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510(k) Data Aggregation
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Digital Medical X-ray Imaging System is intended to acquire X-ray images of the human body by a qualified technician, examples include acquiring two-dimensional X-ray images of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. The visualization of such anatomical structures provide visual evidence to radiologists and clinicians in making diagnostic decisions. This device is not intended for mammography.
uDR Arria and uDR Aris are two models of Digital Medical X-ray Imaging System developed and manufactured by Shanghai United Imaging Healthcare Co., Ltd(UIH). The system is equipped with imaging chain components and utilizes enhanced processing technology, so it can offer radiographic images with high image quality. The intuitive user interface and easy-to-use functions provide clinical users with a experience during patient examination and image processing.
The system is intended to acquire X-ray images of the human body by a qualified technician, examples include acquiring two-dimensional X-ray images of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. The visualization of such anatomical structures provide visual evidence to radiologists and clinicians in making diagnostic decisions. This device is not intended for mammography.
Here's a breakdown of the acceptance criteria and study details for the uDR Arria and uDR Aris devices, based on the provided FDA 510(k) clearance letter:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary provided details for two specific optional software functions: uVision and uAid. Other aspects of the device are X-ray imaging systems, for which the primary "performance" is image quality, which is evaluated subjectively through clinical image evaluation rather than quantitative metrics and acceptance criteria.
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| uVision (Optional) | When users employ the uVision function for automatic positioning, the automatically set system position and field size will meet clinical technicians' criteria with 95% compliance. | In 95% of patient positioning processes, the light field and equipment position automatically set by uVision can meet the clinical positioning and shooting requirements. In the remaining 5% of cases, based on the light field and system position automatically set by the equipment, technicians still need to make manual adjustments. |
| uAid (Optional) | A 90% pass rate for "Grade A" images, aligning with industry standards (e.g., European Radiology and ACR-AAPM-SPR Practice Parameter guidelines which state Grade A image rates in public hospitals generally range between 80% and 90%).Implicitly, for specific criteria: Sensitivity and specificity of whether there is a foreign body, whether the lung field is intact, and whether the scapula is open all exceed 0.9. | Average time of uAid algorithm: 1.359 seconds (longest does not exceed 2 seconds).Maximum memory occupation of uAid algorithm: not more than 2GB.Sensitivity and specificity of whether there is a foreign body, whether the lung field is intact, and whether the scapula is open all exceed 0.9.The uAid function can correctly identify four types of results: Foreign object, Incomplete lung fields, Unexposed shoulder blades, and Centerline deviation, making classifications (Green: qualified, Yellow: secondary, Red: waste). |
| Clinical Image Quality | Each image was reviewed with a statement indicating that image quality is sufficient for clinical diagnosis. | Sample images of chest, abdomen, spine, pelvis, upper extremity and lower extremity were provided. A board-certified radiologist evaluated the image quality for sufficiency for clinical diagnosis. |
2. Sample Size Used for the Test Set and Data Provenance
uVision:
- Sample Size: The evaluation results provided are from a single week's worth of data, totaling 328 chest cases and 20 full spine or full lower limb stitching cases from the specified period (2024.12.17 - 2024.12.23).
- Data Provenance: The device with uVision function (serial number 11XT7E0001) has been in use for over a year at a hospital. The testing data includes individuals of all genders and varying heights capable of standing independently. It is prospective in the sense that it was collected during routine clinical operation after installation and commissioning. The country of origin is not explicitly stated but implied to be China, given the manufacturer's location.
uAid:
- Sample Size: The document does not provide a single total number for the test set. Instead, it breaks down the data by age/gender distribution and the distribution of positive/negative cases for each criterion.
- Age/Gender Distribution: Total 5680 patients (sum of all male/female/no age/no age, no gender categories).
- Criterion-specific counts:
- Lung field segmentation: 465 Negative, 31 Positive
- Spinal centerline segmentation: 815 Negative, 68 Positive
- Shoulder blades segmentation: 210 Negative, 1089 Positive
- Foreign object: 1078 Negative, 3080 Positive
- Data Provenance: Data collection started in October 2017, from the uDR 780i and "different cooperative hospitals." The study was approved by the institutional review board. The data is stored in DICOM format. It is retrospective, collected from existing hospital data. Country of origin not explicitly stated but implied to be China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
uVision:
- Number of Experts: The results were "statistically analyzed by clinical experts." The exact number is not specified, but the term "experts" suggests more than one.
- Qualifications: "Clinical experts" is a general term. Specific qualifications (e.g., radiologist, radiologic technologist, years of experience) are not provided.
uAid:
- Ground truth establishment for uAid's classification categories (Foreign object, Incomplete lung fields, Unexposed shoulder blades, Centerline deviation) is not explicitly described in terms of experts or their qualifications. The acceptance criteria reference "relevant research and literature" and "industry guidelines and standards," suggesting that the ground truth for image quality categorization might be derived from these established definitions.
Clinical Image Quality (General):
- Number of Experts: "A board certified radiologist." This indicates one expert.
