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510(k) Data Aggregation
(35 days)
ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or technician on both adult and paediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
The ProRad series Stationary Radiographic System is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. There are two types of configurations (2FC and 3NC) for ProRad; the difference is in the mounting of the X-ray tube. For X-ray tube mounting the configuration is either the floor mounted (2FC) or ceiling suspension (3NC) assembly.
The devices are a new combination of a previously cleared solid state digital x-ray acquisition panel and software with the diagnostic x-ray components (including Xray tube, high frequency X-ray generator, a tilting vertical bucky, X-ray table and collimator) required to make a complete system. The purchaser may select any of the digital panels and software based on the user's requirements. The other components are also available in different configurations to meet specific customer needs. The X-ray panel and imaging software have been previously cleared by the FDA, and most of the other components are used in previously cleared 510(k) devices.
Here's an analysis of the acceptance criteria and study information for the ProRad 2FC and ProRad 3NC Digital Stationary Radiographic Systems, based on the provided text:
Acceptance Criteria and Device Performance Table:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting and reporting specific performance metrics with acceptance criteria in a comparative table for novel device features. The "Comparable Properties" table (pages 6-8) is used to show alignment with predicate devices.
| Acceptance Criteria Category | Specific Criteria (Implicit from Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Intended Use | Equivalent to predicate devices (K150816, K153119) for diagnostic radiographic exposures of various body parts in adults and pediatrics, excluding mammography. | "Equivalent" to predicate devices. |
| Configuration of Digital Panels | Battery or AC operated wireless IEEE 802.11n or Wired Ethernet. | "Same" as predicate devices. |
| Digital Panel Models and their Clearance Numbers | Utilize previously cleared FDA digital flat panel detectors (specific K numbers listed in Note 1). | "Similar functionality" to predicate devices (Note 1 states the subject device uses different flat panel detectors that are previously FDA cleared, and testing demonstrates no increased safety concern or effect on effectiveness). |
| Image Acquisition Panel Specifications | Comparable pixel resolution and size range (e.g., 3,320 x 3,408 Pixels 125 µm, 3,072 x 3,072 Pixels 139 µm, etc.). | "Similar functionality" to predicate devices (Note 1). |
| DICOM Compliance | DICOM 3 compliant. | "Same" as predicate devices. |
| WiFi Wireless (if applicable) | Functionality similar to predicate wireless detectors. | "Similar functionality" to predicate devices (specific Canon, Varex, PerkinElmer, and DRTECH wireless detectors listed). |
| Image Acquisition Software | Utilize previously cleared FDA image processing software (specific K numbers listed in Note 2). | "Similar functionality" to predicate devices (Note 2 states Prognosys uses previously cleared FDA software and does not modify it). |
| Power Source | AC Line, various voltages available. | "Same" as predicate devices. |
| X-ray Generator | Range of power ratings (e.g., 32 kW to 80 kW, 125 kV/150 kV). | "Same or similar functionality" to predicate devices (Note 3 states the subject device uses similar X-ray generators with different power ratings and that these generators have been used in previously cleared 510(k) devices). |
| X-ray Tubes | Range of kV, focal spot sizes, and heat units (e.g., Toshiba E7239FX, Varex RAD14, etc.). | "Similar functionality" to predicate devices (Note 4 states both configurations provide similar imaging resolution and these tubes have been used in previously cleared 510(k) devices). |
| Collimator | Adequate inherent filtration. | "Similar functionality" to predicate devices (Note 5 states the inherent filtration is different but does not affect safety and effectiveness). |
| Performance Standard Compliance | Compliance with FDA 21 CFR 1020.30-31 (Performance Standards for Diagnostic X-Ray Systems and Their Major Components). | "Same" as predicate devices. |
| Electrical Safety | Compliance with IEC 60601-1. | "Same" as predicate devices. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Device complies with this standard. |
| Radiation Protection | Compliance with IEC 60601-1-3. | Device complies with this standard. |
| Specific Safety/Performance for X-ray Equipment | Compliance with IEC 60601-2-54. | Device complies with this standard. |
| Usability | Compliance with IEC 60601-1-6. | Device complies with this standard. |
| Risk Management | Compliance with ISO 14971. | Device complies with this standard. |
| Cybersecurity | Adherence to "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 2014" guidance for device labeling. | Cybersecurity concerns were addressed based on the US FDA Guidance document. |
1. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a separate "test set" for a dedicated algorithm performance study. Instead, compliance is demonstrated through testing of the integrated system and reliance on previous FDA clearances for individual components.
- Data Provenance: Not applicable in the context of an algorithm performance test set. The clinical images reviewed by a radiologist were "acquired by the device," but the origin (e.g., country, prospective/retrospective status) is not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One radiologist.
- Qualifications of Experts: Only "a radiologist" is mentioned. Specific qualifications (e.g., years of experience, board certification) are not detailed.
3. Adjudication method for the test set:
- Adjudication method: Not applicable. The radiologist's review was a single assessment, not a consensus or adjudication process among multiple readers.
4. 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. The document explicitly states: "Since the digital x-ray panels and software have previously received FDA clearance, a clinical study was not required as per the FDA guidance document." The clinical image review was supplementary.
- Effect size of human reader improvement with AI: Not applicable, as no MRMC study or AI assistance evaluation was conducted. The device is an imaging system, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance Study: No. This device is a diagnostic X-ray system, which intrinsically requires a human (a qualified doctor or technician) in the loop for operation and interpretation. The performance of individual cleared components (digital panels, software) was relied upon.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the supplementary review, the "ground truth" was the radiologist's assessment that the images were "acceptable and allowed the radiologist to make an accurate diagnosis." This is a form of expert opinion on image quality and diagnostic utility, rather than an objective "truth" like pathology or outcomes.
7. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This document does not describe a machine learning algorithm that requires a training set. The device is a conventional X-ray system composed of cleared components.
8. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no machine learning algorithm described.
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