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510(k) Data Aggregation
(118 days)
Televere Podiatry Digital Imaging System
The Televere Podiatry Digital Imaging System is intended for digital image capture use in podiatry radiographic examinations, wherever conventional screen-film systems may be used. Not for mammography. Not for fluoroscopy.
The Televere Podiatry Digital Imaging System consists of a combination of digital imaging software, a flat panel display (FPD), a PC-based computer, and a power supply. The PC based computer, x-ray generator and the power-supply are necessary for a the subject device. The imaging software has previously been cleared by FDA (i.e., K061035, TigerView Professional) and is being used unchanged in the subject device. This previously cleared software provides basic image adjustment features - an image management system allowing the physician to acquire, display, edit (e.g., resize, adjust contrast, crop, etc.), review, store, print, and distribute medical images within a Picture Archiving and Communication System (PACS) environment. TigerView Professional runs on standard PC-compatible computers and is compatible with capture devices which attach to the computer using a Network Adaptor, USB port, PCI slot, parallel port, memory card, S-video port on a video capture card, or SCSI card. The FPD component seeking clearance (VarexPaxScan2530C) has not been previously cleared by FDA as an individual component. The FPD uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide (GadOx) scintillator for displaying high quality images over a wide range of dose settings and is intended to be integrated into a complete X-ray system. This premarket notification seeks clearance for a combination finished device consisting of the combination of the previously cleared digital imaging software and the FPD component. The combination of the digital imaging software and the FPD does not affect the safety or efficacy of either component device alone, or in combination. A gigabit Ethernet port allows for tethered, non-wireless data transmission.
The provided document is a 510(k) premarket notification for the Televere Podiatry Digital Imaging System. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not describe a study involving AI for image analysis.
Instead, it focuses on the physical and performance characteristics of a digital X-ray imaging system component (Flat Panel Display or FPD) and its integration with existing software. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications of the imaging system and comparison to a legally marketed predicate device, rather than the performance of an AI algorithm against clinical ground truth.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance for AI, training set details) are not applicable for a 510(k) submission that doesn't involve an AI component that performs image analysis.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the format of pass/fail thresholds for clinical performance. Instead, it presents a "Substantial Equivalence Chart" which compares specifications of the new device to a predicate device. The implicit acceptance criteria are that the new device's performance metrics are "substantially equivalent" to the predicate.
| Characteristic | Predicate Device (Televere Digital Imaging System K170975) | Device Seeking Clearance (Televere Podiatry Digital Imaging System) | Implicit Acceptance Criteria (based on "Substantial Equivalence Conclusion") | Reported Performance for Device Seeking Clearance (relative to Predicate) |
|---|---|---|---|---|
| Device Name | Televere Digital Imaging System K170975 | Televere Podiatry Digital Imaging System | Substantially Equivalent | Matches |
| Flat Panel Device | XRpadTM 4343F-N | PaxScanTM 2530C | Substantially Equivalent | Different model, but deemed equivalent overall |
| Intended Use | General radiographic exams (skull, chest, shoulders, spine, abdomen, pelvis, extremities). Not for mammography. | Podiatry radiographic exams. Not for mammography. Not for fluoroscopy. | Substantially Equivalent (more specific for podiatry, but similar application) | More specific for podiatry, "substantially equivalent" per conclusion. |
| Configuration | Digital Panel and Software only, no generator or stand provided | SAME | Substantially Equivalent | Matches |
| Digital Panel Pixels | 4318 x 4320 | 1792 x 2176 | Substantially Equivalent | Different (fewer), but deemed equivalent for intended use. |
| Digital Panel Pitch | 100μm | 139μm | Substantially Equivalent | Different, but deemed equivalent for intended use. |
| Internal Image Storage | 1 GB DDR3, 4 GB SDHC card (e.g., 500 images for 10mb) | none | Substantially Equivalent (implies lack of storage is not a safety/efficacy issue) | Different (none), but deemed equivalent. |
| Image Acquisition Time |
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