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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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