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X-Smart Easy is designed for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills (Gates-Glidden).

The X-Smart Easy is an electric motor-driven handpiece intended for root canal preparation procedures in endodontic industry.

The provided text describes the 510(k) submission for the X-Smart Easy dental handpiece. However, it does not include information about specific acceptance criteria related to a numerical performance target (e.g., sensitivity, specificity, accuracy) for an AI/CAD/imaging device, nor does it detail a study designed to prove such criteria.

The document discusses non-clinical performance tests for safety and substantial equivalence, but these are not equivalent to a performance study for an AI algorithm.

Therefore, I cannot fulfill all parts of your request.

Here's what can be extracted based on the provided text, and what cannot:

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

• Cannot provide. The document does not specify numerical acceptance criteria for clinical performance (e.g., accuracy metrics) for the device. It focuses on safety and electrical standards.

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

• Cannot provide. The document does not describe a "test set" in the context of data for an AI/CAD/imaging device. The performance testing mentioned is for electrical safety, EMC, and hardware/software functions, not for diagnostic accuracy on a dataset.

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

• Cannot provide. Ground truth and expert adjudication are not applicable to the non-clinical tests performed for this device.

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

• Cannot provide. Adjudication is not applicable here.

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

• Cannot provide. This type of study is not mentioned as the device is a dental handpiece, not an AI-assisted diagnostic tool.

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

• Cannot provide. Not applicable as this is a physical device, not an algorithm.

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

• Cannot provide. Ground truth is not applicable in the context of the safety and electrical performance tests. The "truth" for these tests would be whether the device meets the specified engineering standards.

8. The sample size for the training set

• Cannot provide. "Training set" is not applicable, as this is a physical device submission, not an AI/ML algorithm submission.

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

• Cannot provide. Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):

The document describes non-clinical performance testing rather than a clinical or AI-specific performance study. These tests were conducted to demonstrate the safety and effectiveness of the X-Smart Easy and its substantial equivalence to the predicate device (Prophy-Mate and Endo Mate Motor Handpiece, K990682).

Key areas of testing included:

• Biocompatibility Testing: Performed in accordance with ISO 10993. All patient contact components were evaluated and found to demonstrate biocompatibility.
• Electromagnetic Compatibility (EMC) and Electrical Safety: The device was tested for conformance to:
  • UL60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety.
  • IEC 60601-1-2 Medical Electrical Equipment, Part 1-2: General Requirements for Safety Collateral Standard Electromagnetic Compatibility.
  • IEC 61000-3-2 Electromagnetic Compatibility (EMC) Part 3: Limits - Section 3: Limitations of Voltage Fluctuations.
    The device was found to conform to these standards.
• Validation Testing: Included both hardware and software functions (details not specified beyond "validation testing").

Conclusion on Substantial Equivalence:

Based on these performance tests, the submitter concluded that the X-Smart Easy is substantially equivalent to the predicate device due to equivalence of intended use, similar features, and technical characteristics. The testing indicated that the device does not raise any new issues of safety, effectiveness, or performance.

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Elation MB metal reinforced plastic brackets is indicated for orthodontic movement of natural teeth.

The marketed product Elation Metal Reinforced Plastic Brackets has a barrel polished bonding base. A modification has been made to replace the base with the previously tested mechanical lock base and an improvement in the tie wing, Elation MB Metal Reinforced Plastic Brackets.

The provided document is a 510(k) summary for a medical device (Elation MB Metal Reinforced Plastic Brackets), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data in the format typically used for software or AI/ML device evaluations. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of statistical metrics, sample sizes, expert ground truth, and comparative effectiveness studies is not applicable or available in this type of regulatory submission.

This document describes a modification to an existing device and justifies its safety and substantial equivalence based on prior use of components and material composition, not through a performance study that measures diagnostic accuracy or clinical outcomes with quantifiable metrics against acceptance criteria.

