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Win-100D intra oral camera system and accessories is indicated for use to provide the dentist and the patient with a view of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as showing the results.

Our device comprises of a light (0.6Kg), small (230mmX12mm), compact design and ergonomic handpiece along with a multi-docking system. The handpiece consists of a focusing mechanism and a capture button to assist the capture intraoral or full face images of the patient. The handpiece connects to a multi-docking system via a cable. The multi-docking system in turn can connect directly to a monitor and PC via a standard composite connection (RCA). It uses high definition imaging (460 TV-lines) to capture images at 80 degrees field of view. It can make the screen in 4 frames or full screen mode via a multi-docking system. It can change the side of the captured image.

The provided text is a 510(k) summary for the Win-100D Intra-Oral Camera System and Accessories. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a new device meets specific acceptance criteria through novel studies. Therefore, much of the requested information regarding acceptance criteria and performance studies in a traditional sense is not directly applicable or available in this document.

The core of a 510(k) is to show that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or, if there are differences, that those differences do not raise new questions of safety and effectiveness.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

Instead of specific quantitative acceptance criteria, the "performance" is evaluated relative to the predicate device's characteristics. The acceptance criteria essentially boil down to demonstrating "substantial equivalence" in performance characteristics.

The study that proves the device meets the acceptance criteria is the comparison presented in the 510(k) submission, which aims to demonstrate substantial equivalence to the predicate device K981663.

Additional Requested Information:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable / Not provided. A 510(k) submission for an intra-oral camera of this nature typically does not involve a "test set" in the sense of clinical trial data with patient samples. The performance evaluation is based on technical specifications and comparison to the predicate, rather than a clinical study with a patient sample. No specific clinical data or patient samples are mentioned.

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

   • Not applicable / Not provided. As no clinical "test set" or ground truth based on expert review is mentioned, this information is not relevant to this 510(k) summary.

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

   • Not applicable / None. No adjudication method is described because there is no clinical test set requiring adjudication.

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:

   • No. This device is an intra-oral camera, not an AI-powered diagnostic tool. MRMC studies or AI assistance are not relevant to this submission.

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

   • No. This is a hardware device (camera) and does not involve an algorithm with standalone performance evaluation in the context of diagnostic interpretation.

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

   • Not applicable / Not provided. The "ground truth" for this submission revolves around the technical performance specifications being comparable to the predicate device, not clinical outcomes or expert diagnoses.

7. The sample size for the training set:

   • Not applicable / Not provided. This is not an AI/ML device requiring a training set.

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

   • Not applicable / Not provided. This is not an AI/ML device requiring a training set with ground truth.

Summary of the "Study" (510(k) Comparison):

The "study" in this context is the side-by-side comparison of technological characteristics between the WIN-100D and the predicate device (Digital Doc, K981663). This comparison is presented in a table format and detailed explanations within the main submission (which are not fully provided here). The core of the evidence is showing that the new device's features (design, materials, stated performance, safety aspects) are "identical" or "similar" to a legally marketed device. Performance is largely demonstrated through technical specifications (e.g., 460 TV-lines, 80 degrees field of view) which are deemed acceptable for the intended use of providing visual information to dentists and patients.

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