(31 days)
The XRoad 4343 F MED, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy for diagnostic X-ray procedures, wherever conventional screen-film (SF), digital radiography (DR), or computed radiography (CR) systems may be used. It is not intended for mammographic use.
The XRpad 4343 F MED is a lightweight, cassette-sized, flat panel X-ray detector for digital radiography. The X-ray detector consists of an amorphous silicon flat panel with a directly deposited CsI:T1 scintillator and dedicated read-out, scan, and control electronics, all packaged in a carbon-fiber and aluminum enclosure. The outside dimensions of the detector are 460 mm × 15 mm, which fits into a standard X-ray cassette Bucky. The active area is 430 mm × 430mm at a pixel pitch of 100um. The detector can be integrated into a fixed room X-ray system to enable digital radiography.
The PerkinElmer XRpad 4343 F MED Flat Panel Detector is a digital radiography device. The acceptance criteria and supporting study details are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria in a dedicated table format with corresponding reported performance for the XRpad 4343 F MED. Instead, it relies on demonstrating equivalence to a predicate device (XRpad 4336 MED, K140551) through comparable non-clinical performance values and the applicability of the predicate's clinical data.
However, key comparative performance characteristics are presented:
| Characteristic | Acceptance Criteria (Predicate Device K140551) | Reported Device Performance (XRpad 4343 F MED) |
|---|---|---|
| Intended Use / | Same as predicate | Same |
| Indications for Use | ||
| Customer Applications | Single energy, single shot RAD in 100 µm | Same |
| Panel | Single substrate amorphous silicon active TFT/diode array | Same |
| Scintillator | Direct deposition CsI:T1 | Same |
| Pixel pitch | 100 µm | Same |
| Limiting resolution | 5 lp/mm | Same |
| Binning capable | 2 × 2 binning for 200 µm | Same |
| Housing material | Aluminum with carbon-fiber | Same |
| X-ray synchronization interface | Dedicated trigger in/out signal lines or Automatic Exposure Detection | Same |
| Software | Windows OS | Same |
| DQE (Detective Quantum Efficiency) | Comparable to predicate device | Comparable to predicate device |
| MTF (Modulation Transfer Function) | Comparable to predicate device | Comparable to predicate device |
Differences noted for the proposed device (not framed as acceptance criteria but as distinguishing features from the predicate):
- Pixel matrix: 3556 × 4320 pixels (Predicate) vs. 4318 × 4320 pixels (Proposed)
- Active area: 355 mm × 430 mm (Predicate) vs. 430 mm × 430 mm (Proposed)
- External dimensions: 384 mm × 460 mm × 15 mm (Predicate) vs. 460 mm × 460 mm × 15 mm (Proposed)
- Weight: Approximately 4 kg (Predicate) vs. Approximately 5 kg (Proposed)
- Communication interface: Gb Ethernet or 802.11n WiFi (Predicate) vs. Gb Ethernet, No wireless capability (Proposed)
- Power: External power supply or battery (Predicate) vs. External power supply (Proposed)
- Battery capacity: 53Wh (Predicate) vs. No battery option (Proposed)
The foundational acceptance criterion is "Substantial Equivalence" to the predicate device, demonstrated by showing that the proposed device has comparable performance and operational standards, produces images of equivalent diagnostic quality, and that potential hazards have been studied and controlled.
2. Sample size used for the test set and the data provenance:
- The document states that a new clinical study was not required for the XRpad 4343 F MED device.
- Instead, the predicate device, XRpad 4336 MED, was cleared using clinical data derived from testing to support K122495 (XRD 1622 AP3 MED).
- The document implies that the "clinical study data submitted in K122495" served as the basis for the clinical evaluation, but it does not provide details on the sample size or data provenance (e.g., country of origin, retrospective/prospective nature) for K122495. It only states that this data was deemed "applicable" to the XRpad 4336 MED and, through non-clinical testing, also applicable to the XRpad 4343 F MED.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not provide information on the number of experts or their qualifications, as it refers to a prior 510(k) submission (K122495) for clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- The document does not provide information on the adjudication method, as it refers to a prior 510(k) submission (K122495) for clinical data.
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 or reported in this 510(k) summary for the XRpad 4343 F MED, nor does it involve AI assistance. This device is a flat panel x-ray detector, not an AI-powered diagnostic tool. The document relies on demonstrating non-inferiority/equivalence to a predicate physical device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This question is not applicable as the XRpad 4343 F MED is a hardware device (flat panel detector) for capturing radiographic images, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document does not explicitly state the type of ground truth used for the clinical data referenced from K122495.
- However, given the nature of radiographic imaging devices, it is highly probable that the ground truth for the clinical data in K122495 would have been established through expert radiological interpretation and potentially confirmed by pathology or clinical outcomes, but this is not confirmed in the provided text.
8. The sample size for the training set:
- The document does not mention any training set for the XRpad 4343 F MED, as it is a hardware device and not an algorithm requiring a training set in the AI/machine learning sense.
9. How the ground truth for the training set was established:
- This question is not applicable as no training set (in the context of algorithms) is mentioned or used for this device.
§ 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.