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JLK-NCCT is a radiological computer-aided triage and notification software designed for analyzing non-contrast head CT (NCCT) images. The software assists hospital networks and trained clinicians by flagging and communicating them of findings suggestive of (1) Intracranial Hemorrhage (ICH) and (2) large vessel occlusion (LVO) involving the internal carotid artery (ICA), middle cerebral artery M1 (MCA-M1) and middle cerebral artery M2 (MCA-M2) on NCCT images.

JLK-NCCT employs an artificial intelligence (AI) algorithm to analyze images and highlight cases with detected (1) ICH or (2) LVO on an on-premises or cloud-based JLK server. This occurs in parallel with the ongoing standard of care image interpretation. Users receive notifications for cases with suspected ICH and LVO findings via mobile devices. Notifications include compressed preview images for informational purposes only and not intended for diagnostic use beyond notification.

The device does not modify the original medical image, and is not intended to be used as a primary diagnostic device. The results of JLK-NCCT are intended to be used in conjunction with other patient information and professional judgment to assist with triage and prioritization of medical images. Clinicians who receive notifications are responsible for reviewing full images per the standard of care. JLK-NCCT is intended for adults use only.

JLK-NCCT is a radiological computer-assisted triage and notification (CADt) software that complies with the DICOM standard. It functions as a Non-Contrast Computed Tomography (NCCT) processing module, prioritizing triage, and notification for suspected intracranial hemorrhage (ICH) and large vessel occlusion (LVO). Operating as a notification-only tool, it assists hospital networks and clinicians by flagging critical cases and alerting specialists independent of standard workflows. JLK-NCCT's AI algorithm analyzes NCCT scans for ICH and LVO indicators and provides automated notifications to streamline clinical decision-making.

JLK-NCCT consists of an AI-based image analysis algorithm hosted on JLK servers either on-premises or cloud-based and a mobile software module for notification management. The AI processes NCCT head scans, detecting suspected ICH and LVO, and transmits mobile notifications with compressed preview images for triage. PACS integration is optional and supported when available. The system does not modify original medical images and is not intended for diagnostic use. JLK-NCCT integrates the JLK-ICH Model (ICH detection), LVO score Model (ischemic assessment), and HAS Model (Hyperdense Artery Sign detection), supporting real-time alerts and prioritization within hospital workflows (the ICH algorithm is the same as the device cleared under K243363).

JLK-NCCT was trained using clinical datasets from the U.S. and South Korea, totaling 3,067 cases, sourced from multiple institutions to ensure diversity and robustness. The dataset included NCCT scans acquired using imaging equipment from various manufacturers, such as GE, Siemens, Philips, and Toshiba, covering a range of scanning parameters to enhance model generalizability. Data were collected from institutions across different geographic locations, including hospitals in North Carolina and Texas in the U.S., as well as Seoul St. Mary's Hospital and other South Korean medical centers. All imaging studies were labeled by board-certified neuroradiologists. This diverse dataset strengthens the AI model's applicability across various clinical environments, supporting its role as a triage and notification tool for assisting clinicians in early detection and prioritization of suspected ICH and LVO cases.

The performance of the device's AI algorithms was validated in a standalone performance evaluation using an independent dataset different from the one used for algorithm training. Each case output from the JLK-NCCT device was compared with a ground truth standard determined by two ground truthers, with a third ground truther intervening in cases of disagreement (i.e., 2+1 truther scheme). All truthers were US board-certified neuroradiologists.

Here's a breakdown of the acceptance criteria and study details for the JLK-NCCT device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on LVO detection performance for the standalone study, as the ICH algorithm was previously cleared.

Study Details for JLK-NCCT Performance Evaluation

Here's a detailed breakdown of the study that proves the device meets the acceptance criteria:

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 288 cases for the standalone evaluation (144 LVO Positive, 144 LVO Negative).
   • Data Provenance: Retrospective study. The data were "newly acquired" and "independent of the training dataset." No specific countries of origin for the test set are mentioned, but the training data was from the U.S. and South Korea.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Number of Experts: Two ground truthers, with a third intervening in cases of disagreement.
   • Qualifications of Experts: All truthers were U.S. board-certified neuroradiologists.

