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The Integrated Endo System is dental device which combine in a single main control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to assist the operator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation.

The Integrated Endo System is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

The Integrated Endo System Meet Endo-II is composed of Main Unit, Adapter, MeetMotor, MeetFill, MeetActivator. It is standalone AC-powered dental control units with a touch display screen to which multiple hand-held dental handpieces for root canal therapy procedure (MeetMotor is for root canal preparation, MeetFill is for root canal backfilling, MeetPex is for working length measurement of root canal, MeetActivator is for root canal irrigation).

These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of the Integrated Endo System different handpieces can be combined with the control unit. The key hand-held components like handpieces or endodontic tools of the Integrated Endo System are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.

The provided document describes a 510(k) premarket notification for the "Integrated Endo System (Meet Endo-II)". This submission is for a dental device, not an AI/ML medical device, and therefore, the information typically found in an AI/ML acceptance criteria and study report (e.g., specific metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication, MRMC studies) is not present.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (EndoPilot2 K202906) through non-clinical performance testing, electrical safety, biocompatibility, and software validation for a "Moderate Level of Concern" software. It is a comparison of technological characteristics and safety standards rather than a performance study on a diagnostic or pattern-recognition AI/ML algorithm.

Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and study details from this document. The document confirms that the device meets various electrical, safety, and performance standards relevant to general medical devices and integrates several dental functions, but it does not describe a study involving an AI/ML algorithm's diagnostic performance.

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Stela Primer: - Dentin and enamel bonding
Stela Capsule - Direct Class I, II, III and V cavities. Ideally Class I and II - Base or liner - Core build-ups.

The Stela Capsule System is an easy to use bulk-fill radiopaque self-cure dental restorative system for dental professional use. The system comprises:

• Stela Capsule - a capsule consisting of powder and liquid components which are mixed and activated when the capsule is pushed down. After mixing with a triturator (amalgamator) an applicator is used to dispense the paste.
• Stela Primer an adhesive liquid packaged in a bottle. A bendable disposable brush applicator is used to apply Stela Primer.
  The combination of Stela Primer and Stela Capsule will bond to both enamel and dentin without scrubbing or light curing.

This is a 510(k) premarket notification for a dental device, specifically the Stela Capsule System. The provided text describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices. However, this document does not contain the detailed acceptance criteria for a study and the specific performance reported against those criteria in the format you requested for AI/algorithm performance.

The document discusses bench testing for physical and chemical properties of the dental material, and biocompatibility testing. These are not studies that define acceptance criteria or performance for an "AI/algorithm" device in the manner you've described.

Therefore, I cannot populate the table or answer questions 2 through 9 as they pertain to AI/algorithm performance in medical image analysis or similar AI-driven diagnostic/therapeutic applications.

The document indicates:

• The device is not an AI/algorithm-based device. It's a dental restorative material (capsule system and primer).
• No standalone or human-in-the-loop performance studies directly related to AI/algorithm performance were conducted or reported.
• No ground truth derived from experts or pathology for AI training/testing is mentioned.
• No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned.

However, I can extract information regarding the bench testing performance for the Stela Capsule System and how it met ISO standards, which serves as a form of "acceptance criteria" for this type of medical device.

Based on the provided text, here's what can be extracted regarding the material performance and acceptance criteria for the Stela Capsule System:

The Stela Capsule System underwent biocompatibility testing and non-clinical performance data (bench testing) to demonstrate its safety and effectiveness relative to predicate devices and relevant ISO standards.

1. Table of Acceptance Criteria and Reported Device Performance (for Bench Testing):

Regarding the other questions (AI/Algorithm specific):

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/algorithm study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/algorithm study. Ground truth in this context refers to chemical/physical measurements and biological reactions, not expert interpretations of data.
4. Adjudication method for the test set: Not applicable.
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, an MRMC study was not done as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an AI device.
7. The type of ground truth used: For biocompatibility, the "ground truth" is the universally accepted biological response measures defined by ISO 10993 series. For bench testing, the "ground truth" is the physical and chemical properties measured against ISO 4049 and ISO 29022 standards.
8. The sample size for the training set: Not applicable. This device does not involve a training set for an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.

