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The da Vinci Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

The Universal Seal (5-12 mm) is a sterile, single-use device. It provides a seal within a port of entry for endoscopes, instruments, and accessories with a diameter range between 5 mm and 12 mm. It also provides an attachment for insufflation accessories and allows for air to flow in or out of the body cavity while minimizing gas leakage.

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The system is a PET/CT system designed for providing anatomical and functional images. The PET provides the distribution of specific radiopharmaceuticals. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. PET and CT scans can be performed separately. The system is intended for assessing metabolic (molecular) and physiologic functions in various parts of the body. When used with radiopharmaceuticals approved by the regulatory authority in the country of use, the system generates images depicting the distribution of these radiopharmaceuticals. The images produced by the system are intended for analysis and interpretation by qualified medical professionals. They can serve as an aid in detection, localization, evaluation, diagnosis, staging, re-staging, monitoring, and/or follow-up of abnormalities, lesions, tumors, inflammation, infection, organ function, disorders, and/or diseases, in several clinical areas such as oncology, cardiology, neurology, infection and inflammation. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

The CT system can be used 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 professional medical society.

The proposed device uMI Panvivo combines a 295/235/534/712 mm axial field of view (FOV) PET and 160-slice CT system to provide high quality functional and anatomical images, fast PET/CT imaging and better patient experience. The system includes PET system, CT system, patient table, power distribution unit, control and reconstruction system (host, monitor, and reconstruction computer, system software, reconstruction software), vital signal module and other accessories.

The uMI Panvivo has been previously cleared by FDA via K251839.The main modifications performed on the uMI Panvivo (K251839) in this submission are the addition of two new models. The previous uMI Panvivo(K251839) is designed with scalable PET rings; uMI Panvivo ES is scaling to 180 PET rings and uMI Panvivo EX is scaling to 240 PET rings, compares to the uMI Panvivo 100 PET rings and uMI Panvivo S 80 PET rings.

Here's a breakdown of the acceptance criteria and study details for the AI-powered features of the uMI Panvivo PET/CT Systems, based on the provided FDA 510(k) clearance letter:

Overview of AI Features and their Studies for uMI Panvivo PET/CT Systems

This document describes the acceptance criteria and study methodologies for four AI-powered features integrated into the uMI Panvivo PET/CT Systems: DeepMAC, uExcel DPR, OncoFocus, and NeuroFocus.Brain, as well as AIEFOV.

1. DeepMAC (Metal Artifact Reduction)

DeepMAC is an image post-processing technology that uses pre-trained neural networks to reduce metal artifacts and improve image quality in CT scans.

Acceptance Criteria and Reported Device Performance for DeepMAC:

Study Details for DeepMAC:

• Sample size for the test set: 20 human subjects (clinical dataset) and PMMA phantom datasets.
• Data provenance: Collected from various clinical sites, different from the training data. No overlap between training and testing data.
• Number of experts and qualifications (for ground truth/evaluation): Two American Board of Radiologists certified physicians.
• Adjudication method for the test set: Not explicitly stated for quantitative evaluation. For clinical evaluation, radiologists independently evaluated images.
• MRMC comparative effectiveness study: Not explicitly mentioned as a formal MRMC study design. However, clinical images were evaluated by radiologists to verify effectiveness.
• Standalone performance: The quantitative evaluation on PMMA phantom data represents standalone algorithmic performance.
• Type of ground truth: For phantom data: "control image" (presumably ideal images without artifacts). For training data: "corresponding ground truth images without metal artifacts" derived from system simulations. For clinical evaluation: expert opinion from board-certified radiologists.
• Sample size for the training set: Not explicitly stated beyond "system simulations".
• How ground truth for training set established: Derived from system simulations, with pairs of image data: images with metal artifacts and corresponding ground truth images without metal artifacts.

