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510(k) Data Aggregation
(121 days)
The SR-8100 Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities). The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted: The device may be used for diagnostic imaging of head, cervical spine, lumbar spine, pelvis or extremities. The device may be used for imaging of the chest when used without a grid.
This device is not to be used on bariatric patients, unless imaging body extremities. This device is not intended for mammography.
This SR-8100 Portable X-ray Unit is a portable digital device developed, designed and manufactured by SIUI. Its high-definition imaging and low-dose X-ray significantly minimize harm to patients and practitioners. The device consists of the following major components: an X-ray main unit, an exposure hand switch and a charger. The X-ray main unit is mainly for emitting X-rays required for X-ray exams; the hand switch is for output control of X-ray emitting, and the charger is for charging the built-in battery in the X-ray main unit.
The device can be used with an X-ray detector (see the table below for the basic requirements), a computer for receiving and detecting signal results and image processing software.
The major components of the X-ray main unit include: handle, enclosure, control panel, system control (SYS) board, high-voltage tank, collimator (beam limiter), lithium-ion battery and system control software running on the SYS board.
The system control software is for real-time interaction and control with various circuit modules inside the portable X-ray unit. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, the battery power status, and control the display of the status indicators.
The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites. Since the kV range of this device is 40~100kVp, which is not suitable for breast exams, the device is not intended for mammography.
The provided text is a 510(k) summary for the SIUI SR-8100 Portable X-ray Unit. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics. Crucially, it explicitly states that "Clinical testing is not necessary for the SR-8100 Portable X-ray unit in order to demonstrate substantial equivalence to the predicate device."
This means the document does not contain information about a clinical study involving human subjects or AI algorithms that would require acceptance criteria, sample sizes for test sets, expert ground truth establishment, or MRMC studies. The device described is a traditional X-ray unit, not an AI-powered diagnostic tool. Therefore, I cannot extract the requested information as it is not present in the provided text.
Specifically, the following requested information cannot be found or is not applicable:
- A table of acceptance criteria and the reported device performance: This is typically for clinical performance or AI algorithm performance. The document only discusses performance in terms of technical specifications (kV, mA, etc.) comparable to a predicate.
- Sample sized used for the test set and the data provenance: No clinical test set is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set is described.
- 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: Not applicable, as this is solely an X-ray imaging device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no clinical study with ground truth is mentioned.
- The sample size for the training set: Not applicable, as this is not an AI algorithm.
- How the ground truth for the training set was established: Not applicable, as this is not an AI algorithm.
The document states that the "performance tests of the device shows that the performance specifications of the device comply with the requirements of mobile X-ray system." and "As confirmed by the radiologist, the results of the image quality test show that the clinical diagnostic requirements of the image quality of each part meet the criteria requirements." However, these are general statements about the device's image quality meeting clinical needs, not a structured clinical study with specific acceptance criteria and detailed performance metrics as would be required for an AI device.
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(58 days)
The SR-8230/SR-8230S Portable X-ray Unit is a portable X-ray device, intended for use by a qualified/trained physician or technician for the purpose of acquiring X-ray images of the desired parts of patient's anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).
The device may be used for handheld diagnostic imaging of body extremities.
The system is subject to the following limitations of use when stand-mounted:
- -The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.
- -The device may be used for imaging of the chest when used without a grid.
This device is not intended for mammography.
