(14 days)
For diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
Axial rotation x-ray source (PC-1000). The PC-1000 panoramic X-ray machine portion of the Sunipan Imaging System generates the required ionizing radiation (x-rays) This unit is identical to the PC-1000 model supplied directly by Panoramic Corporation for use with standard x-ray film. The Sunipan Imaging System combines this base x-ray unit with an available aftermarket digital imaging sensor, creating a filmless digital imaging system.
Digital Image Sensor (Scan300fp/Retropan) is a high speed x-ray camera tailored for dental panographic applications. Originally designed and cleared for retro-conversion of existing standard panographic x-ray units. The sensor system utilizes direct conversion technology which offers a number of benefits over CCD technology. The images obtained may be reviewed and adjusted after exposure to focus on different layers or areas of clinical it rest.
The provided document is a 510(k) premarket notification for the SuniPan Imaging System. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical study data with detailed acceptance criteria and performance metrics typically seen for novel devices or AI/ML-based systems.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance against those criteria, ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies.
Here's a breakdown of why the requested information isn't available in the provided text:
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Premarket Notification (510(k)) Context: A 510(k) submission aims to prove that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and performance claims to the predicate. It usually doesn't require new clinical efficacy studies of the same rigor or depth as a PMA (Premarket Approval) submission, especially for established technologies like X-ray imaging.
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Device Type: The SuniPan is a digital imaging device that combines an existing X-ray unit (PC-1000, identical to a film-based unit) with an aftermarket digital sensor (Scan300fp/Retropan). The digital sensor itself was previously cleared. The focus here is on the combination being equivalent to other digital panoramic systems.
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Absence of Clinical Study Section: The document is primarily administrative and descriptive, listing device details, classification, equivalency claims, and the FDA's clearance letter. It lacks a dedicated "Clinical Study" or "Performance Data" section with detailed methodologies.
Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and study details. The document indicates the device meets the regulatory requirements for "substantial equivalence" based on comparison to predicate devices, but it does not describe a study with explicit acceptance criteria for performance as would be expected for a novel diagnostic instrument.
However, I can extract what is available regarding "equivalency" which serves as the basis for marketing clearance:
1. Table of "Acceptance Criteria" (Implied by Substantial Equivalence) and Reported Device Performance
| Feature/Criterion (Implied by 510(k) Equivalency) | Reported Device Performance (Summary from Document) |
|---|---|
| Premarket Notification Goal | Substantial Equivalence: Suni Medical Imaging, Inc. believes the SuniPan Imaging System is substantially equivalent to legally marketed predicate devices (K051664 Scan300fp/Retropan and K043557 PC 1000). The FDA concurred with this determination, allowing the device to be marketed. |
| Place of Manufacture | Equivalent to predicate devices. |
| Physical Appearance | Equivalent to predicate devices. |
| Functional Testing | Equivalent to predicate devices. (Details of this testing are not provided in the excerpt.) The PC-1000 panoramic X-ray machine portion is identical to a unit supplied by Panoramic Corporation for use with standard x-ray film. The digital image sensor (Scan300fp/Retropan) is a high-speed x-ray camera tailored for dental panographic applications, originally designed and cleared for retro-conversion. It uses direct conversion technology. Images can be reviewed and adjusted after exposure to focus on different layers or areas of clinical interest. |
| Material Certification | Equivalent to predicate devices. |
| Instructions for Use | Equivalent to predicate devices. |
| Indications for Use | Substantially equivalent to predicate devices: "For diagnostic radiographic use in dental, oral surgery, and orthodontic practices." (This indication was formally cleared by the FDA). The system generates required ionizing radiation (x-rays) and combines a base x-ray unit with an aftermarket digital imaging sensor to create a filmless digital imaging system. |
| Patient Safety (Radiation Control) | The device meets general controls provisions of the Act, including, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050. (Implied compliance rather than specific performance metrics against acceptance criteria for radiation dose, etc.). |
2. Sample size used for the test set and the data provenance:
- Not explicitly stated in the document. The 510(k) process typically relies on bench testing, comparison to predicate device specifications, and sometimes limited clinical data, but the specifics are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated. Given it's a 510(k) for an established imaging technology, expert review for image quality or substantial equivalence might have been performed, but the document does not detail this.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not explicitly stated.
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. This is not an AI/ML device, nor is it a multi-reader multi-case study as described in the document. The device is a standard digital X-ray imaging system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/ML diagnostic algorithm. It is a digital imaging acquisition system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For an imaging system, "ground truth" (if established for performance testing) would typically relate to the accuracy of imaging features against known physical standards or clinical outcomes. However, the document relies on its substantial equivalence to previously cleared devices.
8. The sample size for the training set:
- Not applicable as this is not a machine learning/AI device requiring a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.