(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.
§ 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.