- Qualifications: "Board certified radiologist." This is a specific and high qualification for evaluating radiographic images.
4. Adjudication Method for the Test Set
uVision:
- The document states that the results were "statistically analyzed by clinical experts." This implies some form of review and judgment, but a formal adjudication method (e.g., 2+1, 3+1) is not described. It's presented as an evaluation of the system's compliance with technician criteria.
uAid:
- The method for establishing ground truth classifications for uAid's criteria (Foreign object, Incomplete lung fields, Unexposed shoulder blades, Centerline deviation) is not detailed, so an adjudication method is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not explicitly described for either uVision or uAid or the overall device. The studies focused on evaluating the standalone performance of the AI features and the overall clinical image quality (subjective expert review), rather than comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, standalone performance was evaluated for both uVision and uAid.
- uVision: The reported performance is how well the "automatically set system position and field size" meet "clinical technicians' criteria" when the uVision function is used for automatic positioning. While technicians use the function, the performance metric itself is about the accuracy of the system's automatic output before manual adjustment.
- uAid: The reported performance metrics (sensitivity, specificity, processing time, memory usage) are direct measurements of the algorithm's output in categorizing image quality criteria. The system classifies images and presents the evaluation "instantly accessible to radiologic technologists," but the evaluation itself is algorithmic.
7. The Type of Ground Truth Used
uVision:
- The ground truth for uVision appears to be clinical technicians' criteria. The metric is "meet clinical technicians' criteria with 95% compliance," implying that the "correct" positioning is defined by the standards and expectations of experienced technicians.
uAid:
- The ground truth for uAid's image quality classification is based on established clinical quality control criteria for chest X-rays. The acceptance criteria explicitly reference "mature industry guidelines and standards, such as those from European Radiology and the ACR-AAPM-SPR Practice Parameter." This suggests an expert consensus-driven or guideline-based ground truth for what constitutes a "Grade A" image or the presence of specific issues like foreign objects or incomplete lung fields.
8. The Sample Size for the Training Set
uVision:
- The sample size for the training set for uVision is not provided. The document explicitly states that the "testing dataset was collected independently from the training dataset, with separated subjects and during different time periods."
uAid:
- The sample size for the training set for uAid is not provided. It is mentioned that "The data collection started in October 2017... from different cooperative hospitals" for the overall data reservoir, but specific numbers for training versus testing are not given. Similar to uVision, the testing data is stated to be "entirely independent and does not share any overlap with the training data."
9. How the Ground Truth for the Training Set Was Established
uVision:
- The method for establishing the ground truth for the training set for uVision is not provided.
uAid:
- The method for establishing the ground truth for the training set for uAid is not provided. While the testing set's ground truth is implied to be based on industry guidelines and clinical criteria, the process for prospectively labeling training data is not detailed.
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(51 days)
UltraPrint-Dental Denture UV is indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures.
UltraPrint-Dental Denture UV is intended for continuous use in the oral environment, exclusively for professional dental work.
UltraPrint-Dental Denture UV can be used in combination with a 3D printer using a 385nm light source. A 3D-printer is not part of the device.
The Subject device is a light-cured methacrylate-based resin used in 3D printers for the production of full or partial denture base. The Subject device is used by a dentist or dental technician for the CAD/CAM manufacturing of full or partial denture base.
The Subject device is used within a validated manufacturing workflow to create the intended dental device. Dental devices fabricated using the Subject device are prescription-only devices.
Methacrylates are known materials, commonly used in the dental industry for fixed and removable prosthetic devices due to their physical-chemical, mechanical, and biocompatible properties.
The Subject device is intended to be sold by the bottle and used with compatible hardware 3D printers and their nesting software, and post-curing devices.
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(119 days)
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150)
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is specifically indicated for use in MRI procedures for the delivery of the following contrast media:
- Gadobutrol Injection in single-dose (SD) container or Imaging Bulk Package (IBP)
- Gadopiclenol Injection in SD container or IBP
- Gadobenate dimeglumine Injection in SD container
- Gadoterate meglumine Injection in SD container
Easy-Click-Cassette – flex Max 2M and Easy-Click-Cassette – flex Max 3 are used for a maximum time of twenty-four (24) hours or a maximum of 96 bottles of contrast media, whichever comes first.
Use time expiration per SD container is a maximum of four (4) hours, unless otherwise stated by the contrast media labeling.
Use time expiration per IBP or saline container is a maximum of twenty-four (24) hours, unless otherwise stated by the media labeling.
Spike for MRI disposable is for single-bottle use only and must be discarded with the media container. The Patient tubing must be discarded after each patient procedure.
ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is to be used only by and under quasi-continuous supervision of trained healthcare professionals in an appropriate licensed healthcare facility, in a room designated for radiological procedures that involve intravascular administration of contrast agent.
