Search Results
Found 4591 results
510(k) Data Aggregation
(132 days)
The DeVilbiss 5 Liter (555) Oxygen Concentrator is intended to provide supplemental oxygen to adult patients requiring oxygen therapy. The device may be used in the home or an institutional setting. The device is not intended to be life sustaining or life supporting.
The DeVilbiss 5-Liter (555) Oxygen Concentrator (hereafter referred to as "555") is a portable device that produces an oxygen enriched gas mixture by drawing in room air and extracting nitrogen through a pressure swing adsorption process, allowing oxygen to be delivered at a range of prescribed flows to patients in need of supplemental oxygen.
N/A
Ask a specific question about this device
(107 days)
The NOMAD Pro 3 Handheld X-ray System is indicated for use only by a trained and qualified dentist or dental technician for both adult and pediatric subjects as an extraoral diagnostic dental X-ray source to produce X-ray images using intraoral image receptors.
NOMAD Pro 3 Handheld X-ray System is a battery-operated, portable dental X-ray source designed for handheld operation. It is designed to produce diagnostic quality X-rays images utilizing either film or digital imaging techniques. The NOMAD Pro 3 Handheld X-ray System is designed for use in a dental office. It can also be used in other similar environments (orthodontic office, general practitioner's office, hospital ward, etc.) where appropriate safeguards are implemented. The device uses a rechargeable battery to allow for the use of the NOMAD Pro 3 Handheld X-ray System where transportation or use of other x-ray devices might be prohibitive due to the other device's size and/or lack of mobility.
System Description and Overview: The NOMAD Pro 3 Handheld X-ray System is an X-ray device with a DC generator. The handheld device features a main unit (tube head), rechargeable battery (handset), charger, and charger AC/DC power supply. The power is supplied by a rechargeable Lithium-ion battery core pack built into a handset. This facilitates portability of the device. A beam-limiting cone is incorporated within the device. Internal and external shielding provide sufficient radiation protection to allow the clinician to remain in the operatory with the patient.
To make the system as simple as possible for the operator, NOMAD Pro 3 Handheld X-ray System uses a fixed tube voltage of 65kV and a fixed tube current of 2.5mA. The only operator-adjustable parameter is the exposure time. This adjustment can be quickly accomplished through the user-friendly control panel.
The battery core pack consists of standard production, high discharge, cylindrical, Lithium-ion cells. The vendor builds the cells into custom, potted enclosure which also contains control and safety circuitry in the form of a semi-custom Battery Management Unit (BMU). The internal potting provides protection against liquid ingress and further inhibits flame propagation in the event of a single cell failure. The BMU provides charge control, discharge control, battery capacity management, safety control and communication. The electrical interface includes a two-wire serial interface which may be used to obtain status of the battery core pack.
Control buttons, display, and a trigger provide the primary operator interface. Exposure settings can be selected and displayed. Voltage (65 kV) and current (2.5 mA) are fixed with the exposure time varying based on patient type, detector type, and anatomical feature. Exposures can be completed using the trigger. The device can be used with three detector types: film, digital imaging intraoral sensors, and phosphor plates.
User warnings and markings will be on the upper portion of the device near the user interface. Technical and regulatory markings will be on the underside of the device, top of the handset (not visible when attached to device), and bottom of charging cradle.
Principles of Operation: The NOMAD Pro 3 Handheld X-ray System is used like any other extraoral dental X-ray source for intraoral application. An image receptor, such as film, is placed in the patient's oral cavity behind the teeth. The device is powered on, and the appropriate exposure time is set by the operator. The operator should follow appropriate instructions to ensure proper alignment of the X-ray beam to the receptor, and proper positioning of the receptor in the patient's mouth. To prevent inadvertent exposure to X-rays, the operator must first press and release the trigger to enable and then ready the device. A flashing green ENABLED indicator light and an audible signal confirm that the NOMAD Pro 3 Handheld X-ray System is enabled. X-rays are initiated by pulling and holding the trigger on the handle for the duration of the exposure. The system has numerous alarms and alerts to communicate with the operator.
