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The ADX4000-L, DX3000-L Cordless Portable Dental X-ray System is indicated for use only by trained and qualified dentists or dental technician for both adult and pediatric subjects for taking diagnostic extraoral dental X-rays using digital sensors.

The ADX4000-L, DX3000-L are Cordless Portable Dental X-ray System operated by battery-powered and hand-held dental x-ray machine, This is a prescription device that can be used on pediatric and adult patients.

Acceptance Criteria and Device Performance Study for ADX4000-L, DX3000-L

Based on the provided 510(k) summary (K083532), the device's acceptance criteria and performance study are primarily focused on demonstrating equivalence to a predicate device and adherence to consensus standards, rather than specific performance metrics against a predefined acceptance threshold.

The document indicates that the device's performance was evaluated through "Bench testing" and by meeting "consensus standards." It does not provide a table of quantitative acceptance criteria with corresponding device performance values, nor does it detail a study that directly measures performance against such criteria.

Here's an analysis of the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, a direct table of quantitative acceptance criteria and reported device performance is not present in the provided 510(k) summary.

The summary states that the device is "**equivalent to the predicate devices in its intended use and technological characteristics, including: *indications for use technological characteristics performance properties". This suggests that the "acceptance criteria" were met by demonstrating this equivalence and compliance with relevant standards.

The "reported device performance" is broadly stated as:

• "This device meets consensus standards IEC 601-1, 60601-1-2, 60601-1-2, 60601-2-7 etc."
• "Bench testing was also conducted to demonstrate performance specifications."

Without specific metrics from the bench testing, it's impossible to create a quantitative table.

2. Sample Size for Test Set and Data Provenance

The 510(k) summary does not specify any sample size for a "test set" in the context of clinical images or patient data. The testing mentioned (bench testing and meeting consensus standards) implies engineering/design verification rather than a clinical performance study using a test set of images or patient data.

Therefore, information regarding data provenance (country of origin, retrospective/prospective) is also not provided.

3. Number of Experts and Qualifications for Ground Truth

The 510(k) summary does not mention using experts to establish ground truth for a test set. The focus is on demonstrating technological equivalence and compliance with engineering standards.

4. Adjudication Method for the Test Set

Since no clinical "test set" with ground truth established by experts is mentioned, an adjudication method is not applicable and therefore not provided in the document.

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

The 510(k) summary does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. The device is an X-ray system, not typically an AI-driven image analysis tool, so comparative effectiveness with human readers using or not using AI assistance is not relevant to this submission.

6. Standalone (Algorithm Only) Performance Study

The 510(k) summary does not describe a standalone (algorithm only) performance study. The device is a hardware product (dental X-ray system), not an AI algorithm.

7. Type of Ground Truth Used

The term "ground truth" as typically used in AI/image analysis studies (e.g., pathology, outcomes data, expert consensus) is not applicable to the type of testing described in this 510(k) summary. The "ground truth" for the device's performance would be compliance with the functional and safety requirements defined by the IEC standards and internal performance specifications.

8. Sample Size for the Training Set

The 510(k) summary does not mention a training set. This device is a traditional medical imaging hardware product and does not involve machine learning or AI models that would require a training set.

9. How Ground Truth for the Training Set Was Established

Since no training set is mentioned (as explained in point 8), the method for establishing its ground truth is not applicable and therefore not provided.

In summary, the K083532 submission focuses on demonstrating substantial equivalence to a predicate device and compliance with recognized electrical and medical device safety standards through bench testing. It does not contain information about clinical performance studies, evaluation by expert readers, or the use of AI/machine learning, which would typically involve the detailed criteria requested in the prompt.

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