FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The purpose of the device is to remove plaque from the surface of the tooth through using ultrasonic vibration generated by the electricity(24 V ~) and water supply received in a dental chair and other dental devices.

The product is provided in the form of parts that can be installed and used inside a dental chair and other dental devices. The control of the water supply is made from the dental chair and other dental devices.

AI/ML Overview

The provided text is a 510(k) summary for a dental ultrasonic scaler, the "Compact S." It focuses on demonstrating substantial equivalence to a predicate device, the "CLEANSE S+," rather than presenting a performance study with acceptance criteria in the manner typically used for new AI/ML-driven medical devices.

Therefore, many of the requested details, such as the sample size for the test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are not applicable or not present in this document. This document is a regulatory submission for a physical medical device, not a software-based diagnostic AI.

Here's an attempt to extract and describe what's available based on the provided text, and point out what is missing:

Device Name: Compact S, Compact S (LED)
Device Type: Ultrasonic Scaler (Dental)

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific quantitative acceptance criteria for clinical performance against which the device was tested to demonstrate accuracy. Instead, it relies on demonstrating functional and technological equivalence to a predicate device and compliance with relevant electrical and safety standards.

Acceptance Criteria Category	Reported Device Performance (Summary)
Electrical Safety	Met IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) requirements.
Electromagnetic Compatibility (EMC)	Met IEC 60601-1-2: 2007 (Third Edition) requirements.
Basic & Essential Performance	Met requirements (detailed criteria not specified, but implied to be similar to predicate).
Software Validation	Met requirements (per IEC 62304: 2006).
Sterilization & Cleaning Validation	Met requirements (per ISO 17665-1/2).
Biocompatibility	Met requirements (per ISO 10993-1: 2009).
Functional Equivalence	Demonstrated through comparison to predicate (CLEANSE S+), with differences not affecting safety or performance. Key functional parameters (e.g., frequency range, water supply pressure, handpiece output) were shown to be similar or within acceptable ranges.
Indications for Use	Identical to predicate device.

Study Information Pertaining to Device Performance:

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not applicable. This submission relies on bench testing and comparison to a predicate device, not a clinical test set with patient data for diagnostic accuracy.
Data Provenance: Not applicable. (No patient data was used).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No ground truth based on patient data with expert consensus was established as this was not a clinical performance study for an AI/ML device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No test set involving human interpretation requiring adjudication was used.

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 physical ultrasonic scaler, not an AI-assisted diagnostic 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 physical device, not an algorithm. Bench tests were performed on the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For functional and safety testing: Ground truth was based on engineering specifications, regulatory standards (like IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, ISO 17665-1/2, IEC 62304, ISO 10993-1), and the performance characteristics of the predicate device. For example, "Maximum output power with load" was tested against a specified value (24VA).

8. The sample size for the training set:

Not applicable. This is not an AI/ML device and does not involve a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary of Approach:

This 510(k) submission demonstrates substantial equivalence by showing that the "Compact S" device is fundamentally the same as its predicate, "CLEANSE S+," with minor structural modifications (removal of exterior case, keypad) that do not affect safety or performance. The primary method of proving this was through:

Bench Testing: Non-clinical performance testing for electrical safety, EMC, basic/essential performance, software validation, sterilization/cleaning validation, and biocompatibility.
Comparison to Predicate: Demonstrating that the indications for use, core functional characteristics (frequency range, water supply pressure, handpiece output), and main components are either identical or acceptably similar to the predicate device.
No Clinical Testing: The submission explicitly states, "No clinical testing was conducted to support this submission," as substantial equivalence was established through non-clinical data and comparison to the predicate.

Summary

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.