N/A
Ask a specific question about this device
(37 days)
The ValvuloPro Valvuloplasty Balloon Catheter is indicated for balloon aortic vavuloplasty.
The ValvuloPro Valvuloplasty Balloon Catheter is intended for use in balloon aortic valvuloplasty procedures. The device consists of an inflatable balloon mounted at the distal end of a coaxial catheter shaft. The catheter has an effective working length of 130 cm.
The proximal end of the catheter is equipped with a Y-shaped hub, comprising one port dedicated to balloon inflation and deflation and a second port designed for guidewire access. Two radiopaque tantalum marker bands are positioned at the proximal and distal shoulders of the balloon, providing fluoroscopic visualization to facilitate accurate balloon placement across the target valvular stenosis.
The balloon catheter is sterilized using ethylene oxide and is intended for single use only.
N/A
Ask a specific question about this device
(87 days)
The PEG Catheter Kit is intended for percutaneous endoscopic gastrostomy placement to provide enteral nutrition and/or medication to patients requiring nutritional support and gastric decompression. This device is indicated for adult use only.
The Degania Silicone Percutaneous Endoscopic Gastrostomy (PEG) Kit with ENFit® connection is a single-use, sterile, disposable kit intended for the initial percutaneous endoscopic placement of a feeding tube (PEG catheter) into the stomach of adult patients who require enteral nutrition or medication delivery and cannot be fed orally.
The PEG Kit provides direct access to the stomach through a minimally invasive endoscopic procedure, allowing administration of nutrition, fluids, or medication directly into the gastrointestinal (GI) tract. The system is designed for use in patients with functional GI tracts who are unable to maintain adequate oral intake.
The device is available in two French sizes (20 Fr and 24 Fr) and four configurations, corresponding to the two standard PEG placement techniques:
- Push method – 20 Fr
- Push method – 24 Fr
- Pull method – 20 Fr
- Pull method – 24 Fr
All configurations are supplied sterile (EtO sterilization) and intended for single use.
Each PEG Kit includes:
- A silicone feeding catheter (PEG tube) designed for either the Pull or Push placement method
- A two-way ENFit® connector compliant with ISO 80369-3.
- An external retention device (ERD) to secure the catheter externally
- Tools and accessories for site preparation and tube placement (e.g., guidewire, looped placement wire, scalpel, syringe, hypodermic needles, hemostat, drape, and gauze).
N/A
Ask a specific question about this device
(90 days)
- Indicated for bite registration in prosthodontics, orthodontics, and implantology.
- Used for recording the occlusal relationship to aid in the fabrication of crowns, bridges, dentures, and orthodontic appliances.
- Suitable of occlusal analysis and adjustment in clinical dental procedures.
Dia-X Sil Bite is vinyl polysiloxane (VPS) – based bite registration material designed for occlusal capture. Classified as Type B under ISO 4823 standards.
No. Model Name Composition
1 Dia-X Sil Bite A Type Dia-X Sil Bite 50ml Cartridge 1ea
2 Dia-X Sil Bite C Type Dia-X Sil Bite 50ml Cartridge 2ea
3 Dia-X Sil Bite E Type Dia-X Sil Bite 50ml Cartridge 4ea + Mixing Tip 10ea
4 Dia-X Sil Bite G type Dia-X Sil Bite 50ml Cartridge 10ea
N/A
Ask a specific question about this device
(372 days)
Deep Capsule® is an artificial intelligence (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding. The clinician is responsible for conducting their own assessment of the findings of the AI-assisted reading through review of the entire video, as clinically appropriate. This tool is not intended to replace clinical decision-making.
Deep Capsule® is an artificial intelligence (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers (SBCapER) in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule endoscopy images were obtained for suspected small bowel bleeding.
Deep Capsule® is capable of detecting small bowel lesions, without differentiating them. The detection of lesions by Deep Capsule® is insufficient to achieve a direct diagnosis, which is dependent on the clinical integration of the different findings. Deep Capsule® should be integrated into this multifactorial and complex context, both in the diagnostic workup or in the patient follow-up.
