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Seg Pro V3 is a software device intended to assist trained radiation oncology professionals, including, but not limited to, radiation oncologists, medical physicists, and dosimetrists, during their clinical workflows of radiation therapy treatment planning by providing initial contours of organs at risk on DICOM images. Seg Pro V3 is intended to be used on adult patients only.

The contours are generated by deep-learning algorithms and then transferred to radiation therapy treatment planning systems. Seg Pro V3 must be used in conjunction with a DICOM-compliant treatment planning system to review and edit results generated. Seg Pro V3 is not intended to be used for decision making or to detect lesions.

Seg Pro V3 is an adjunct tool and is not intended to replace a clinician's judgment and manual contouring of the normal organs on DICOM images. Clinicians must not use the software generated output alone without review as the primary interpretation.

The proposed device, Seg Pro V3, is a standalone software that is designed to be used by trained radiation oncology professionals to automatically delineate (segment/contour) organs-at-risk (OARs) on DICOM images. This auto-contouring of OARs is intended to facilitate radiation therapy workflows.

The device receives images in DICOM format as input and automatically generates the contours of OARs, which are stored in DICOM format and in RTSTRUCT modality. The device must be used in conjunction with a DICOM-compliant treatment planning system (TPS) to review and edit results. Once data is routed to Seg Pro V3, the data will be processed and no user interaction is required, nor provided.

The deployment environment is recommended to be in a local network with an existing hospital-grade IT system in place. Seg Pro V3 should be installed on a specialized server supporting deep learning processing. The configurations are only being operated by the manufacturer.

• Local network setting of input and output destinations.
• Presentation of labels and their color.
• Processed image management and output (RTSTRUCT) file management.

Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided FDA 510(k) clearance letter for Seg Pro V3 (RT-300):

Acceptance Criteria and Reported Device Performance

Study Details Proving Device Meets Acceptance Criteria

2. Sample size used for the test set and the data provenance:

• Sample Size: 175 cases.
• Data Provenance: Consecutively collected from the Cancer Imaging Archive (TCIA) datasets. The data was acquired independently from product development training and internal testing. Race and ethnic distribution within the study data patient population was unavailable.
• Geographic Origin (inferred): TCIA is primarily a US-based resource, so data is likely from the United States or a diverse international collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Three.
• Qualifications of Experts: Board-certified radiation oncologists.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Adjudication Method: "Each OAR contour used as ground truth (GT) was independently generated by three board-certified radiation oncologists." This implies a consensus or agreement among all three experts was used to define the ground truth, effectively a 3-way consensus. The document does not explicitly state an adjudication method like 2+1, but the independent generation by three experts suggests a high-quality, agreed-upon ground truth.

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: No. The study primarily evaluated the standalone performance of the AI algorithm. The clinical validation mentions that Seg Pro V3 "operates as intended within a clinical workflow and supports its intended use as an adjunct tool," but it does not present data from an MRMC study comparing human reader performance with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone Performance: Yes. "a standalone performance evaluation was conducted to assess the Organ-at-Risk (OAR) contouring capabilities of Seg Pro V3. The observed results indicated that Seg Pro V3 by itself, in the absence of any interaction with a clinician, can contour developed OARs with satisfactory results." The reported DSC and HD metrics are from this standalone evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Ground Truth Type: Expert consensus. The ground truth (GT) for each OAR contour was "independently generated by three board-certified radiation oncologists."

8. The sample size for the training set:

• The document explicitly states that the 175 cases used for the standalone performance evaluation were "acquired independently from product development training and internal testing." However, the document does not specify the sample size of the training set used to develop the deep learning models.

9. How the ground truth for the training set was established:

• The document does not specify how the ground truth for the training set was established. It only describes the ground truth establishment for the test set.

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The GBT Machine AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis.

The GBT Machine AIRFLOW Prophylaxis Master is intended for use in the following dental and periodontal applications:

• Removing supra and subgingival calculus deposits and stains from teeth
• Periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planing

The GBT Machine AIRFLOW Prophylaxis Master is intended for use in the cleaning and polishing of teeth by the Projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.

