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The New Device is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details invisible to the naked eye or with a mirror (thanks to its magnification).

The New Device is an intra-oral video camera equipped with LEDs to light the inspection site. Thanks to its technology based on fluorescence phenomenon (given by its LED lamps) and chromatic amplification, this camera will permit a global care of the patient. The optics and the charge coupled device (CCD) sensor in the New Device picks up the images containing this fluorescence highlight site and converts them to a video signal that is sent to a video monitor or computer monitor. Dental practitioner and/or hygienist, as an aid for diagnosis, can use the results of this image.

Here's a detailed breakdown of the acceptance criteria and study information for the SOPROCARE device, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The document states the "aims of this study were to determine if: New Device has a comparable effectiveness as Predicate Device SOPROLIFE." It then presents the performance metrics of the new device and the practitioner's eyes. The acceptance criteria are implicitly defined by requiring "high accuracy," "high sensitivity," and "high specificity" and comparing them against the "gold standard."

Study Information

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size:
     • Dental plaque and inflammation analysis: 120 teeth
     • Pit and fissure caries detection: 128 teeth
     • Number of participants: 20 people (9 women, 11 men)
   • Data Provenance:
     • Country of Origin: Marseille, France (study conducted from January 6 to February 7, 2012)
     • Retrospective or Prospective: Prospective (clinical data was "collected during the following study").

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document states that the predicate devices (SOPROLIFE for caries, GC Tri Plaque ID Gel for dental plaque, and bleeding upon probing technique for gingival inflammations) were used as "gold standards." It defines a gold standard as "the best available under reasonable conditions... supposed to never be wrong and so have sensitivity and specificity of 100%."
   • It does not specify a number of human experts used to establish the ground truth for the test set, nor does it provide qualifications for any such experts. The "gold standard" here refers to the performance of the predicate device or technique itself.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • The document does not describe an adjudication method for the test set; the ground truth was established by the "gold standard" predicate devices/techniques.

4. 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:

   • A comparative effectiveness study was done comparing the device's performance to "practitioner eyes" (human readers without the device).
   • This was not an MRMC study in the typical sense of evaluating human readers with vs. without AI assistance. Instead, it evaluated the standalone performance of the device against a "gold standard" and also documented the performance of "practitioner eyes" against the same "gold standard."
   • The document implies that the device improves diagnosis capability compared to practitioner using only visual inspection. However, it doesn't quantify "human readers improve with AI vs without AI assistance" as a direct effect size, but rather presents the device's performance separately from the "practitioner eyes."
     • SOPROCARE (Device) Performance: Accuracy 87%, Sensitivity 91%, Specificity 90%
     • Practitioner Eyes Performance (without device): Accuracy 66%, Sensitivity 25%, Specificity 97%

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance metrics for "New Device" (SOPROCARE) described as "High accuracy (87% in average)", "High Sensitivity (91% in average)", and "High specificity (90% in average)" represent the standalone, algorithm-only performance, as it is compared directly to the "gold standard."

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth was established by using predicate devices/techniques as "gold standards":
     • For pit and fissure caries detection: SOPROLIFE (K092583)
     • For dental plaque highlight: GC Tri Plaque ID Gel (Predicate Device)
     • For gingival inflammations: Bleeding upon probing technique (Predicate Device)

7. The sample size for the training set:

   • The document does not mention a separate training set or its sample size. The clinical study described appears to be for performance evaluation.

8. How the ground truth for the training set was established:

   • Since no training set is explicitly mentioned, the method for establishing its ground truth is not provided.

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