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510(k) Data Aggregation
(94 days)
RADspeed Pro
The RADspeed PRO is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed Pro enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The RADspeed PRO uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals. The device is not intended for mammographic applications.
The RADspeed PRO is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The RADspeed PRO can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed PRO consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. Optionally, the device is also used to perform tomosynthesis radiography by three different reconstruction modes. Filtered Back-Projection (FBP) mode is used to obtain a tomosynthesis image by performing back-projection after correcting the projection data. Shift Addition (SA) mode is used to obtain a tomosynthesis image at an arbitrary slice plane height by shifting each image according to projection angle of the tube based on the reconstruction height, and by applying image addition processing to them. Iteration (IR) mode is used to reduce metal artifact in tomosynthesis image. FBP mode is generally recommended for all body parts. In case an artifact is observed at joints and other similar places, SA mode may remedy this artifact. In case metal artifact is obviously displayed, IR mode is recommended to reduce metal artifact.
The provided document is a 510(k) premarket notification for the Shimadzu Corporation's RADspeed PRO, referencing K233722. It primarily focuses on demonstrating substantial equivalence to a predicate device (K152244) rather than presenting a performance study against specific acceptance criteria for a new clinical indication or AI algorithm.
The modifications to the RADspeed PRO are described as mainly cosmetic and updates to hardware components (larger displays, updated imaging panels that are themselves cleared 510k devices) and software infrastructure (programming language, operating system) without changes to the underlying software functionality or core technological features. The device does not appear to incorporate a new AI algorithm for diagnostic purposes that would require a study with clinical performance metrics like sensitivity, specificity, or reader improvement.
Therefore, the requested information regarding acceptance criteria and performance study results for an AI algorithm (including sample sizes, ground truth establishment, expert adjudication, MRMC studies, or standalone performance) is not present in the provided text.
The document states:
- "The fundamental technological features are the same for the subject and the predicate systems. The modifications are mainly cosmetic in nature." (Page 4)
- "The software functionality remains unchanged." (Page 5, Page 6)
- "The imaging components were replaced by more recently cleared digital x-ray receptor panels made by FUJIFILM. ... All the imaging panels have 510(k) clearance... The integration software, although updated, has the identical functionality to the predicate." (Page 5)
- "The radiation safety aspects of the device have not changed. The device remains compliant with the FDA Radiation Safety Standards." (Page 9)
- "The non-clinical data supports the safety of the device and the hardware and software verification and validation demonstrate that new device should performs as intended in the specified use. Based on our risk analysis and bench testing, the differences do not affect its clinical safety or effectiveness." (Page 9)
The performance testing mentioned (Software Validation, EMC and Electrical Safety Testing) is related to regulatory compliance and safety for the modified device, not to the clinical performance of a new diagnostic algorithm.
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(315 days)
RADspeed Pro
The RADspeed Pro is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The RADspeed Pro enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position.
The RADspeed Pro uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes. The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition.
The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals.
The device is not intended for mammographic applications.
The RADspeed Pro is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The RADspeed Pro can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed Pro consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well.
Optionally, the device is also used to perform tomosynthesis radiography by three different reconstruction modes. Filtered Back-Projection (FBP) mode is used to obtain a tomosynthesis image by performing back-projection after correcting the projection data. Shift Addition (SA) mode is used to obtain a tomosynthesis image at an arbitrary slice plane height by shifting each image according to projection angle of the tube based on the reconstruction height, and by applying image addition processing to them. Iteration (IR) mode is used to reduce metal artifact in tomosynthesis image. FBP mode is generally recommended for all body parts. In case an artifact is observed at joints and other similar places, SA mode may remedy this artifact. In case metal artifact is obviously displayed. IR mode is recommended to reduce metal artifact.
The provided text describes a 510(k) summary for the RADspeed Pro X-ray system. Here's a breakdown of the acceptance criteria and study details based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with quantitative performance metrics for disease detection or diagnostic accuracy. Instead, the performance studies primarily aim to demonstrate "substantial equivalence" to predicate devices, focusing on image quality and artifact reduction.