The GBT Machine AIRFLOW Prophylaxis Master can be used for the following cleaning procedures:

• plaque removal for placement of sealants
• surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
• surface preparation prior to placing composite restorations
• effective plaque and stain removal for orthodontic patients
• cleaning prior to bonding ortho brackets
• cleaning implant fixture prior to loading
• stain removal for shade determination
• plaque removal prior to fluoride treatment
• plaque and stain removal prior to whitening procedure

The GBT Machine AIRFLOW Prophylaxis Master is also intended for use as an air-polisher in patients suffering from periodontal disease. The GBT Machine AIRFLOW Prophylaxis Master is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The GBT Machine AIRFLOW® Prophylaxis Master is a dental device that combines ultrasonic scaling and air-polishing functions into a single integrated system. It is a modified version of the AIRFLOW Prophylaxis Master previously cleared under 510(k) K190124. The device is compatible with EMS ultrasonic scaling instruments cleared under 510(k) K190124 and with prophylaxis powders including AIRFLOW CLASSIC (K190124), AIR-FLOW PERIO (K190124), and AIR-FLOW PLUS (K171189).

The device is composed of a central control unit, interchangeable handpieces (PIEZON, AIRFLOW, and PERIOFLOW), powder chambers, an irrigation system, and a wireless Bluetooth foot pedal. The control unit contains the power supply, ultrasonic generator, powder and fluid delivery circuits, and a microprocessor control system.

Treatment is activated via the wireless foot pedal, and the control panel allows the clinician to adjust power and irrigation levels. The ultrasonic scaling function operates in the 24-32kHz range using piezoelectric vibration to remove calculus and stains, while the air-polishing function sprays a mixture of air, water, and powder for supragingival and subgingival cleaning.

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The Ascent3T Neonatal Magnetic Resonance Imaging System (Ascent3T) is a whole-body magnetic resonance scanner designed for neonates and infants. The system can produce cross-sectional images of the internal structure of the head, body or extremities in any orientation.

Images produced by the Ascent3T show the spatial distribution of protons exhibiting magnetic resonance. Images produced by the Ascent3T, when interpreted by a trained physician, may provide information useful in diagnosis.

The Ascent3T Neonatal Magnetic Resonance Imaging System is suitable for neonates and infants weighing up to 9kg (19.8 lbs).

The Ascent3T Neonatal Magnetic Resonance Imaging System (Ascent3T) is a high-field magnetic resonance imaging system, appropriately sized and optimized for the neonate and infant population, with a format that allows siting near point of care. The Ascent3T presents a solution for the technical limitations associated with using an adult-size MRI system and provides clinicians with an improved ability to visualize and diagnose disease in the neonatal patient population.

The Ascent3T is equipped with a small format superconducting magnet designed for neonate applications. The system is designed to operate at 3.0 Tesla and achieves a high level of homogeneity over a 24cm diameter spherical volume using passive shims. The magnet requires a minimal amount of helium and no quench pipe. These features, in combination with the size and weight of the magnet, support near-patient siting.

The Ascent3T patient table is detachable and can serve as a patient transport device. The patient table includes a tabletop cradle with features for securing the patient during scanning. The patient table is mobile, providing flexibility in workflow based on institutional needs and preferences.

The Ascent3T contains a menu of pulse sequences intended to provide the user with a variety of sequences useful for producing images for diagnostic purposes.

Key Features of the Ascent3T:

• 3T superconducting magnet with 25cm patient bore.
• Minimal helium capacity with no quench pipe required.
• Gradient system: 80 mT/m maximum amplitude per axis, 300 mT/m/ms slew rate per axis.
• Real-time SAR monitoring and alerts with Normal and First-Level Controlled Operating Modes.
• Capable of producing images in axial, sagittal, coronal, and oblique orientations.
• Accommodates neonates and infants weighing up to 9 kg (19.8 lbs).
• Detachable, mobile patient table with built-in safety features.

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Elitone for Men is a non-implanted muscle stimulator designed to aid early continence recovery in men immediately following prostate surgery.