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The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.

The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.

The provided document is a 510(k) summary for the PS System, a dental device used for endodontic irrigation. It describes the device's function, comparison to a predicate device, and non-clinical and clinical performance data.

Based on the document, here's an analysis of the acceptance criteria and study information, addressing your points:

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

The document does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of performance tests conducted and then concludes based on the results. The key "acceptance criteria" appear to be:

• Ability to deliver and evacuate endodontic irrigation solutions.
• Performance akin to the predicate device (EndoVac System K140685).
• Reduction of apical extrusion risk compared to conventional positive pressure syringe irrigation.
• Safety and effectiveness equivalent to the predicate.

Reported Device Performance (based on the "Non-Clinical Performance Testing and Compliance" section):

The document states that the following performance tests were conducted as part of design verification:

• Suction Flow Rate Performance
• Critical Dimensions for Clinical Performance Analysis
• Corrosion Testing
• Simulated Canal Performance Testing
• Shelf Life Verification
• Biocompatibility Analysis
• Transit Testing
• Additive Manufacturing Summary Document

The conclusion states that based on "extensive comparative analysis and testing," the PS System is substantially equivalent to the predicate, and that differences "do not raise any new questions of safety and effectiveness." This implies the tests successfully demonstrated comparable performance and met the underlying safety and effectiveness expectations for such a device. However, specific quantitative performance metrics or pass/fail thresholds for these tests are NOT provided in this summary document.

2. Sample sizes used for the test set and the data provenance

The document is a 510(k) summary, which typically provides an overview rather than detailed study protocols. As such, the sample sizes for the non-clinical tests are not specified.

Data Provenance: The studies are described as "Non-Clinical Performance Testing." The document is submitted by Inter-Med, Inc. from Racine, WI, USA, suggesting the testing was likely conducted in the US or by a US-affiliated entity. The document doesn't specify if the data is retrospective or prospective, but as it's for design verification, it would inherently be prospective testing.

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

This information is not provided in the document. The tests performed are primarily engineering and material performance tests (e.g., suction flow rate, corrosion, biocompatibility, dimensions). These types of tests typically rely on established standards and laboratory measurements rather than expert human interpretation for "ground truth." Therefore, experts in establishing "ground truth" would not be relevant in the same way they would be for, say, an AI-based diagnostic device.

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

Adjudication methods (like 2+1, 3+1 for consensus readings) are typically used in clinical studies or studies involving human readers/interpreters, especially for AI or diagnostic devices where subjective interpretation is involved. Since this document focuses on non-clinical performance testing of a physical medical device, adjudication methods are not applicable and thus not mentioned.

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 PS System is a dental handpiece/irrigation system, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

No. This is not an algorithm or AI device. It is a physical medical device for irrigation. Therefore, a standalone algorithm performance study is not applicable and was not performed.

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

For the non-clinical performance tests mentioned (Suction Flow Rate, Critical Dimensions, Corrosion, Simulated Canal Performance, Shelf Life, Biocompatibility, Transit), the "ground truth" would be established by:

• Reference standards and measurements: For dimensions, flow rates, and physical properties.
• Standardized testing protocols: For corrosion, shelf life stability, and transit resilience.
• ISO standards and established biological assays: For biocompatibility (e.g., ISO 7405, ISO 10993-1).

There is no mention of expert consensus, pathology, or outcomes data being used for ground truth in this context, as they are not relevant to the types of tests described.

8. The sample size for the training set

The device is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

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

As there is no "training set" (see point 8), this question is not applicable.

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The EndoPilot2 systems are dental devices which combine in a single control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to locate the file tip in the rot canal and an ultrasonic-handpiece for root-canal cleaning and preparation.

The EndoPilot is intended solely for use by trained dental professional health care facilities on patients that need root-canal-treatment.

