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The Sonendo GentleWave(R) System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave Molar Handpiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo Gentle Wave Anterior Premolar Handpiece, the System is indicated for anterior and premolar teeth.

The Sonendo GentleWave® System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo GentleWave® System is comprised of a Console, and a disposable single-use Handpiece. The Handpiece is offered in two versions: a Molar Handpiece which is intended to be used on 1st and 2nd molar teeth and an Anterior/Premolar Handpiece which is intended to be used on anterior and pre-molar teeth.

The provided text is a 510(k) summary for the Sonendo GentleWave System, seeking to demonstrate substantial equivalence to a previously cleared predicate device (K160905). This document does not describe an artificial intelligence (AI) or machine learning (ML) device, nor does it detail a study involving human experts validating AI performance.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's assumptions (acceptance criteria for AI, ground truth establishment by experts for AI, MRMC studies for AI, standalone AI performance) are not applicable to the content of this document.

The document discusses performance data related to:

• Root Canal Cleaning Efficacy
• Apical Pressure
• Sterilization (Sterility Assurance)

These tests are for the physical device's function, not for an AI algorithm's diagnostic or analytical performance.

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The Sonendo GentleWave(R) System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave(R) Molar Handpiece, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo GentleWave(R) Anterior/Premolar Handpiece, the System is indicated for and premolar teeth.

The Sonendo GentleWave® System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo GentleWave® System is comprised of a Console, and a disposable single-use Handpiece. The Handpiece is offered in two versions: a Molar Handpiece which is intended to be used on 1st and 2nd molar teeth and an Anterior/Premolar Handpiece which is intended to be used on anterior and pre-molar teeth.

The provided text is a 510(k) premarket notification summary for the Sonendo GentleWave® System, which is an ultrasonic scaler for root canal therapy. It does not describe a study involving specific acceptance criteria and device performance metrics in the way that would typically be done for a new AI/medical device with diagnostic or prognostic capabilities where accuracy, sensitivity, or specificity are key.

Instead, this document is a submission to demonstrate substantial equivalence to a legally marketed predicate device (Sonendo GentleWave® System K153157) under the FDA's 510(k) pathway. The primary "acceptance criteria" here relate to demonstrating that the modified device (K160905) is as safe and effective as the predicate device, despite a change in the ability to select treatment fluid concentrations.

Therefore, the information requested cannot be fully provided in the context of this document as it focuses on demonstrating equivalence rather than establishing performance against new clinical endpoints or diagnostic accuracy.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for therapeutic efficacy or diagnostic output since it's an ultrasonic scaler. The "performance data" section states: "Based on the results of this testing, the modified GentleWave System performs as intended and is substantially equivalent to the predicate device." This implies the "acceptance criteria" are related to maintaining equivalence, not necessarily achieving specific clinical outcomes that are quantified in this document.

The key "performance data" criteria mentioned relate to software validation:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. Software validation typically involves testing against requirements, but the specific "sample size" of test cases for software or the data provenance is not detailed.

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)

This information is not provided. The device is an ultrasonic scaler for root canal therapy; the concept of "ground truth" established by experts for a diagnostic output is not directly applicable in the context described here. The "ground truth" for a therapeutic device performance would typically relate to successful treatment, which is not quantified in this summary.

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

This information is not provided. Not applicable in the context of this 510(k) summary.

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

There is no indication of an MRMC study. This device is a therapeutic device (ultrasonic scaler), not a diagnostic device involving human readers or AI assistance in interpretation. The document explicitly focuses on changes to a therapeutic system and its software, not on interpretive capabilities.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable for this type of device. The GentleWave System is a physical medical device that prepares, cleans, and irrigates root canals. It has "software-controlled user interface" and "software validation," but it is not an "algorithm" operating in a standalone diagnostic capacity.

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

As noted previously, the concept of a "ground truth" as typically understood for diagnostic devices is not directly applicable here. The substantial equivalence relies on the fundamental scientific technology and indications for use remaining the same, and the modifications (fluid concentration selection) not affecting safety or effectiveness. The "ground truth" for the software validation would be that the software performs according to its specifications. For the device as a whole, it relies on being "substantially equivalent" to a predicate device already deemed safe and effective.

8. The sample size for the training set

This information is not provided. The device is not an AI/ML algorithm that is "trained" on a dataset in the typical sense for a diagnostic device. Software validation tests are run against detailed specifications, not a "training set."

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

This information is not provided and is not applicable as there is no "training set" in the context of an AI/ML algorithm being developed or assessed here.

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The Sonendo GentleWave™ System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave™ Molar Handpiece, the System is indicated for 1 and 200 molar teeth. When used with the Sonendo GentleWave™ Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.

