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The CD-Dent Digital Imaging Devices for Dental X-Ray Systems are intended for digital dental radiography using a phosphor storage screen for radiographic diagnostic intraoral and extraoral images.

The CD-Dent Digital Imaging Devices for Dental X-Ray Systems are filmless systems intended for digital intraoral, extraoral and cephalometric radiography using a phosphor storage screen. They enable the dentist to scan or import images for display, review or storage in a database. They consist of reusable phosphor storage screens for recording radiographic images, an image reader/digitizer, and software for displaying, enhancing, and storing dental radiographs using a userprovided personal computer.

This 510(k) summary (K990049) for the CD-Dent Digital-Imaging Device for Dental X-Ray Systems does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria. The provided document is primarily an administrative summary for a 510(k) submission, confirming the device's substantial equivalence to predicate devices.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this document. The summary focuses on product description, intended use, and a list of predicate devices.

However, I can extract the available information and state where information is missing:

Response based on K990049 Summary:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The 510(k) summary does not list specific acceptance criteria or provide a table of reported device performance against such criteria. The FDA's decision of substantial equivalence in this context typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering analysis, performance testing, and comparison of technical characteristics, rather than explicitly stated acceptance criteria and a detailed performance table in the summary.

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

Not available in the provided document. The 510(k) does not describe a specific clinical or performance test set, its sample size, or the provenance of any data used for such a test.

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

Not available in the provided document. No information is given regarding ground truth establishment, experts, or their qualifications.

4. Adjudication Method for the Test Set

Not available in the provided document. No mention of an adjudication method is made.

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

Not available in the provided document. The summary does not indicate that an MRMC comparative effectiveness study was performed, nor does it discuss human reader improvement with or without AI assistance. The device is described as an "Accessory to Electrostatic X-Ray imaging system," which implies it is for image acquisition and display, not an AI diagnostic tool in the modern sense.

6. Standalone (Algorithm Only) Performance Study

Partially available/Inferable, but no specific study details. The core of a 510(k) submission for an imaging device often includes technical performance data to demonstrate that the device produces images of comparable quality to predicate devices. While a formal "standalone" algorithm performance study in the context of AI isn't detailed, the substantial equivalence determination implies that the imaging system itself (the "digitizer" and "software for displaying, enhancing, and storing dental radiographs") has met performance expectations. However, no specific study, metrics, or results are provided in this summary.

7. Type of Ground Truth Used

Not available in the provided document. The document does not specify any type of ground truth used for performance evaluation (e.g., expert consensus, pathology, outcomes data).

8. Sample Size for the Training Set

Not applicable/Not available in the provided document. Given the device is an "Accessory to Electrostatic X-Ray imaging system" and was approved in 1999, it is highly unlikely to involve machine learning or "AI" in the contemporary sense, which would require a training set. Therefore, there's no mention of a training set or its size.

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

Not applicable/Not available in the provided document. As there is no indication of a training set, this information is not provided.

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The DenOptix Barrier Envelope is a single-use device intended for use with the DenOptix Digital Imaging System (K955643) to prevent contamination of the phosphor imaging plate with saliva and other bodily fluids.

The DenOptix Barrier Envelope is a single-use pouch available in sizes corresponding to standard intra-oral imaging plate dimensions. Imaging plates used for intraoral dental x-ray procedures are sealed inside the envelope before being placed into the patient's mouth. The envelope is opaque on one side to protect the imaging plate from ambient light.

This document describes the DenOptix Barrier Envelope, a dental barrier envelope. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with explicit acceptance criteria and performance metrics against those criteria. Therefore, much of the requested information regarding AI device testing is not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define quantitative acceptance criteria for performance as it's a substantial equivalence submission for a physical barrier. Instead, it relies on demonstrating that the new device is essentially the same as a legally marketed predicate and performs equivalently or better in relevant aspects.

Instead of a table with specific performance metrics against acceptance criteria, the document states:

• Acceptance Criteria (Implied): The DenOptix Barrier Envelope must perform equivalently to the Kodak ClinAsept Barrier Envelope (K884827) in preventing contamination of imaging plates and provide light protection.
• Reported Device Performance:
  • "Physical testing was performed to demonstrate performance relative to light protection." (No specific quantitative results are provided in the summary).
  • "Biocompatibility testing was conducted in accordance with ISO 10993." (No specific results are provided in the summary).

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

This information is not provided in the summary. The "physical testing" and "biocompatibility testing" mentioned likely involved specific sample sizes for their respective tests, but these details are not included in the 510(k) summary. Given the nature of the device (a physical barrier), it's highly unlikely this involved a clinical test set with data provenance in the context of AI studies, but rather laboratory testing of materials and design.

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

This information is not applicable as the device is a physical barrier envelope and not an AI or diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the device is a physical barrier envelope and not an AI or diagnostic device requiring expert interpretation for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not applicable. The device is a physical barrier envelope; no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is a physical barrier envelope; no algorithm is involved.

7. The Type of Ground Truth Used

This information is not applicable in the context of AI or diagnostic device performance. For a physical device, "ground truth" would relate to objective measurements of its physical properties (e.g., light blocking, material integrity, biocompatibility), which would be established through standard engineering and materials testing.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical barrier envelope and does not involve a training set as would be used for an AI algorithm.

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

This information is not applicable. The device is a physical barrier envelope and does not involve a training set or its associated ground truth establishment.

Summary of the Study and Conclusion from the Provided Text:

The study proving the device meets its (implied) acceptance criteria is a demonstration of substantial equivalence to an existing predicate device, the Kodak ClinAsept Barrier Envelope (K884827).

The rationale for substantial equivalence is based on:

• Same Indications for Use: Both the DenOptix Barrier Envelope and the predicate device share the same intended purpose: prevention of contamination of phosphor imaging plates.
• Equivalent Materials and Manufacturing: The new device is manufactured by the same contract manufacturer using equivalent materials, manufacturing processes, and inspection/test procedures as the predicate.
• Minor Difference: The only difference is the addition of a blue colorant to one side of the DenOptix Barrier Envelope for ambient light protection.
• Testing Performed:
  • Physical Testing: "Physical testing was performed to demonstrate performance relative to light protection." (No specific results are detailed in the summary).
  • Biocompatibility Testing: "Biocompatibility testing was conducted in accordance with ISO 10993." (No specific results are detailed in the summary).

The Conclusion states that the DenOptix Barrier Envelope was found to be substantially equivalent to the predicate device, with the added benefit of ambient light protection due to the opaque colorant. This implies that the testing performed confirmed the device's ability to provide light protection and ensured biocompatibility, thereby meeting the necessary safety and effectiveness requirements for a substantially equivalent device.

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