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510(k) Data Aggregation
(257 days)
CRW-1 SYSTEM; K944463
The CRW Stereotactic System is a stereotactic system to be used for neurosurgical procedures that require precise target localization, such as craniotomies, biopsies, and functional stereotaxy. Localization is performed using CT or MR imaging.
Part of the CRW™ Stereotactic System is comprised of the following components:
- Universal Compact Head Ring (UCHR),
- Luminant Localizer Frame (LL01) ●
- Disposable Head Ring Screws (DHRSS- Short, DHRSL- long) ●
The Universal Compact Head Ring is placed on the patient and secured with the Disposable Head Ring Screws. The Luminant Localizer Frame is then attached to the base ring and the patient is taken to the neuroradiology department where a CT or MR imaging is performed. The image obtained in conjunction with the localizer allows the neurosurgeon to compute the exact three dimensional position of the region of interest.
The provided text describes the 510(k) summary for the CRW Stereotactic System, focusing on non-clinical testing for a labeling change to add an MR Conditional claim. It's important to note that this document is not a study proving device performance against clinical acceptance criteria in the sense of accuracy for a diagnostic or therapeutic medical AI device. Instead, it describes tests performed to establish safety and compatibility for a physical medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| MR testing (Magnetic Resonance safety and compatibility) | Compliance with FDA Guidance: "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance Environment (August 21, 2008)" and relevant ASTM Standards (F2052, F2213, F2182, F2119). Specifically, to support an MR conditional claim. | "Results met pre-established acceptance criteria. MR labeling included in the submission is in compliance with FDA Guidance and ASTM F2503. The results demonstrate substantial equivalence by complying with current FDA Guidance and consensus standards requirements." (For 1.5T and 3.0T MR environments) |
| Sterilization – Devices provided to the user sterile | Sterilization to a Sterility Assurance Level (SAL) of 10-6, in accordance with FDA Guidance regarding devices packaged sterile. | "Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device in terms of sterility for devices provided to the user sterile." |
| Sterilization – Devices to be sterilized by the end user | Sterilization to a SAL of 10-6 using EtO, steam, and Sterrad® cycles. | "Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device in terms of sterility for devices intended to be sterilized by the end user." |
| Shipping/Stability | Maintenance of sterile device packaging integrity and stability to support a three-year shelf life claim, according to ASTM D4169 and ASTM F1980. | "Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device of the sterile device packaging in terms of shipping integrity and stability." |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11 for patient-contacting devices. | "Results met pre-established acceptance criteria, demonstrating substantial equivalence to the predicate device in terms of biocompatibility." |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing of the physical device components, not a clinical study involving patient data. Therefore, there is no "test set" in the context of patient data, nor a "data provenance" (like country of origin, retrospective/prospective). The "samples" referred to are physical units or worst-case samples of the device components.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth in this context refers to established standards and guidelines (e.g., ASTM standards, FDA guidance, ISO standards) for physical device testing, rather than expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. The tests involve objective measurements against predefined engineering and safety standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. This document is for a physical medical device and its safety/compatibility in specific environments, not a diagnostic or AI-assisted system where human reader performance would be a factor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for these tests is based on:
- Established engineering and safety standards (e.g., ASTM F2052, F2213, F2182, F2119, F2503 for MR; ASTM D4169, F1980 for shipping/stability; ISO 10993 series for biocompatibility).
- Regulatory guidance documents (e.g., FDA Guidance: "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance Environment," FDA Guidance regarding devices packaged sterile).
- Scientific principles for sterilization (SAL of 10-6).
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device and therefore does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set, there's no ground truth established for one.
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(85 days)
The Cosgrove Depth Electrode Kit (CDEK) allows the user to place and secure epilepsy electrodes via a lateral orthogonal surgical approach or stereotactically using Radionics CRW and BRW Stereotactic Arc Systems which have been cleared through the FDA.
The CDEK Cosgrove Depth Electrode Kit addressed in this premarket notification has similar intended use and technological characteristics as accessories provided in the commercially available Radionics Todd-Wells Stereotaxic Guide (a pre-amendment device), the Radionics CRW and BRW Stereotactic Arc Systems, and Radionics Bipolar Forceps (a pre-amendment device).
The provided text describes a medical device, the Cosgrove Depth Electrode Kit (CDEK), and its intended use, but it does not contain information about acceptance criteria or a study proving the device meets said criteria in the way you've outlined for an AI/CAD system.
The document is a "Summary of Safety and Effectiveness" for a traditional medical device (a kit for electrode placement), focusing on its substantial equivalence to predicate devices and general safety instructions. It doesn't involve performance metrics like sensitivity, specificity, or reader studies that would be typical for an AI-powered diagnostic device.
Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided input. The document discusses regulatory aspects and device characteristics, not performance evaluation data as would be generated for a software or AI-driven system.
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