(30 days)
SIDEXIS is a digital imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
SIDEXIS consists of intraoral and extraoral digital X-ray sensors, image acquisition boards, and software to be installed into an IBM-compatible personal computer. This Special 510(k) is being submitted to document a new sensor and associated software for digital transverse slice imaging in conjunction with the Orthophos Plus DS / Plus DS Ceph family of digital extraoral source X-ray imaging devices. Other minor modifications discussed in this Special 510(k) include: 1) a new XAB image acquisition board to interface SIDEXIS to the Orthophos X-ray systems via the Ethernet; 2) a new USB (Universal Serial Bus) Box to interface the SIDEXIS with the intraoral sensors; and 3) software enhancements to improve the overall function of SIDEXIS (resulting in software version 5.5).
Based on the provided text, the document is a 510(k) summary for a modified medical device, not a study report detailing acceptance criteria and performance evaluation against them. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not present in the provided text.
The document states that the SIDEXIS Digital Radiography Imaging System is a modification of a previously cleared device (K992644). The basis for substantial equivalence is that the modified device has the "same intended use and principles of operation... as well as substantially equivalent technical specifications."
Here's a breakdown of what can and cannot be extracted from the provided text regarding your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from "Substantially Equivalent") | Reported Device Performance |
|---|---|
| Intended Use: Replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. | The device maintains the "same intended use" as the predicate device (K992644). This implies it performs this function acceptably. |
| Principles of Operation: (Not explicitly stated, but implied to be similar to predicate) | The device has the "same principles of operation" as the predicate device. |
| Technical Specifications: (Not explicitly detailed, but implied to be similar to predicate) | The device has "substantially equivalent technical specifications" to the predicate device. |
| Safety and Effectiveness: (Implied by 510(k) clearance) | A hazard analysis and validation testing were submitted to support substantial equivalence. |
| Performance in digital transverse slice imaging (for new sensor and software) | The new sensor and associated software are for "digital transverse slice imaging in conjunction with the Orthophos Plus DS / Plus DS Ceph family." The 510(k) clearance indicates this functionality is deemed substantially equivalent. |
| Performance of new XAB image acquisition board | The new board interfaces SIDEXIS to Orthophos X-ray systems via Ethernet, and its performance is considered substantially equivalent. |
| Performance of new USB Box | The new USB Box interfaces SIDEXIS with intraoral sensors, and its performance is considered substantially equivalent. |
| Overall function of software version 5.5 | Software enhancements are made to "improve the overall function of SIDEXIS," and the improved version is considered substantially equivalent. |
Missing Information: Specific quantitative acceptance criteria (e.g., specific image resolution, contrast, diagnostic accuracy metrics like sensitivity/specificity) are not provided in this 510(k) summary. The "performance" is primarily described as being "substantially equivalent" to the predicate device, or "improved" for software, which is a regulatory conclusion rather than a detailed performance report.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not provided. The document mentions "validation testing" but gives no details on the sample size (number of images, patients, etc.) used for this testing.
- Data Provenance: Not provided. There is no mention of the country of origin of data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided. Since specific performance data and test sets are not detailed, there's no information about expert involvement in establishing ground truth.
4. Adjudication method for the test set
- Not provided. No details on adjudication methods are given.
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 indication of an MRMC study related to AI assistance. The document describes a "digital radiography imaging system," which replaces film, but does not mention Artificial Intelligence (AI) or machine learning components that would typically be evaluated with MRMC studies for human reader improvement. The 510(k) process here focuses on substantial equivalence to a predicate, not necessarily a comparative effectiveness study showing human improvement with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly stated as a "standalone" algorithm performance study. The device is presented as a system for "dental radiographic examination and diagnosis," implying human involvement. The 510(k) is for the imaging system itself, not necessarily an AI algorithm to be used stand-alone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided. Given the lack of detail on the "validation testing," the type of ground truth is not specified. For dental imaging, this typically involves expert reads, but the document does not confirm this.
8. The sample size for the training set
- Not applicable/Not provided. This document does not describe a machine learning algorithm that would require a "training set." It describes a hardware and software system for digital radiography.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, this isn't a machine learning algorithm with a training set.
Summary of the Study (as described in the 510(k) Summary):
The "study" described in this 510(k) summary is not a detailed clinical trial or performance study against specific acceptance criteria in the conventional sense. Instead, it's a regulatory submission for a modified device. The "proof" that the device meets its requirements is based on demonstrating substantial equivalence to a legally marketed predicate device (SIDEXIS Digital Radiography System -- K992644).
The evidence provided to the FDA for this substantial equivalence included:
- A hazard analysis.
- Validation testing (specifics not detailed).
- A Declaration of Conformity to Design Controls.
The conclusion is that the modified SIDEXIS system has the "same intended use and principles of operation as the original SIDEXIS, as well as substantially equivalent technical specifications." The FDA agreed with this assessment, issuing a letter that "allows you to begin marketing your device as described in your 510(k) premarket notification."
§ 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.