The EndoPilot2 systems, including the models "comfort", "plus", "ultra plus" and the model variant under brand "CanalPro Jeni" (marketed by Distributor Coltène/Whaledent Inc. and identical for technical aspects to model EndoPilot² comfort) are standalone AC-powered dental control units with a touch display to which multiple hand-held dental handpieces for root canal preparation (Apex measurement, EndoMotor, Ultrasonic handpiece) and/or root-canal filling (DownPack, BackFill handpiece) can be connected.

These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of these EndoPilot2 systems different handpieces can be combined with the control unit and different device variants (systems) of the EndoPilot²exist. The key hand-held components like handpieces or endodontic tools of the EndoPilot² are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.

The provided document describes the EndoPilot2, a dental device, for which the manufacturer, Schlumbohm GmbH & Co. KG, sought 510(k) clearance from the FDA. The submission (K202906) claims substantial equivalence to predicate devices: EMS-200 and SUPRASSON P5 NEWTRON. The document details the non-clinical performance data used to support this claim.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" against which specific quantitative numerical performance metrics of the EndoPilot2 are directly compared. Instead, it describes various non-clinical performance tests conducted and states that the device "PASSED required testing" or "all requirements were met."

Therefore, I will extract the performance specifications and the stated outcome for the most relevant functional components where quantitative values are mentioned, and then for other types of tests, I will summarize the general pass/fail outcome.

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Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation.

Vista Rinse and Vista Rinse Plus are endodontic irrigating solutions that cleanse the root canal system by removing the smear layer after endodontic instrumentation. Both medical devices are packaged in bottles. Clinical use of the medical devices requires the irrigant to be expelled from syringes through irrigation tips, which are class I medical devices per EIC product code (syringe, periodontic, endodontic, irrigating) and CFR regulation number 872.4565 and are 510(k) exempt.

The provided document is a 510(k) summary for the Vista Rinse and Vista Rinse Plus endodontic irrigating solutions. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria as one might find for a novel medical device. Therefore, much of the requested information regarding a study proving acceptance criteria and specific performance metrics in a clinical context is not explicitly available in this document.

However, I can extract information related to the non-clinical performance testing which served as the basis for demonstrating substantial equivalence.

Here's the breakdown based on the provided text:

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

The document does not define explicit "acceptance criteria" in a quantitative sense as might be found in a clinical trial protocol. Instead, it relies on demonstrating comparable performance to predicate devices through non-clinical testing. The reported device performance is presented as being "commensurate with" or "identical to or better than" the predicate devices.

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

The document does not specify the sample sizes (e.g., number of test specimens, number of wells for cytotoxicity) used for the non-clinical tests.

• Cytotoxicity Testing: No specific sample size is mentioned.
• SEM Evaluation & Calcium Chelation Testing: No specific sample size is mentioned for the SEM evaluations or calcium chelation.
• Data Provenance: The testing was conducted by Inter-Med/Vista Dental Products, the submitter, as part of their 510(k) submission. The exact country of origin or whether the data was retrospective or prospective (for non-clinical lab studies) is not detailed.

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

This information is not applicable. For non-clinical performance testing like cytotoxicity and smear layer removal, the "ground truth" is established by scientific methodologies and laboratory measurements, not by expert consensus. There were no human experts adjudicating test results in this context.

4. Adjudication method for the test set

Not applicable, as there was no human expert adjudication of test results for these laboratory studies.

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 endodontic irrigating solution, not an AI-assisted diagnostic or therapeutic device that would involve human readers or MRMC studies.

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

Not applicable. This device is a medical solution, not a software algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical performance testing was based on:

• Laboratory measurements and analytical chemistry: For composition verification (analytical testing), pH, and chelation characteristics.
• Standardized biological assays: For cytotoxicity testing (ISO 10993-5:2009).
• Microscopic imaging and qualitative assessment: For smear layer removal (SEM evaluation). The effectiveness was compared to the known performance of predicate devices, which utilize 17% EDTA, considered the "gold standard."

