(17 days)
For diagnostic radiographic use in dental, oral surgery, and orthodontic practices.
The PC-1000 panoramic X-ray machine provides a panoramic picture, showing 70-80% more anatomy than a standard series of full-mouth X-rays. Inscribed lines and an angled mirror aid in accurately establishing the Frankfort plane and the midsagittal plane. In addition, the numbered temple supports allow accurate measurement of skull density for proper kVp settings, eliminating the guess work typical in panoramic radiography.
The provided text describes a 510(k) premarket notification for the Model PC-1000 Panoramic / Cephalometric X-ray Systems. This document is a predicate device comparison for substantial equivalence rather than a study demonstrating an AI device's performance against acceptance criteria.
Therefore, many of the requested categories for AI device performance are not applicable to this submission. The document focuses on showing the new device is as safe and effective as a previously marketed device (K882436) through benchmarking its characteristics against the predicate and compliance with relevant standards.
Here's an attempt to address the request based on the available information, noting the significant gaps due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device K882436) | Reported Device Performance (Modified Model PC-1000) | Meets Criteria? |
|---|---|---|---|
| Intended Use | Diagnostic Dental X-Rays (Panoramic and Cephalometric) | SAME (Diagnostic Dental X-Rays) | Yes |
| Energy Source | 120 V Ac 20 A | SAME (120 V Ac 20 A) | Yes |
| User Interface | Dedicated Controls | Touch Controls | N/A (Technological Difference, deemed not to affect safety/effectiveness) |
| Maximum output | 90 kVp | SAME (90 kVp) | Yes |
| Focal spot | 0.5 mm x 0.5 mm | SAME (0.5 mm x 0.5 mm) | Yes |
| Tube Current | 6 ma | SAME (6 ma) | Yes |
| Exposure time | 12 seconds | SAME (12 seconds) | Yes |
| Method of Control | Analog Hardware | (3) Microprocessors | N/A (Technological Difference, deemed not to affect safety/effectiveness) |
| Performance Standard | Complies with 21 CFR Part 1020 | SAME (Complies with 21 CFR Part 1020) | Yes |
| International Standards | IEC 60601-1 (1988-12) & amend., IEC 60601-2-7, IEC 60601-2-28, IEC 60601-1-2 | SAME (IEC 60601-1 (1988-12) & amend., IEC 60601-2-7, IEC 60601-2-28, IEC 60601-1-2) | Yes |
| Safety | UL Listing | SAME (UL Listing) | Yes |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is detailed in the "Summary of Safety and Effectiveness" (referred to as Exhibit 2, although content from the exhibit is spread across the provided text) which broadly states: "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices."
The "Substantial Equivalence Chart" (likely part of Exhibit J) explicitly compares the characteristics of the new Model PC-1000 (Modified) against the predicate Model PC-1000 (K882436). The conclusion states: "After analyzing bench, user, and standards testing data, it is the conclusion of Panoramic Corporation that the Model PC-1000 Panoramic / Cephalometric X-ray Systems are as safe and effective as the predicate device, have few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate device."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document references "bench, user, and standards testing data" without providing specific numbers of tests conducted or units observed.
- Data Provenance: Not specified. This type of submission would typically involve internal testing by the manufacturer (Panoramic Corp.) and potentially accredited lab testing for standards compliance. The document does not mention country of origin for data or if it was retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a comparison of hardware technical specifications and compliance with safety standards, not a diagnostic accuracy study requiring expert ground truth for image interpretation.
4. Adjudication method for the test set:
- Not Applicable. As above, this is not an diagnostic accuracy or image interpretation study. Adjudication methods are common for clinical studies involving disagreement among readers/experts.
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 is not an AI device or a diagnostic aid. It's a conventional panoramic/cephalometric X-ray system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device does not have an "algorithm only" component in the way an AI diagnostic or analytical tool would.
7. The type of ground truth used:
- For technical specifications (e.g., kVp, focal spot, exposure time, current), the "ground truth" would be established by physical measurements and calibration according to industry standards and engineering principles.
- For compliance with standards (e.g., 21 CFR Part 1020, IEC standards, UL Listing), the "ground truth" is verified through audits and specific tests mandated by those standards, conducted by the manufacturer or accredited testing bodies.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML algorithm is involved.
§ 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.