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The C-1805M is designed to clean the dental unit water lines by means of injecting pressurized air and than a solution

The C-1805M is a pressurized bottle system capable of supplying a solution to the dental unit water lines or pressurized air. The system is used with solutions to clean the dental unit waterlines by air purging the waterlines or injecting a solution. The system can be used to supply water to the dental unit if necessary.

The provided text is a 510(k) premarket notification summary and an FDA clearance letter for a dental device called "C-1805M." This documentation asserts equivalence to a predicate device and does not contain information about a study proving the device meets specific acceptance criteria in the context of AI or diagnostic performance.

The device described, the C-1805M, is a "Pressurized bottle system" for cleaning dental unit water lines. It is a Class I medical device (Dental Operative Unit and Accessories) and its function is mechanical/fluid handling, not diagnostic or AI-driven.

Therefore, the requested information cannot be extracted from this document. The concepts of "acceptance criteria," "device performance," "sample size," "experts," "ground truth," "MRMC study," "standalone performance," and "training set" as they relate to AI effectiveness studies are not applicable to the content provided.

Summary of why the requested information cannot be provided:

The provided text describes a mechanical dental device and its FDA clearance process, which relies on demonstrating substantial equivalence to a predicate device, not on proving diagnostic accuracy or AI performance through a detailed study with acceptance criteria. Therefore, the information requested in the prompt, which is relevant to AI/diagnostic device performance studies, is not present in the given document.

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The C-1890 is designed to clean the dental unit water lines by means of injecting pressurized air and than a solution

The C-1890 is a pressurized bottle system capable of supplying a solution or pressurized air to the dental unit water lines. The system can be used with solutions to clean the dental unit waterlines by air purging the waterlines and/or injecting a cleaning solution.

This document is a 510(k) premarket notification for a medical device called C-1890, a pressurized bottle system for dental unit water lines. It's a regulatory document demonstrating substantial equivalence to a predicate device, not a study report with acceptance criteria and performance data in the typical sense of AI/algorithm performance.

Therefore, many of the requested sections about acceptance criteria, study details, expert involvement, and ground truth for an AI device are not applicable to the provided document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

• Not applicable. This document is a premarket notification comparing a new device (C-1890) to an existing predicate device (K962665 A-Dec Self-Contained Water System) to demonstrate substantial equivalence, not an AI performance study with acceptance criteria. The "performance" discussed is in terms of functionality and safety, not statistical metrics like sensitivity or specificity. The substantial equivalence is based on comparing design features and intended use.

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

• Not applicable. There is no "test set" in the context of an algorithm's performance evaluation. The comparison is feature-based against a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable. There is no ground truth establishment for a test set in this kind of device submission. The FDA reviews the provided information to determine substantial equivalence.

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

• Not applicable. There is no test set or adjudication process for performance evaluation in this context.

5. 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

• Not applicable. This device is a pressurized bottle system for dental water lines, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is a hardware device, not an algorithm.

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

• Not applicable. Ground truth, in the context of algorithm performance, is not relevant here. The "ground truth" for this submission is implicitly the established safety and effectiveness of the legally marketed predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI device that requires a training set or ground truth establishment in that manner.

Information that can be extracted from the document related to the device and its comparison:

• Device Name: C-1890 (Trade Name), Pressurized bottle system (Common Name)
• Predicate Device: K962665 A-Dec Self-Contained Water System
• Intended Use/Indications for Use: The C-1890 is designed to clean the dental unit water lines by means of injecting pressurized air and then a solution.
• Key Comparisons with Predicate Device:
  • Both are pressurized systems supplying solution from a reservoir.
  • Both use similar fittings of similar materials.
  • Both control water with a switch.
  • C-1890 can inject pressurized air by a switch (K962665 does not have this switch).
  • C-1890 has a shroud covering tubing and valves.
  • Both include a heavy-duty reservoir.
  • C-1890 has a preset air pressure regulator.
• Regulatory Classification: Class I, Product Code: EIA, Regulation Number: 872.6640 (Dental Operative Unit and Accessories)

In summary, the provided document is a regulatory submission for a physical medical device, not a study evaluating the performance of an algorithm or AI system. Therefore, most of the requested information regarding acceptance criteria and study design for AI are not present or applicable.

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Portable pressurized system to deliver a solution to a scalar. Scalar being a dental device powered by air or electricity to remove tartar from the teeth requiring a solution for its performance.

