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510(k) Data Aggregation
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The CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The working principle of CO2 laser system instrument is that the laser power supply drives the laser emitter to emit light, through the refraction of several mirrors, the light is transmitted to the treatment head, and then the light is aggregated into one point by the focusing mirror, which can reach a very high temperature, so that the treatment area can be sublimated into gas in an instant, so as to achieve the purpose of treatment.
The CO2 laser system comprises essential components including the main unit, treatment handpiece, foot switch, and various accessories. The wavelength of CO2 laser system is 10600nm.
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(179 days)
Trained medical professionals use Contour ProtégéAI as a tool to assist in the automated processing of digital medical images of modalities CT and MR, as supported by ACR/NEMA DICOM 3.0. In addition, Contour ProtégéAI supports the following indications:
• Creation of contours using machine-learning algorithms for applications including, but not limited to, quantitative analysis, aiding adaptive therapy, aiding image registration, transferring contours to radiation therapy treatment planning systems, and archiving contours for patient follow-up and management.
• Segmenting structures across a variety of CT and MR anatomical locations.
Appropriate image visualization software must be used to review and, if necessary, edit results automatically generated by Contour ProtégéAI.
Contour ProtégéAI+ is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI+ is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
Compared to the predicate device, the intended use and indications for use for the subject device include minor modifications to improve clarity and completeness.
The upcoming 2.0.0 release of Contour ProtégéAI+ serving as the subject device in this 510(k) submission includes one new 4.3.0 neural network model (MR Brain) using the existing architecture cleared by the predicates, as well as one 5.0.0 neural network model (CT Male Pelvis) using the new architecture to allow the training of smaller networks for individual structures or groups of adjacent structures.
This 510(k) submission also includes plans for further development activities to Contour ProtégéAI+. Proposed modifications in the PCCP are categorized as follows:
● New CT models or MR models
● New CBCT models for CBCT IRIS imaging data (cleared in K252188) acquired from Elekta's Evo, Versa HD, and Harmony Pro systems
● Re-training models due to improvements in training data
● Re-training models on cleared architecture
● Re-applying CT models for CBCT IRIS imaging data (cleared in K252188) acquired from Elekta's Evo, Versa HD, and Harmony Pro systems
Here's a breakdown of the acceptance criteria and the study that proves the Contour ProtégéAI+ device meets them, based on the provided FDA 510(k) clearance letter:
Acceptance Criteria and Reported Device Performance
Table 1: Acceptance Criteria and Reported Device Performance for Contour ProtégéAI+
| Criteria Category | Specific Metric | Acceptance Criteria | Reported Device Performance (Contour ProtégéAI+) |
|---|---|---|---|
| Per-Structure Performance | Dice Score (Non-Inferiority) | Lower 95th percentile confidence bound of the difference between Contour ProtégéAI+ mean Dice and MIM Atlas mean Dice > -0.1 | Demonstrated equivalence or better performance than MIM Maestro atlas segmentation (many indicated by *) |
| MDA Score (Non-Inferiority) | Upper 95th percentile confidence bound of the difference between Contour ProtégéAI+ mean MDA and MIM Atlas mean MDA < 2mm | Demonstrated equivalence or better performance than MIM Maestro atlas segmentation (many indicated by *) | |
| User Evaluation Score (Average) | Average score of 3 or higher (on a five-point scale, where 3 = minor edits in less time than starting from scratch, 4 = minor edits not necessary, 5 = can be used as-is) | Scores ranged from 2.6 to 4.75 across structures (many indicated above 3, some below but passed other criteria) | |
| Model-Level Performance | Cumulative Added Path Length (APL) (Non-Inferiority) | Statistically non-inferior cumulative APL compared to the reference predicate | 4.3.0 MR Brain: 36.87 ± 72.40 (3.63%) * (Non-inferiority demonstrated) 5.0.0 CT Male Pelvis: 165.44 ± 235.96 (-21.5%) * (Non-inferiority demonstrated) |
| Overall Acceptance | Inclusion in Final Models | Structures must pass two or more of the three per-structure tests (Dice, MDA, User Evaluation). | All included structures passed this criterion. |
Study Details
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Sample Size Used for the Test Set and Data Provenance:
- Test Set Size: 189 individual patient images.