In summary, although the Deep Capsule® detects small bowel lesions, it acts only as a support to the clinical decision. The ultimate diagnosis will always be given by the small bowel capsule endoscopy reviewers ("human in the loop").
It is important to note that Deep Capsule® also provides in the findings count as a non-AI software output, and user inputs that are inserted and edited by SBCapERs, including CapE device model, patient exam priority category, procedure date, responsible physician, clinical indication and medical notes.
Deep Capsule® software includes a main algorithm as illustrated in Figure 1:
• Small bowel lesion detection, which includes the small bowel lesion image analysis algorithm designed to automatically identify and localize potential small bowel lesions in capsule endoscopy images. Suspected findings are selected automatically from the video frames as illustrated in Figure 1 below, with the active video displayed on the left side of the user interface. On the right side, AI-selected frames are presented as a structured gallery of thumbnails, allowing the reviewer to efficiently navigate through suspected findings. The interface also provides exam details, frame indexing, clinical indication, findings count, and medical notes to support structured review.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) clearance letter for Deep Capsule®:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance letter does not explicitly define "acceptance criteria" for the device's performance in a table format. However, it presents the results of its performance studies against benchmarks like "Expert Reading" (standalone algorithm testing) and "Expert Board (Ground Truth)" (clinical validation).
Based on the provided data, we can infer the performance metrics deemed acceptable:
| Metric (Inferred Acceptance Criteria) | Reported Device Performance (Deep Capsule®) | Study Phase |
|---|---|---|
| Standalone Algorithm Testing (Lesion Detection Function) | ||
| Patient-level Sensitivity | 95.8% (95% CI: 92.7%-97.9%) | Internal Test Set |
| Patient-level Specificity | 75% (95% CI: 34.9%-96.8%) | Internal Test Set |
| Image-level Sensitivity | 92.1% (95% CI: 91.9%-92.3%) | Internal Test Set |
| Image-level Specificity | 88.0% (95% CI: 87.4%-88.6%) | Internal Test Set |
| Clinical Validation Study (AI-aided CapE vs. SoC vs. Expert Board) | ||
| Diagnostic Yield (Non-inferiority to SoC) | 0.961 (0.934 - 0.977) for AI-aided CapE, 0.761 (0.712 - 0.803) for SoC; non-inferiority established (p < 0.001) | Clinical Validation |
| Per-Patient Sensitivity (AI-aided CapE) | 0.972 (0.947 - 0.986) | Clinical Validation |
| Per-Patient Specificity (AI-aided CapE) | 0.125 (0.055 - 0.261) | Clinical Validation |
| Per-Patient PPV (AI-aided CapE) | 0.890 (0.850 - 0.920) | Clinical Validation |
| Per-Patient NPV (AI-aided CapE) | 0.385 (0.177 - 0.645) | Clinical Validation |
| Image-level Sensitivity (AI-aided CapE) | 94% (89.6 - 96.9) | Clinical Validation |
| Image-level Specificity (AI-aided CapE) | 84.9% (82.6 - 87.2) | Clinical Validation |
| Image-level PPV (AI-aided CapE) | 27% (21.5 - 32.9) | Clinical Validation |
| Image-level NPV (AI-aided CapE) | 99.6% (99.3 - 99.8) | Clinical Validation |
| Reduction in Mean Reading Time with AI-aided reading | "significantly reduced" (quantification not provided) | Clinical Validation |
2. Sample Size for the Test Set and Data Provenance
-
Standalone Algorithm Testing Test Set:
- Patients: 272 patients (from a total dataset of 1,133 patients).
- Images: 101,802 images (from a total dataset of 321,357 images).
- Data Provenance: Retrospectively collected from two clinical institutions in Portugal (Centro Hospitalar Universitário São João, Porto, Portugal; and ManopH – Laboratório de Endoscopia e Motilidade Digestiva, Lda., Vila Nova de Gaia, Portugal).
-
Clinical Validation Study Test Set:
- Patients: 330 patients.