3. Adjudication Method for the Test Set:

   • Method: 2+1 truther scheme. Two ground truthers independently assessed each case, and a third ground truther intervened to resolve any disagreements.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

   • Was it done?: Yes, a reader performance study was conducted.
   • Effect Size (Improvement with AI vs. without AI assistance):
     • Sensitivity: JLK-NCCT demonstrated a sensitivity of 0.792.
       • Improvement over all readers (Neuroradiologist and General Radiologist average): 0.224 (0.792 - 0.568), (95% CI: 0.144–0.306).
       • Improvement over general radiologists: 0.159 (0.792 - 0.633), (95% CI: 0.083–0.237).
       • Improvement over neuroradiologists: 0.267 (0.792 - 0.525), (95% CI: 0.174–0.356).
     • Specificity: JLK-NCCT demonstrated a specificity of 0.933.
       • Improvement over all readers (Neuroradiologist and General Radiologist average): 0.093 (0.933 - 0.840), (95% CI: 0.038–0.150).
       • Improvement over general radiologists: 0.137 (0.933 - 0.796), (95% CI: 0.070–0.205).
       • Improvement over neuroradiologists: 0.064 (0.933 - 0.869), (95% CI: 0.005–0.126).
     • The device "satisfied both criteria show General Radiologist superiority and Neuroradiologist non-inferiority." This indicates that the AI significantly improved performance for general radiologists and did not degrade (or potentially improved) performance for neuroradiologists.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

   • Was it done?: Yes. The document states, "A standalone performance evaluation using an independent dataset different from the one used for algorithm training." Performance metrics (Sensitivity, Specificity, AUC for LVO detection, and Time-to-Notification) are reported for this standalone performance.

6. The Type of Ground Truth Used:

   • Type: Expert consensus, established by U.S. board-certified neuroradiologists using a 2+1 truther scheme.

7. The Sample Size for the Training Set:

   • Sample Size: 3,067 cases.

8. How the Ground Truth for the Training Set Was Established:

   • Method: "All imaging studies were labeled by board-certified neuroradiologists." The exact number of neuroradiologists per case or the adjudication method for the training set is not specified, but it was expert-labeled.

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This device is intended to measure blood pressure and pulse rate in patients over 12 years old with an upper-arm circumference ranging from 22 cm to 45 cm (8.7 in to 17.7 in). It is not suitable for neonates, pregnant individuals, or patients with pre-eclampsia. The device can be used at home or in a healthcare facility.

YUWELL® Blood Pressure Monitor (Model: YE630CR) is a rechargeable lithium battery-powered, automatic, noninvasive upper-arm blood pressure measuring system intended for over-the-counter (OTC) use. YE630CR is designed for people with upper arm circumference ranging from 22 cm to 45 cm (8.7 in to 17.7 in). The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated by an air pump and it deflates via an exhaust valve. During inflation, the cuff pressure is monitored, and the pulse waveform data is captured. The pulse waveform data is then further analyzed by software which determines pulse rate, as well as the systolic and diastolic blood pressures.

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This product is indicated for measuring blood pressure and pulse rate in patients older than 12 years. It is not suitable for neonates, pregnant individuals, or patients with pre-eclampsia. The device can be used at home or in a healthcare facility.

YUWELL® Blood Pressure Monitor (Model: YE650AR) is a rechargeable lithium battery-powered, automatic, noninvasive, upper-arm blood pressure measurement system intended for use by adults. The YE650AR is designed for upper arm circumference ranging from 22 cm to 32cm (8.7 in to 12.5 in) or 22 cm to 45 cm (8.7 in to 17.7 in). The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve. During deflation, the cuff pressure is monitored, and pulse waveform data is captured. The pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.

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YUWELL® Finger Pulse Oximeters are non-invasive, non-sterile, reusable, and spot-checking devices that measure and display SpO₂ and pulse rate (PR) via the patient's finger. They are indicated for use in adults and children (weight > 30 kg) and are intended for professional and home settings. These devices are unsuitable for continuous monitoring, use during motion, or in patients with low perfusion.

