(20 days)
Indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures, excluding fluoroscopic, angiographic, and mammographic applications.
The PIXX series are digital radiography systems, featuring an integrated flat panel digital detector (FPD). They are designed to perform digital radiographic examinations as a replacement for conventional film. This integrated platform provides the benefits of PACS with the advantages of digital radiography for a filmless environment and improves cost effectiveness. The major functions and principle of operation of the updated panels are the same as our previous panel retaining the Wi-Fi wireless features. The modification involves adding battery power capability to the devices in our previous submission K180976.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Predicate Device) | Reported Device Performance (New Devices) |
|---|---|---|
| Intended Use | Indicated for general radiographic images of human anatomy, replacing film/screen systems in general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications). | UNCHANGED (Same) |
| Pixel Pitch | 140um | SAME |
| Limiting Resolution | Over 3 lp/mm | SAME |
| DQE (CSI) at 2 lp/mm | 26.5% | SAME |
| MTF (CSI) at 2 lp/mm | 44% | SAME |
| DQE (GOS) at 2 lp/mm | 21% | SAME |
| MTF (GOS) at 2 lp/mm | 35% | SAME |
| A/D Conversion | 16 bits | SAME |
| Active Area | 17x17 inch, 14x17 inch, 12x12 inch | PIXX 1717: 17x17 inch |
| PIXX 1417: 14x17 inch | ||
| PIXX 1212: 12x12 inch | ||
| Dimensions (mm) / Weights (Kg) | PIXX 1717: 460(W)x461(L)x15(H)/3.0Kg | |
| PIXX 1417: 385(W) x 460(L) x 15(H)/2.8Kg | ||
| PIXX 1212: 308.5(W) x 319.5(L) x 15(H)/1.9Kg | SAME | |
| Pixels | PIXX 1717: 3,072x3,072 | |
| PIXX 1417: 2,560 x 3,072 | ||
| PIXX 1212: 2,048 x 2,048 | SAME | |
| Software Output | DICOM image | SAME |
| DICOM Compatibility | Yes | Yes |
| Scintillator | CsI or GOS | UNCHANGED |
| Interface | Wired: Gigabit Ethernet (1000BASE-T); Wireless: IEEE802.11ac, backward compatible | SAME |
| Power Source | AC Line only | AC Line and/or Rechargeable Lithium Battery; |
| PIXX 1717/1417: 5 hours/300 images | ||
| PIXX 1212: 8 hours/480 images (New feature) | ||
| Electrical Safety | IEC/UL 60601-1 | SAME (plus IEC 62133 Battery safety for new devices) |
| EMC | IEC 60601-1-2 | SAME (plus IEC 62133 Battery safety for new devices) |
| Battery Safety | Not applicable (for predicate) | IEC 62133 Edition 2.0 2012-12 (for new devices) |
| Risk Analysis | ISO 14971:2012 and EN 62304 | SAME |
| Cybersecurity | Not specified for predicate | Precautionary labeling per FDA guidance (new for these devices) |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated for specific image evaluations. The device modification primarily involved adding battery power, and the manufacturer stated that "Clinical images were not required because the panel technology did not change from K180976."
- Data provenance: Not explicitly stated, as no clinical image study was conducted for this submission. The predicate device (K180976) would have had its own testing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical image study requiring expert review of a test set was conducted for this submission.
4. Adjudication method for the test set:
- Not applicable, as no clinical image study requiring adjudication was conducted for this submission.
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:
- No MRMC comparative effectiveness study was done. The submission is for Digital Diagnostic X-ray Receptor Panels, which are imaging hardware, not an AI-enabled diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done or is applicable for this type of hardware device.
7. The type of ground truth used:
- Not applicable for image-based ground truth related to a diagnostic algorithm, as this is a hardware device. The ground truth for this submission was based on bench testing against established engineering and safety standards (e.g., IEC/UL for electrical safety, IEC for EMC, IEC for battery safety) and performance specifications (Pixel Pitch, Limiting Resolution, DQE, MTF, A/D Conversion, etc.) which were determined to be identical to the predicate device. For the new battery feature, battery life testing was conducted to verify its stated performance.
8. The sample size for the training set:
- Not applicable, as this is a hardware device and not an AI/algorithm-based system requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable, as this is a hardware device and not an AI/algorithm-based system requiring a training set or its associated ground truth establishment.
§ 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.