This SR-8230/SR-8230S Portable X-ray Unit is a portable digital device developed, designed and manufactured by SIUI. The device consists of the following major components: an X-ray main unit, an exposure hand switch and a charger. The X-ray main unit is mainly for emitting X-rays required for X-ray exams; the hand switch is for output control of X-ray emitting, and the charger is for charging the built-in battery in the X-ray main unit. The difference between SR-8230 and SR-8230S is the operation interface of the device only. The SR-8230 has the display interface with button-operation digital tube, while the SR-8230S has the display interface with touch screen operation. Except for the difference above, the 2 models (SR-8230 and SR-8230S) are completely the same in all the other mechanical and circuit design. The major components of the X-ray main unit include: handle, enclosure, control panel, system control (SYS) board, high-voltage tank, collimator (beam limiter), lithium-ion battery and system control software running on the SYS board. The system control software is for real-time interaction and control with various circuit modules inside the portable X-ray unit. The software responds to user operations on the control panel. The user can adjust and control the kV and mAs parameters, and the software will display the parameters or directly load the APR parameters. The software loads the control data from X-ray output into the high-voltage generation control circuit of the system control board, and control the high-voltage tank to generate high-voltage to excite the X-ray tube inside to emit X-rays, control the switch of the collimator indicator, and monitor the working status of the device, the battery power status, and control the display of the status indicators. The system is for X-ray imaging and diagnosis in facilities with mobile or fixing sites. Since the kV range of this device is 40~125kVp, which is not suitable for breast exams, the device is not intended for mammography. The device can be used with an X-ray flat panel detector, a computer for receiving and detecting signal results and an image processing software. The portable X-ray unit SR-8230 /SR-8230S is designed for handheld or stand-mounted imaging. The portable X-ray unit SR-8230 / SR-8230S can be configured to an optional portable stand/rack or use a stand that complies with IEC 60601- 1 safety standard.
This document is a 510(k) summary for the SR-8230/SR-8230S Portable X-ray Unit. It appears to focus on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria for AI performance or a study demonstrating such.
Therefore, the following information you requested regarding acceptance criteria and performance study for an AI device is largely not applicable to this document, as it describes a conventional X-ray unit, not an AI-powered diagnostic device.
However, I can extract the general acceptance criteria for the device itself (not AI performance) and how it met those, primarily through compliance with medical device standards and comparison to predicate devices.
General Acceptance Criteria and Reported Device Performance (Non-AI)
| Acceptance Criteria Type | Acceptance Criteria (General Device) | Reported Device Performance |
|---|---|---|
| Safety and Essential Performance | Compliance with IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-54 (X-ray specific), IEC 60601-1-3 (Radiation Protection) | The device "complies with and/or was tested in accordance with" these standards. "The test results showed compliance with the above standards." |
| Risk Management | Compliance with ISO 14971 (application of risk management) | Not explicitly detailed, but implied by overall compliance and substantial equivalence claim. |
| Biocompatibility | Compliance with ISO 10993-1 (evaluation & testing), ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation & hypersensitivity) | Not explicitly detailed, but implied by overall compliance and substantial equivalence claim. |
| Software Life-cycle | Compliance with IEC 62304 (software life-cycle processes) | "The system control software... is new software designed by SIUI. The software adopts development languages of keil, the program language is C language, the hardware platform is ARM." Implied compliance with the standard through development process. |
| Usability | Compliance with IEC 60601-1-6 (usability), IEC 62366-1 (usability engineering) | Not explicitly detailed, but implied by overall compliance and substantial equivalence claim. |
| Labeling | Compliance with ISO 15223-1 (symbols for labels), ISO 13485 (quality management) | Not explicitly detailed, but implied by overall compliance and substantial equivalence claim. |
| Substantial Equivalence | Comparable technical features, general functions, applications, and indications for use to predicate devices, without raising new safety or effectiveness concerns. | Detailed comparison tables (Table 1, Table 2, Table 3) are provided, highlighting similarities and differences. The conclusion states, "The subject device SR-8230/SR-8230S system and the predicate device are comparable in terms of technical features, general functions, applications and indications for use." |
| Image Quality | (Implied for X-ray devices) Provide images addressing diagnostic requirements. | "In terms of effectiveness, the clinical images of bone and soft tissues of the subject device can address doctor's diagnostic requirements for the sites." (From 5.10 Conclusion) |
Information Not Applicable to this Document (as it is not an AI device submission):
- Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical performance study with a test set of patient data for an AI algorithm. The "test results" mentioned pertain to engineering and electrical safety standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for an AI algorithm is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This document describes a physical X-ray unit, not an AI algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Nature:
This 510(k) submission is for a conventional portable X-ray unit (SR-8230/SR-8230S). The primary method for demonstrating its safety and effectiveness is through compliance with recognized electrical and medical device standards (e.g., IEC 60601 series, ISO 14971) and by showing substantial equivalence to existing legally marketed predicate X-ray devices. The document explicitly states that "Clinical testing is not necessary for the SR-8230/SR-8230S Portable X-ray unit in order to demonstrate substantial equivalence to the predicate device." Therefore, there are no AI-specific acceptance criteria or performance studies mentioned within this submission.
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