C-1890

• K Number: K023896
• Device Name: C-1890
• Manufacturer: ANODIA SYSTEMS
• Date Cleared: 2003-06-19 ( 209 days)
• Product Code: EIA
• Regulation Number: 872.6640
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: K962665
• Predicate For: N/A

Intended Use

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

Device Description

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.

AI/ML Overview

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.

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.