The closest to "acceptance criteria" are the conformities to various standards and the stated goal of achieving image quality comparable to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformity to IEC60601-1-2 (Electromagnetic compatibility) | Both the new device and primary predicate device are in conformity with IEC60601-1-2. (Difference in edition does not affect safety and effectiveness.) |
| Conformity to IEC10993-1 (Materials and Bio-compatibility) | All materials and components of the new device are in conformity with IEC10993-1 and are in clinical use by other commercial products. (Difference between new device and primary predicate device does not affect safety and effectiveness.) |
| Electrical, Mechanical, Chemical, and Thermal Safety | New device and primary predicate device are substantially equivalent by their conformed standards. |
| Software Risk Analysis, Verification, and Validation (as per FDA guidance) | Software Risk Analysis and Verification and Validation testing were conducted. The level of concern associated with the new device was identified, and documentation consistent with that level was provided. (Risk analysis indicates the difference does not affect safety and effectiveness.) |
| Image Quality - General Radiography (for software processing differences) | Non-clinical performance bench tests and image quality evaluations were conducted between the new device and predicate devices. The result demonstrates substantial equivalence in image acquisition, image processing, and image quality capabilities. |
| Image Quality - Dual Energy Subtraction (distinction of lesions) | An additional test report was submitted to assure the distinction of lesions overlying bones to calcification or tubercle shade. |
| Metal Artifact Reduction (Tomosynthesis option) | FBP (Filtered Back-Projection) mode and IR (Iteration) mode of the new device have the same level of metal artifact reduction capability as the mode with artifact reduction of its predicate device. |
| Image Quality - Tomosynthesis Reconstruction (anthropomorphic phantoms) | A U.S. board-certified radiologist review of anthropomorphic phantom images of tomosynthesis reconstruction covers an evaluation of each reconstruction mode for each anatomy. The review supports that the new device is substantially equivalent in its image quality of tomosynthesis reconstruction as compared to its predicate devices. SA (Shift Addition) mode is acceptable as a traditional image but is suggested for use with FBP or IR mode. |
| Radiation Safety (Conformity to CFR and IEC60601-1-3) | New device and primary predicate device are substantially equivalent by their conformities of CFR and IEC60601-1-3. |
| Overall Safety and Effectiveness | The non-clinical data support the safety of the device, and the hardware and software verification and validation demonstrate that the new device performs as intended. Differences do not affect clinical safety or effectiveness. The device is as safe, effective, and performs as well as or better than the predicate device(s). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions "several different anatomical body phantoms" for phantom tests, and an unspecified number of "anthropomorphic phantom images" for the tomosynthesis reconstruction review. Specific numerical sample sizes (e.g., number of phantoms, number of images reviewed) are not provided.
- Data Provenance: The studies were non-clinical performance testing using phantoms. There is no mention of human patient data (retrospective or prospective) being used for the performance evaluation detailed in Section V.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: "A U.S. board-certified radiologist" (singular) was used for the review of the tomosynthesis anthropomorphic phantom images.
- Qualifications: "U.S. board-certified radiologist." No information about years of experience or subspecialty is provided.
4. Adjudication Method for the Test Set
The document mentions "a U.S. board-certified radiologist review" for the tomosynthesis images. This single-reader review implies no adjudication method (like 2+1 or 3+1 consensus) was conducted, as there was only one expert involved in that specific review. For other non-clinical tests (bench tests, image quality evaluations), the method of evaluation and any expert involvement or adjudication is not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The radiologist review mentioned was for phantom images to assess image quality for substantial equivalence, not a comparative reader study to measure improvement from AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, implicitly. The "non-clinical performance bench test and image quality evaluate substantial equivalence of image processing technique" were conducted comparing the new device's output to predicate devices. This implies evaluating the algorithm's performance (specifically, its image processing and reconstruction capabilities) on phantom data. The metal artifact reduction function of the tomosynthesis option was also "conducted performance testing" which would be a standalone evaluation of the algorithm's output. The radiologist review of phantom images could be seen as an 'expert-in-the-loop' check on the standalone output.
7. The Type of Ground Truth Used
- Phantom Gold Standard: For the non-clinical performance testing (including general image quality, tomosynthesis reconstruction, and metal artifact reduction), the ground truth was established by the physical properties and known characteristics of the anatomical body phantoms used. The 'truth' is inherent in the phantom's design and the controlled testing environment. For Dual Energy Subtraction, it was related to the "distinction of lesion overlying bones to calcification or tubercle shade" within a phantom context.
- Expert Review of Phantom Images: For the tomosynthesis reconstruction review, a U.S. board-certified radiologist provided an evaluation, which serves as an expert opinion on the image quality rendered from the phantom data against the expected 'truth' from the phantom.
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This submission focuses on the performance testing of the modified device against predicate devices for substantial equivalence, not on the development or training of an AI algorithm from a dataset in the typical sense. While software processing is mentioned, details about machine learning training are absent.
9. How the Ground Truth for the Training Set was Established
As no training set is mentioned, there is no information on how its ground truth might have been established.
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