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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

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."

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The 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. Accessories to be used with the intraoral sensors include holders and hygienic covers. Use of the SIDEXIS differs from conventional X-ray imaging only due to the use of the PC and the X-ray sensors. The X-rays are produced using the customary method of the intraoral or extraoral X-ray system, however, an electronic, radiation sensitive sensor element is used in place of the conventional film carrier. The radiation is then converted into electronic signals that are relayed through cables connecting the sensor to the PC directly or through a network.

The SIDEXIS can be used with:

• Intraoral sensors and an intraoral dental X-ray device (e.g., Heliodent DS); and .
• Panoramic or cephalometric sensors and an extraoral source X-ray device (e.g., . Orthophos 3DS, DS, or DS Ceph).

The provided document is a 510(k) Special Summary for the SIDEXIS Digital Radiography Imaging System. This type of submission is for modifications to a device that has already received 510(k) clearance and relies on the substantial equivalence to a predicate device. It does not contain a study demonstrating that the device meets acceptance criteria in the way a de novo or a new 510(k) for a novel device would.

Instead, the submission focuses on validating that the modifications to the already cleared SIDEXIS system do not raise new questions of safety and effectiveness and that the modified device remains substantially equivalent to its predicate.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, and detailed study methodologies for proving performance against those criteria are not present in this document, as they would have been part of the original K972168 submission or are covered by the general principles of substantial equivalence for a modified device.

However, I can extract information related to the basis for substantial equivalence for this modified device:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a Special 510(k) for modifications, specific numerical "acceptance criteria" and "reported device performance" in the context of clinical metrics (e.g., sensitivity, specificity for a diagnostic task) are not provided in this document. The acceptance for this submission is based on maintaining substantial equivalence to the predicate device after modifications.

The document states:

• "A hazard analysis, validation testing, and Declaration of Conformity to Design Controls were submitted to support the substantial equivalence of the modified to the original SIDEXIS Digital Radiography Imaging System."

This indicates that validation testing was performed, and the acceptance criterion appears to be that the modified device performs adequately and safely according to the design controls, and does not negatively impact the performance established for the prior cleared device (K972168). While the specific results of this validation testing are not detailed, the FDA's clearance implies these criteria were met.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable/Not provided in this Special 510(k) document. The submission focuses on hardware and software modifications and their validation rather than a new clinical test set.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable/Not provided in this Special 510(k) document.

4. Adjudication Method for the Test Set

Not applicable/Not provided in this Special 510(k) document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable/Not provided in this Special 510(k) document. The submission focuses on device modifications and substantial equivalence, not a comparative effectiveness study with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable/Not provided in this Special 510(k) document. This is an imaging acquisition system, not an AI algorithm for standalone diagnostic performance.

7. Type of Ground Truth Used

For the modifications described (additional sensors, acquisition boards, operating systems, computer platform), the "ground truth" would likely relate to objective physical measurements (e.g., image quality metrics like spatial resolution, contrast-to-noise ratio, signal-to-noise ratio) and functional verification (e.g., successful interface, software compatibility, system stability). This isn't a "ground truth" in the diagnostic sense (e.g., pathology report). The document implicitly states that these were validated through "validation testing" and compliance with "Design Controls."

8. Sample Size for the Training Set

Not applicable/Not provided in this Special 510(k) document. This is not an AI/machine learning device requiring a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not provided in this Special 510(k) document.

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