(28 days)
Intended for use by a qualified/trained doctor or technologist on both and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts on both adult and pediatic patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography
This device is a medical x-ray image acquisition device. X-rays generated by X-ray generator/ tube that penetrate patient's body are converted to a digital file by the detector. After that the detector sends this digital file to a pc where the companion software has been installed. This software was cleared in our previous submission, K170202. A monitor displays this image. Images can then be transferred via the DICOM protocol. This device is nearly identical to the predicate but now the digital panels have Wi-Fi in addition to Ethernet interfaces. The Aquarius 8600 will be marketed in two possible configurations: Aquarius 8600 1717WCl (tethered or wireless), 17 x 17 inch flat panel as a retrofit package with Magellan software). Aquarius 8600 1417WCl (tethered or wireless), 14 x 17 inch flat panel as a retrofit package with Magellan software).
The provided text is a 510(k) premarket notification for a stationary x-ray system (Aquarius 8600 1417WCI; Aquarius 8600 1717WCI). It describes the device, its similarity to a predicate device, and the non-clinical tests conducted to establish substantial equivalence.
Based on the provided information, no specific acceptance criteria or a dedicated study proving the device meets those criteria are explicitly detailed in a format that would allow for a complete answer to all parts of your request.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Aquarius 8600 1417TC/1717TC, K170202) and references a cleared flat panel detector (K160810). The testing described is primarily non-clinical.
Here's an analysis of what information can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
No explicit table of acceptance criteria is provided. The document states "Performance characteristics" are similar to the predicate and provides some technical specifications (MTF, DQE, Panel Resolution, Pixel Size) for both the predicate and the new device. It notes that the new panels have "slightly better MTF" and "slightly lower DQE," implying these performance characteristics were measured against the predicate's performance rather than predefined acceptance criteria.
| Characteristic | Predicate Device Performance (Aquarius 8600 1417TC/1717TC K170202) | New Device Performance (Aquarius 8600 1417WCI; Aquarius 8600 1717WCI) | Acceptance Criteria |
|---|---|---|---|
| Panel Communication | Tethered Gigabit Ethernet | Tethered Gigabit Ethernet or Wireless via previously cleared panel (K160810) | Not explicitly stated, implied to be equivalent or enhanced wireless capability is acceptable. |
| Sensor Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same as predicate, implying acceptance. |
| Scintillator | CsI: TI | CsI: TI | Same as predicate, implying acceptance. |
| Panel Resolution | 2816 x 3328 or 3328 x 3328 | 2304 x 2800 or 3072 x 3072 | Not explicitly stated, "NOT A MEANINGFUL DIFFERENCE" is asserted. |
| Panel Size | 14x17 inches or 17x17 inches | 14x17 inches or 17x17 inches | Same as predicate, implying acceptance. |
| Pixel Size | 127 μm | 150 μm (14x17) or 139 μm (17x17) | Not explicitly stated, "NOT A MEANINGFUL DIFFERENCE" is asserted. |
| Resolution (lp/mm) | 3.9 lp/mm | 3.59 lp/mm or 3.33 lp/mm | Not explicitly stated, "NOT A MEANINGFUL DIFFERENCE" is asserted. |
| Image Depth | 14 bits | 14 bits | Same as predicate, implying acceptance. |
| Preview Image | 2 seconds | Less than 3 seconds | "EQUIVALENT" asserted, implying acceptance for slight increase. |
| MTF @1 lp/mm | 14 x 17: 0.608 | ||
| 17 x 17: 0.517 | 14 x 17: 0.667 | ||
| 17 x 17: 0.706 | "The new panels have slightly better MTF," implying this improved performance is acceptable. | ||
| DQE (0) | 14 x 17: 0.74 | ||
| 17 x 17: 0.68 | 14 x 17: 0.40 | ||
| 17 x 17: 0.53 | "The new panels have slightly lower DQE," implying this reduced performance is deemed acceptable for substantial equivalence. | ||
| Safety/EMC | EN/IEC 60601-1, Safety | ||
| EN/IEC 60601-1-2 EMC | SAME (Tested to IEC 60601-1:2012, IEC 60601-1-2:2007) | Compliance with standards, implying acceptance. |
2. Sample size used for the test set and the data provenance
The document mentions "Clinical images were provided," but explicitly states "these images were not necessary to establish substantial equivalence based on the modifications to the device... but they provide further evidence... that the complete system works as intended."
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as the clinical images were not presented as part of a formal study with ground truth established by experts for performance evaluation against a specific clinical claim. They were "further evidence" of system functionality.
4. Adjudication method for the test set
Not applicable, as no formal clinical study with ground truth and expert adjudication is described for the purpose of establishing device performance against acceptance criteria.
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
Not applicable. This device is an x-ray imagine acquisition device, not an AI-powered diagnostic tool. No AI component is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an x-ray imagine acquisition device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no formal clinical study with ground truth for performance evaluation is described. For the non-clinical bench testing, the "ground truth" would be the physical properties and measurements of the device components themselves, following established engineering and physics principles.
8. The sample size for the training set
Not applicable. This is a hardware device (x-ray panel and system), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a hardware device, not an AI algorithm.
§ 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.