(65 days)
The PrestoDR Portable ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.
The PrestoDR Portable is a Digital Radiography system, featuring an integrated portable flat panel digital detector (FPD) K090625 WIRELESS PORTABLE DETECTOR FD-W17, Philips Medical Systems North America CO (this is the 510(k) for the wireless portable flat panel detector) and CMT's proprietary technology, which incorporates state of the art object-oriented software and connectivity. The legally marketed SMARTRAD K003438 has been modified: To integrate the portable flat panel digital detector (FPD) K090625, improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.
The provided text is a 510(k) Summary and related FDA correspondence for the PrestoDR Portable, a Digital Radiography system. It focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study proving performance against specific acceptance criteria for AI or diagnostic accuracy.
The document indicates that the PrestoDR Portable is primarily a hardware and software system for general radiography, replacing conventional screen-film systems. The "Reason for 510(k) Submission" states it's a "Special 510(k) Submission" due to integration of a portable flat panel digital detector and redesign of "aging technologies and components (hardware and software)." It explicitly says, "The device major functions and principle of operation were not changed."
Therefore, the submission does not contain the detailed study results, acceptance criteria for device performance (especially in a diagnostic context), or specific data regarding AI-driven diagnostic improvements as requested in the prompt. The text focuses on regulatory compliance and substantial equivalence to a predicate device, as opposed to a clinical performance study with specific diagnostic accuracy metrics.
Here's a breakdown of why most of the requested information cannot be found in the provided text:
1. Table of acceptance criteria and the reported device performance
- Not found. The document states, "Tests data demonstrate that the PrestoDR Portable meets the required specifications." However, it does not specify what those specifications or acceptance criteria are, nor does it provide a table of reported device performance against them. The focus is on safety and effectiveness through substantial equivalence and compliance with 21CFR 820.30 regulations for design, verification, and validation, rather than specific clinical performance metrics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not found. No information is provided about any specific test set, its sample size, or data provenance. The submission describes a device modification and asserts substantial equivalence, which typically relies on demonstrating that the modified device performs similarly to the predicate, rather than new clinical trials measuring diagnostic accuracy.
3. 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)
- Not found. Since no specific test set or clinical performance study is described, there is no mention of experts establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not found. No adjudication method is described because no specific test set or study requiring such a method is presented.
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 found. The document does not describe an MRMC study or any AI assistance. The device is a digital radiography system; while it uses "state of the art object-oriented software," this doesn't imply an AI-driven diagnostic aid that would require an MRMC study to show human reader improvement with AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not found. There is no mention of a standalone algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not found. No ground truth type is specified, as no clinical performance study involving diagnostic accuracy is detailed.
8. The sample size for the training set
- Not found. There is no mention of a training set, as the document doesn't describe the development or validation of a diagnostic algorithm based on machine learning.
9. How the ground truth for the training set was established
- Not found. Consequently, no information is provided on how ground truth for a training set was established.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.