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510(k) Data Aggregation
(60 days)
Sonendo, Inc.
Sonendo Filling Material 5C is intended for permanent obturation of the root canal following root canal treatment.
The Sonendo Filling Material 5C is a two-part filling material developed for permanent root canal filling. It is a water-soluble acrylate which is radiopaque and hardens with a chemical curing system. The Sonendo Filling Material 5C is packaged in plastic syringes with a syringe mixer and a dispensing tip. The syringe and dispensing tips are the only patient contacting devices packaged with the Sonendo Filling Material 5C and are commercially available.
Based on the provided text, the device in question is a dental root canal filling material, and the provided document is an FDA 510(k) summary for its clearance. This document type focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a medical device's performance through a clinical comparative effectiveness study against specific acceptance criteria like an AI algorithm would.
Therefore, the requested information regarding acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details cannot be fully provided from this document. This document specifies that no human clinical testing was conducted to support substantial equivalence.
However, I can extract the relevant performance data that was conducted, which focuses on device properties compared to industry standards and the predicate device.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
For a root canal filling material, performance is evaluated based on physical and chemical properties as defined by ISO standards, rather than diagnostic accuracy metrics. The "acceptance criteria" are implied by the ISO standard requirements, and "device performance" is the measured value for the Sonendo Filling Material 5C compared to the predicate and the standard.
| Element (Acceptance Criteria per ISO 6876:2012) | Sonendo Filling Material 5C (Subject Device) | Predicate Device (EndoREZ Dual Cure) | Comparison / Meets Criteria? |
|---|---|---|---|
| Flow (≥ 17mm) | 33.45 mm | 17.31 mm | Passed ISO 6876 test requirements |
| Working Time (implied by predicate & standard) | 32.98 mm | 17.38 mm | Passed ISO 6876 test requirements |
| Setting Time (Between 1 - 24 hours) | 60 minutes, 7 seconds | 25 minutes, 46 seconds | Passed ISO 6876 test requirements |
| Film Thickness (≤ 50 μm) | 5 μm | 5 μm | Passed ISO 6876 test requirements |
| Solubility & Disintegration (≤ 3.0% by mass; No Disintegration) | 2.03% (No disintegration) | 0.77% (No disintegration) | Passed ISO 6876 test requirements |
| Radio-opacity (≥ 3 mm of Aluminum) | 3.10 mm Al | 6.6 mm Al | Passed ISO 6876 test requirements |
Note: The "Working Time" and "Setting Time" acceptance criteria are stated as "Passed ISO 6876 test requirements" rather than specific numeric thresholds for the subject device.
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated in terms of number of "samples" for each test. The ISO testing involves specific laboratory procedures using test specimens, but the quantity of these specimens is not detailed.
- Data Provenance: The tests were conducted to comply with ISO standards. The location of the testing is not specified, but this is a U.S. FDA submission. These are laboratory/benchtop tests, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For this type of device (root canal filling material) and the testing performed (physical/chemical properties per ISO standards), human expert "ground truth" as you would define for an AI diagnostic algorithm is not relevant. The "ground truth" is the objective measurement of the material's properties according to the specified ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept relates to reconciling discrepancies in human expert interpretations, which is not part of the ISO standard physical/chemical testing for a dental material.
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
- No. The document explicitly states: "No human clinical testing was conducted to support substantial equivalence." An MRMC study is a clinical study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical dental material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the performance data presented is based on measurements derived from standardized laboratory tests according to ISO 6876:2012, such as flow, setting time, film thickness, solubility, and radio-opacity. Biocompatibility was assessed against ISO 10993 standards.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device; it does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set.
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(88 days)
Sonendo, Inc
The Sonendo Gentle Wave X System is intended to prepare, clean, and irrigate teeth indicated for root canal therapy. When used with the Sonendo GentleWave Molar Procedure Instrument or Molar CrossFire™ Procedure Instrument, the System is indicated for 1st and 2nd molar teeth. When used with the Sonendo Gentle Wave Anterior/Premolar Procedure Instrument, the System is indicated for anterior and premolar teeth. When used with the Sonendo Gentle Wave Premolar CrossFire™ Procedure Instrument, the system is indicated for premolar teeth.
The Sonendo GentleWave X System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo GentleWave X System is comprised of a Console, and disposable single-use Handpieces and accessories. The Handpiece is offered for molar, anterior and premolar treatments. A Molar Handpiece (original or CrossFire™ model) is intended to be used on 1st and 2nd molar teeth. An Anterior/Premolar (APM) Handpiece is intended to be used on anterior and pre-molar teeth and CrossFire™ Premolar Handpiece is intended for pre-molar teeth only. The Sonendo GentleWave X System delivers a stream of treatment fluids into the pulp chamber of the tooth. The treatment fluids delivered to the tooth are 3% Sodium Hypochlorite (NaOCl) solution and an 8% Ethylenediaminetetraacetic acid (EDTA) utilized in traditional endodontic treatments.
