(35 days)
The SNN system with the Olivier Double-Chuck Support Arm Option is indicated for patients who have space occupying lesions or malformations (both soft tissue and osseous) in the head. It is also indicated for patients who require decompressive or reconstructive surgery of the spine, or who have imaged space-occupying lesions or malformations of the spine.
The Olivier Double-Chuck Support Arm Option can provide mechanical support and guidance for vanous frameless stereotaxic procedures, turnor resections, biopsies, and endoscopies.
The SNN system is contraindicated for patients suspected of having Creutzfeld-Jacob's disease if adequate sterilization of the instruments cannot be assured.
The Olivier Double-Chuck Support Arm is an optional component of the SNN image-guided surgical system. The arm itself can be positioned and locked into place. The double-chuck head has one chuck to firmly hold a surgical instrument in the desired location. The instrument can also be moved up or down by sliding it through the chuck. The second chuck is used to prevent excessive vertical movement, by stabilizing the arm against the skull.
This 510(k) summary does not contain the detailed study information needed to fully address your request in the specified format. The document focuses on establishing substantial equivalence to predicate devices rather than presenting a standalone study with acceptance criteria and performance data.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the provided text. Because this is a 510(k) summary, the "acceptance criteria" for the device's market clearance are primarily based on demonstrating substantial equivalence to predicate devices, rather than meeting specific quantitative performance metrics from a formal study.
- Reported Device Performance: Not detailed in the provided text. The document states that the intended use and technological characteristics of the SNN image-guided surgical device, including the Olivier Double-Chuck Support Arm option, are substantially equivalent to predicate devices and "do not pose any new issues of safety and effectiveness." This is a general claim of equivalence, not specific performance data.
Missing Information (Not available in the provided text):
Since the document is a 510(k) summary focused on substantial equivalence, it does not include the detailed results of a dedicated study with specific performance metrics. Therefore, the following cannot be answered from the provided text:
- Sample size used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method for the test set: Not available.
- 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 available. The device is an image-guided surgical system, not an AI diagnostic tool that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not available. The device is a surgical system that requires human interaction.
- The type of ground truth used: Not available.
- The sample size for the training set: Not available.
- How the ground truth for the training set was established: Not available.
Summary of available information related to acceptance and study:
The acceptance for market clearance (510(k) clearance) was based on the claim of substantial equivalence to existing predicate devices:
- The SNN image-guided surgical system.
- The Philips EasyTaxis option to the EasyGuide system.
- The Radionics Optical Tracking System with the frameless cranial biopsy indication.
The determination of substantial equivalence was made by Surgical Navigation Specialists Inc. and accepted by the FDA. The FDA's letter (K992457) confirms this substantial equivalence based on the provided information, allowing the device to be marketed. The specific "study" referenced in the 510(k) summary is the comparison made by the manufacturer to predicate devices, focusing on intended use and technological characteristics to demonstrate no new safety or effectiveness concerns.
§ 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).