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StarPACS Dental™ device is a software package that scans (using direct digital capture using a solid state sensor) and stores those images. Additionally, the software has the ability to import DICOM images from volumetric data sets for visualization, analysis and reporting. The software allows the practitioner to perform surgical demonstrations for dental implant planning, cephlometric analysis, measurements and bone graft visualizations. The purpose of the software is to provide the doctor with a convenient method for visualization of these multiple imaging modalities, facilitates communication between multiple practitioners and to demonstrate treatment plan for the patient.

STARPACS Dental™ is a new software application that has been developed to handle digital templates for dental implants, which are placed over digital dental images. The overlay of digital templates onto digital dental images is useful in planning dental implants. The software is used together with the existing STARPACS solution (one of the predicate devices K031013). In addition to imaging and workflow features, STARPACS Dental allows dental implants simulations for dental implanting with the digital template library. STARPACS Dental is not intended to replace the skill and the experience of a qualified medical practitioner but to assist in surgical decisions and possibly to shorten surgery time.

The provided K051715 510(k) summary for INFINITT Co., Ltd.'s STARPACS Dental™ device does not contain acceptance criteria or a study that proves the device meets specific performance criteria.

This 510(k) submission is primarily focused on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than on a clinical performance study with defined acceptance criteria.

The document states:

• "The 510(k) Pre-Market Notification for STARPACS Dental™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate devices."
• "STARPACS Dental™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey."
• "The submission contains the results of a hazard analysis and the potential hazards have been classified as 'Minor'."

These statements indicate that the submission relies on standards compliance, hazard analysis, and comparison to predicates for safety and effectiveness, rather than a quantifiable performance study against specific acceptance criteria.

Therefore, I cannot provide the requested information because it is not present in the provided text.

Specifically, the following information is missing from the document:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample sized used for the test set and the data provenance: No test set described, thus no sample size or provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment described.
4. Adjudication method for the test set: No adjudication method described.
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 MRMC study described. The device is for "assisting in surgical decisions" and "demonstrating treatment paths," not for improving reader performance in diagnostic tasks in a quantifiable manner against a baseline.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device description emphasizes that it "is not intended to replace the skill and the experience of a qualified medical practitioner but to assist in surgical decisions" and that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed," indicating it's not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth explicitly mentioned or used for device evaluation in the provided summary.
8. The sample size for the training set: No training set mentioned.
9. How the ground truth for the training set was established: Not applicable, as no training set is mentioned.

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