The Elitone for Men device is an electrical muscle stimulator designed to speed continence recovery in men following prostate surgery. Stimulation is delivered to the pelvic floor muscles and surrounding structures via a disposable electrode component configured to be applied to the skin in the perineal region. A small control unit component generates a therapeutic stimulation and allows the patient to increment or decrement the stimulation intensity. The applied electrical stimulation causes muscle contraction and relaxation in a treatment regimen that, with regular use over multiple weeks, is intended to speed continence recovery.

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The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

• Severe arthropathy with a grossly deficient rotator cuff;
• Previously failed joint replacement with a grossly deficient rotator cuff;
• Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
• Bone defect in proximal humerus;
• Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
• Inflammatory arthritis including rheumatoid arthritis;
• Correction of functional deformity.

The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures.

All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

The AltiVate Reverse® ADLC Glenosphere is a line extension to the existing Reverse Shoulder Prosthesis® (RSP) Glenosphere for use in reverse Total Shoulder Arthroplasty (TSA) applications. The new implants consist of glenospheres manufactured from titanium alloy (Ti-6Al-4V) and coated on the articulating surface with amorphous diamond-like carbon (ADLC).

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The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licensed medical practitioner.

It is intended to assist a licensed medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation.

Elekta Synergy and Elekta Harmony are the default entry-level configurations. It is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, and hypofractionation in all areas of the body where such treatment is indicated.

Elekta Infinity and Elekta Harmony Pro are the default mid-level configuration. It is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy – SBRT; stereotactic ablative radiotherapy – SABR) in all areas of the body where such treatment is indicated.

Versa HD and Elekta Evo are the default high-level configuration. It is intended to be used for single or multiple fractions using standard fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy – SBRT; stereotactic ablative radiotherapy – SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated and for the treatment of functional disorders, such as trigeminal neuralgia.

The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.

The Elekta Medical Linear Accelerator (EMLA) is an external beam, image guided Radiation Therapy device to assist a licensed practitioner in the delivery of ionizing radiation to a defined target volume. The system is located in a radiation-shielded treatment room and consists of several sub-systems, such as, the electron accelerator, beam shaping, imaging, computerized control systems and a treatment table to support the patient with accessories for patient positioning and set-up to deliver therapeutic treatments.

The EMLA is equipped with a MV portal imaging sub-system, i.e. iViewGT, and an optional kV imaging sub-system, i.e. XVI. The table is capable of linear and rotational movements.

The user interface controlling devices are located partly in the treatment room and partly in the control room.

The EMLA is made available in the following models: Elekta Synergy, Elekta Harmony, Elekta Infinity, Elekta Harmony Pro, Versa HD, Elekta Evo. The major differences are described in section VII.

The provided FDA 510(k) clearance letter and summary for the Elekta Medical Linear Accelerator (EMLA) describes performance testing for differences between the subject devices (new EMLA models) and the predicate devices (older EMLA models, K210500). The primary focus of the performance testing detailed in the summary is related to improvements in CBCT image quality and reconstruction.

Here’s a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria alongside corresponding reported device performance values. Instead, it describes general improvements and conformance to standards. The acceptance is implicitly based on meeting or exceeding the predicate device's performance, especially for the high-definition (HD) reconstruction.

2. Sample size used for the test set and the data provenance

• FDK based reconstruction function (Image Quality Evaluation): "acquired image quality phantom data" - Specific sample size not provided, likely laboratory phantom data.
• FDK based reconstruction function (Image Registration Accuracy): "phantom data and CT reference data" - Specific sample size not provided, likely laboratory phantom data.
• HD Reconstruction vs. FDK (Image quality comparison - clinical data sets): A total of 124 different clinical data sets.
• HD Reconstruction vs. FDK (Image registration accuracy - clinical patient CBCT projection data sets): A total of 13 different clinical patient CBCT projection data sets.
• HD Reconstruction vs. FDK (Clinical image quality evaluation - clinical patient data): Specific number of patients/data sets not explicitly stated, but clinical patient data was used for qualitative comparison.

