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The device is intended to be used with endoscopic accessories such as a biopsy forceps and Electronic Endoscope Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.

The Flexible Ureterorenoscope System consists of a sterile Flexible Ureterorenoscope and an Electronic Endoscope Image Processor with its accessories power adapter. The Flexible Ureterorenoscope is provided sterile (sterilized by EO) and is single use.

The Flexible Ureterorenoscope consists of a head section, bending section, insertion section, operating section, electrical connection section, and built-in LED light source. The Electronic Endoscope Image Processor is powered by the main line.

The Flexible Ureterorenoscope is an endoscope instrument and is intended to be used with the Electronic Endoscope Image Processor during endoscopic procedures. The handle section features several key components, including a control lever, a handle for manipulation, a button for capturing photos or video, and a Luer port for the insertion of accessories or irrigation to the working channel.

The insertion section houses a working channel and wiring to transmit the image signals to the image processor. The distal bending section of the insertion section contains a camera lens for real-time image capture, an LED light source for illumination, and a distal outlet for the working channel.

The Electronic Endoscope Image Processor is a video processor which is intended and designed for use during endoscopic procedures. It receives and processes image signals from the endoscope and outputs signals to an external medical monitor for display.

The Electronic Endoscope Image Processor has integrated software to control the operation of the device and is a reusable device that does not require sterilization before use, as there is no direct/in-direct patient contact material. The image processor is intended to be cleaned and disinfected before use, the cleaning and disinfection method is validated and recommend in the User Manual.

The equipment is for use in a hospital or qualified medical institution. It is only to be used by skilled physicians trained in clinical endoscopic techniques and procedures.

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Diode Laser Hair Removal Machine (Model: GLD01) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

The Diode Laser Hair Removal Machine (Model: GLD01) consists with the power system, microprocessor controller system, operation and screen system, cooling system, laser module and security alarm system. The microprocessor control the laser power, which can provide the constant current for the laser module. The inner high energy diode, from the laser module, transform the electronic to light energy, which output the constant laser with wavelength.The laser light on the skin by leaded crystal, penetrate into the deep tissue of the skin. The light energy is absorbed and then turned into the thermal energy, which can destroy the hair follicle tissue, make it gone and never grow again.

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The Q-Renew LLLT Hair Growth Helmet is indicated for the promotion of hair growth in males who have Norwood-Hamilton classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.

The Q-Renew LLLT Hair Growth Helmet is a non-invasive, at-home low-level laser/light therapy (LLLT) device designed to promote hair growth in both men and women. It uses a dual light system that combines laser diodes (wavelength 655nm) with LEDs (wavelengths 630nm, 660nm, and 680nm) to deliver optimal light absorption by the scalp.

The device consists of a Q-Renew LLLT helmet, a charging base and a USB-C charging cable.

The helmet features an adjustable fit, controlled by a rear adjustment wheel, and an intuitive LCD screen for operation. Users can:

• Start or pause treatments
• Select treatment zones
• Check battery status
• View remaining session time

The helmet has a power button for turning the device on/off. The device also includes smart sensors—removing the helmet automatically pauses the session, while repositioning it resumes treatment. Each session lasts 12 minutes, after which the device stop the treatment automatically.

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The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.

The SER Pen Carain MicroSystem is a handheld powered microneedling device consisting of a rechargeable motorized handpiece and disposable, single-use needle cartridges (12-pin and 36-pin). Microneedles are made of surgical-grade stainless steel (304) and are gamma sterilized.

Design modifications include:

• Addition of a powered 7-speed control head (6,200–9,000 RPM) with direct corded power option.
• Modified disposable cartridge (Model T2.0), shortened by 7 mm, with protective cap and compensatory spring.

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The Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.

The Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP434-, BP420-, BP431-, BP432-, BP400-) is a wearable powered breast pump intended to be used by lactating women to express and collect milk from their breast. The device is a non-sterile reusable device to be used by single user. The breast pump stimulates lactation and extracts milk from the breasts by creating a seal around the nipple and applying and releasing suction to the breast. The milk is collected in a milk collector. The device is electrically powered through a rechargeable Lithium battery (3.7V) that can be charged using the USB cable provided with the device.

The subject device includes three operating modes, namely - stimulation mode, expression mode, and mixed mode, with 15 levels of operation within each mode and a maximum suction of -315mmHg. In stimulation mode, the breast pump begins with a quick and short sucking pattern to get the milk to start flowing. In expression mode, the breast pump begins with a slow and long sucking pattern for milk expression, sucking more deeply and more slowly. In mixed mode, the breast pump begins with a quick and short sucking pattern, followed by a slow and long sucking pattern. The device features a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed during milk expression.

