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The intended use of the Satelec PIEZOTOME 2 is to supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.

The Satelec PIEZOTOME 2 is a dental operative unit that supplies utilities to and serves as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.

This 510(k) premarket notification is for the Satelec PIEZOTOME 2, a dental operative unit. This submission is a declaration of substantial equivalence to a predicate device, the Satelec PIEZOTOME (K060274). As such, it relies on the safety and effectiveness established for the predicate device rather than presenting new clinical study data to meet acceptance criteria.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. Substantial equivalence claims do not typically involve setting new acceptance criteria or reporting new performance data. Instead, the claim is that the new device performs as safely and effectively as the predicate device.

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

Not applicable. There is no new test set or clinical study for this 510(k) submission. The device is claimed to be substantially equivalent based on similarities to a previously cleared device.

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

Not applicable. No new ground truth establishment was conducted for this submission.

4. Adjudication Method for the Test Set

Not applicable. No test set was used.

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

Not applicable. This is not a comparative effectiveness study. It's a substantial equivalence submission for a new version of an existing device.

6. Standalone Performance (Algorithm only without human-in-the-loop performance)

Not applicable. This device is a physical dental operative unit, not an AI algorithm.

7. Type of Ground Truth Used

Not applicable. No new ground truth was established for this submission. The "ground truth" for the device's safety and effectiveness relies on the predicate device's clearance.

8. Sample Size for the Training Set

Not applicable. This is not an AI/algorithm-based device requiring a training set.

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

Not applicable. No training set was used.

Summary of the 510(k) Document:

• Device: Satelec PIEZOTOME 2
• Predicate Device: Satelec PIEZOTOME (K060274)
• Claim: Substantial Equivalence
• Differences: "Differences that exist between the devices relating to technical specification, performances and intended use are minor and do not affect the safety and effectiveness of the PIEZOTOME 2."
• Indications for Use: To supply utilities to and serve as a base for dental tools such as ultrasonic scaler, bone cutting instrument and accessories for use by qualified dental practitioners in periodontics, endodontics, scaling, prosthesis and oral surgery.

In essence, the "study" proving the device meets acceptance criteria in this context is the FDA's review and determination that the PIEZOTOME 2 is substantially equivalent to the previously cleared PIEZOTOME. This implies that the new device meets the same safety and effectiveness standards that were established for the predicate device, without requiring a new clinical study or the specific metrics you've requested for AI/algorithm-based devices.

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