- Data Provenance: Retrospectively collected between January 2021 and April 2024 from seven independent clinical centers across four countries: Portugal, Spain, Brazil, and the United States. No overlap existed between training and clinical validation datasets, and clinical validation sites were independent from the institutions used for model development.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Standalone Algorithm Testing (Internal Test Set): The document states that images were "expert-labeled images." It does not specify the exact number of experts, their qualifications, or the adjudication method for this initial labeling of the training/internal test dataset.
- Clinical Validation Study (Ground Truth):
- Adjudicators: 5 independent expert adjudicators.
- Qualifications: "board-certified gastroenterologists with extensive capsule endoscopy experience."
- Clinical Readers: 15 board-certified gastroenterologists.
- Qualifications mentioned for Clinical Readers: "certified specialists in gastroenterology and/or digestive endoscopy with a minimum of 5 years of post-fellowship clinical experience." Readers were located across the United States, Portugal, Spain, and Brazil. There was no overlap between clinical readers and adjudicators.
- Image-level ground truth: "established by expert reviewers blinded to AI outputs." (Implies the 5 expert adjudicators).
4. Adjudication Method for the Test Set
- Standalone Algorithm Testing (for initial expert-labeled images - training/internal test): Not explicitly stated, but implies expert consensus or single expert labeling for the "expert-labeled images."
- Clinical Validation Study (for Expert Board Ground Truth): "Ground truth was established through independent manual review of full capsule endoscopy videos by two experienced gastroenterologists, with adjudication by an expert board in cases of disagreement." This is a 2+1 adjudication model.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
Yes, an MRMC comparative effectiveness study was done.
- Effect Size of Human Readers Improving with AI vs. without AI assistance:
- Diagnostic Yield: AI-aided CapE showed a Diagnostic Yield (DY) of 0.961 compared to Standard-of-Care (SoC) at 0.761. The difference in DY between AI-aided and SoC was 0.200 (0.149 - 0.251), with non-inferiority established (p < 0.001). This indicates a substantial improvement in diagnostic yield when readers are assisted by AI.
- Sensitivity (Per-Patient): AI-aided CapE had a sensitivity of 0.972 compared to SoC at 0.762. The improvement in sensitivity for AI-aided reading over unaided (SoC) was 21.0% (13.9 - 27.6%).
- Specificity (Per-Patient): AI-aided CapE had a specificity of 0.125 compared to SoC at 0.250. The difference in specificity was -12.5% (-34.7 - 11.9%). It decreased with AI assistance (due to the AI prioritizing sensitivity and detecting more potential lesions, leading to more "false positives" that clinicians must then review for true positivity).
- Mean Reading Time: "mean reading time was significantly reduced with AI+Physician reading, as compared to standard reading." (Specific quantification of reduction not provided in the excerpt).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone algorithm performance study was done. This is referred to as "Standalone Algorithm Testing" or "PERFORMANCE TESTING – BENCH – STANDALONE PERFORMANCE."
- Patient-Level Performance: Sensitivity 95.8%, Specificity 75%.
- Image-Level Performance: Sensitivity 92.1%, Specificity 88.0%.
7. Type of Ground Truth Used
- Standalone Algorithm Testing: "Expert-labeled images."
- Clinical Validation Study: Expert board reference standard involving "independent manual review of full capsule endoscopy videos by two experienced gastroenterologists, with adjudication by an expert board in cases of disagreement."
8. The Sample Size for the Training Set
- Patients: 861 patients (from a total of 1,133 patients).
- Images: 219,555 images (from a total of 321,357 images).
9. How the Ground Truth for the Training Set Was Established
The document states: "Images included in the dataset [which includes the training set] were labeled by expert readers following a structured annotation process." It does not provide further details on the number of experts, their qualifications, or the exact adjudication method during the training data labeling phase.
Ask a specific question about this device
(113 days)
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:
- Osteoarthritis
- Post-traumatic arthrosis
- Focal avascular necrosis of the humeral head
- Previous surgeries of the shoulder that do not compromise the fixation
The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Fractures of the humeral head (with Short Humeral Stems).
- Fractures of the humeral head and proximal humerus, where other methods of treatments are deemed inadequate (with Standard or Long Stems).
- Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.