8. The sample size for the training set

Not applicable. This document describes a traditional medical device (chemical solution), not a machine learning or AI-driven device that requires a training set.

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

Not applicable, as no training set was used.

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BA Pit & Fissure Sealant is intended to seal pit and fissure depressions/faults in the biting surfaces of teeth. For dental professional use only.

Pit and Fissure sealants are used as a preventive measure to fill defects and prevent decay within crevices, voids or fissures on the surface of teeth. These voids are more challenging to keep free of substances that can lead to caries and eventual breakdown of tooth structure. BA Pit & Fissure Sealant is a material designed to fill these voids with a wear resistant material, ultimately preserving natural tooth structure.

BA Pit & Fissure Sealant is a light activated / photopolymerizable, glass filled, urethane dimethacrylate material that is placed onto an etched enamel surface and light activated for 20 seconds. The result after application is a tooth that has been sealed with a tough, wear resistant material.

Here's a breakdown 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 does not explicitly state "acceptance criteria" with numerical targets for each test. Instead, it presents the results of various non-clinical performance tests for the subject device (BA Pit & Fissure Sealant) and then compares them to a predicate device (Pulpdent (Activa) Pit & Fissure Sealant with MCP) and sometimes a reference device (Prevent Seal) to establish substantial equivalence. The "acceptance criterion" in this context is generally that the subject device's performance is "similar" or "equivalent" to the predicate device, or that any differences do not raise additional concerns regarding safety or efficacy.

2. Sample sizes used for the test set and the data provenance

The document describes non-clinical benchtop testing. For these types of tests, sample sizes are typically specified within the referenced ISO or ADA standards. However, the exact sample sizes for each specific test conducted for K190998 are not explicitly mentioned in the provided text.

The data provenance is retrospective, as the tests were conducted prior to the 510(k) submission to demonstrate substantial equivalence. The country of origin of the data is not specified, but given the applicant is Apex Dental Materials, Inc. with an address in Lake Zurich, Illinois, it is likely the studies were conducted in the USA or by contract labs.

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

This section is not applicable as the document describes non-clinical benchtop performance testing, not studies involving human interpretation or expert-established ground truth. The "ground truth" for these tests would be the measurement obtained from the laboratory instruments according to the specified standards.

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

This section is not applicable as the document describes non-clinical benchtop performance testing, not studies involving human reading or adjudication.

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

This section is not applicable. The device is "BA Pit & Fissure Sealant," which is a material used for dental sealing, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study or AI component is mentioned.

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

This section is not applicable. The device is a physical material (dental sealant), not an algorithm or software device.

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

The "ground truth" for the non-clinical tests is based on measurements obtained following standardized test methods (e.g., ISO, ADA standards). For example, for compressive strength, the ground truth is the force at which the material fractures, as measured by a testing machine according to the specified standard.

8. The sample size for the training set

This section is not applicable. The device is a physical material, not an AI model, and therefore does not have a "training set."

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

This section is not applicable. The device is a physical material, not an AI model, and therefore does not have a "training set" or ground truth relevant to AI model training.

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armor LC™ is a resin-based, light-cured protective barrier material recommended to protect dental materials or tissues.

armor LC™ is a light-cured resin dam designed to seal around and protect the gingival tissue during professional dental procedures. It consists of a viscous urethane dimethacrylate (UDMA)based resin foam supplied in a black 1 mL syringe. armor LC™ is only for prescription use and is a single-use, non-sterile, product. Using an applicator tip, the uncured product is applied over the gingival margin where it flows to form a seal at the base of the teeth. It is then rapidly light cured in situ to form a flexible material barrier. After the dental procedure it is readily removable with simple dental instruments.

The provided FDA 510(k) summary for the Mavrik Dental Systems Ltd.'s armor LC™ device does not include the detailed acceptance criteria or the study data proving the device meets those criteria for the specific performance tests listed. The document generally states that the device "functioned as intended and met the pre-defined acceptance criteria" for each test.

