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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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The PIEZON® 707 BIK and PIEZON® BIK LED is intended for use for the following indications:

Scaling

• Removal of supragingival calculus
• Removal of stains

Endo

• Preparation, cleaning and irrigation of root canals
• Condensing gutta-percha
• Removal of crowns, bridges and restorations

Restorative

• Preparation of cavities
• Cementation of restorations
• Condensing of amalgams

Periodontics

• Scaling and root planing
• Periodontal therapy

The PIEZON® 707 BIK and PIEZON® BIK LED is an ultrasonic scaling unit consisting of an ultrasonic generator supplied with a Piezon Handpiece and scaling instruments. The PIEZON® 707 BIK and PIEZON® BIK LED are supplied with the Piezon Handpiece EN-061 and Piezon Handpiece LED EN-060, respectively. The PIEZON® 707 BIK and PIEZON® BIK LED ultrasonic generator is designed for installation into a dental chair.

The ultrasonic generator produces piezo-electric vibrations (ultrasonics) for water or dry work instruments. The appropriate instrument for a particular application is screwed onto the handpiece supplied with the scaling unit prior to beginning the procedure. The power control is handled via the potentiometer or the chair main control. The water control is handled via the handpiece or the chair main control. The treatment is carried out by placing the instrument tip onto the tooth surface according to the Operating Instruction for the instrument selected.

The provided text describes the regulatory clearance for the PIEZON® 707 BIK and PIEZON® BIK LED ultrasonic scaler. It states that no clinical testing was conducted to support this submission, and therefore, an AI/algorithm-specific acceptance criteria and study proving its meeting of those criteria in a MRMC or standalone manner are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (Satelec SP Newtron Module, K033764) through non-clinical performance testing.

Here's the information parsed from the document based on your request, with an emphasis on what is not applicable due to the nature of the submission (device, not AI/ML):

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

The document does not explicitly state "acceptance criteria" in a quantitative, threshold-based manner typical for AI/ML performance. Instead, it indicates that "all design inputs... were satisfied by the design outputs" and that "the device met the predetermined acceptance criteria" based on non-clinical tests.

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

Not applicable. This was non-clinical performance and safety testing of a physical device, not an AI/ML algorithm's performance on a data test set. The testing was performed on the device itself, integrated with a dental chair and handpiece.

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)

Not applicable. Ground truth as typically defined for AI/ML performance evaluation (e.g., derived from expert consensus on medical images) is not relevant here. The "ground truth" for this device's performance would be engineering specifications and safety standards.

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

Not applicable. No expert adjudication process for a data test set was described.

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. No clinical testing, and specifically no MRMC comparative effectiveness study was performed or described. This device is an ultrasonic scaler, not an AI-assisted diagnostic tool. The submission explicitly states: "No clinical testing was conducted to support this submission."

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

Not applicable. This device is a physical medical device (ultrasonic scaler), not an AI algorithm. Its performance is measured by its physical operation and adherence to engineering and safety standards, not as a standalone algorithm.

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

For the non-clinical performance testing of the ultrasonic scaler, the "ground truth" was based on:

• Engineering specifications: The design inputs and predetermined performance specifications for the device's electrical, mechanical, and functional characteristics.
• International standards: Compliance with standards like IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

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

Not applicable. As there is no training set, this question is not relevant.

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The PIEZON 150 is a device for delivering ultrasonic movement and water to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:
• Periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planning
• Removal of supra and subgingival calculus and stains from teeth
• Intended for use in dental and periodontal applications performed by an ultrasonic scaler.

The proposed PIEZON 150 ultrasonic scaler is a modification of the previously cleared miniPiezon (K953026). The working instrument for the scaling function is the handpiece, which is connected to the control unit via a handpiece cord and mounted in a holder on the side of the control unit.

The PIEZON 150 connects to an external water supply and delivers water via the connected handpiece. The power of ultrasonic vibrations is adjusted via a power knob on the top of the control unit. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit.

The PIEZON 150 is supplied with two handpieces - the Piezon Handpiece LED (lightemitting diode) or the Piezon Handpiece. The Piezon Handpiece LED is identical to the Piezon Handpiece LED described in K093000 for the Piezon Master 700 ultrasonic scaler (K093000) and contains 6 LEDs in the body of the handpiece and a light guide that is positioned under the nozzle. The Piezon Handpiece is identical to the Piezon Handpiece LED, except that the Piezon Handpiece does not have LEDs or the light guide. All instruments compatible with the PIEZON 150 have been previously cleared (see 510(k) numbers referenced in Section 3).

The modifications made to the miniPiezon to produce the PIEZON 150 include:
• Shape and contours of the control unit redesigned to accommodate the finger-tip power control, improve aesthetics, facilitate cleaning, and enhance ergonomics
• Use of a potentiometer for power regulation via the power control knob to improve ultrasonic power control.
• One operating mode with a Standard power range (0-100% power) for scaling procedures and a Perio range (0-37.5% power) for periodontal procedures
• Supported handpieces (Piezon Handpiece (FT-215#) and Piezon Handpiece LED (FT-223#)
• Ultrasonic generator upgraded to EJ-110. the Light command, Motor/Solenoid valve command and Pedal command have been added.

The provided document is a 510(k) summary for a medical device modification, specifically for the PIEZON 150 ultrasonic scaler. It states that no clinical testing was conducted for this submission. Instead, substantial equivalence was determined based on non-clinical performance testing and comparison to predicate devices.

Therefore, the requested information regarding acceptance criteria derived from a study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, cannot be extracted from this document, as these types of studies were not performed or reported for this submission.

Here's a summary of what can be gathered, addressing the relevant points from your request:

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

The document states: "Non-clinical performance testing demonstrates that all design inputs for the PIEZON 150 were satisfied by the design outputs, that the device meets electrical safety and electromagnetic compatibility requirements, and functional and performance requirements."

While the document generally states that "functional and performance requirements" were met, it does not explicitly list quantitative acceptance criteria for these functional performance aspects, nor does it provide specific "reported device performance" metrics against such criteria in a measurable way beyond stating they were satisfied.

The comparison table (sections 3 and 4 of the input) highlights the technological characteristics of the proposed device and predicate devices, which implicitly defines the expected performance by showing similarity. For instance:

The "reported device performance" essentially aligns with the characteristics of the predicate devices, and any noted "improvements" (like the potentiometer for power regulation) are presented as enhancing an already acceptable functionality.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set data was used. Non-clinical performance testing was conducted, but details on sample sizes or data provenance for these engineering tests are not provided.

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)
Not applicable. No clinical studies requiring expert ground truth were conducted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical studies requiring adjudication were conducted.

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 an ultrasonic scaler, not an AI-based diagnostic tool, and therefore MRMC studies are not relevant. No such study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No clinical studies requiring ground truth were conducted. Substantial equivalence was based on non-clinical performance and comparison to predicate devices, implying that the established safety and efficacy of the predicate devices serve as the "ground truth" for the modified device's expected performance.

8. The sample size for the training set
Not applicable. No algorithm training was performed for this hardware device.

9. How the ground truth for the training set was established
Not applicable. No algorithm training was performed and therefore no ground truth for a training set was established.

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