The pump remembers the mode and suction level settings. When restarted, it will resume with the same mode and suction level as when it was last turned off. Each mode's suction level setting is also remembered individually and remains consistent during future use.

The device can be connected wirelessly to a mobile device through Bluetooth and be operated through a dedicated mobile application (Mobile flow). By using the application, users can either select one of three preset operating modes or define a personalized mode. The personalized mode supports personalized sessions, each of which can select its own mode, suction level, and duration. Users can also enable a milk overflow reminder function in the app. Pumping output can also be recorded and tracked by users in the app.

The device is available in one or two pumps in a pack to allow for single/double pumping. The subject device includes an LED display that displays information regarding working mode, running time, suction level, battery status, full milk indicator and Bluetooth indicator. The user interface includes on/off/pause switch, mode selection switch, decrease pumping level, increase pumping level and Toggle button to select breast pump direction to left or right. The subject device includes a diaphragm to prevent milk backflow into the vacuum system as well as software based overflow protection.

The device includes a milk collection set that consists of the following: double-sealed flange (Polyphenylsulfone (PPSU) + Silicone), flange insert, diaphragm assembly, duckbill valve assembly, milk collector (Tritan) and main unit pump motor. Each component can be purchased separately by the user if needed.

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-- C822W
This Medical Monitor is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

-- C1216W
This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

-- C821W
This Medical Monitor is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

C1216W is 31 inch TFT color LCD monitor, C822W and C821W are 31.5 inch TFT color LCD monitor, they are intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.

These products have been strictly calibrated so that they can meet DICOM Part 3.14 and other standards. They use the latest generation of LED backlight panel. The built-in brightness stabilization control circuit makes sure the brightness of these monitors is stable, so this product meets the demand of high precision medical imaging. The anti-glare screen can prevent display from reflection under highlight conditions, make the image and display clearer.

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The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

The AETOS humeral stems (AETOS Humeral Meta Stems) and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement.

When used with the AETOS Humeral Meta Stems, The AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff.

When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by:

• Non-inflammatory degenerative joint disease
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only.

In Reverse:

The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by:

• Rheumatoid arthritis
• Non-inflammatory degenerative joint disease
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of devices if sufficient bone stock remains

The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear.

The coated humeral stems are indicated for uncemented use. The coated glenoid base plate is intended for cementless application with the addition of screws for fixation.

Note: All implant components are single use.

The AETOS Shoulder System Meta Humeral Prosthesis Size 0 subject to this submission is intended for press-fit fixation as of an implant construct in anatomic and/or reverse total shoulder arthroplasty for the treatment of skeletally mature individuals with degenerative diseases of the glenohumeral joint.

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• Class I and II restorations in deciduous teeth
• Class I, and non-stress bearing Class II restorations in permanent teeth
• Stress bearing Class II restorations in permanent teeth, keeping ≥1 mm distance from the cusp tips

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The Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure as well as the pulse rate by using the arm cuff. The device can be used in medical facilities or at home, and only for indoor use. It is supplied for OTC use.

The blood pressure monitor is a fully automatic, non-invasive upper arm measurement device using oscillometric methodology to measure systolic pressure, diastolic pressure and pulse rate. The device features an inflatable cuff that wraps around the arm, with a built-in pressure sensor and transducer that analyze arterial pulsations to determine blood pressure values. Measurement results are clearly displayed on the LCD screen.

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Syngo Carbon Clinicals is intended to provide advanced visualization tools to prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by the medical imaging modalities (for example, CT, MR, etc.)

OrthoMatic Spine provides the means to perform musculoskeletal measurements of the whole spine, in particular spine curve angle measurements.

The TimeLens provides the means to compare a region of interest between multiple time points.

The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired by medical imaging modalities.

An interface shall enable the connection between the Syngo Carbon Clinicals software package and the interconnected software solution for viewing, manipulation, communication, and storage of medical images.

Syngo Carbon Clinicals is a software only Medical Device, which provides dedicated advanced imaging tools for diagnostic reading. These tools can be called up using standard interfaces any native/syngo based viewing applications (hosting applications) that is part of the SYNGO medical device portfolio. These tools help prepare and process the medical image for evaluation, manipulation and communication of clinical data that was acquired by medical imaging modalities (e.g., MR, CT etc.)