Based on the provided text, the device in question is the Sonendo GentleWave X System, an ultrasonic scaler used for root canal therapy.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in numerical targets (e.g., "accuracy > 90%"). Instead, it focuses on demonstrating substantial equivalence to a predicate device (Sonendo GentleWave System cleared under K160905). The acceptance is therefore based on showing that the new device performs as intended and equivalently to the predicate device through various non-clinical performance tests.
Here's a table summarizing the performance tests conducted (which imply the acceptance criteria are to pass these tests) and the reported outcome:
| Test Category | Specific Test | Implied Acceptance Criteria (Pass/Fail) | Reported Device Performance |
|---|---|---|---|
| Performance Verification | Thermal test | Pass (demonstrates proper thermal operation) | "performed and passed" |
| Cavitation test | Pass (demonstrates effective cavitation) | "performed and passed" | |
| Hydroacoustic test | Pass (demonstrates effective hydroacoustic action) | "performed and passed" | |
| Cleaning test | Pass (demonstrates effective cleaning) | "performed and passed" | |
| Apical pressure test | Pass (demonstrates acceptable apical pressure) | "performed and passed" | |
| Apical extrusion test | Pass (demonstrates acceptable apical extrusion) | "performed and passed" | |
| Human Factors | Human Factor Evaluation (per FDA Guidance) | Pass (demonstrates safe and effective usability) | "performed and passed" |
| Software Validation | Software Validation (moderate level of concern) | Pass (demonstrates software functions as intended) | "performed and passed" |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation | Pass (demonstrates biological safety) | "performed and passed" |
| Material Mediated Pyrogenicity | Pass (demonstrates non-pyrogenic materials) | "performed and passed" | |
| Acute Systemic Toxicity | Pass (demonstrates no acute systemic toxicity) | "performed and passed" | |
| Safety & EMC | Electromagnetic Compliance & Electrical Safety | Pass (demonstrates compliance with safety standards) | "performed and passed" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each of the non-clinical performance tests (e.g., how many units were tested for the thermal test, or how many simulated canals were cleaned for the cleaning test). It simply states that "All necessary performance testing has been conducted."
- Data Provenance: The data is all non-clinical bench testing. The country of origin is not explicitly stated for the testing, but the company (Sonendo, Inc.) is located in California, USA. The testing is prospective in the sense that it was conducted specifically to support this premarket notification.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This is not applicable (N/A) because the study relies on non-clinical bench testing and engineering verification, not human expert assessment of medical images or patient outcomes. The "ground truth" for these engineering tests are established engineering specifications and measurement standards.
4. Adjudication Method for the Test Set
- N/A. Since the testing is automated or standardized bench testing with objective measurements (e.g., temperature, pressure, electrical parameters), there is no need for human adjudication of results in the way it would be applied to clinical image readings. The results are typically compared against pre-defined engineering limits or specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size of human readers improvement with AI vs. without AI assistance.
- No. The document explicitly states: "No clinical data is submitted in support of this Premarket Notification." This means no MRMC study was conducted, and therefore no effect size for human reader improvement with AI assistance is reported. The device is not an AI-assisted diagnostic tool; it is a physical medical device for root canal therapy.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- N/A (for "algorithm only"). The device's performance is not primarily based on an "algorithm only" in the sense of a standalone AI diagnostic tool. It's a system with hardware and software. The "performance verification" tests assess the overall device's functional performance standalone, in a bench setting, against its specifications. The software validation is for the embedded software controlling the device, not a standalone AI diagnostic algorithm.
7. The Type of Ground Truth Used
- The ground truth for this device's acceptance is based on engineering specifications, recognized consensus standards (e.g., ISO, IEC), and established physical principles. For example, the "cleaning test" would likely have a pre-defined objective measure of cleanliness that constitutes "ground truth" for successful cleaning. Similarly, pressure and temperature measurements have objective "ground truth" values defined by physics and instrumentation. There is no biological or clinical ground truth (like pathology or outcomes data) used in this submission.
8. The Sample Size for the Training Set
- N/A. As no clinical data or AI/machine learning model dependent on a training dataset was used or submitted for this premarket notification, there is no "training set" in the context of AI model development.
9. How the Ground Truth for the Training Set Was Established
- N/A. (See point 8).
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(29 days)
Sonendo, Inc.
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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(96 days)
Sonendo, Inc.
Permanent obturation of the root canal following root canal treatment.
