(196 days)
The ACCUSYTE™ 3D Fiducial Markers are used to mark the location of a tumor cavity after the tumor has been removed. In addition, the Markers are indicated on situations where soft tissue needs to be marked for future medical procedure such as subsequent Radiation Therapy.
The ACCUSYTE™ 3D Fiducial Marker is an implantable marker comprised of an absorbable suture (polylactic acid) component which absorbs completely in less than one year, and a permanent component, a Platinum or Gold Marker attached to the suture by a crimping operation similar to the operation use to attach the Stainless-Steel Needle. The ACCUSYTE™ 3D Fiducial Marker is provided Sterile for single use and is implantable.
The provided text describes a 510(k) submission for the ACCUSYTE™ 3D Fiducial Marker, aiming to establish substantial equivalence to predicate devices. The study focuses on demonstrating the device's technical characteristics and performance, particularly its visualization compatibility and MRI safety. However, it does not contain the information needed to fully answer all aspects of your request, especially regarding specific acceptance criteria, detailed study designs for those criteria, or the role of AI.
Here's an analysis of the available information:
This document describes a medical device called the ACCUSYTE™ 3D Fiducial Marker. It is a K180027 510(k) Pre-market Notification from 2018 for a Medical Charged-Particle Radiation Therapy System, and thus the description below is limited purely to the device as presented in the document.
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria with specific thresholds for visualization or other performance metrics. Instead, it describes performance data gathered to demonstrate the device's capabilities and substantial equivalence to predicate devices.
| Performance Aspect | Reported Device Performance (ACCUSYTE™ 3D Fiducial Marker) |
|---|---|
| Visualization Clarity | - Bench tested for clarity of visualization using a phantom breasts model across computed tomography (CT), kilovoltage (KV), cone-beam CT (CBCT), and megavoltage (MV) linear accelerator imaging. |
- Radiographic Imaging 6-8 weeks after implantation.
- Mammography imaging after 1-year post implantation.
(No specific quantitative clarity metrics or acceptance thresholds are provided, only that it was "clear visualization.") |
| MRI Safety | MR Conditional:
- Static magnetic field of 1.5-Tesla or 3-Tesla.
- Maximum spatial gradient magnetic field of 4,000-gauss/cm (40-T/m).
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg in the Normal Operating Mode.
- Expected to produce a maximum temperature rise of ≤2°C after 15-minutes of continuous scanning at 3 Tesla. |
| MRI Image Artifact | - Image artifact not expected to extend more than 10-mm from the device when imaged with a gradient echo pulse sequence and a 3-Tesla MRI system. |
| Absorbable Suture Testing| Performed on the Absorbable Suture component (K130735): - Bacterial Endotoxin (USP Pharmacopeia ) - Pyrogenicity.
- Biocompatibility (ISO-10993) - suture component - Implant.
- Physical Testing - USP 30
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.