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The proposed devices, PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED, represent a change in presentation from the stand alone PIEZON 150 (predicate) to a device which is built in to the dental chair (OSSTEM K3 (K152830) ). The proposed device and the predicate device are both manufactured using the same internal componentry, the only difference is that instead of housing the device for stand alone use, the componentry is installed into a dental chair.

The difference between PIEZON® BUILT-IN KIT LED and PIEZON® BUILT-IN KIT is that the handpiece of the first features integrated light (LED) while the second does not. All other aspects are identical. Each system consists of the wireless module and handpiece cord and is provided with a wire harness for installation as well as the appropriate accessories. Additionally, spare parts are available.

As with other ultrasonic scalers, the ultrasonic generator component of the PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED (Piezon® Module EJ-110, installed in a dental chair) generates piezo-electric vibrations (ultrasonics) for water or dry work instruments. The PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED are supplied with the Piezon Handpiece EN-061/OS and Piezon Handpiece LED EN-060/OS, respectively. Instruments mounted in the Piezon Handpiece or Piezon Handpiece LED vibrates with a controlled oscillatory movement when activated.

Instruments A is supplied as part of all kits. Instruments P and PS are additionally included in the kits with OS1 suffix. The appropriate instrument for the particular application is screwed onto the handpiece prior to beginning the procedure. The treatment is carried out by placing the instrument tip onto the tooth surface according to the Operating Instruction for the instrument selected.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the PIEZON BUILT-IN KIT, which is an ultrasonic scaler intended for dental cleaning. The primary claim for substantial equivalence is that the new device is essentially the same as a previously cleared predicate device (PIEZON 150), with the main difference being that the components are integrated into a dental chair rather than being a standalone unit.

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

1. A Table of Acceptance Criteria and the Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" for clinical performance in the sense of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for an AI/CADe device. Instead, the acceptance criteria are related to engineering performance, electrical safety, electromagnetic compatibility, and functional integration, demonstrating that the reconfigured device performs equivalently to its predicate.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Risk Management	All identified risks are reduced to acceptable levels.	A Risk Assessment was performed for the configurable kit as a standalone product and an additional risk analysis for its integration as a subsystem in a dental chair. All residual risks post-mitigation were deemed acceptable.
Functional Specifications & Components	No changes to functional specifications or components.	The proposed device and predicate device use the "same internal componentry" and "same attached accessories."
Biocompatibility	Patient-contacting components are biocompatible and equivalent to the predicate.	Biocompatibility assessment was performed according to ISO 10993-1. No new testing was necessary as all patient contacting components are identical to the cleared predicate (Piezon 150, K132443).
Electrical Safety	Conforms to relevant electrical safety standards.	Electrical Safety is equivalent to the predicate device based on IEC 60601-1. All tests passed, and conformance is confirmed.
Electromagnetic Compatibility (EMC)	Conforms to relevant EMC standards.	Electromagnetic Compatibility is equivalent to the predicate device based on IEC 60601-1-2. All tests passed, and conformance is confirmed.
Integration/Functional Performance	The device functions correctly when integrated into the dental chair; performance is not impacted by the change in housing.	"functional testing was completed on the integrated product to confirm product functionality." This included "verification of device installation into the chair as per installation specifications and confirmation of product functionality." All tests were successfully performed and all acceptance criteria were met.
Safety and Effectiveness Questions	Does not raise new questions of safety or effectiveness.	"No new questions of safety and effectiveness were identified during review of Risk Management documentation or during execution of testing."

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

The document does not describe a "test set" in the context of a clinical study or AI model validation with patient data. The testing performed is related to engineering verification and validation of the device's physical and electrical properties, and its functional integration.

Sample Size: Not applicable in the context of patient data. The "sample" for testing would be units of the device (PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED) and their integration within dental chairs. The document states "All tests were successfully performed," implying sufficient physical units were tested to demonstrate compliance.
Data Provenance: Not applicable in the sense of patient data origin. The "data" comes from engineering tests performed by the manufacturer. It is internal company data.
Retrospective or Prospective: Not applicable in the sense of patient data. The engineering tests were implicitly prospective (i.e., designed and executed to verify the new product configuration).

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

Not applicable. This device is an ultrasonic scaler, a physical medical device, not a diagnostic AI/CADe system requiring expert-adjudicated ground truth from medical images. The "ground truth" for its performance is derived from engineering standards, functional tests, and comparison to the predicate device's proven performance.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for image interpretation or diagnosis described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is an ultrasonic scaler, not an AI/CADe system for diagnostic assistance. Therefore, an MRMC study is not relevant to its clearance.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's substantial equivalence claim relies on:

Engineering Standards: Compliance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards.
Functional Verification: Demonstrating that the device operates as intended in its new integrated configuration.
Predicate Equivalence: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (PIEZON 150). The argument is that since the new device uses the same internal components and technology and only differs in its housing (integrated into a dental chair vs. standalone), its performance is inherently equivalent.
Risk Analysis: A detailed risk assessment confirming that the change in housing does not introduce new or unacceptable risks.

8. The Sample Size for the Training Set

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

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

Not applicable. As above, this is not an AI/ML device.

In summary, the provided document details a 510(k) submission for a traditional medical device (ultrasonic scaler) where the primary evidence for substantial equivalence comes from engineering testing and a comparison to a predicate device, rather than a clinical study involving patient data or AI model performance metrics. The "acceptance criteria" and "proof" relate to the physical and electrical performance of the device and its safe integration into a dental chair.

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