The ulricheasyINJECT Max 2M / 3 (XD 10140 / XD 10150) is not intended for injection of contrast media (CM) for high-pressure angiography.
ulricheasyINJECT Max 3 (XD 10180)
ulricheasyINJECT Max 3 (XD 10180) is a contrast media management system that is indicated for the controlled, automatic administration, on the venous side, of contrast media and saline (NaCl), to human subjects undergoing diagnostic examinations in magnetic resonance (MR) applications.
ulricheasyINJECT Max 3 (XD 10180) is specifically indicated for use in MRI procedures for the delivery of the following contrast media:
- Gadobutrol Injection in single-dose (SD) container or Imaging Bulk Package (IBP)
- Gadopiclenol Injection in SD container or IBP
- Gadobenate dimeglumine Injection in SD container
- Gadoterate meglumine Injection in SD container
ulricheasyINJECT Max is a syringeless contrast media management system that is designed for the controlled, automatic venous administration of contrast media in conjunction with physiological saline solution to human subjects undergoing diagnostic examinations in Magnetic Resonance Imaging (MRI or PET MRI).
The ulricheasyINJECT Max device consists of a terminal, injector, and tubing system. The injector is a mobile pedestal device that consists of an injector head and injector base with rechargeable battery. The tubing system is the only component that comes in contact with the patient and has indirect contact with the blood path of a patient for a limited duration (few minutes). The tubing system consists of the following three components:
- Spikes,
- Easy-Click-Cassette – flex
- Patient Tubing
The ulricheasyINJECT Max uses a peristaltic pump as part of the injector which is designed to transport the media fluid through the tubing system (spikes, cassette, and patient tubing). ulricheasyINJECT Max is intended to be used with the following components that are not supplied with the system:
- Saline containers,
- Single-dose contrast media bottles,
- Imaging Bulk Package (IBP) contrast media containers, and
- Cannula.
ulricheasyINJECT Max is equipped with multiple hardware and software controls that work together for the safe operation of the intended use of the system. Controls include air detectors to detect the presence of air in the tubing system without direct contact with the medium, pressure controls to manage and regulate pressure inside the tubing system, and check valves to prevent backflow of media and avoid retrograde contamination.
The ulricheasyINJECT Max is provided in three models:
- ulricheasyINJECT Max 2M (XD 10140),
- ulricheasyINJECT Max 3 (XD 10150), and
- ulricheasyINJECT Max 3 (XD 10180).
The Max 3 models have 3 media connection points: 1 NaCl and 2 Contrast Media connections. The Max 2M has 2 media connection points: 1 NaCl and 1 Contrast Media connections. Max 2M and Max 3 are technically identical except the different available media connection points.
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(82 days)
The Universal Spinal System is intended for non-cervical posterior and anterolateral fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Universal Spinal System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e. scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Universal Spinal System is intended to treat pediatric patients diagnosed with spondylolisthesis/ spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The HOBBIT Growth Connectors are indicated in patients under 10 years of age with potential for additional spinal growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early-onset spinal deformities associated with thoracic insufficiency, including early-onset scoliosis, as part of a growing rod construct.
Universal Spinal System includes the HOBBIT 4.75 Spine System, HOBBIT 5.5/6.0 Spine System, HOBBIT MIS Spine System, HOBBIT 5.5/6.0 HA coated spine system and Anterior Thoracic-lumbar Spine System. Universal Spinal System consists of a variety of structures and sizes of pedicle screws, nut, rods, connectors, hook, transconnectors.
Universal Spinal System is made from Ti-6Al-4V ELI following ASTM F136 or Ti-6Al-4V following ASTM F1472 or Co-Cr-Mo following ASTM F1537.
The implants are provided as sterile or non-sterile, while the instruments are provided as non-sterile.
The implants are intended for single-use only, while the instruments are reusable.
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(169 days)
Unimed Reusable SpO2 Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.
The subject device is Unimed Reusable SpO2 Sensors intended for non-invasive measurement of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in clinical settings. The sensor is designed for compatibility with CSI 8100EP1, and is supplied non-sterile.
The sensor consists of a connector, a cable, and a finger clip housing incorporating a light-emitting diode (LED) and photodetector (PD). The subject device operates on the same principle and share similar design features, materials, and performance characteristics as the predicate device.
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(169 days)
Unimed Reusable SpO2 Sensors are indicated for the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in adult patients weighing greater than 30 kg who are either well or poorly perfused. The device is intended for use under no-motion conditions in professional healthcare environments. These devices are for prescription use only.
The subject device (U403S-06) is Unimed Reusable SpO2 Sensor and are fully compatible for use with BCI SPECTRO2 10. The sensor is supplied non-sterile.
The subject sensor consists of a plug/connector (BCI DB9 sensor connector), a cable (1.1 m), and a patient-contacting sensor (soft tip: U403S-06) where light-emitting diode (LED) and photodetector (PD) are located. The subject sensor shares the same principle of operation as the predicate device for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements. Also, the subject sensor has identical material composition and performance characteristics to the predicate device.
The purpose of the submission is to receive clearance to market U403S-06 under their own 510k.
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