The RDH-2000 is a portable bottle system. It dispenses solution from its bottle to a scalar. It is attached to the dental unit's quick disconnect air to pressurize the system. The RDH-2000 is composed of two parts; the manifold and the bottle. The manifold has a male quick disconnect. The quick disconnect connects to the dental units air supply via a female air quick disconnect. The system becomes pressurize only when attached to the dental unit. Within the manifold after the male quick disconnect is an internal preset mini air regulator. This is preset at 35 psi. The pressurized air is vented into the bottle via the top of the manifold is a pressure relief button to allow the bottle to be depressurized before unscrewing. The threads in the manifold accept the 28 mm threads of the bottle. A pick up tube goes to the base of the bottle which allows a means for the solution to exit. The pick up tube goes into the manifold and connects to a female quick disconnect with automatic shut-off. The female quick disconnect with the automatic shut-off prevents solution from being dispensed when the system is pressurized. A scalar with a male quick disconnect can attach at this point. This allows the scalar to obtain solution from the bottle. The bottle is a one liter high density polyethylene bottle. The threads have vertical grooves which acts as a pressure relief valve.

The provided text describes a 510(k) premarket notification for the RDH-2000/C-1310 device, a portable bottle system designed to dispense solution to a dental scalar. However, the document does not contain specific acceptance criteria or a detailed study plan/results in the way one would typically find for performance evaluation of AI/ML devices or complex medical diagnostic systems.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use. The "results of in-house testing" mentioned are very brief and qualitative.

Therefore, many of the requested sections regarding acceptance criteria, sample sizes, ground truth, and expert evaluation cannot be directly extracted from the provided text. I will address each point by stating what is available and what is not.

Acceptance Criteria and Study Details for RDH-2000/C-1310

1. A table of acceptance criteria and the reported device performance

Notes: The document focuses on demonstrating substantial equivalence rather than meeting specific, quantitative performance acceptance criteria typical for diagnostic devices. The "in-house testing" description is very high-level and does not provide specific performance metrics or thresholds.

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

• Sample Size for Test Set: Not specified. The document only mentions "in-house testing" without detailing the number of units tested, solutions used, or conditions applied.
• Data Provenance: Not specified, but implied to be internal testing conducted by Anodia Systems.
• Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable or specified. The testing described appears to be functional or engineering-based ("performed to dispense a solution when air activated") rather than requiring expert judgment for ground truth establishment.
• Qualifications of Experts: Not applicable or specified.

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

• Adjudication Method: Not applicable or specified. The nature of the "in-house testing" does not suggest a need for expert adjudication.

5. 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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.
• Effect Size of AI Improvement: Not applicable, as this device (RDH-2000) is a mechanical device for fluid delivery, not an AI-assisted diagnostic or decision-support tool for human readers.

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

• Standalone Performance Study: The "in-house testing" can be considered a form of standalone performance assessment of the device's basic function ("performed to dispense a solution when air activated"). However, it's not described as a formal study with statistical rigor, but rather a functional verification.

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

• Type of Ground Truth: Not formally established as with diagnostic devices. The "ground truth" for the in-house testing would simply be whether the device successfully dispensed solution when air activated, as intended by its engineering design. This is a functional verification against its design specifications rather than a comparison to a clinical gold standard.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document describes a traditional medical device (fluid delivery system), not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Ground Truth Establishment for Training Set: Not applicable, as this is not an AI/ML device.

Summary of Device Performance (from the text):

The primary statement regarding performance is:
"Results of in-house testing indicated that the RDH-2000 performed to dispense a solution when air activated as designed."

The submission focuses on demonstrating substantial equivalence to predicate devices (K882491, K962665) by highlighting similar technological characteristics and enhancements that contribute to safety and effectiveness, such as:

• High-density polyethylene bottle (reservoir) with vertical grooves for pressure relief.
• Delrin material for manifolds.
• Pressure regulators.
• Pressurized by air to dispense solution.

It also notes enhancements in the RDH-2000:

1. Pressure relief valve.
2. Preset pressure regulator valve in the manifold.
3. Male quick disconnect for portability.
4. Female quick disconnect with automatic shut-off to prevent free dispensing.

In conclusion, the provided document does not contain the detailed, quantitative acceptance criteria and study results typically found for performance studies of diagnostic or AI/ML devices. It is a 510(k) summary focused on demonstrating substantial equivalence of a general dental operative unit and accessories (a fluid delivery system) through a comparison of technological characteristics and a qualitative statement about in-house functional testing.

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