Fixation Methods
The humeral stem is intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The anatomic glenoid and anatomic hybrid glenoid are intended for cemented use only. The baseplate components of the convertible glenoids are intended for cementless application with the addition of screw fixation. When a convertible glenoid liner is used, the baseplate is indicated for use with a central screw and three peripheral locking screws that are 25mm or greater in length. The peripheral non-locking screws, peripheral posts and central posts are not indicated for use with the convertible glenoid.
Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.
- A severely painful, disabling, arthritic joint
- Fractures of the humeral head (with Short Humeral Stems)
- Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
- Revision of previously failed shoulder joint replacement
Fixation Methods
The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation. When a Peripheral Post is used, the baseplate is indicated for use with a Central Screw and two Peripheral Locking Screws that are 25mm or greater in length. The peripheral Non-Locking screws and Central Post are not indicated for use with the Peripheral Post.
The INHANCE Reverse Total Shoulder System consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-Linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), a baseplate (titanium alloy), peripheral screws (titanium alloy), a baseplate augment (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy). The purpose of this submission is to add alternate angle humeral liners to the INHANCE reverse shoulder system. The subject device is manufactured from a Cross-linked, VE UHMWPE. Size options include diameter 32mm, 36mm and 40mm with thickness +0mm or +4mm. Standard and Retentive options are available.
N/A
Ask a specific question about this device
(112 days)
VELYS™ Hip Navigation is an image-processing software indicated to assist in the positioning of total hip replacement components. It is intended to assist in precisely positioning total hip replacement components intra-operatively by measuring their positions relative to the bone structures of interest provided that the points of interest can be identified from radiology images.
VELYS™ Hip Navigation is also indicated for assisting healthcare professionals in preoperative planning and postoperative analysis of orthopaedic surgery in Total Hip Replacement and Total Knee Replacement. The device allows for overlaying of prosthesis templates on radiological images and includes tools for performing measurements on the image and for positioning the template. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.
VELYS™ Hip Navigation (VHN) is a Software as a Medical Device that provides the clinician with intra-operative measurements and visuals of acetabular cup orientation, femoral component leg length and offset calculations, and implant constructs based on user-defined, but machine learning (ML) default-positioned, bony-anatomy landmark points.
VHN includes a machine learning model that places the default position of the landmark based on the output of the model; the user has full control to manipulate the landmark positions after placement. The model inputs the x-ray or fluoroscopy images and outputs a default location for the landmark annotation tool. This machine learning model is Human-in-the-Loop, as the user is expected to position the annotation as they see fit.
The provided FDA 510(k) clearance letter and summary for VELYS™ Hip Navigation contain information about its acceptance criteria and some aspects of the study proving its performance. However, several requested details are not explicitly stated in the document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes one main performance study related to Human vs AI System Output Validation.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| For each of the 5 respective outputs (leg length, femoral offset, total offset, cup inclination, and cup anteversion), the machine learning model generated data point was within the range of the human operator data points on each of the test images. | The study resulted in a "Full Pass" which validates the acceptance criteria. This means the machine learning model generated data points fell within the range of manual operated data points for Leg Length, Femoral Offset, Total Offset, Inclination, and Anteversion outputs. |
| (Implicit) Workflow Efficiency: Reduced time to complete workflows when AI-Assisted Landmarks are enabled. | Human vs AI System Output Validation testing showed the time to complete the workflows took less time than the manual cases when AI-Assisted Landmarks are enabled. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document does not explicitly state the sample size for the "Human vs AI System Output Validation" test set. It mentions "each of the test cases" but not the total number of cases.
- Data Provenance: The x-ray and fluoroscopic image data used for model training were extracted from user data from the production VHN software. It also states that "Clinical institutions geographically spread across the US were strategically selected in an effort to capture the widest range of patient populations and minimize bias." This suggests retrospective data collected from real-world clinical usage.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Unspecified. The acceptance criteria state "human operator data points," implying multiple human operators, but the exact number isn't quantified.