YUWELL® Finger Pulse Oximeter (the Oximeter) is a finger pulse oximeter designed to measure functional oxygen saturation (SpO₂) of arterial hemoglobin and pulse rate (PR) in adults and children (weight > 30 kg). The device operates by detecting changes in light absorption caused by blood pulsation in the vascular bed, which are used to determine SpO₂ and PR. It contains light-emitting diodes (LEDs) and a photodetector, with the photodetector positioned on the opposite side of the probe from the LEDs. SpO₂ and PR are displayed on the device's LED/OLED screen, providing a visual pulse indicator that blinks in sync with the detected PR.

The Oximeter is powered by two AAA alkaline batteries and does not feature alarms. The YX310 and YX110 models can transfer data to a mobile device wirelessly whereas the YX105 and YX106 models do not transfer data.

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Arm-type Fully Automatic Digital Blood Pressure Monitors(Model: DBP-62F4L, DBP-62F4B, DBP-61F4, DBP-61F4L, DBP-61D2L, DBP-63D2L, DBP-61D9L, DBP-63D9L) are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm.

Arm-Type Fully Automatic Digital Blood Pressure Monitor( Model: DBP-61D2L-P, DBP-63D2L-P, DBP-61D9L-P, DBP-63D9L-P, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm. The device is also indicated in pregnant women with normotension, gestational hypertension, or preeclampsia with circumference ranging from 22cm to 42cm.

Arm-Type Fully Automatic Digital Blood Pressure Monitor( Model: DBP-61D2L, DBP-63D2L, DBP-61D9L, DBP-63D9L, DBP-62F4L, DBP-62F4B, DBP-61F4, DBP-61F4L,) are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm.

Arm-Type Fully Automatic Digital Blood Pressure Monitor( Model:DBP-61D2L-P,DBP-63D2L-P, DBP-61D9L-P, DBP-63D9L-P, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P)are intended to measure blood pressure (systolic and diastolic) and pulse rate of adults and adolescents over 12 years of age with circumference ranging from 22cm to 42cm. The device is also indicated in pregnant women with normotension, gestational hypertension, or preeclampsia with circumference ranging from 22cm to 42cm.

They are automatic, non-invasive, blood pressure measurement system for over-the-counter (OTC) use at home and clinical environment. The systolic and diastolic pressures are determined using the oscillometric method, where the cuff is inflated with an integral controllable piezoelectric pump and deflates via an electric automatic rapid deflation valve. During inflation measurements, an electric pump within the main unit slowly inflates the arm cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The cuff can measure pressure range from 0 to 299mmHg, and the pulse rate range from 30 to 180 beats/min. The pulse rate measurement is compare the longest and the shortest time intervals of detected pulse waves to mean time interval and displays a warning signal with the reading to indicate the detection of irregular heartbeat when the difference of the time intervals is over 25%.The devices are not intended to detect atrial fibrillation or any other arrhythmias. The Irregular heartbeat indicator is solely intended as a technical error/indicator. Irregular heartbeat rhythm is defined as rhythm that is either 25% slower or faster than the average rhythm detected while measuring systolic blood pressure and diastolic blood pressure.

DBP-62F4L, DBP-62F4B, DBP-62F4L-P, DBP-62F4B-P with bluetooth function can be used as a stand-alone unit to finish the blood pressure measurement or in conjunction with the APP through embed a 2.4GHz BLE module that allow users to connect with nearby BT receiving terminal. Once measurement is over, the LCD display of the device appears results. And the device will start to transmit data to the pair-up terminal automatically.

DBP-63D2L, BP-63D9L, DBP-63D2L-P, DBP-63D9L-P with additional WiFi function can also allow users better receive measurement result on mobile phone.

With the use of software (including APP) and wireless communication module, the wireless software function and hardware function are solely intended to transfer, store, convert formats, or display medical device data and results (blood pressure and pulse rate readings), without controlling or altering the functions or parameters of any connected medical devices, which is not be intended for active patient monitoring, therefore, based on the FDA guidance titled 'Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices' (issued on September 28, 2022.), this software function is belong to Non-device-MDDS, and the hardware function is belong to Device-MDDS, they are not subject to FDA laws and regulations applicable to devices.

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The manual wheelchair is to provide mobility to persons limited to a sitting position.

A wheelchair is a chair with wheels, designed to be a replacement for walking, where it is propelled by the seated occupant turning the rear wheels by hand. There are also handles behind the seat for someone else to do the pushing. The device is intended for adults only.