2. uExcel DPR (Deep Progressive Reconstruction for PET)

uExcel DPR is a deep learning-based PET reconstruction algorithm designed to optimize the iterative reconstruction process, reduce noise, and improve contrast by utilizing pre-trained deep neural networks.

Acceptance Criteria and Reported Device Performance for uExcel DPR:

Study Details for uExcel DPR:

• Sample size for the test set: 8 human subjects (clinical dataset) and two NEMA IQ phantom datasets.
• Data provenance: Collected from uMI Panvivo EX and uMI Panvivo ES systems. Testing data are entirely independent from the training data, collected using different types of PET/CT scanners. Asian ethnicity (100%).
• Number of experts and qualifications (for ground truth/evaluation): Two American board-certified nuclear medicine physicians.
• Adjudication method for the test set: Blind comparison between images reconstructed using uExcel DPR and OSEM algorithms. Physicians evaluated images independently.
• MRMC comparative effectiveness study: Yes, a blind comparison was conducted, showing images with uExcel DPR had lower noise, improved contrast, and greater sharpness compared to OSEM. The effect size, though not quantified by a specific metric like AUC improvement, states a "maximum noise reduction of 47% and an average SNR improvement of 131%" in phantom analysis, and "superior image SNR" in human subjects.
• Standalone performance: Yes, NEMA IQ phantom analysis directly assesses algorithmic performance.
• Type of ground truth: For training: "Full-sampled data" serves as ground truth, while "corresponding down-sampled data" (created with varying factors) acts as training input. For validation: NEMA IQ phantom standards; OSEM reconstruction images for comparison; expert opinion from board-certified nuclear medicine physicians.
• Sample size for the training set: Not explicitly stated, sourced from uEXPLORER and uMI Panorama GS PET/CT systems.
• How ground truth for training set established: Full-sampled data from long-axis datasets (from uEXPLORER and uMI Panorama GS PET/CT systems) served as the ground truth.

3. OncoFocus (Respiratory Motion Correction)

OncoFocus is a motion correction technique that uses deep learning to correct respiratory motion artifacts in PET/CT images, improving accuracy of SUV and lesion volume. It includes a body cavity segmentation network (CNN-SEG) and an attenuation map synthesis network (CNN-AC).

Acceptance Criteria and Reported Device Performance for OncoFocus:

Study Details for OncoFocus:

• Sample size for the test set: 13 human subjects (clinical patient cases) specifically tested on uMI Panvivo EX and uMI Panvivo ES.
• Data provenance: Collected from clinical scenarios, different from the training data. No overlap between training and testing data. Asian ethnicity (100%).
• Number of experts and qualifications (for ground truth/evaluation): Two American Board of Radiologists-certified physicians.
• Adjudication method for the test set: Not explicitly stated for quantitative metrics. For clinical evaluation, radiologists independently compared OncoFocus images and NMC images.
• MRMC comparative effectiveness study: Not explicitly mentioned as a formal MRMC study design. Clinical evaluation involved comparison by radiologists, showing enhancement of diagnostic confidence.
• Standalone performance: Yes, quantitative measurements like ∆Volume and ∆SUVmax demonstrate algorithmic performance.
• Type of ground truth: For training data:
  • CNN-SEG: Input data are CT-derived attenuation coefficient maps; target data are body cavity region images.
  • CNN-AC: Input data are non-attenuation-corrected (NAC) PET reconstruction images; target data are reference CT attenuation coefficient maps.
    For validation: NMC images for comparative quantitative analysis; expert opinion from board-certified radiologists.
• Sample size for the training set: Not explicitly stated, collected from "general clinical scenarios" using UIH PET/CT systems.
• How ground truth for training set established:
  • CNN-SEG: Target data (body cavity region images) were established based on CT-derived attenuation coefficient maps.
  • CNN-AC: Target data (reference CT attenuation coefficient maps) were established using NAC PET reconstruction images.