However, I can extract and infer some information based on the context of a 510(k) submission for a non-software/AI device:

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

For a mechanical device like an orthodontic bracket, "acceptance criteria" usually relate to mechanical strength, biocompatibility, and fit, often tested against industry standards or the performance of a predicate device. The document states that the device meets these, but detailed quantitative criteria and performance values are not provided in this summary.

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

Not applicable in the context of this 510(k) summary. This document does not describe a clinical or performance study with a test set of data points in the way a software/AI device would. The "tests" here refer to material and mechanical evaluations, likely performed on a sufficient number of bracket samples to ensure product quality and regulatory compliance, but specific sample sizes are not disclosed in this summary. Data provenance is not described as it is not a data-driven device.

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

Not applicable. The "ground truth" for a mechanical device like this is established through material science principles, engineering testing (e.g., tensile strength, bond strength), and biocompatibility assessments, not by expert consensus on clinical cases.

4. Adjudication method for the test set

Not applicable. There is no "test set" in the context of clinical cases 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

Not applicable. This is a physical orthodontic bracket, not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a physical orthodontic bracket.

7. The type of ground truth used

For a non-AI/ML medical device like this, the "ground truth" is typically:

• Material Science Specifications: Conformance to established standards for materials (e.g., plastics, metals used in the bracket).
• Biocompatibility Data: Established safety profiles for the materials used, often from prior regulatory clearances or published standards.
• Mechanical Engineering Principles: Performance of the mechanical lock, retention, and overall structural integrity, verified through in-vitro laboratory testing (e.g., bond strength tests).
• Predicate Device Performance: The underlying assumption that if the new device's materials, design modifications (like the base), and intended use are substantially equivalent to a legally marketed predicate device, its performance and safety are also equivalent.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML model.

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

Not applicable.

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Allure® MB Ceramic Brackets and Mystique MB Ceramic Brackets are indicated for orthodontic movement of natural teeth excluding mandibular bicuspid teeth.

The marketed product Allure® has a chemically treated base. A modification has been made to replace that base with a new mechanical lock base, Allure® MB. The mechanical lock base includes rhomboid and "torque-in-the-base" features.

The provided 510(k) summary for the Allure® MB Ceramic Brackets (K090454) is for a dental device, specifically orthodontic brackets. This type of submission focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and material composition, rather than a clinical study evaluating AI performance. Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and sample sizes for training/test sets are not applicable to this submission.

Here's the information that can be extracted and a clear indication of what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This 510(k) relies on demonstrating substantial equivalence through technical characteristics and material composition, not a clinical study with a test set of data.

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

• Not Applicable. As no clinical study or test set with ground truth was presented in this 510(k) for AI performance.

4. Adjudication method for the test set

• Not Applicable. No test set requiring adjudication for AI performance was presented.

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 a device modification for an orthodontic bracket, not an AI-powered diagnostic or assistive tool for human readers.

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

• Not Applicable. This is not an AI algorithm.

7. The type of ground truth used

• Not Applicable. While the device seeks "substantial equivalence," the "ground truth" in this context is the safety and effectiveness of the predicate devices and their components. This is not derived from expert consensus, pathology, or outcomes data in the way an AI system's performance would be.

8. The sample size for the training set

• Not Applicable. This device did not involve an AI training set.

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

• Not Applicable. No training set was used for this type of device submission.

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The Cavitron Steri-Mate Handpiece Sterile Lavage Kit is indicated for use with the DENTSPLY Cavitron Ultrasonic Scaler in general prophylaxis and periodontal treatments, and other areas of operative dentistry for the supragingival and subgingival removal of calculus, plaque and stain from teeth with sterile fluid delivery.

The Cavitron® Steri-Mate® Handpiece Sterile Lavage Kit is an accessory for Cavitron® Ultrasonic Scalers that use the 30K Steri-Mate® Sterilizable Handpiece. This kit is intended to provide the clinician with a method to use sterile lavage with a Cavitron® Ultrasonic Scaler. The kit consists of a pressurized infuser bag and a Steri-Mate Handpiece Adapter. The Pressurized Infuser bag can be hung from a standard IV pole or similar device. The Steri-Mate Handpiece Adapter is easily installed between the handpiece cable and the Steri-Mate Handpiece. The adapter does not affect the operation of the Cavitron® Unit or the Steri-Mate Handpiece.

