(61 days)
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.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.