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510(k) Data Aggregation
(259 days)
x-mind dc (and Owandy-RX DC under trademark Owandy Radiology) is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device.
The device is operated and used by dentists, radiologists and other legally qualified health care professionals.
x-mind dc consists of the following parts:
- 1 X-ray control unit (timer)
- 2 Wall plate and horizontal bracket
- 3 Pantograph type arm (scissor arm)
- 4 X-ray source assembly (tubehead)
- 5 Collimator cone (Beam Limiting Device)
The timer is the control panel used to manage the exposure settings and to safely use the tubehead. It allows easy and clear selection, with the help of clear and visible signals, of the exposure settings, perform personal settings and display alarms of the device in case of incorrect operation or eventual failures.
The horizontal bracket it is available in 3 different lengths and represents the support for the scissor arm. The pantograph arm, being adjustable in height and depth, allows the precise positioning of the tubehead. The tubehead of the device contains the X-ray tube, the high voltage board and the high frequency generator. It is the component of the device which emits the X-rays.
The collimator cone represents the part of the device in contact with the patient and it allows the correct focal spot to skin distance, ensures the dimension, direction and centering of the X-ray beam.
x-mind dc can be used with conventional chemical films (D, E, F speed films), phosphor plates (PSP), RVG digital detectors (CCD or CMOS).
The provided text outlines the 510(k) summary for the x-mind dc (and Owandy-RX DC) device, which is an extraoral source X-ray system intended for intra-oral radiographic exams. The core of the summary demonstrates substantial equivalence to a predicate device, Endograph DC (K130109), and a reference device, PHOT-X II, MODEL 303 (K042260).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for the device in the sense of performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm. Instead, it details the device's technical specifications and compliance with various international and national standards and regulations. The "acceptance criteria" here are implicitly the successful adherence to these standards, demonstrating safety and essential performance comparable to the predicate device.
To frame this in the requested format, we can list key technical specifications and their comparison to the predicate/reference devices, which serve as the "performance" verification. The ultimate "acceptance criterion" is the determination of substantial equivalence by the FDA.
| Characteristic | Acceptance Criteria (Predicate/Reference) | Reported Device Performance (x-mind dc) | Outcome |
|---|---|---|---|
| Intended Use/Indications | Dental radiographic examination/diagnosis of teeth, jaw, oral structures (adult & pediatric) by qualified professionals. | Same indications as the predicate device. | Equivalent |
| Generator Type | High frequency, constant potential (DC) | High frequency, constant potential (DC) | Same |
| Nominal Anode Voltage | 60 / 65 / 70 kV (Predicate), 60 / 70 kV (Reference) | 60 / 70 kV | Similar/Same |
| Nominal Anode Current | 6 mA (Predicate), 4 / 7 mA (Reference) | 4 / 8 mA | Different/Similar |
| Exposure Time | 0.01 s – 2.0 s (36 steps) (Predicate), 0.01 s – 3.2 s (23 steps) (Reference) | 0.020 s – 3.2 s (23 steps) | Different/Similar |
| Focal Spot Size | 0.4 mm (Predicate), 0.7 mm (Reference) | 0.7 mm | Different/Same |
| Anode Material | Tungsten | Tungsten | Same |
| Total Filtration at 70 kV | ≥ 2.5 mm Al (Predicate) | 2.4 mm Al | Similar |
| Half Value Layer (HVL) at 70 kV | > 2 mm Al (Predicate) | 2.2 mm Al | Similar |
| Leakage Radiation |
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(28 days)
Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor).
Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
The Star-X is an X-ray generator for dental intra-oral X-ray imaging and intended to be used for producing diagnostic dental radiographs for treatment of disease of teeth, jaw and oral structures. The Star-X is consisted of X-ray generator, beam limiting device (cone), control panel, mechanical arm, support device, chair and backrest. The control panel allows for accurate exposure control and adjustable arm provide for convenient patient positioning.
The provided text is a 510(k) summary for the Star-X Intraoral X-ray System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a new AI/CAD device. Therefore, much of the requested information regarding acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, ground truth establishment, and expert qualifications for performance evaluation is not present in the given document.
The document primarily addresses the safety and technical characteristics of the X-ray system itself, comparing it to existing X-ray units. It does not describe a study to prove meeting acceptance criteria in the context of an AI/CAD system for image analysis.
Here's a breakdown of what can be extracted and what is missing based on your specific request:
Acceptance Criteria and Reported Device Performance
The document describes compliance with various electrical safety, electromagnetic compatibility, and radiation protection standards for an X-ray system. It does not present acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/CAD system.
The "device performance" reported here is about the technical specifications of the X-ray unit, not an AI's diagnostic capabilities.
| Acceptance Criterion Type (as implied for an X-ray system) | Reported Device Performance (Star-X) |
|---|---|
| Electrical Safety | Complies with ES60601-1 |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2 |
| Radiation Protection | Complies with IEC 60601-1-3 |
| Dental Intra-Oral X-Ray Equipment Requirements | Complies with 60601-2-65 |
| Rated mains voltage | 100-120/200-240 VAC |
| Tube Voltage | 65 kV |
| Tube Current | 3 or 6 mA |
| Exposure Time | 0.01-3.2 s (in 0.01 step) |
| Inherent Filtration | 0.8 mm Al |
| Total Filtration | > 1.8 mm Al |
| Focal Spot Size | 0.8 mm |
| Anode Material | Tungsten |
| Compatible with Digital Imaging | Applicable |
| Duty Cycle | 1:60 |
| Software Validation | Designed, developed, verified, and validated according to FDA guidance (Moderate level of concern) |
| Cybersecurity | Complies with FDA guidance |
Missing Information for AI/CAD System Evaluation:
The following information cannot be provided from the given document as it pertains to the regulatory submission for an X-ray imaging device, not an AI/CAD diagnostic software.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is an X-ray hardware device, not an AI/CAD system being evaluated for diagnostic performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable (for AI model training). The software mentioned is for the control and operation of the X-ray machine.
- How the ground truth for the training set was established: Not applicable.
Summary of the Document's Content:
The provided document is a 510(k) premarket notification for the "Star-X, Intraoral X-ray System." It seeks to establish substantial equivalence to existing predicate X-ray devices. The "study" referenced in the document is a series of non-clinical tests demonstrating compliance with electrical safety, EMC, radiation protection, and performance standards relevant to X-ray hardware. It also mentions software validation for the control software of the X-ray system, confirming it was designed, developed, verified, and validated for a moderate level of concern, and that cybersecurity information was provided. This is not a diagnostic performance study of an AI algorithm on medical images.
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