Sonendo Material A is a single component injectable paste material intended for permanent obturation of the root canal following root canal treatment. The device is comprised of alginate and a calcium containing compound which crosslinks in the presence of water to form an insoluble polymer. The placement into the root canal can be accomplished with or without the use a root canal point. The material is radiopaque and has physical properties such that it is suitable for root canal obturation. The material is packaged in either a syringe with single use dispensing tips or in a single dose capsule.
The provided text describes Sonendo Material A, a root canal filling resin, and its FDA 510(k) clearance based on substantial equivalence to a predicate device, iRoot SP Root Canal Sealer (K080917).
However, the document does not contain any information about an AI/ML powered device, nor does it provide details about acceptance criteria for an AI/ML product, performance metrics typically associated with AI/ML (e.g., accuracy, sensitivity, specificity, AUC), or studies involving human readers or ground truth established by experts/pathology for an AI model.
The "Performance Data" section of the document refers to bench testing to demonstrate physical-chemical properties and biocompatibility, which are standard for medical devices like root canal filling resins, not AI/ML software.
Therefore, I cannot fulfill your request for information related to AI/ML device acceptance criteria and study details. The input document pertains to a traditional medical device (root canal filling resin) and its regulatory clearance process.
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(63 days)
SONENDO, INC.
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:
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Software validation | "Performs as intended" and "substantially equivalent to the predicate device" after validation in accordance with ANSI/AAMI/IEC 62304:2006 |
| Safety & Effectiveness | Maintained substantial equivalence to predicate device with modified fluid concentration settings. |
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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(88 days)
SONENDO, INC.
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 1st and 2nd molar teeth. When used with the Sonendo GentleWave™ Anterior/Premolar Handpiece, the System is indicated for anterior and premolar teeth.
Not Found
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the Sonendo GentleWave™ System, confirming its substantial equivalence to a predicate device and outlining its indications for use. It does not include data from performance studies.
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(150 days)
Sonendo, Inc.
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
| Criteria Category (where applicable to AI/Software) | Acceptance Criteria/Test | Reported Device Performance | Reference |
|---|---|---|---|
| Software Validation | Validated per FDA Guidance: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 2005." | Passed all validation tests. | Performance Data section |
| Other Device Performance Tests | Sterility | Sterile per ISO 11137-1,-2 | Performance Data section |
| Biocompatibility | Biocompatible per ISO 10993-1, -5, -10, -11 | Performance Data section | |
| Electromagnetic Compliance and Electrical Safety | Certified per IEC 60601-1 and IEC 60601-1-2 | Performance Data section | |
| Thermal Test (External Tooth Surface) | Determined temperature generated on the external surface of the tooth. | Performance Data section (Internal Test Method) | |
| Cavitation Test | Evaluated transient cavitation bubbles which clean root canals. | Performance Data section (Internal Test Method) | |
| Hydroacoustics Test | Demonstrated hydroacoustic characteristics of the device. | Performance Data section (Internal Test Method) | |
| Cleaning Test | Demonstrated cleaning efficacy of the device on extracted teeth. | Performance Data section (Internal Test Method) | |
| Apical Pressure Test | Determined hydraulic pressure exerted at the apical terminus. | Performance Data section (Internal Test Method) | |
| Apical Extrusion Test | Measured relative volume of treatment fluid extruded through the apical terminus. | Performance Data section (Internal Test Method) |
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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(157 days)
SONENDO, INC.
The Sonendo OmniClean Endotherapy System is intended to prepare, clean and irrigate 181 and 2nd molar teeth indicated for root canal therapy.
The Sonendo OmniClean Endotherapy System is a medical device intended to prepare, clean and irrigate 15 and 2nd molar teeth indicated for root canal therapy. The Sonendo OmniClean Endotherapy System is comprised of a Console, Foot Pedal and Molar Procedure Kit with a Handpiece.
