Search Results
Found 1 results
510(k) Data Aggregation
(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 <85>) - Pyrogenicity. - Biocompatibility (ISO-10993) - suture component - Implant. - Physical Testing - USP 30 <861, <871, and <881 - suture component. - Residual Strength and Absorption Rate studies as outlined in FDA's Class II Special Controls Guidance Document: Surgical Sutures. |
| Human Study (Safety) | No complications reported such as bleeding, pain, inflammation, or tissue reactions. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Description: The document refers to a "human study" where complications were assessed.
- Sample Size: The sample size for the human study is not specified.
- Data Provenance: The document does not specify the country of origin or whether the human study was retrospective or prospective. Given it references "implantation" and "6-8 weeks after implantation" and "1-year post implantation" within the context of a "human study" with no complications reported, it suggests a prospective, clinical observation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The study primarily focuses on the physical properties and visibility of the marker, not diagnostic accuracy requiring expert interpretation of images relative to a ground truth. The "human study" mentioned is for safety, not for establishing ground truth for image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the type of study described (assessing physical visibility and safety) does not involve adjudication of diagnostic interpretations.
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
- MRMC Study: An MRMC comparative effectiveness study was not done.
- AI Improvement Effect Size: The document does not mention AI or any AI assistance in its evaluation. This is a medical device (fiducial marker), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not done because the device is a physical fiducial marker, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the visualization characteristics, the "ground truth" seems to be the physical presence and known location of the marker within the phantom or human subjects, allowing direct assessment of its visibility. For the safety aspects, the ground truth was the observed clinical outcomes/complications in the human study.
8. The sample size for the training set
This information is not applicable as the ACCUSYTE™ 3D Fiducial Marker is a physical device and not an AI model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the ACCUSYTE™ 3D Fiducial Marker is a physical device and not an AI model that requires a training set.
Ask a specific question about this device
Page 1 of 1