SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION

• K Number: K994421
• Device Name: SNN STEREOTAXIC PLANNING APPLICATION; SNN STEREOTACTIC APPLICATION
• Manufacturer: SURGICAL NAVIGATION SPECIALISTS, INC.
• Date Cleared: 2000-02-23 ( 56 days)
• Product Code: HAW
• Regulation Number: 882.4560
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: K990724 , K013444 , K033325
• Predicate For: N/A

Intended Use

The SNN Stereotactic Planning Application module is intended to be used as an accessory for planning stereotactic frame-based procedures such as biopsies, functional stereotaxy, turnor resections, vascular malformation surgeries, thalamotomies and pallidotomies.

Device Description

The SNN Stereotactic Planning Application software is an optional module of the SNN System software. The SNN Stereotactic Planning Application module registers medical scan images with stereotactic frame space and calculates frame and arc system coordinates.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary and an FDA clearance letter for the SNN Stereotactic Planning Application. It primarily focuses on:

• Device Identification: Trade name, common name, classification, and intended use.
• Predicate Devices: Comparison to existing legally marketed devices to establish substantial equivalence.
• Regulatory Information: FDA contact information, clearance date, and general regulatory requirements.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample size, data provenance, expert qualifications, or adjudication methods for a test set.
3. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
4. Data on standalone (algorithm only) performance.
5. The type of ground truth used in any study.
6. Sample size for a training set or how its ground truth was established.

The text states that the device is "substantially equivalent" to predicate devices and "do not pose any new issues of safety and effectiveness," implying that extensive new performance studies (especially clinical ones) were likely not required beyond validation that it functions as intended and safely. However, the details of such validation are not provided in this document.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).