Data Provenance: The document does not explicitly state the country of origin for the clinical data or explicitly state whether it was retrospective or prospective. Given it's clinical data sets for evaluating reconstruction, it's highly likely to be retrospective data collected from clinical operations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states:

• For the FDK based reconstruction: "reconstruct a CBCT volume image which is suitable for visualizing anatomies to enable certain clinical judgment" - this implies expert judgment in assessment, but does not specify the number or qualifications.
• For the HD Reconstruction: "suitable for visualizing the pelvic anatomies to enable certain clinical judgment".
• "A clinical image quality evaluation was performed between HD Reconstruction function and FDK based reconstruction function, using clinical patient data, where user qualitatively compared image quality between the predicate device and the subject device and reported improved image quality." - This indicates qualitative evaluation by "user", but the number and specific qualifications (e.g., radiologist with X years of experience) are not defined. The document also mentions "Formal validation of the clinical workflows has been performed by competent and professionally qualified personnel" but does not specify them in relation to ground truth establishment for the test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth or evaluating the clinical image quality. It generally refers to qualitative comparison by "user" or "competent and professionally qualified personnel".

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

The document mentions "A clinical image quality evaluation was performed between HD Reconstruction function and FDK based reconstruction function, using clinical patient data, where user qualitatively compared image quality between the predicate device and the subject device and reported improved image quality." It also notes "A clinical survey shows a preference towards the HD Reconstruction of the subject device over the predicate."

This suggests a form of reader study or survey was conducted, where users (human readers) compare images from the legacy FDK method (without the new AI-ML component) to the HD Reconstruction (which "includes an AI-ML based component to estimate the scatter"). However, it's not explicitly labeled as a "multi reader multi case (MRMC) comparative effectiveness study" in the formal sense, and no quantitative effect size of improvement for human readers is provided. The improvement is described qualitatively (e.g., "improved image quality," "better uniformity and HU accuracy," "preference").

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, standalone algorithm performance evaluation was done for the FDK and HD reconstruction functions. This is evident from:

• "Image quality evaluation was performed for the FDK based reconstruction function, using acquired image quality phantom data, to evaluate uniformity, spatial resolution, low contrast visibility, and geometric accuracy in accordance with IEC 60601-2-68;"
• "Image quality comparison was performed between HD Reconstruction function and FDK based reconstruction function, using data acquired on phantom data, to evaluate uniformity, spatial resolution, low contrast visibility, and geometric accuracy in accordance with IEC 60601-2-68."
• "Image quality comparison was performed between HD Reconstruction function and FDK based reconstruction function, using a total of 124 different clinical data sets, to evaluate uniformity, Hounsfield Unit consistency, signal-to-noise ratio, contrast-to-noise ratio, and contrast consistency."

These evaluations measure the intrinsic performance of the reconstruction algorithms without explicit human interaction beyond setting up the evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The types of ground truth used include:

• Phantom Data: For evaluating image quality metrics (uniformity, spatial resolution, low contrast visibility, geometric accuracy) and image registration accuracy (against CT reference data). Phantoms often have known properties or are designed to allow for quantitative measurement of image accuracy.
• CT Reference Data: Used for comparing image registration accuracy. CT imaging is considered a high-fidelity reference.
• Clinical Patient Data: Used for comparing various image quality metrics (Hounsfield Unit consistency, signal-to-noise ratio, contrast-to-noise ratio, contrast consistency) and for qualitative "user" comparison of image quality. The "ground truth" for clinical image quality comparison would effectively be the subjective assessment of the users or experts performing the comparison against each other, and against the clinical utility standards.
• Simulated Monte Carlo data: Used to train the neural network component of the HD reconstruction that estimates scatter. This implies a simulated ground truth for scatter estimation.

8. The sample size for the training set

The document states: "It includes an AI-ML based component to estimate the scatter to enable its automatic removal from the projection images acquired by the imager ahead of the volume reconstruction. Simulated Monte Carlo data is used to train the network."

The specific sample size for the training set (i.e., the amount of simulated Monte Carlo data) for the AI-ML component is not provided.

9. How the ground truth for the training set was established

The ground truth for the training set of the AI-ML component was established through Simulated Monte Carlo data. Monte Carlo simulations are a computational method that can model the physical interactions of radiation with matter, providing a "ground truth" for scatter estimation in this context.

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