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The IOS FastScan Spray is indicated as a coating medium for optical impressions with the IOS FastScan System. It aids in intraoral topographical recordings of prepared and unprepared teeth and their surroundings.

The IOS FastScan Spray is a coating medium applied by a dentist, by spraying onto the area of interest on the teeth and gums. After the coating application, the IOS FastScan System is used to optically capture a 3D impression of the coated dentition. Once the dentist has completed the optical impression, the patient's mouth is rinsed and suctioned to remove the IOS FastScan Spray. The IOS FastScan Spray consists of a pigment suspension in ethanol with a fluorinated hydrocarbon propellant.

The provided document describes the IOS FastScan Spray and its substantial equivalence to the CEREC Opti Spray. It outlines non-clinical and clinical studies conducted to demonstrate its performance.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the IOS FastScan Spray were to demonstrate substantial equivalence to the predicate device, CEREC Opti Spray, specifically showing no statistically significant difference in accuracy for 3D digital models derived from impressions.

Clinical study: "The clinical in-vitro and in-vivo impression 3D model accuracy data show that the 20 dentists involved in the study achieved essentially the same accuracy result with the IOS FastScan Spray as was achieved with the CEREC Opti Spray." |
| Biocompatibility: No cytotoxic, irritative, or sensitizing effects. | "The testing found that 'no cytotoxic, irritative and sensitizing effects should be expected'." |
| Acute Systemic Toxicity: No signs of toxicity or mortality from acute oral dose.| "The study found that there were no signs of toxicity or mortality from an acute oral dose of the IOS FastScan Spray." |
| Absence of Adverse Events/Complications in Clinical Use. | "There were no adverse events or complications experienced during the clinical testing." |

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Non-clinical: Not explicitly stated, but involved "repeated applications" to a master typodont model.
  • Clinical: 20 dentists, each performing an in-vitro and in-vivo digital optical impression. The same volunteer subject was used for all 20 in-vivo tests.
• Data Provenance:
  • Non-clinical: In-vitro lab setting, using a master typodont model.
  • Clinical: Prospective clinical testing, taking place at the dental practice of each of the 20 participating dentists. The country of origin is not specified but given the submitter information (San Diego, CA), it is likely the USA.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly mention "experts" being solely responsible for establishing ground truth in the traditional sense of diagnostic interpretation. Instead, the ground truth for accuracy appears to be established by comparing the 3D digital models generated by the device to those generated by the predicate device (which is assumed to be accurate).

For the clinical study, 20 dentists were involved in taking the impressions and evaluating performance. Their qualifications are not specified beyond being "dentists." It's stated they compared the data for "validation of precision" and "comparison of performance."

4. Adjudication Method

The document does not describe an adjudication method in the context of multiple expert readers interpreting images or data. The comparison methodology involved statistically comparing the accuracy of 3D digital models from the test device against the predicate device.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study as typically understood in AI performance evaluation (comparing human readers with and without AI assistance to measure effect size) was not performed. The clinical study involved 20 dentists directly comparing the performance of the IOS FastScan Spray to the predicate CEREC Opti Spray, not measuring improvement of human readers using the AI (the spray itself is not an AI).

6. Standalone Performance

Yes, a form of standalone performance was implicitly evaluated. The non-clinical studies specifically focused on the "performance characteristics of the IOS FastScan Spray in comparison to the performance characteristics of the predicate device CEREC Opti Spray" by scanning a master typodont model. This indicates the device's ability to capture accurate 3D models on its own, independent of variable human factors in some aspects (though humans apply the spray and use the system). The clinical studies then validated this performance in a real-world setting with dentists.

7. Type of Ground Truth Used

The ground truth for evaluating the accuracy of the 3D digital models was an established reference model.

• Non-clinical: A "master typodont model" served as the reference for accurate 3D geometry which was then spirally scanned to capture an optical impression. The accuracy of the generated 3D digital models was compared against impressions from this known reference model, and against the performance of the predicate device on the same model.
• Clinical: The "same master typodont dental model test specimen" for in-vitro tests and "the same section of dentition of a volunteer subject" for in-vivo tests served as the subject for comparison, again implying that the objective was to match the performance of the predicate device when applied to these 'ground truth' dentitions.

8. Sample Size for the Training Set

The document does not mention a training set, as the device (IOS FastScan Spray) is a medical device (coating medium) and not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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