- Data Provenance: All testing data originated from the United States.
- Regional breakdown: Midwest (18.5%), South (54.0%), West (12.7%), and Northeast (14.8%).
- Sex distribution: 28.0% female, 46.8% male, and 25.4% unknown.
- Age distribution: 6.9% between 20-40 years, 17.5% between 40-60 years, 51.3% over 60 years, and 24.3% unknown.
- Manufacturer representation: GE (46.6%), Siemens (36.0%), Phillips (4.8%), Accuray (5.8%), and TomoTherapy (6.9%).
- Nature of data: Retrospective, obtained from clinical treatment plans for patients prescribed external beam or molecular radiotherapy.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- The document implies a team-based approach for ground truth establishment. For "Re-segmented" data, segmentation is performed by a dosimetrist, then reviewed by a team of dosimetrists, and separately reviewed by a radiation oncologist. Segmentations that failed review were re-contoured by a dosimetrist and re-reviewed. The exact number of individual experts (dosimetrists, radiation oncologists) involved is not explicitly stated.
- Qualifications: Dosimetrists and Radiation Oncologists are "trained medical professionals" and "consultants (physicians and dosimetrists)". Specific years of experience are not provided, but their roles in clinical treatment planning and review imply significant expertise.
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Adjudication Method for the Test Set:
- The document describes a review process where segmentations are reviewed by a team of dosimetrists and separately reviewed by a radiation oncologist. If segmentations fail review, they are referred for re-contouring and re-reviewed. This suggests a form of consensus or expert adjudication, but a specific "2+1" or "3+1" method is not detailed. It's a qualitative review leading to re-contouring if disagreements are significant enough to "fail review."
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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:
- No MRMC comparative effectiveness study was explicitly described in terms of human readers improving with AI assistance.
- A "user beta testing" was conducted to evaluate "time savings compared to contouring from scratch," which is related to AI assistance. However, it measured the quality of the AI-generated contour (on a 5-point scale), not the improvement in human reader performance with the AI.
- The primary comparative effectiveness study was Contour ProtégéAI+ (AI standalone) vs. MIM Maestro Atlas Segmentation (reference device), not AI-assisted human vs. unassisted human.
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If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance study was done. The Dice and MDA scores presented in Table 2 are direct comparisons of the Contour ProtégéAI+ algorithm's output against the ground truth, and against the MIM Maestro atlas segmentation (another automated method). The user evaluation scores also reflect the quality of the algorithm's output, which would then be reviewed by a human.
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The Type of Ground Truth Used:
- Expert Consensus / Clinically Established Guidelines: The ground truth for the test set consisted of contours derived from clinical treatment plans. These contours were either "Not be Re-segmented" (original treatment plan segmentations, implicitly considered ground truth) or "Re-segmented" and then meticulously reviewed and approved by a team of dosimetrists and a radiation oncologist, ensuring adherence to established clinical guidelines.
- Outcome Data: Not explicitly mentioned as a source for ground truth.
- Pathology: Not explicitly mentioned as a source for ground truth.
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The Sample Size for the Training Set:
- The document states, "The CT images for this training set were obtained from clinical treatment plans for patients prescribed external beam or molecular radiotherapy and were re-segmented by consultants (physicians and dosimetrists) specifically for this purpose." However, the specific sample size (number of patients/images) for the training set is not provided. It only mentions that the images for the verification data (189 images) are independent from the training data.
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How the Ground Truth for the Training Set was Established:
- The ground truth for the training set was established by "consultants (physicians and dosimetrists)" who re-segmented clinical treatment plans. This implies expert-driven manual contouring or correction to create the reference data used to train the machine learning models. The process for internal review and quality assurance of these training contours is not detailed to the same extent as for the test set ground truth.
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(88 days)
CyClean Cord is knitted retraction cord made from 100% lyocell, impregnated with Aluminum Chloride Hexahydrate for the temporary gingival retraction and hemostasis of the gingival margin.