Deployment Scenario: Syngo Carbon Clinicals is a plug-in that can be added to any SYNGO based hosting applications (for example: Syngo Carbon Space, syngo.via etc…). The hosting application (native/syngo Platform-based software) is not described within this 510k submission. The hosting device decides which tools are used from Syngo Carbon Clinicals. The hosting device does not need to host all tools from the Syngo Carbon Clinicals, a desired subset of the provided tools can be used. The same can be enabled or disabled thru licenses.

When preparing the radiologist's reading workflow on a dedicated workplace or workstation, Syngo Carbon Clinicals can be called to generate additional results or renderings according to the user needs using the tools available.

This document describes performance evaluation for two specific tools within Syngo Carbon Clinicals (VA41): OrthoMatic Spine and TimeLens.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• OrthoMatic Spine:

  • Test Set Sample Size: 150 spine X-ray images (75 frontal views, 75 lateral views) were used in a reader study.
  • Data Provenance: The document states that the main dataset for training includes data from USA, Germany, Ukraine, Austria, and Canada. While this specifies the training data provenance, the provenance of the specific 150 images used for the reader study (test set) is not explicitly segregated or stated here. The study involved US board-certified radiologists, implying the test set images are relevant to US clinical practice.
  • Retrospective/Prospective: Not explicitly stated, but the description of "collected" images and patients with various spinal conditions suggests a retrospective collection of existing exams.

• TimeLens: No specific test set details are provided as a reader study/bench test was not required.

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

• OrthoMatic Spine:

  • Number of Experts: Five US board-certified radiologists.
  • Qualifications: US board-certified radiologists. No specific years of experience are mentioned.
  • Ground Truth for Reader Study: The "mean values obtained from the radiologists' assessments" for the 150 spine X-ray images served as the reference for comparison against the algorithm's output.

• TimeLens: Not applicable, as no reader study was conducted.

4. Adjudication Method for the Test Set

• OrthoMatic Spine: The algorithm's output was assessed against the mean values obtained from the five radiologists' assessments. This implies a form of consensus or average from multiple readers rather than a strict 2+1 or 3+1 adjudication.
• TimeLens: Not applicable.

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

• OrthoMatic Spine: A reader study was performed, which is a type of MRMC study. However, this was a standalone performance evaluation of the algorithm against human reader consensus, not a comparative effectiveness study with and without AI assistance for human readers. Therefore, there is no reported "effect size of how much human readers improve with AI vs without AI assistance." The study aimed to show the algorithm replicates average human rater performance.
• TimeLens: Not applicable.

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

• OrthoMatic Spine: Yes, a standalone performance evaluation of the OrthoMatic Spine algorithm (without human-in-the-loop assistance) was conducted. The algorithm's measurements were compared against the mean values derived from five human radiologists.
• TimeLens: The description suggests the TimeLens tool itself is a "simple workflow enhancement algorithm" and its performance was evaluated through non-clinical verification and validation activities rather than a specific standalone clinical study with an AI algorithm providing measurements.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• OrthoMatic Spine:
  • For the reader study (test set performance evaluation): Expert consensus (mean of five US board-certified radiologists' measurements) was used to assess the algorithm's performance.
  • For the training set: The initial annotations were performed by trained non-radiologists and then reviewed by board-certified radiologists. This can be considered a form of expert-verified annotation.
• TimeLens: Not specified, as no clinical ground truth assessment was required.

8. The Sample Size for the Training Set

• OrthoMatic Spine:
  • Number of Individual Patients (Training Data): 6,135 unique patients.
  • Number of Images (Training Data): A total of 23,464 images were collected within the entire dataset, which was split 60% for training, 20% for validation, and 20% for model selection. Therefore, the training set would comprise approximately 60% of both the patient count and image count. So, roughly 3,681 patients and 14,078 images.
• TimeLens: Not specified.

9. How the Ground Truth for the Training Set Was Established

• OrthoMatic Spine: Most images in the dataset (used for training, validation, and model selection) were annotated using a dedicated annotation tool (Darwin, V7 Labs) by a US-based medical data labeling company (Cogito Tech LLC). Initial annotations were performed by trained non-radiologists and subsequently reviewed by board-certified radiologists. This process was guided by written guidelines and automated workflows to ensure quality and consistency, with annotations including vertebral landmarks and key vertebrae (C7, L1, S1).
• TimeLens: Not specified.

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