(85 days)
The indications for use for the FUJI SPBBD SUITE is the same as the predicate de-Inc : Indiagraphic exposures of the entire body specifically the skull, spinal column, chest, and abdomen, as well as extremities, the identification, capture, digitization, and processing of diagnostic x-ray images, and associating patient and exam identification with the images.
The Speed Suite combines the following components and devices in one package.
12) Fuji Computed Radiography Image Reader (FCR 5501D, FCR 5501D-ES, or FCR 5502D table).
13) IIP Workstation
14) ID-T741A ID terminal
15) Siemens X-ray Tube (Optitop 150/40/80HC)
16) Siemens X-ray Generator (Polydoros IT 55)
17) Siemens Automatic Collimator (AL01)
18) Siemens Tube Stand
a. Floor Mounted Tube Stand Multix-L
b. Ceiling Mounted Tube Stand 3D Top-ACSS with optional tracking
19} Central electronic unit (ZE)
20) Siemens Multix Compact K bucky table
21) Siemens Rasterwanderat bucky wall stand
22) X-CON software
The Speed Suite utilizes devices that have already received 510(k) marketing clearance from FDA. The primary difference is the addition of the X-CON software that allows the Fuji image readers to I he primary and interface with the Siemens X-ray equipment. X-CON refers to a combination of software and hardware that will integrate the Fuji ID-T741 or IIP workstation with the Siemens Polydoros IT 55. The ID-T741 or IIP workstation will interface directly to both the Fuji image reader and to the Polydoros IT55 via cabling. The software for the ID-T741 and IIP workstation is adapted to inte wate existing patient anatomical menus according to defaults, so that a selected patient exam will display parameters for an associated x-ray exposure menus can be adjusted according to user preferences, and all defaults can be overridden. Once the patient exam is selected, the exposure data information is transferred to the generator, thus initiating the exposure according to direcsure and morniance to the fixed data for kV, mAs and spot size will be sent back to the ID-T741 terminal or IIIP workstation.
Here's an analysis of the provided text regarding acceptance criteria and study information, formatted as requested:
This document is a 510(k) summary for the Fuji Speed Suite, submitted in 2001. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. In such submissions, extensive clinical studies demonstrating performance against specific acceptance criteria for AI/ML devices, as would be expected today, are often not present, especially for devices that are integrations of existing cleared components.
Based on the provided text, the device is an integrated system combining existing X-ray equipment and image readers with new "X-CON software" for communication. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against novel acceptance criteria through detailed clinical studies for a new algorithmic component.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as stated in document) |
|---|---|
| No explicit, quantitative acceptance criteria are presented for the device's performance in terms of diagnostic accuracy, sensitivity, specificity, or image quality derived from a study specifically for the Speed Suite. | "Based on validation studies and risk analysis, we believe this is a minor change that is of minimal risk." |
| "We conclude the subject device to be as safe and effective as the predicate devices." | |
| The primary claim of performance is substantial equivalence to the predicate devices. |
Explanation: The document describes the Speed Suite as "minor revision to devices that have been already cleared by FDA" and focuses on the "X-CON software that allows the Fuji image readers to interface with the Siemens X-ray equipment." The performance data section states, "Based on validation studies and risk analysis, we believe this is a minor change that is of minimal risk." This indicates that the validation focused on ensuring the integrated system functions safely and effectively, similar to the individual cleared components, rather than meeting new diagnostic performance metrics. The conclusion explicitly states the device is "as safe and effective as the predicate devices."
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document does not describe a clinical test set with a specific number of cases or patients for evaluating diagnostic performance. "Validation studies" are mentioned but without details.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable, as no described test set with ground truth established by experts is provided in the summary.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable, as no described test set with adjudicated ground truth is provided.
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
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described in the document. The device is not an AI-assisted diagnostic tool in the contemporary sense; it is an integrated radiography system.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Study: No, a standalone performance study for the "X-CON software" or any algorithmic component in terms of diagnostic performance is not described. The software's function is integration and communication, not independent diagnostic assessment.
7. The type of ground truth used
- Type of Ground Truth: Not applicable, as no specific performance study against a defined ground truth is presented in this 510(k) summary for the device's diagnostic capabilities. The ground truth for the "validation studies" mentioned likely relates to the technical functioning and safety of the integrated system, rather than diagnostic accuracy.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. The "X-CON software" described is for system integration and communication; it is not presented as a machine learning algorithm requiring a "training set" in the context of diagnostic image analysis.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.