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• Rinse, flush, lubricate and steam sterilize dental handpieces, air-motors, and . attachments which are suitable for steam sterilization
• Rinse and steam sterilize dental instruments which are suitable for steam ● sterilization
• Steam sterilization at 134℃ and 3.1 bar absolute for ten minutes .
• Maximum load is six (6) dental handpieces (highspeed handpieces, . air-motors, and/or attachments) or five (5) dental instruments
• Sterility of devices is compromised on exposure to a non-sterile environment .

The CLS-2000 UNIT is an integrated unit for rinsing, flushing, lubricating, and steam sterilizing dental handpieces, air-motors, and attachments, and for rinsing and steam sterilizing static instruments which are suitable for steam sterilization.

Dental handpieces and instruments are placed in the CLS-2000 UNIT. The CLS-2000 UNIT utilizes water and pulsed steam to rinse and flush the articles. The CLS-2000 UNIT then utilizes saturated steam at elevated pressures in order to attain an effective kill of infectious bio-organisms and prevent crosscontamination. The CLS-2000 UNIT is also equipped with a lubrication feature for the delivery of service oil to dental handpieces, air-motors, and attachments.

The provided text describes the Dentsply CLS-2000 UNIT, a steam sterilizer for dental instruments, and its 510(k) submission. It details its function, intended use, technological characteristics, and testing performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated as a numerical count of instruments or loads. The testing included:
  • "half-cycle testing, replicates, with and without lubricant"
  • "full-cycle simulated use testing"
  • "in-use testing"
    These phrases indicate multiple tests were performed, but the specific number of test cycles or articles per test is not provided.
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission to the FDA, it is expected that the testing was conducted per recognized standards (AAMI ST55) and would likely be prospective testing carried out by the manufacturer or a contracted lab. There is no indication of retrospective data or data originating from specific countries other than the manufacturer's location (York, PA, USA).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not applicable to this type of device and study. The "ground truth" for a sterilizer's performance is objective (e.g., presence/absence of microbial growth, temperature readings, pressure readings). It does not rely on expert consensus or interpretation in the same way a diagnostic imaging device might. The "experts" involved would be microbiologists and engineers validating the testing protocols and results, but their number and specific qualifications are not detailed as they would be for an AI-based diagnostic device.

4. Adjudication Method for the Test Set:

This is not applicable. The outcome of sterilization (sterility or non-sterility) is determined by objective biological and physical measurements, primarily the absence of Geobacillus Stearothermophilus growth for the biological testing. There is no human interpretation or "adjudication" of findings in the traditional sense for these types of tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No. An MRMC comparative effectiveness study is designed to assess how human readers' performance changes with or without AI assistance, typically in diagnostic imaging. This is a sterilizer, not a diagnostic device, and therefore such a study is irrelevant and was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, in essence. The entire testing regimen described for the CLS-2000 UNIT (physical and biological testing) represents the standalone performance of the device without human intervention influencing the sterilization outcome. The device, once started, operates automatically to achieve its intended function.

7. The Type of Ground Truth Used:

The ground truth used is a combination of:

• Biological End-point: Absence of microbial growth (specifically, Geobacillus Stearothermophilus spores) after sterilization. This is a direct measure of efficacy.
• Physical Parameters: Temperature profiling meeting the specified standard (AAMI ST55). This verifies the physical conditions required for sterilization are met.

8. The Sample Size for the Training Set:

This is not applicable. The CLS-2000 UNIT is a physical device, not an AI/ML algorithm that requires a training set. Its design and operational parameters are engineered, not learned from data.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the reason stated in point 8.

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