(23 days)
The PEDRA Digital Flat Panel X-ray detector is indicated as a digital imaging solution designed for the general radiographic system for human anatomy. It is intended to replace film or screen-based radiographic systems in all general-purpose diagnostic procedures. It is not to be used for mammography.
The PEDRA are wired or wireless digital flat panel detectors that have been designed for a faster, more streamlined approach to digital stationary X-rav systems. The PEDRA detector utilizes a combination of propriety TFT glass and scintillators (CsI / Gadox), and those and electronics are housed in one package. The detectors support an auto-trigger signal sensing technology that allows the detectors to be used without generator integration. The flat panel sensors of the PEDRA are fabricated using thin-film technology based on amorphous silicon technology. Electronically, the sensors are much like conventional photodiode arrays. Each pixel in the array consists of a light-sensing photodiode and a switching Thin Film Transistor (TFT) in the same electronic circuit. Amorphous silicon photodiodes are sensitive to visible light, with a response curve roughly comparable to human vision. The sensitivity of amorphous silicon photodiodes peaks in green wavelengths, well-matched to scintillators such as CSI and Gadox. The response has the excellent linearity of a charge-integrating-biased photodiode. SDK-Pedracalib(DMS) is the software of Detector that performs image acquisition, image correction, and pre-processing. An x-ray generator (an integral part of a complete diagnostic x-ray system) is not part of this submission.
The provided text describes a 510(k) submission for the "PEDRA-1417" digital flat panel X-ray detector. However, it does not contain specific acceptance criteria or the study details proving the device meets those criteria, as typically found in a clinical study report.
The document primarily focuses on demonstrating substantial equivalence to predicate and reference devices based on technical characteristics and compliance with electrical safety, EMC, and software validation standards. It explicitly states that clinical data is not required to establish substantial equivalence.
Therefore, many of the requested details about acceptance criteria, test set sample size, expert ground truth, adjudication, MRMC studies, standalone performance, and training set information are not available in the provided text.
Here's a summary of the available information based on your request:
Acceptance Criteria and Device Performance
Since no specific clinical performance acceptance criteria are provided, this section will reflect the technical characteristics compared for substantial equivalence.
| Acceptance Criteria (Not explicitly stated as such, but inferred from comparison) | Reported Device Performance (PEDRA-1417) |
|---|---|
| Indications for Use: General radiographic system for human anatomy, replacing film/screen-based systems, not for mammography. | Same as predicate and reference devices. The PEDRA Digital Flat Panel X-ray detector is indicated as a digital imaging solution designed for the general radiographic system for human anatomy. It is intended to replace film or screen-based radiographic systems in all general-purpose diagnostic procedures. It is not to be used for mammography. |
| Pixel Pitch: 140µm | 140µm (Same as predicate and reference devices) |
| High Contrast Limiting Resolution: Max. 3.4 lp/mm (from predicate) | Max. 3.4 lp/mm (Same as predicate) |
| DQE: Similar to predicate (S4335-AW: 70%@0.1lp/mm) | 69%@0.1lp/mm (PEDRA-1417MC) - Stated as "similar or better DOE" |
| MTF: Similar to predicate (S4335-AW: 95%@0.1lp/mm) | 96%@0.1lp/mm (PEDRA-1417MC) - Stated as "similar or better DOE" |
| Communication: Wired/Wireless (comparable to reference device) | Wired/Wireless (Same as reference device) |
| Scintillator type: CsI/Gadox | CsI / Gadox (Same as predicate and reference devices) |
| Exposure Mode: Normal Mode(Manual), AED Mode (Auto Exposure Detection) | Same as predicate and reference devices. |
| Electrical Safety, EMC, and Software Validation: Compliance with standards. | Complies with ES60601-1:2005 (R)201 and A1:2012, IEC 60601-1-2 Edition 2014-02, and FDA guidance for Wireless Technology and Software Validation. |
Study Details:
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A table of acceptance criteria and the reported device performance:
- Please see the table above. The "acceptance criteria" are inferred from the characteristics of the predicate and reference devices to which substantial equivalence is claimed.
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Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The submission explicitly states "Clinical data is not required to establish substantial equivalence." Performance testing (e.g., DQE, MTF) was conducted according to IEC 62220-1-1, which typically involves physical measurements on the device itself rather than a test set of patient cases.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No clinical test set or ground truth established by experts was used.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No clinical test set or adjudication was performed.
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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. An MRMC study was not conducted, as this device is a digital X-ray detector, not an AI-powered diagnostic aid. The submission explicitly states "Clinical data is not required."
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. This device is a digital X-ray detector, not an algorithm, and no such standalone performance study was mentioned. The performance tests focused on technical imaging characteristics like DQE and MTF.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. For the technical performance tests (DQE, MTF), the "ground truth" would be the physically measured values against the standard specified in IEC 62220-1.
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The sample size for the training set:
- Not applicable / Not provided. This device is hardware (a digital X-ray detector), not an AI algorithm that requires a training set. The software mentioned (SDK-Pedracalib(DMS)) performs image acquisition, correction, and pre-processing, which are deterministic operations, not machine learning that would typically use a training set.
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How the ground truth for the training set was established:
- Not applicable / Not provided. As no training set was used, no ground truth establishment method for it is relevant.
§ 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.