Therefore, many of the requested details cannot be extracted from this document. However, based on the information provided, here's what can be stated:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified for any of the performance tests.
• Data Provenance: The studies were "Mavrik Dental Systems conducted several performance tests," implying they were conducted by the manufacturer. The document does not specify the country of origin, but the applicant's address is Israel. The tests are "Non-Clinical Performance Data" and "Bench Performance Testing," indicating they are likely laboratory-based studies rather than retrospective or prospective clinical studies involving human patients.

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

• Not applicable as this is a non-clinical bench testing and biocompatibility study, not a study requiring expert readers for ground truth establishment.

4. Adjudication method for the test set:

• Not applicable as this is a non-clinical bench testing and biocompatibility study.

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 is not an AI-assisted device, nor does the document describe an MRMC study.

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

• Not applicable. This is not an AI algorithm. The performance described is for the device itself (a light-cured resin dam).

7. The type of ground truth used:

• For Bench Performance Testing: The "ground truth" would be the pre-defined acceptance criteria based on engineering specifications and comparison to predicate devices, but these specific criteria are not detailed in the document.
• For Biocompatibility: The "ground truth" or standard for acceptance was compliance with specific international consensus standards (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 7405).

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning or AI that would require a training set.

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

• Not applicable as there is no training set for this device.

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The Pelton & Crane P50 series Dental Operative Units and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The Pelton & Crane P50 series Dental Operative Units and Accessories are designed for use by a trained professional in the field of dentistry.

The P50 series Dental Operative Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, patient dental chair, foot control, and a junction box that houses a power supply and air/water regulators. The unit may also include a dental operating light and a monitor. Various handpieces, instruments, and accessories can be added to the P50 series Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them to the P50 series Dental Operative Units. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments. Water quality is maintained automatically by the preprogramed cleaning functions for the water lines, cuspidor spouts, and instrument hoses including motors and syringes. Instructions are provided for waterline treatment and suction cleaning agents. Water supply is available by either the municipal water supply or a self-contained water bottle.

The retrieved document is a 510(k) Pre-Market Notification for the Pelton & Crane P50 series Dental Operative Unit and Accessories. This notification focuses on demonstrating substantial equivalence to a predicate device rather than providing a study proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable or available in this type of submission.

However, I can extract the relevant information that is present:

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

The document does not present specific acceptance criteria in the form of a table with numerical thresholds for performance metrics. Instead, it provides a comparison table (Table 5.3) outlining technological characteristics between the proposed device (P50 series Dental Operative Unit and Accessories) and the predicate device (ESTETICA Dental Treatment Unit and Accessories, K161488). The document states that "The performance testing results provided in this submission supports that the proposed device performs as well as the predicate devices for its intended use" and that "Hence, the device is deemed to be substantially equivalent to the ESTETICA Dental Treatment Unit and Accessories (K161488)."

Here is a summary of the comparative characteristics, serving as the basis for "performance" as described in this 510(k) submission:

2. Sample sizes 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. The submission relies on "Non-Clinical Test Data" to demonstrate substantial equivalence, which primarily involves performance bench testing against international standards and comparative performance testing of integrated accessories versus cleared stand-alone devices. There is no mention of a traditional "test set" in the context of clinical data for performance evaluation.

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 is not applicable as there was no clinical test set requiring ground truth establishment by experts for a specific performance metric.

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

This is not applicable as there was no clinical test set requiring adjudication.

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

This is not applicable. The device is a "Dental Operative Unit and Accessories" and is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Its primary function is to provide power, air, water, and vacuum for other dental instruments.

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

This is not applicable. The device is a physical dental unit, not an algorithm.

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

For the non-clinical performance testing, the "ground truth" was adherence to established international standards (e.g., AAMI ES60601-1, IEC 60601-1-2, ISO 10993-1, etc.) and comparative performance to cleared stand-alone predicate devices for integrated accessories. Specific outcomes data or expert consensus on clinical findings are not mentioned as "ground truth" in this context.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device requiring a training set.

