand(K911783) | SNT StealthStation(K954276) | Picker ViStar(K905070) | ViewPoint |
| Intended Use | The Viewing Wand is intended for use with patients who have imaged space occupying lesionsor malformations (both soft tissue and osseous) such as: intra-cerebral tumors and cysts, skull-based tumors and cysts, vascular malformations such as cavernous malformations and arterio-venous malformations, epilepsy, acute sinusitis with complications, chronic sinusitis andcerebrospinal fluid leaks. There are no known restrictions on patient population other thanpatients with Creutzfeld-Jakob's disease. The Wand is intended for use during planning andsurgery provided the attainable correlation accuracy is adequate for the intended use. | The StealthStation is intended for use for precise stereotactic determination of cranial andneurological targets and is suitable for locating tumors during open surgery, and forpercutaneous tumor biopsy and ventriculostomy. | The ViStar systems used with HPQ and 2055HP systems do not change the existing indicationswhich are: The Picker International Vista HPQ and 2055 HP systems are indicated for use asNMR devices that produce images that: (1) correspond to the distribution of protons exhibitingNMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-latticerelaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structureof the head and whole body. When interpreted by a trained physician, these images yieldinformation that can be useful in the determination of a diagnosis. | The ViewPoint is intended for use as a device which uses diagnostic images of the patientacquired specifically to assist the physician with presurgical planning and to provide orientationand reference information during intra-cranial surgical procedures involving space occupyinglesions or malformations (including soft tissue, vascular and osseous). |
PICKER INTERNATIONAL, INC. (VIEWHD)
(3/21/96)
I-2
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PICKER INTERNATIONAL, INC. (VIEWHD)
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(3/21/96)
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§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.