4. NeuroFocus.Brain (Head Artifact Elimination in Brain PET)

NeuroFocus.Brain is a motion management technology that incorporates AI to eliminate head artifacts in brain PET imaging, automatically detecting motion and selecting motion-free data for reconstruction. It includes a brain segmentation network (CNN-SEG) and a CNN-based attenuation map synthesis network (CNN-AC).

Acceptance Criteria and Reported Device Performance for NeuroFocus.Brain:

Study Details for NeuroFocus.Brain:

• Sample size for the test set: One Monte Carlo-simulated brain phantom case (with motion and stationary scenarios) and 7 human subjects (clinical volunteer cases with notable head motion artifacts).
• Data provenance: For clinical cases: retrospecitively identified. Testing datasets for the networks were collected on a scanner different from the one used for the training data, ensuring complete separation. Asian ethnicity (100%).
• Number of experts and qualifications (for ground truth/evaluation): Two American Board of Radiologists-certified physicians.
• Adjudication method for the test set: Not explicitly stated for quantitative metrics. For clinical evaluation, radiologists independently compared reconstructed images with and without NeuroFocus.Brain.
• MRMC comparative effectiveness study: Not explicitly mentioned as a formal MRMC study design. Clinical evaluation involved comparison by radiologists, showing enhancement of diagnostic confidence.
• Standalone performance: Yes, quantitative measurements on simulated phantom and clinical cases assess algorithmic performance.
• Type of ground truth: For training data:
  • CNN-SEG: Input data are CT-derived attenuation coefficient maps; target data are brain region images.
  • CNN-AC: Input data are non-attenuation-corrected (NAC) PET reconstruction images; target data are reference CT attenuation coefficient maps.
    For validation: Monte Carlo simulated stationary scans (ideal without motion); reconstruction without NeuroFocus.Brain for clinical comparison; expert opinion from board-certified radiologists.
• Sample size for the training set: Not explicitly stated, collected from "general clinical scenarios" using UIH PET/CT systems.
• How ground truth for training set established:
  • CNN-SEG: Target data (brain region images) were established based on CT-derived attenuation coefficient maps.
  • CNN-AC: Target data (reference CT attenuation coefficient maps) were established using NAC PET reconstruction images.

5. AIEFOV (Artificial Intelligence Extended Field of View)

AIEFOV aims to improve the accuracy of CT values, and the accuracy and uniformity of PET image SUV by performing attenuation correction with CT generated by the AIEFOV algorithm, especially when the scanned object exceeds the CT field of view.

Acceptance Criteria and Reported Device Performance for AIEFOV:

| Evaluation Item | Criteria | Reported Device Performance |
| :--------------------- | :--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------0-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | :--------------------------------------------------------- |
| Quantitative evaluation | When scanned object exceeds CT field of view: AI EFOV shall improve the accuracy of CT value, and improve the accuracy and uniformity of PET image SUV by performing attenuation correction with CT generated with AIEFOV algorithm. Compared to the ground truth, the uniformity and SUV deviation of PET image obtained by using AIEFOV for attenuation correction should be less than 5%. When scanned object does not exceed CT field of view: AI EFOV shall have consistent CT value, and PET image SUV by performing attenuation correction with CT generated with AIEFOV algorithm. | Pass (improves SUV accuracy when object exceeds CT-FOV; consistent SUV when within CT-FOV) |
| Clinical Evaluation | AI EFOV has the potential to enhance homogeneity and reduce image artifacts. | Verified |

Study Details for AIEFOV:

• Sample size for the test set: Bench tests included water phantom scans. Clinical evaluation included 6740 images from 4 patients (Table 10).
• Data provenance: For clinical cases, collected from uMI Panvivo EX/ES. Testing datasets were collected from various clinical sites and were different from the training data. No overlap between training and testing data. Asian ethnicity (100%).
• Number of experts and qualifications (for ground truth/evaluation): Two American Board qualified clinical experts for blind comparison.
• Adjudication method for the test set: Blind comparison by two experts for image artifacts, homogeneity, and diagnostic confidence.
• MRMC comparative effectiveness study: Not explicitly mentioned as a formal MRMC study. Clinical evaluation involved blind comparison by experts.
• Standalone performance: Yes, performance bench tests on water phantoms and quantitative SUV deviation measurements represent algorithmic performance.
• Type of ground truth:
  • For phantom study: the "ground truth" for SUV deviation and uniformity is implied to be a reference value from an ideal (untruncated) scan.
  • For training: "simulated gold standard" consists of images free from truncation artifacts, derived from system simulations based on the same patient.
  • For clinical evaluation: expert opinion from board-qualified clinical experts.
• Sample size for the training set: Not explicitly stated, collected from "clinical data with different patient body sizes and different scanning positions."
• How ground truth for training set established: "Simulated gold standard" (images free from truncation artifacts) was used as the network output, generated by reconstructing from data where both sides of the detector had not been truncated, contrasting with the input (images reconstructed with truncation artifacts). manually quality-controlled.

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The UltraScore™ Focused Force PTA Balloon is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post dilatation of balloon expandable stents, self-expanding stents, and stent grafts in the peripheral vasculature.

The UltraScore™ Focused Force PTA Balloon consists of a flexible, over-the-wire (OTW) catheter shaft with a semi-compliant balloon fixed at the distal end. For all balloon lengths, radiopaque markers delineate the working length of the balloon and aid in balloon placement. For balloon lengths of 100 mm and greater, two radiopaque markers are positioned on the distal portion of the balloon and one radiopaque marker is positioned on the proximal portion of the balloon to differentiate between the distal and proximal ends of the balloon. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. Two scoring wires, oriented 180° apart, provide focused force upon dilatation. The UltraScore™ Focused Force PTA Balloon is compatible with 0.014" or 0.035" guidewires, as denoted by the product labeling. The distal portion of the 0.014" guidewire compatible catheters is hydrophilically coated. The proximal portion of the catheter includes a female luer lock hub connected to the catheter with a guidewire lumen and an inflation lumen. Packaged with every product is a protective sheath that is positioned over the balloon and must be removed prior to use. A stylet is placed into the tip of the catheter. These products are not made with natural rubber latex.

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The UV Smart D60 is indicated for use in a healthcare environment to achieve a high level disinfection (HLD) of external surfaces of Transesophageal Echocardiogram (TEE) probes that do not contain lumens and that do not contain indentations or channels that are deeper than their widths.

The UV Smart D60 provides chemical-free high level disinfection using Ultraviolet-C (UV-C) light within a fully enclosed disinfection chamber. The system features eight UV-C lamps, UV-C-reflective chamber walls, and UV-C-transmitting instrument holders designed to suspend the intended load in an optimal position. The fixed disinfection cycle time of 120 seconds is the only critical determinant of disinfection efficacy. The disinfection efficacy is verified during each cycle by two independent threshold sensors—one for UV-C dose and one for power consumption.

The UV Smart D60 is intended to be used in healthcare facilities by trained personnel. Prior to disinfection, each soiled instrument must be cleaned at the bedside and manually cleaned in accordance with the original equipment manufacturer (OEM) instructions for use. Under normal operating conditions, the UV Smart D60 has an expected service life of ten years, with preventive maintenance and lamp replacement required annually, as specified in the UV Smart D60's Instructions for Use.

To ensure that the intended load is both physically compatible with the disinfection chamber and capable of receiving the required HLD UV-C dose (Minimum Effective Dose or MED) on its surfaces, the intended load is approved for use with the UV Smart D60. Once approved, the intended load is released for use in the UV Smart D60's traceability system. The UV Smart D60 will not initiate a disinfection cycle unless a registered instrument is recognized, ensuring that only approved instruments can be processed.

Each disinfection cycle accommodates a single instrument, which is suspended entirely within the D60's disinfection chamber—ensuring that all surfaces, including handles and attached cables, receive the MED for validated high level disinfection.