The provided document is a 510(k) summary for the Cavitron Steri-Mate Handpiece Sterile Lavage Kit, which is an accessory for ultrasonic scalers used in dentistry. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with detailed acceptance criteria and quantitative results for a specific performance characteristic (like diagnostic accuracy).

Therefore, many of the requested elements for describing a study proving acceptance criteria cannot be extracted directly from this document. However, I can provide the available information based on the text.

Here's a breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document refers to "comparative operations" and "testing to the procedures described in the United States Pharmacopeia (31), National Formulary (26), 2008, Chapter Sterility Test." These typically involve controlled laboratory tests rather than human subject test sets with "samples."
• Data Provenance: The sterility testing refers to the United States Pharmacopeia, implying performance was validated according to US standards. The nature of the "comparative operations" data provenance (e.g., in-house testing, external lab) is not specified. It is likely retrospective in the sense that the device was developed and then tested.

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

Not applicable. The tests performed are engineering/performance validations (e.g., functionality, sterility), not diagnostic accuracy studies requiring expert-established ground truth on a test set (e.g., imaging review).

4. Adjudication Method for the Test Set

Not applicable, as this was not a study requiring adjudication of expert opinions (e.g., 2+1, 3+1). The testing involved objective measurements and procedures (e.g., sterility test, functional verification).

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

No. This sort of study is not relevant to this device, which is an accessory for an ultrasonic scaler and not a diagnostic or AI-based image interpretation tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is an accessory to a human-operated medical device. There is no algorithm, and therefore no a standalone algorithm performance measurement.

7. The Type of Ground Truth Used

• For the sterile fluid delivery capability, the ground truth was established by following the procedures and standards outlined in the United States Pharmacopeia (31), National Formulary (26), 2008, Chapter Sterility Test. This is a laboratory-based, objective standard for sterility.
• For functional and performance equivalence, the ground truth was established by direct comparison to the performance of the predicate device. This would involve quantifiable measures of operation (e.g., ultrasonic vibration, fluid flow) relative to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. No training set was used.

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Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

The Orthodontic Ceramic Bracket is in commercial distribution and consists of a chemically treated base. The modification to the Orthodontic Ceramic Bracket consists of a mechanical lock base and the brackets: are referred to as the Mystique MB Ceramic Brackets. Mystique MB Ceramic Brackets are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The mechanical lock base includes rhomboid and "torque-in-the-base" features. The bracket is transparent and has indented walls and is available with or without glass coating in the wire slot.

The provided text does not contain information about acceptance criteria or a study proving device performance in the way typically associated with medical device clinical or performance studies (i.e., sensitivity, specificity, accuracy, etc., for a diagnostic device).

This document is a 510(k) summary for a DENTSPLY Mystique MB Ceramic Brackets, seeking substantial equivalence to a predicate device (K042178). The key points from the document are:

• Device Description: The Mystique MB Ceramic Brackets are a modification to an existing orthodontic ceramic bracket, primarily involving a mechanical lock base and specific design features (rhomboid, "torque-in-the-base"). The bracket itself is transparent and has indented walls, available with or without glass coating in the wire slot.
• Intended Use: Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth. This is explicitly stated to be the same as the predicate device (K042178).
• Technological Characteristics: The manufacturer claims minor design modification and no changes in intended use or fundamental scientific technology compared to the predicate device. All components have been used in legally marketed devices and/or found safe for dental use. The composition is stated as the same as the predicate device.
• Justification for Safety and Effectiveness: The manufacturer states that "prior use of the components of Mystique MB Ceramic Brackets in the legally marketed devices, the performance data provided, and previously submitted biocompatibility data support the safety and effectiveness."