W50 is a mechanical wheelchair including four wheels, a steel frame cover black paint and a textilene upholstery that is flame resistant. W50 has a physical dimension of 1130mm x 840mm x 950mm (depth x width x height) with the seat itself has a dimension of 525mm x590mm x 470mm (depth x width x height). The device has a weight capacity of 227 kilograms, and weighs about 24 kilograms. The color is dark black.

Occupant mass group of the manual wheelchair belongs to III. Armrest is non flip back/non height adjustable. Rear axle is offset axle, quick release axle.

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The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

The digitally designed personalized copings to be used with the Direct Connection Screw to Multi-Unit Abutment are to be:

• Sent to Straumann for manufacture at a validated milling center, or
• Manufactured following the Neodent InLab Validated Workflow.

The Neodent InLab Validated Workflow is indicated for the design and fabrication of screw-retained multi-unit restorations for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components: scan files from intra-oral scanners, CAD software, CAM software, milling machines and associated tooling and accessories.

The purpose of this premarket notification is to obtain market clearance to expand the options for fabrication of digitally designed personalized copings for use with the Neodent Direct Screw to multiunit abutment (MUA) from a "validated milling center" (cleared in K242686), to include a digital dentistry workflow.

The Neodent InLab Validated Workflow is integrated by multiple components of digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, milling machines and associated tooling and accessories. This new workflow employs optical impression files that document the topographical characteristics of teeth and traditional dental impressions, which are transferred to the CAD software (CARES® Visual, 3Shape or Exocad) and allows the design of the desired restorations, according to the Direct Screw to MUA dimensions. The CAM software converts the digital restoration design into the tooling and tool path commands needed to fabricate the restoration by the indicated milling equipments (Roland and Zirkonzahn).

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The Ready-to-Use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for individuals (men, women, pediatrics) who are unable to promote natural urine flow or have a significant volume of residual urine following a natural bladder-voiding episode.

The catheter is inserted into the urethra to reach the bladder, allowing urine to drain and ensuring bladder emptying.

Ready to use Nelaton Catheter is a sterile, single use catheter, intended to be inserted through the urethra to the bladder for intermittent urine drainage. The catheters are available in a variety of lengths and French sizes to accommodate individual anatomy of adult and pediatric patients (including males and females).

The catheter is made of polyurethane, and is not made with PVC. It is prelubricated with a hydrophilic coating. The distal end is either a smooth closed straight or coude tip with two eyelets for efficient drainage. The color-coded funnel at the proximal end can be connected to a urine collection container. There is a gripper on the catheters for adult males (length of 40cm), which serves as protection from the user's touch and aids the user during insertion.

The catheter is sealed in a foil pouch with the hydration liquid (distilled water) in one compartment, so the coated catheter is lubricated by direct contact with the hydration liquid and can be ready to use. Ready to use Nelaton Catheter is sterilized by E-beam irradiation, and the shelf life is 3 years.

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ARMI® Hysteroscopy System 2.0 is intended to be used for viewing of the adult cervical canal and uterine cavity for the purpose of performing diagnostic and operative procedures.

The ARMI® Hysteroscopy System 2.0 (subject device) is a hysteroscope and compatible accessories consisting of the following components:

• ARMI® Endoscopic Video Image Processor (non-sterile, reusable), JY-MIP-3000
• ARMI® Single-Use Hysteroscope (sterilized with ethylene oxide), SH-01A, SH-02A, SH-03A, SH-04A, SH-05A, SH-01B, SH-02B, SH-03B, SH-04B, SH-01C, SH-02C, SH-03C, SH-04C
• Disposable Electronic Hysteroscope (sterilized with ethylene oxide) (510(k) cleared under K210270),
• Power cord and Power adapter (non-sterile, reusable),
• Hysteroscope cable (non-sterile, reusable), and
• HDMI cable (non-sterile, reusable) (optional)

Both hysteroscopes are single-use and the rest of the components are reusable.

The image processor is powered by an AC adapter (100 – 240V AC, 50/60 Hz) or battery (7.4V DC).

The subject device includes 13 models of the ARMI Single-Use Hysteroscope. The models have a working length of 245 mm. The models have different image resolutions, tip angles, insertion diameters, and instrument channel diameters.

The subject devices are noted to contain two different LED models (0301, 9653) and three different image sensors (ovm6946/ochsa10/ov9734).

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