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

This is not applicable as this is not an AI/ML device requiring a training set.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-Clinical Test Data" and primarily involves:

• Performance bench testing: Conducted according to international standards for dental operative units to determine conformance in regards to basic safety and essential performance. Relevant standards cited include:
  • AAMI ES60601-1:2005 +AC1; A2
  • IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)
  • IEC 60601-1-2 Edition 3: 2007-03 (EMC)
  • IEC 80601-2-60 Edition 1.0 2012-02 (Dental equipment specific)
  • ISO 9168 Third edition 2009-07-15 (Hose connectors)
  • ISO 14457 First edition 2012-09-15 (Handpieces and motors)
  • ISO 7494-2 Second edition 2015-04-01 (Air, water, suction)
  • ISO 7494-1 Second edition 2011-08-15 (General requirements)
• Biocompatibility testing: Completed for applicable components, referencing ISO 10993-1 and ISO 7405. Reference devices (Spirit - K143696 and ELECTROmatic - K163317) were used due to identical patient contacting parts.
• Software documentation: For moderate level of concern per FDA Guidance Document for Software Contained in Medical Devices, referencing IEC 62304.
• Comparative performance testing: The functions of the integrated accessories were compared to "cleared stand-a-lone device[s]."
• Risk Management: Compliance with ISO 14971:2007, with the Risk Management File reviewed by Intertek for 60601-1 certification.

The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

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The ESTETICA Dental Treatment Unit and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The ESTETICA Dental Treatment Unit and Accessories are designed for use by a trained professional in the field of general dentistry.

The ESTETICA Dental Treatment Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The device includes a patient chair, foot control, dentist element, assistant element and a water unit. The unit may also include a dental operating light and a monitor. Various handpieces and accessories can be added to the ESTETICA Dental Treatment Unit and Accessories. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes and SE and HVE vacuum instruments.

The provided text describes the 510(k) premarket notification for the ESTETICA Dental Treatment Unit and Accessories. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Here's a breakdown of the requested information based on the provided document:

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

The document does not present specific acceptance criteria in a table format with corresponding reported device performance metrics in the way one might see for a diagnostic AI device (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly defined by conformance to various international and national standards for dental operative units and medical electrical equipment. The "reported device performance" is broadly stated as "Performance bench testing according to international standards for dental operative units has been conducted to determine conformance" and "the performance of the ESTETICA Dental Treatment Unit and Accessories has been verified utilizing the following standards."

Here's an interpretation based on the provided text, outlining the areas of conformance:

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

The document does not detail specific sample sizes for particular performance tests. It refers to "Performance bench testing" and "Comparative performance testing" but does not specify the number of units or test subjects used in these tests. The provenance of the data (country of origin, retrospective/prospective) is also not specified, as these are non-clinical bench tests, not clinical studies.

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 product is a dental treatment unit, not an AI or diagnostic device that requires expert-established ground truth for its performance evaluation in the typical sense of medical image analysis. The "ground truth" here is adherence to engineering and safety standards, verified through bench testing. Therefore, there were no experts used to establish ground truth in the context of clinical interpretation or diagnosis.

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

Not applicable. As a device undergoing non-clinical bench testing for conformance to standards, there is no "adjudication method" in the clinical sense (e.g., for conflicting expert opinions). Performance is evaluated against documented technical specifications and standard requirements.

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 dental operative unit, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed.

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

This device does not involve an "algorithm only" component for diagnostic or interpretative tasks. It is a physical medical device that provides power and functions for dental procedures. Performance evaluations were done on its physical and electrical characteristics according to relevant standards.

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

The "ground truth" for the performance evaluation of the ESTETICA Dental Treatment Unit and Accessories is the set of specifications and requirements outlined in the international and national standards listed (e.g., ISO 7494-1, IEC 60601-1). Performance is assessed based on whether the device operates within the parameters defined by these standards. No expert consensus, pathology, or outcomes data were used for establishing ground truth in this context.