Based on this, the 510(k) emphasizes substantial equivalence to a predicate device rather than presenting a performance study with explicit acceptance criteria for a new device's efficacy or diagnostic accuracy. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

Here's a breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
* Not available. The document refers to "performance data provided" but does not detail any specific test sets, their sizes, or provenance. This is typical for a 510(k) summary relying on substantial equivalence and previous data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not available. No specific "ground truth" establishment for a test set is described, as this is not a diagnostic device and the clearance is based on substantial equivalence to an existing device.

4. Adjudication method for the test set:
* Not applicable/Not available. No test set or adjudication method is 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. This device is an orthodontic bracket, not an AI-assisted diagnostic or imaging tool.

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

7. The type of ground truth used:
* Not applicable/Not available. No "ground truth" in the context of diagnostic accuracy is discussed. The "truth" for this device lies in its physical properties, biocompatibility, and ability to facilitate orthodontic movement, which is inferred to be equivalent to the predicate device.

8. The sample size for the training set:
* Not applicable/Not available. No "training set" in the machine learning sense is used or mentioned. The manufacturer relies on prior use of components and existing data.

9. How the ground truth for the training set was established:
* Not applicable/Not available. See point 8.

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The Pre-Cemented Orthodontic Bracket System Extension is indicated for use in bonding orthodontic appliances for orthodontic treatment.

The Pre-Cemented Orthodontic Bracket System Extension is comprised of pre-cemented ceramic and metal orthodontic brackets, transfer tray, and the adhesives described in K061252. Components of this system are used exactly as described in K061252 (Pre-cemented Orthodontic Bracket System) with the same fundamental technology and for the same intended use. This modification adds a second ceramic orthodontic bracket to the Pre-cemented Orthodontic Bracket System (K060837).

This 510(k) submission (K081291) describes a modification to an existing device, adding a second ceramic orthodontic bracket to an already cleared Pre-Cemented Orthodontic Bracket System (K061252), which itself includes components from K060837. This submission does not contain information about a study based on acceptance criteria in the traditional sense of a clinical performance study with defined endpoints like sensitivity, specificity, or inter-reader agreement.

The device, a Pre-Cemented Orthodontic Bracket System Extension, is a dental device intended for use in bonding orthodontic appliances. The core of this submission focuses on demonstrating that the new component maintains the same safety and effectiveness characteristics as the predicate devices.

Here's an breakdown of the information available in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. There is no explicit "test set" in the context of a clinical performance study to evaluate diagnostic performance or similar metrics. The evaluation relies on established safety and performance data from predicate devices and component materials rather than a new clinical trial.
• Data Provenance: Not applicable. The submission refers to "previous biocompatibility data" and "performance date (data)" from the predicate devices (K060837 and K061252) and the prior use of components in legally marketed devices. This would be considered retrospective in the sense of leveraging existing data, but it's not a prospective study.

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

• Not applicable. There is no "test set" in the context of a clinical performance study requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is not an AI-based diagnostic tool, but rather a physical orthodontic bracket system. Therefore, the concept of human readers improving with or without AI assistance is not relevant.

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

• No, a standalone algorithm performance study was not done. This is not an AI algorithm.

7. The Type of Ground Truth Used

• The ground truth, in an indirect sense, is established by regulatory clearance and historical safety/effectiveness of the predicate devices and the individual components used. The biocompatibility data also serves as a ground truth for a specific safety aspect. It's not based on expert consensus for diagnostic accuracy, pathology, or outcomes data from a new study.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI-based device that requires a training set.

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

• Not applicable. No training set for an AI algorithm is involved.

Summary of the Study (or Lack Thereof) to Prove Acceptance Criteria:

The "study" in this context is a benchmarking and equivalency assessment against predicate devices and known material safety. The manufacturer did not conduct a new clinical study to establish acceptance criteria for performance; instead, they demonstrated that:

• The device components are already used in legally marketed devices.
• The device's materials have established biocompatibility, and since the formulation hasn't changed, no new biocompatibility testing was deemed necessary.
• The device maintains the same fundamental technology and intended use as its predicate.