The Sonendo GentleWave System (Console and Handpiece) delivers a stream of degassed treatment fluids into the tooth. The treatment fluids delivered to the tooth include a 3% Sodium Hypochlorite (NaOCI) solution and an 8% Ethylenediaminetetraacetic (EDTA) solution which are commonly utilized in traditional endodontic treatments. The stream of solutions delivered into the tooth come in contact with accumulated fluid and are redirected by a deflection plate, creating hydroacoustic and hydrodynamic effects which result in removal of organic and inorganic debris from the root canals. The Console collects the treatment fluid from the tooth into a waste collection canister.

The GentleWave System requires use with a Sonendo Handpiece which is used to treat 1* and 20 molar teeth or the Anterior/Premolar Handpiece which is used to treat anterior and premolar teeth. The Molar and Anterior/Premolar Handpieces are hand held dental instruments which are connected to the Console and provide treatment fluid delivery and waste fluid recovery. The Molar Handpiece is used with various accessories provided with the System. Both the Molar and Anterior/Premolar Handpieces are provided sterile and intended for single use only.

The provided document is a 510(k) summary for the Sonendo GentleWave™ System, an ultrasonic scaler intended for root canal therapy. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and validation study results for a new AI/software component.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI device cannot be entirely extracted from this document, as it describes a physical medical device.

However, I can extract information related to the software validation which is mentioned and could be considered a component of the device's overall performance.

Here's the closest possible interpretation of your request based on the provided text, focusing on the software component where applicable, and noting limitations:

Description of Acceptance Criteria and Study for Sonendo GentleWave™ System

The Sonendo GentleWave™ System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. The 510(k) summary indicates that "all necessary performance testing has been conducted... to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended."

1. Table of Acceptance Criteria and Reported Device Performance

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

• For Software: The document states "Software: Validated per FDA Guidance." This generally implies that testing was performed on the software, but the specific sample size (e.g., number of test cases, scenarios, or patients if applicable to clinical data in this context) and data provenance (country, retrospective/prospective) are not provided in this summary.
• For Cleaning Test: The cleaning efficacy was demonstrated on "extracted teeth." The number of extracted teeth used for this test is not specified. The provenance (e.g., country of origin) of these extracted teeth is also not provided. This was a retrospective test on non-living material.

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

• For Software: This information is not provided. Software validation typically involves system engineers and test specialists, but not necessarily medical experts for ground truth establishment in the same way as, for example, diagnostic imaging AI.
• For Other Tests: For the physical device tests (e.g., Cleaning Test), experts (e.g., endodontists or dental researchers) would likely be involved in assessing cleaning efficacy, but the number of experts and their specific qualifications are not mentioned in this summary.

4. Adjudication Method for the Test Set

• Not explicitly stated for any of the tests. The document indicates passage of internal test methods and compliance with standards, implying that results met predefined specifications, but the specific adjudication process (e.g., 2+1, 3+1 consensus) for subjective assessments (like cleaning efficacy) is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done as described in the document. This type of study is specifically relevant for diagnostic or interpretive AI systems where human readers' performance with and without AI assistance is evaluated. The Sonendo GentleWave™ System is a treatment device, not a diagnostic imaging AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Given it is a physical device with an embedded software component for control, the "standalone" performance would refer to the device operating according to its specifications. The tests listed (Thermal, Cavitation, Hydroacoustics, Cleaning, Apical Pressure, Apical Extrusion) are demonstrations of the device's function in a standalone manner (without a "human-in-the-loop" influencing its intrinsic operation, though a human operates the device).
• However, if "standalone" refers to an AI purely making decisions without human oversight, this is not applicable to this device.

7. The Type of Ground Truth Used

• For Software: Ground truth for software validation would typically be defined by the pre-established functional and performance requirements of the software, and whether its outputs (e.g., control signals, UI responses, calculations) match expected values during testing.
• For Cleaning Test: The ground truth for "cleaning efficacy" (on extracted teeth) would likely be established through quantitative or qualitative assessment methods (e.g., microscopic evaluation, dye penetration, or histological analysis) to determine the removal of debris or bacteria within the root canal system. The specific method is not detailed, but it would presumably be an expert-determined assessment based on established dental evaluation techniques.
• For Other Tests: Ground truth is typically derived from physical measurements (e.g., temperature, pressure, flow rate) according to engineering and scientific principles.

8. The Sample Size for the Training Set

• This information is not provided. For a device cleared via 510(k), especially one not primarily an AI/machine learning diagnostic tool, details about a "training set" (in the machine learning sense) are typically not included in this type of summary. The software validation is likely based on traditional software engineering testing rather than AI model training.

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

• Not applicable or not provided, as details of an AI-specific training set or its ground truth establishment are absent from this 510(k) summary.

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