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uCT 780 is a computed tomography x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac and vascular).

uCT 780 is intended to be used 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 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.

uWS-CT-Dual Energy Analysis is a post-processing software package that accepts UIH CT images acquired using different tube voltages and/or tube currents of the same anatomical location. The various materials of an anatomical region of interest have different attenuation coefficients, which depend on the used energy. These differences provide information on the chemical composition of the scanned body materials and enable images to be generated at multiple energies within the available spectrum. uWS-CT-Dual Energy Analysis software combines images acquired with low and high energy spectra to visualize this information.

The Computed Tomography X-ray system, uCT 780, is intended to produce cross-sectional images of the patient by computer reconstruction of X-ray transmission data taken at different angles and planes. These images may be obtained either with or without contrast.

This 510(k) is to request modifications for the cleared Computed Tomography X-ray system uCT 780. uCT 780 has been previously cleared by FDA via K241079.The modification performed on the uCT 780 (K241079) in this submission is due to the addition of a new high voltage generator. At the same time, we introduce a mobile configuration which supports installation in vehicles. A summary of the modified hardware is provided below:

• A new model of high voltage generator uXG 100 has been introduced in the mobile configuration, and the predicate model CT140N80X4889 is still used in other non-mobile configurations.
• A tilt lock has been introduced to the gantry and a horizontal movement lock has been introduced to the standard config patient table, and the system software has been updated to include the relevant controls and prompts.
• PSC has been modified, including adding a shock-absorbing base, strengthening the sheet metal structure, and optimizing the fixing method of PSC.

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The Unity DX instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of anterior and posterior ocular structures and measurement of anterior segment and biometric parameters including:

• Axial Length
• Anterior Chamber Depth
• Central Corneal Thickness
• Lens Thickness

The Reference Image functionality is intended for use as an ocular image capture tool.

The UNITY DX instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of anterior and posterior ocular structures and measurement of anterior segment and biometric parameters including axial length, anterior chamber depth, corneal thickness, lens thickness, and reference image. The UNITY DX device has four (4) measurement modalities: HP-OCT, wavefront measurement, reference image, and reflective topography.

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UpDoc is a software as a medical device (SaMD) intended to provide medication management for patients aged 18 years and older who have been diagnosed with type 2 diabetes.

UpDoc provides patients with insulin treatment plan instructions based on a healthcare provider (HCP)-specified treatment plan.

UpDoc contains two user-interactive software components:

• Patient User Interface (UpDoc mobile application): Intended for use by patients with type 2 diabetes as an aid in optimizing insulin management. Patients use the mobile application to log blood glucose, meal, symptom, and medication adherence data, and receive treatment plan instructions. Data may be entered manually or reported via voice or text-based interactions. The application may also receive blood glucose data via a Bluetooth-enabled glucometer or continuous glucose monitor.

• HCP User Interface (UpDoc web portal): Intended for use by trained healthcare providers to configure and manage the patient-specific insulin treatment plan. This includes insulin dosing instructions (type, starting and maximum doses, adjustment algorithm, and blood glucose targets) and safety protocols to address non-emergency hypoglycemia, hyperglycemia, and related symptoms.

Insulin instructions are computed in UpDoc's cloud-based application based on the HCP-defined treatment parameters.

UpDoc is a software as a medical device (SaMD) designed to assist patients aged 18 years and older with insulin management for type 2 diabetes. Healthcare providers (HCPs) set an individualized treatment plan for their patients that includes monitoring and insulin titration instructions. UpDoc engages with patients to help them follow their designated treatment plan and supports HCPs in monitoring reported health data, medication adherence, and treatment progress.

UpDoc is composed of three modular software components: a provider-facing web portal (UpDoc Provider Portal), a patient mobile application (UpDoc Patient App), and a cloud-based application consisting of a Conversation Service (UpDoc Agent) and a Clinical Service. These components work together to support safe and effective provider-directed insulin therapy.

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