8. The sample size for the training set

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

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

Not applicable. There is no training set for this device.

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The EMS-200 is a dental device which combines in a single LCD unit an endo motor which ablates the tooth to expand the root canal, a dental obturator to fill and pressurize various shaped packing elements and an electronic apex locator which assists the operator the location of the front tip in the root canal, for use by trained dental professionals.

The EMS -200 dental unit is device that combines the 1) Endo-motor Handpiece (K133298) which ablates the tooth to expand the root canal, a 2) Endodontic Obturation Unit which is used to fill and pressurize various shaped packing elements, and 3) Electronic apex locator (K112508) which is used to ensure the location of the front tip in root canal through changes of electric resistance value into one unit. The working of each of the components is displayed through a single touch screen.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the EMS-200 dental device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative, pass/fail manner with specific thresholds. Instead, the document compares the EMS-200's functional specifications to its predicate devices. The primary 'acceptance' is that the new device is "substantially equivalent" to legally marketed predicate devices and introduces "no new issues of safety and efficacy."

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

The document does not explicitly state sample sizes for specific test sets in a detailed manner that would typically be found in a clinical study report.

• Test Set: For bench testing (e.g., ISO 14457 comparison), no specific "sample size" of devices or cases is mentioned. For usability testing, it states "testing by the intended user" but doesn't specify the number of users.
• Data Provenance: The studies appear to be non-clinical bench tests performed by the manufacturer, Meta Systems Co., Ltd., based in Korea. The document does not indicate the country of origin for any data related to user testing (e.g., where the "intended user" for usability testing was located). All testing described seems to be prospective in nature as it's for a new device submission.

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

• Number of Experts: Not specified.
• Qualifications: "Intended user" for usability testing, but no specific professional qualifications (e.g., "dental professionals" as per Indications for Use) or experience levels are mentioned for those users. For other tests (e.g., bench tests), the "ground truth" is typically defined by the test standard itself or the specifications of the predicate device, not by expert consensus in this context.

4. Adjudication Method for the Test Set

No adjudication method is mentioned for any of the testing described. Decisions are based on conformance to specifications or standards.

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 MRMC comparative effectiveness study was mentioned.
The EMS-200 is a dental device combining an endo motor, obturator, and electronic apex locator. These are mechanical/electronic tools for dental procedures, not an AI-assisted diagnostic or interpretative system that would involve "human readers" or AI for image analysis. Therefore, a study of this nature is not applicable to this device description.

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

A standalone performance evaluation was implicitly done for each component (Motor, Apex Locator, Pack, Fill) through:

• Bench testing: "Bench testing for conformance to ISO 14457"
• Safety testing: Compliance with various IEC, ISO, EN standards.
• Biocompatibility testing: Compliance with ISO 10993-1.
• Software validation: "Software documentation and validation for software of moderate level of concern per the FDA Guidance Document for Software Contained in Medical Devices."

The device itself is a standalone system in the sense that the individual functions (e.g., apex location) operate based on the device's algorithms or mechanics. The "human-in-the-loop" for this device refers to the dental professional using the device, not assisting an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance evaluations (e.g., accuracy of apex locator, temperature ranges for pack/fill, motor speed/torque) is primarily established by:

• Predicate device specifications: The comparison table clearly shows the EMS-200's specifications are benchmarked against those of the K133298, K112508, and K031664 predicate devices.
• International standards: Conformance to relevant ISO, IEC, EN standards defines the "ground truth" for safety, electrical compatibility, software, and sterilization.
• Referenced literature: For Gutta percha temperature, "Referenced literature articles regarding the temperature of gutta percha" are cited.

8. The Sample Size for the Training Set

No training set is mentioned as this is not an AI/machine learning device. The device's operational parameters are based on engineering design and historical predicate device performance, not a learned model from a dataset.

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

Not applicable, as there is no training set for this type of device.

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