Search Results
Found 1 results
510(k) Data Aggregation
(118 days)
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 | < 5 seconds | 1 second | Substantially Equivalent (implies faster is okay/better) | Faster (1 second) |
| DICOM 3 | YES via software cleared in K061035 | SAME | Substantially Equivalent | Matches |
| A/D Conversion | 16 Bit | SAME | Substantially Equivalent | Matches |
| Scintillator | Gadolinium Oxysulfide (GadOx) | SAME | Substantially Equivalent | Matches |
| MTF (RQA5) | 55% (1 cy/mm), 25% (2cy/mm), 5% (4 cy/mm) | 55% (1 cy/mm), 23% (2cy/mm), 5% (4 cy/mm) | Substantially Equivalent (differences are minor) | Slightly lower at 2cy/mm (23% vs 25%) but stated as "similar enough not to make a notable difference" and "substantially equivalent". |
| DQE (RQA5) | 40% (0 cy/mm), 30% (1 cy/mm), 10% (3 cy/mm) | 31% (0 cy/mm), 22% (1 cy/mm), 7% (3 cy/mm) | Substantially Equivalent (differences are present but deemed acceptable) | Lower across all points (e.g., 31% vs 40% at 0 cy/mm) but stated as "similar enough not to make a notable difference" and "substantially equivalent". |
| Interface | Gigabit Ethernet Port | SAME | Substantially Equivalent | Matches |
| Panel Size | 460 mm (w) × 460 mm (l) × 15 mm (h) | 249 mm (w) x 302 mm (l) x 49 mm (h) | Substantially Equivalent (implies different physical dimensions are acceptable for podiatry use) | Different, smaller. |
| Power Source | External Power Supply 100-240 VAC | SAME | Substantially Equivalent | Matches |
| Electrical Safety & EMC | IEC 60601-1-2 Ed 3:2007-03, IEC 60601-1-2 Ed 4.0 2014-02 | SAME | Substantially Equivalent | Matches |
2. Sample sized used for the test set and the data provenance:
- The document states "clinical images from the new device were also provided however they were not necessary to demonstrate substantial equivalence."
- This suggests that formal, quantitative clinical performance testing with a 'test set' as one would define for an AI algorithm was not the primary method for demonstrating equivalence.
- The focus was on bench testing (MTF, DQE, electrical safety, EMC) and comparison of specifications to the predicate device. Therefore, sample size and data provenance for a "test set" in the context of clinical image analysis are not provided or applicable for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for clinical conditions based on expert consensus is not described as a part of this submission framework. The "ground truth" here is the performance of the predicate device and relevant engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set requiring adjudication in the context of diagnostic accuracy is described.
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 applicable. This submission is for an imaging system (hardware and associated software for image management), not an AI diagnostic algorithm. No human reader studies for diagnostic improvement are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" or reference standard for this submission appears to be:
- Performance metrics of the legally marketed predicate device (K170975).
- International Electrotechnical Commission (IEC) Standards for Electrical Safety and Electromagnetic Compatibility (IEC 60601-1-2).
- FDA guidance documents for solid-state digital X-ray panels.
- "Clinical image inspection" by Televere, noting "Professional evaluation of imaging samples were of excellent quality, high resolution, clinically acceptable." This implies some internal review, but not a blinded, rigorous clinical study designed to establish diagnostic accuracy against a separate ground truth.
8. The sample size for the training set:
- Not applicable. This is not an AI algorithm that requires a training set. The "imaging software" (TigerView Professional K061035) was previously cleared and "is being used unchanged in the subject device," implying it was already "trained" or developed prior to this submission.
9. How the ground truth for the training set was established:
- Not applicable, as it's not an AI training set for this submission.
Ask a specific question about this device
Page 1 of 1