The CyClean Cord is a dental gingival retraction cord containing aluminum chloride Hexahydrate in 100% lyocell knitted yarn, and is used to temporarily retract gingival tissue prior to obtaining a dental impression, and at the same time remove blood, saliva, and gingival fluid remaining in the gingival hotspots.
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(268 days)
The CUVIS-joint is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.
The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty (TKA).
The CUVIS-joint is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and effective and where references to rigid anatomical structures may be made.
The CUVIS-joint is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The CUVIS-joint facilitates accurate positioning of TKA implants, relative to these alignment axes.
The CUVIS-joint is compatible with the following Knee Implant System:
-United U2 Knee System
The CUVIS-joint is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require total joint arthroplasty. The device is intended as an alternative to manual template planning and preparation of the bone with patients requiring primary total knee arthroplasty (TKA).
The CUVIS-joint consists of two main components: 1) the Planner which is a three-dimensional (3D) preoperative planning workstation which uses preoperative CT scans of patient anatomy to aid a surgeon in planning the position and orientation of the implant components relative to 3D models of the patient's anatomy, and 2) the Robotic Arm Tool which executes the surgical plan and includes a an electromechanical arm, an arm base including control electronics and computer, optical tracking system, a display monitor, operating software, pendant control, and tools and accessories. When used according to the Instructions for Use (IFU), the CUVIS-joint enables precise implant positioning possible before and during TKA surgical procedures.
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(186 days)
The proposed CT Rembra RT, CT Areta RT, and CT Rembra are Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment support, components and accessories. The system is indicated for diagnostic imaging in radiology, head and whole-body X-ray Computed Tomography applications in oncology as part of treatment preparation and radiation therapy planning, vascular, interventional, neurology and cardiology, for patients of all ages.
These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs/protocols that have been approved and published by either a governmental body or a professional medical society.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
The proposed CT Rembra RT, CT Areta RT, and CT Rembra proposed devices have similar technological characteristics, software operating platform, and supported software characteristics as the predicate devices.
The proposed devices expand the CT product family with improved performance, workflow and functionality for oncology applications. They also provide a large-bore radiology solution on the Incisive Host software platform.
The design of the proposed CT Rembra RT, CT Areta RT, CT Rembra is based on the currently marketed CT 5300 (K232491), with hardware and software modifications. These include the addition of new oncology software features and workflow enhancements for radiotherapy planning support.
The proposed system is a whole-body computed tomography (CT) x-ray system featuring a continuously rotating x-ray tube, detectors, and gantry with multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. It produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Philips. The CT images can be used by trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system.
The proposed device has an 85 cm bore and includes a detector array that provides 60 cm scan field of view (SFOV) and 85cm extended field of view (EFOV).
The key system modules and functionalities of proposed device are: Gantry [X-ray tube assembly, HV generator, Collimator, DMS (Data Measurement System), Touch Panels], Patient Table (Couch), Console and optional components as well as accessories. This system also includes hardware and software for data acquisition, display, manipulation, storage and filming as well as post-processing into views other than the original axial images.
Upgrade Kits are available to upgrade CT Rembra RT, CT Areta RT, CT Rembra installations to the latest version in forward production.
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(82 days)
The Skeletal Dynamics Clavicle Fixation System is indicated for fractures, osteotomies, and non-unions of the Clavicle including osteopenic bone.
The Clavicle Fixation System features titanium (Ti 6Al-4V ELI) bone plates, offered in various sizes for the repair of the superior midshaft and superior lateral regions, as well as the anterior midshaft and anterior lateral areas. Included in the Clavicle Fixation system are titanium (Ti 6Al-4V ELI) and Cobalt-Chrome (CoCrMo) bone screws offered in 2.5mm, 2.7mm and 3.5mm diameters. Each plate is designed to accept specific compatible screw sizes, depending on the plate configuration. In addition, the system offers pegs that accept orthogonal screws, K-wires, and specialized instrumentation. The system is provided non-sterile and is sterilized at the user's facility.
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