- Qualifications of Experts: Unspecified. They are referred to as "human operators" but their specific qualifications (e.g., orthopedic surgeons, radiologists, years of experience) are not provided in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not explicitly stated. The acceptance criteria refer to the "range of the human operator data points," which suggests a comparison against a collective outcome of human operators, but a specific adjudication method like 2+1 or 3+1 is not detailed.
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 Comparative Effectiveness Study: The document describes a "Human vs AI System Output Validation" which compares AI-assisted performance (where the ML model generates default landmark positions, and the user confirms/adjusts) against manual performance (human operators manually selecting landmarks). This is a comparative study of a sort, but not explicitly labeled as a standard MRMC study in the context of reader improvement.
- Effect Size of Human Improvement (with AI vs. without AI): An effect size related to improvement in accuracy is not provided. However, the study did show an improvement in workflow efficiency: "When AI-Assisted Landmarks are enabled, Human vs AI System Output Validation testing showed the time to complete the workflows took less time than the manual cases." The magnitude of this time reduction (effect size) is not quantified.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not explicitly stated in the context of the user-facing output metrics (leg length, offset, inclination, anteversion). The "Human vs AI System Output Validation" explicitly involves human operators. The "Model Performance Metrics" (mAR, mAP, mAP@0.75) for OneTrial, CupCheckGuidedBilateral, and CupCheckGuidedUnilateral models might represent standalone algorithm performance metrics before the human-in-the-loop interaction, but it's not directly applied to the final output values of the VHN software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth (for Human vs AI System Output Validation): The ground truth for the "Human vs AI System Output Validation" appears to be the "range of the human operator data points." This falls under a form of expert consensus/reference range, where human operators' established measurements serve as the benchmark.
8. The sample size for the training set
- Training Set Sample Size: The model development used a total of 18,550 images. This dataset was split into:
- 90% for training: (0.90 * 18,550) = 16,695 images
- 5% for validation
- 5% for test (this test set is independent from the training/validation data, and separate from the "Human vs AI System Output Validation" test set mentioned above).
9. How the ground truth for the training set was established
- Ground Truth for Training Set: "Training data was pulled from user data from the production VHN software. Clinicians used the software and annotated the patient images in a clinical setting. Therefore, the reference standard is the clinician's annotations for each image which was pulled with the image." This indicates that the ground truth for the training set was established by clinician annotations (expert annotations) during routine clinical use of the production software.
Ask a specific question about this device
(107 days)
The SureSmile Software is indicated for use as a front-end device for management of orthodontic models, systematic inspection, detailed analysis, treatment planning and simulation and the design of custom appliance systems, which may include sequential aligners, retainers, IDB trays, brackets, or wires, and dental casts. These applications are based on 3D models of the patient's dentition before the start of the orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of the SureSmile Software requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
The SureSmile® Software is suitable for use for patients requiring orthodontic treatment; it allows the user to plan therapy and then order patient matched orthodontic appliances. The software includes many features to support diagnosis, planning, appliance design and treatment tracking. Additionally, SureSmile Software acts as the order management system for all SureSmile Digital Lab services and appliance production. SureSmile Software contains features to support ordering and shipment tracking. The software does not have any contact with the body.
N/A
Ask a specific question about this device
(28 days)
The Mammotome Prima™ MR Vacuum-Assisted Breast Biopsy System is intended to acquire breast tissue from an imaged abnormality during MRI-guided breast biopsy procedures for histologic examination.
The extent of a histologic abnormality cannot always be reliably determined from an imaged appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
The Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System is a battery operated, vacuum-assisted breast biopsy device designed to conduct minimally invasive procedures in the MRI environment. It is intended for use in an MR environment. The system is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The system, used with MR imaging modality, facilitates the diagnostic removal of tissue with fluid management through a combination of vacuum and radial cutting functions. The system is comprised of reusable and disposable components. Reusable components include: a battery-operated cordless control module for in-room use, two batteries and a battery charger, a foot pedal switch, and an optional tray. Disposable components include: an 8 gauge probe; a universal targeting set consisting of a targeting cube, targeting sleeve, obturator cap; and obturator with integrated insertion tip and removable obturator handle.
N/A
Ask a specific question about this device
Page 1 of 460