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510(k) Data Aggregation
(34 days)
"HDS" Intra-oral Imaging System is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed, and manipulated for diagnostic use by dentists.
The Intra-oral image system (HDS) is a device for digital intra oral X-rays imaging. It is fully USB compliant and can be plugged in any when computer is turned on.
Intra-oral image system (HDS) block diagram
PC
· Image interface box (Read-out Box)
· X-ray sensor
The provided document describes the VATECH "HDS" Intra-oral Imaging System, which is an intra-oral digital x-ray sensor. The submission is a 510(k) premarket notification, indicating that the device is seeking to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Suni Intraoral Imaging System, K021718) rather than setting specific numeric acceptance criteria for device performance. The "acceptance criteria" are implicitly the functional and performance characteristics of the predicate device, which the HDS system aims to match or exceed.
| Feature | Predicate: Suni Intraoral Imaging System (K021718) | "HDS" Intraoral Imaging System (Reported Performance) | Comparison to Predicate |
|---|---|---|---|
| Intended Use | Collect dental x-ray photons and convert them into electronic impulses for diagnostic use by dentists. | SAME | Equivalent |
| Computer interface | USB (version not specified) | USB, Specification 2.0 | Equivalent (with specific version) |
| Pixel Matrix | 271,000, 462,000, 1.26 M, or 1.8 M pixels (model dependent) | 650,000 pixels (688 × 944 pixel) | Within range/Comparable |
| Pixel Size | 22.5 or 45 um (model dependent) | 35 um | Within range/Comparable |
| Active Area | 26.8 x 21.6 mm, 32.7 x 20.6 mm, 36.8 x 26.6 mm, 36.8 x 26.6 mm | 24.08 mm x 33.04 mm | Within range/Comparable |
| External Dimensions | 32.5 x 26.4 mm, 37.8 x 24.7 mm, 43.0 x 31.8 mm, 43.0 x 31.8 mm (Thickness 3.2 mm) | 29 × 41 mm (Thickness 3.5 mm) | Within range/Comparable |
| Spatial Resolution | 12 lp/mm (Standard res model) | 14 lp/mm | Higher (Better) |
| Applicable PC | Not specified | Pentium 3, 1 GHz CPU; 128 MB RAM; 10GB HDD; 1024x768x24 bit VGA; Windows XP, Serial/USB port | Specified (Meets system requirements) |
2. Sample size used for the test set and the data provenance:
The provided document does not mention the sample size for any clinical test set, nor does it specify data provenance (country of origin, retrospective/prospective). The testing described appears to be internal engineering and software validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document does not describe any studies involving human experts establishing ground truth for diagnostic accuracy.
4. Adjudication method for the test set:
Not applicable. No clinical test set involving human readers or adjudication 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:
No MRMC comparative effectiveness study is mentioned. This device is an imaging acquisition system, not an AI-powered diagnostic aid.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a hardware sensor for image acquisition. Performance is related to image quality and system functionality, not an "algorithm only" diagnostic performance.
7. The type of ground truth used:
For the technical performance aspects (e.g., spatial resolution, pixel matrix), the "ground truth" would be established using physical phantoms, test patterns, and metrology equipment rather than clinical ground truth (pathology, expert consensus, outcomes data). The document refers to "internal company procedures" and "written test protocols" for software testing and validation.
8. The sample size for the training set:
Not applicable. This device is a hardware sensor and does not utilize a training set in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable.
Summary of the Study and Evidence Presented:
The document describes a 510(k) submission for the VATECH "HDS" Intra-oral Imaging System. The primary "study" presented is a comparison of the technical specifications and intended use of the HDS system against a legally marketed predicate device, the Suni Intraoral Imaging System (K021718).
The evidence for meeting "acceptance criteria" (which are implicitly the performance characteristics of the predicate) is presented in the table comparing features of the HDS system to the predicate. The HDS system demonstrates comparable or superior technical specifications (e.g., higher spatial resolution), and identical intended use.
The document states: "Testing was performed according to internal company procedures. Software testing and validation were done according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release. Test results support the conclusion that actual device performance satisfies the design intent."
This indicates that internal technical assessments and software validation were conducted to confirm the device's functionality and performance met the design requirements, thereby supporting the claim of substantial equivalence to the predicate device. There is no mention of clinical trials, human expert studies, or AI-specific performance evaluations.
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