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510(k) Data Aggregation
(55 days)
DIGORA PCT/DIGIPOD
The Digora PCT or Digipod imaging system is indicated for capturing, digitization and processing of extraoral, maxillofacial, cephalometric and podiatric X-ray images stored in imaging plate recording media.
A digital radiography system for imaging plates located in cassettes. The system may be used with x-ray equipment utilizing film or similar cassettes. The image is recorded on reusable imaging plate which substitutes for conventional x-ray film. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by pixel by a scanning laser. An optical system collects the emission for photoelectronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Digora PCT or Digipod device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Digora PCT or Digipod) |
|---|---|
| Dose required to produce equal pixel value of a known object (compared to predicate device Fuji FCR 9000HQ) | Substantially equal to Fuji FCR 9000HQ |
| Spatial Resolution (compared to predicate device Fuji FCR 9000HQ) | Substantially identical, specifically 4 - 5 lp/mm |
| Diagnostic Capability (compared to predicate device Fuji FCR 9000HQ) | Substantially equivalent diagnostic capability |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The study described is a comparison study against a predicate device, focusing on technical performance parameters rather than a clinical trial with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for a test set. The evaluation primarily focuses on direct technical comparisons of objective metrics (dose, spatial resolution) and a general statement about diagnostic capability, rather than an assessment of diagnostic accuracy by human readers.
4. Adjudication Method for the Test Set
No adjudication method is mentioned as there is no indication of human expert review being part of the test set evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on direct technical comparisons between the device and its predicate, not on the improvement of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The "Performance data" section describes a comparison of the Digora PCT or Digipod directly against the predicate device (Fuji FCR 9000HQ) in terms of dose requirements and spatial resolution. This is an evaluation of the device's inherent technical capabilities, independent of human interpretation.
7. The Type of Ground Truth Used
The ground truth for the technical performance study appears to be objective physical measurements rather than clinical ground truth like pathology or outcomes data.
- For dose comparison, the ground truth was a "known object" and the "equal pixel value" it produced.
- For spatial resolution, the ground truth was the objective measure of line pairs per millimeter (lp/mm).
8. The Sample Size for the Training Set
The document does not mention a training set. The device described is an imaging plate reader, not an AI or machine learning algorithm that requires a training set. The "processing" mentioned refers to conventional image processing, not AI model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for an AI/machine learning model.
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(29 days)
DIGORA PCT
The Digora PCT imaging system is indicated for capturing, digitization and processing of extraoral, maxillofacial and cephalometric x-ray images stored in imaging plate recording media.
A digital radiography system for imaging plates located in cassettes. The system may be used with x-ray equipment utilizing film or similar cassettes. The image is recorded on reusable imaging plate which substitutes for conventional x-ray film. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by pixel by a scanning laser. An optical system collects the emission for photoelectronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals. Further image processing, display and achieving are carried out with an auxilia software (such as Digora for Windows K983267), a PC and a CRT.
The provided text describes the Digora PCT, an imaging plate reader, and its performance compared to a predicate device (Digora) and a conventional film-screen combination.
Here's the information extracted and organized to answer your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Digora PCT) |
|---|---|---|
| Physical Performance | ||
| Dose required | 1/4 of Digora PCT (This is inverse, meaning Digora PCT needed less dose for the same pixel value) | 4x less dose than Digora to produce an equal pixel value of a known object |
| Spatial Resolution | 6 lp/mm (Digora) | 4 lp/mm |
| Diagnostic Capability | Equivalent to Kodak T-Mat G film/Lanex Regular intensifying screens | Substantially equivalent to Kodak T-Mat G film/Lanex Regular intensifying screens for diagnostic capability |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of images or patients) used for either the physical performance comparison or the diagnostic capability comparison.
The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin. However, the submitter is "Soredex Instrumentarium Corporation Nilsiankatu 10 - 14 00510 Helsinki Finland," suggesting the testing may have been conducted in Finland.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts used or their qualifications for establishing ground truth in the diagnostic capability study. It only states that a "comparison... was made to evaluate the ability of the device to provide images of equivalent diagnostic capability."
4. Adjudication Method for the Test Set
The adjudication method is not described in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
The document does not explicitly mention a multi-reader multi-case (MRMC) comparative effectiveness study. It states a "comparison... was made to evaluate the ability of the device to provide images of equivalent diagnostic capability," which could imply a human reader study, but details about its design (MRMC) and effect size are absent.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
For the Digora PCT, this device is an imaging plate reader, which is a physical device that processes images. It does not appear to be an AI algorithm in the contemporary sense. Therefore, the concept of a standalone AI performance study (without human-in-the-loop) isn't directly applicable in this context. The performance described relates to the image acquisition and processing capabilities of the hardware.
7. The Type of Ground Truth Used
- Physical Performance: For dose and spatial resolution, the "ground truth" was established based on objective measurements against the predicate device (Digora). For dose, it was "pixel value of a known object." For spatial resolution, it was "lp/mm" (line pairs per millimeter).
- Diagnostic Capability: The ground truth for diagnostic capability was based on a comparison to the diagnostic capability of a "cleared film screen combination" (Kodak T-Mat G film/Lanex Regular intensifying screens). This implies that the accepted diagnostic performance of the film-screen combination served as the benchmark. The method by which this diagnostic capability was assessed (e.g., expert interpretation of images for specific pathologies) is not detailed.
8. The Sample Size for the Training Set
The document does not refer to a "training set" as this device is not an AI/ML algorithm that undergoes a distinct training phase. It is a physical device for image acquisition and processing.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device, the concept of a "training set" and associated ground truth establishment does not apply. The device's performance is characterized through physical measurements and comparisons to established imaging technologies.
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