The provided 510(k) summary for the Sonendo OmniClean Endotherapy System does not contain detailed acceptance criteria or a study dedicated to proving the device meets specific performance metrics in the way often seen in AI/ML performance studies. Instead, it relies on demonstrating substantial equivalence to predicate devices through various performance tests.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a table of explicit acceptance criteria with corresponding performance results in a quantitative manner (e.g., "Device must achieve X% flow rate accuracy, and it achieved Y%"). Instead, it lists performance data categories and implies that testing within these categories showed the device performs as intended and is similar to predicate devices.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| Simulated Use | Performed as intended, demonstrating substantial equivalence to predicate devices. |
| EMC and Electrical Safety | Complies with relevant standards, ensuring safe operation. |
| Thermal Safety | Complies with relevant standards, ensuring safe operation and preventing tissue damage. |
| Hydroacoustics | Similar hydroacoustic wave generation and fluid motion to predicate devices, confirming the reported Principle of Operation. |
| Apical Extrusion and Pressure | Demonstrated to be safe and effective, minimizing apical extrusion and maintaining appropriate pressure levels, similar to predicate devices. |
| Cleaning Effectiveness | Demonstrated effective cleaning of root canals, comparable to predicate devices for its intended use. (Note: Specific metrics or comparative results are not provided in this summary but are implied to be satisfactory for substantial equivalence). |
| Flow Rate | 45 +/- 10 ml/min. (This is a specific technical characteristic, and the testing implicitly confirmed it met this specification.) |
| Duration of Application | Leak test = 1 minute, Treatment time = 7 minutes and 45 seconds. (These are specific technical characteristics, and the testing implicitly confirmed the device operates within these parameters.) |
| Irrigation Fluid Compatibility | Compatible with NaOCl, EDTA, and Water. (Testing implicitly confirmed compatibility with these specified fluids, similar to predicates.) |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not specify sample sizes for any of the performance tests. It states that "All testing was performed on test units representative of finished devices," but the number of units or teeth/canals tested is not provided.
The data provenance is also not specified. It's generally assumed that such testing for a 510(k) submission would be conducted by the manufacturer (Sonendo, Inc.) in a controlled lab or simulated environment during device development, but details regarding external data, country of origin, retrospective or prospective nature are absent.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable and not provided in the context of this 510(k) summary. This device is an endotherapy system for preparing, cleaning, and irrigating root canals, not an AI/ML diagnostic or image analysis device that would typically rely on expert ground truth for test sets.
4. Adjudication Method
This information is not applicable and not provided for the same reasons as #3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not applicable and not mentioned. This type of study investigates the impact of AI assistance on human reader performance, which is not relevant for a physical endotherapy device.
6. Standalone (Algorithm Only) Performance
A standalone algorithm performance study is not applicable for this device, as it is a physical medical device, not an algorithm or software-only product.
7. Type of Ground Truth Used
The concept of "ground truth" in the AI/ML context doesn't directly apply here. The "ground truth" for a physical device like this would be derived from:
- Engineering specifications and standards conformance: The device performs according to its design and meets relevant safety and performance standards (e.g., electrical safety, thermal safety).
- Biomechanical/physiological effects: Demonstrating that the hydroacoustic waves and fluid motion effectively clean root canals without causing harm (e.g., minimal apical extrusion). This would likely involve in vitro or ex vivo models but not "expert consensus" in the diagnostic sense.
- Comparison to predicate devices: The primary "ground truth" or benchmark is the performance of legally marketed predicate devices, demonstrating that the new device is "substantially equivalent" and "performs as intended."
The specific methods for establishing these "truths" (e.g., documented lab tests, measurements, comparative data) are summarized but not detailed.
8. Sample Size for the Training Set
This is not applicable and not provided. This device does not involve a "training set" in the machine learning sense. The development and testing of this device would involve engineering design, prototyping, and various verification and validation tests, not machine learning model training.
9. How Ground Truth for the Training Set Was Established
This is not applicable and not provided for the same reasons as #8.
In summary:
This 510(k) summary for the Sonendo OmniClean Endotherapy System primarily relies on demonstrating substantial equivalence to existing predicate devices. The performance data section lists various categories of testing (Simulated Use, EMC/Electrical Safety, Thermal Safety, Hydroacoustics, Apical Extrusion/Pressure, Cleaning) that were conducted to confirm the device performs as intended and is comparable to its predicates. However, it does not provide quantitative acceptance criteria, specific sample sizes for testing, or details about expert involvement or ground truth establishment in the manner applicable to AI/ML or diagnostic devices.
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(159 days)
SONENDO, INC.
The Sonendo Endotherapy System is intended to prepare, clean and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
The Sonendo Endotherapy System is a medical device intended to prepare, clean and irrigate root canals. The Sonendo Endotherapy System is comprised of a Console, Foot Pedal and Molar Procedure Kit with a Handpiece.
The provided text describes the Sonendo Endotherapy System and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the format requested.
The document states that "All necessary performance testing has been conducted for the Sonendo Endotherapy System to assure substantial equivalence to the predicate devices and demonstrate the devices perform as intended." It then lists the types of testing performed:
- Simulated Use
- EMC and Electrical Safety
- Thermal Safety
- Hydroacoustics
- Apical Extrusion and Pressure
- Cleaning
However, it does not provide details on:
- A table of acceptance criteria and reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study results or effect size
- Stand-alone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document focuses on establishing substantial equivalence based on intended use, principle of operation, and technological characteristics, rather than reporting detailed performance against specific acceptance criteria.
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