(74 days)
The PortaVision PVMed DDR 2520 Digital Imaging System is intended for use in generating radiographic images of human anatomy. (The system is not intended to be use for mammography). It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This imager is intended for incorporation into a complete x-ray system by a qualified equipment manufacturer. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.
The PortaVision PVMed DDR 2520 Digital Imaging System consists of two components, an amorphous silicon digital x-ray imager and software for viewing the captured images on a Windows-based computer. The digital imager is composed of an amorphous silicon flat panel imager which uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide scintillator. The PVMed DDR 2520 Digital Imaging System will display high quality images in less that 5 seconds over a wide range of X-Ray dose settings. The System is not intended to be use for mammography.
"The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria. Instead, it focuses on the device's substantial equivalence to a predicate device. Therefore, I cannot extract the requested information directly.
However, I can infer from the text that the primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing legally marketed devices. The study proving this "acceptance criterion" is the 510(k) submission itself, which presents a comparison of the technological characteristics and intended use of the PortaVision PVMed DDR 2520 Digital Imaging System with those of predicate devices.
Here's an attempt to answer your questions based on the available text, highlighting what's explicitly stated and what cannot be determined:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The PortaVision PVMed DDR 2520 Digital Imaging System has the same intended use and the same technological characteristics (amorphous silicon digital x-ray imager and software for viewing images on a Windows-based computer) as the predicate device (Paxscan 4030 Medical Digital Imaging Systems, Varian Medial Systems, Inc.). The only difference noted is the size, with the proposed device being smaller than the predicate. |
| Safety and Effectiveness | The submission concludes that "the PortaVision PVMed DDR 2520 Digital Imaging System does not raise any questions regarding safety and effectiveness" and "is as safe and effective as the predicate device." |
| Image Display Quality and Speed | The device "will display high quality images in less than 5 seconds over a wide range of X-Ray dose settings." (This is a performance characteristic but not explicitly framed as an acceptance criterion in the provided text.) |
| Intended Use | Intended for use in generating radiographic images of human anatomy (excluding mammography), replacing film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This matches the intended use of the predicate device implicitly. |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The provided text does not mention a specific test set, its sample size, or data provenance related to a performance study. The submission focuses on a comparison of technical specifications and intended use against a predicate device for substantial equivalence.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- The provided text does not mention a test set, ground truth establishment, or experts for such a purpose.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The provided text does not mention a test set or any adjudication method.
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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
- The provided text does not indicate that an MRMC comparative effectiveness study was done. The device described is a digital imaging system, not an AI-assisted diagnostic tool, so such a study would not be expected in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The provided text does not describe a standalone algorithm performance study. The device is an imaging system designed for use by qualified medical personnel.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The provided text does not mention a specific ground truth type as no performance study with a test set is detailed. The "ground truth" for this 510(k) submission is essentially the legally marketed status and established safety/effectiveness of the predicate device.
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The sample size for the training set
- The provided text does not mention a training set sample size. This type of information is typically relevant for machine learning or AI-based devices, which this imaging system is not described as.
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How the ground truth for the training set was established
- The provided text does not mention a training set or how a ground truth for it would be established.
In summary: The provided 510(k) summary is for an imaging system seeking substantial equivalence to a predicate device. It primarily relies on demonstrating that the new device shares the same intended use and technological characteristics as the already-cleared predicate, rather than presenting a detailed clinical performance study with a test set, ground truth, or expert evaluations in the manner typically seen for AI/ML-driven diagnostic aids."
§ 892.1630 Electrostatic x-ray imaging system.
(a)
Identification. An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.