The FDA's review concluded that the device is "substantially equivalent" to the predicate devices, thereby meeting the necessary regulatory acceptance for marketing. This type of submission relies heavily on a comparison to existing, cleared devices rather than new performance data generation for defined acceptance criteria.

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The Modified TempRx Esthetic Provisional System is:

• · Indicated for the fabrication of all provisional dental restorations for a term of use of up to 6 months.
• · Indicated for fabrication of the following long-term provisional dental restorations (without metal substructures) for a term of use greater than 6 months up to 3 years:
  • Inlays/ Onlays
  • Veneers
  • Crowns
  • 3-unit bridges through the 2nd bicuspid.

· Indicated for the build up of a tooth on denture base resins.

The Modified TempRx Esthetic Provisional System is a visible light cured composite based resin and accessories used to create provisional restorations for patients waiting for final prosthodonic restorations.

The provided text is a 510(k) summary for a dental device, "Modified TempRx Esthetic Provisional System." It focuses on device description, intended use, and technological characteristics compared to predicate devices for regulatory clearance. It does not contain information about acceptance criteria, a study proving device performance against such criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory submission for substantial equivalence rather than a detailed performance study report.

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The COMPOSITE ALIGNER BUTTON is an accessory that is attached to dental or orthodontic aligners to assist in minor tooth movement.

The COMPOSITE ALIGNER BUTTON is made of plastic and is bonded to an aligner for attaching elastics and other appliances.

The provided documentation is a 510(k) summary for the DENTSPLY COMPOSITE ALIGNER BUTTON. This submission primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a study demonstrating performance against specific acceptance criteria in the manner often seen for more complex diagnostic or image analysis AI/ML devices.

Therefore, much of the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert roles, MRMC studies) is not applicable or not present in this type of regulatory submission for this specific device.

Here's an breakdown based on the information available and what is not applicable:

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

• Not Applicable / Not Provided. This 510(k) relies on demonstrating that the Composite Aligner Button has similar technological characteristics (made of plastic, components used in legally marketed devices, biocompatibility) and the same intended use as legally marketed predicate devices. The "performance" in this context is the general safety and effectiveness implied by its composition and intended use, which is established through comparison to predicates rather than a specific performance metric against a defined acceptance criterion.

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

• Not Applicable / Not Provided. No "test set" in the context of performance metrics (like sensitivity, specificity, accuracy) is mentioned or required for this type of device submission. The submission is based on the characteristics of the device itself and its components, not on its performance in a clinical study with a test set of data.

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 / Not Provided. No ground truth establishment for a test set is discussed, as there was no performance study of this nature.

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

• Not Applicable / Not Provided. No test set or adjudication method is 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:

• Not Applicable / Not Provided. This device is an accessory for orthodontic aligners, not an AI/ML diagnostic or image analysis tool. Therefore, an MRMC study related to AI assistance is irrelevant and was not conducted.

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

• Not Applicable / Not Provided. This device is a physical accessory and does not involve an algorithm.

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

• Not Applicable / Not Provided. No ground truth is referenced as no performance study requiring a ground truth was conducted.

8. The sample size for the training set:

• Not Applicable / Not Provided. No training set for an AI/ML algorithm is involved with this physical accessory.

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

• Not Applicable / Not Provided. As no training set is discussed, there's no ground truth establishment for it.

Summary of available relevant information from the 510(k) submission:

• Device Name: COMPOSITE ALIGNER BUTTON
• Intended Use: An accessory that is attached to dental or orthodontic aligners to assist in minor tooth movement.
• Technological Characteristics claimed to ensure safety and effectiveness:
  • Made of plastic.
  • Components have been "used in legally marketed devices and/or were found safe for dental use."
  • Appropriate biocompatibility testing has been completed.
• Predicate Devices:
  • Align System K981095
  • Thermoform Sheet Materials and Accessories K072522
• Basis for Acceptance: The device was found substantially equivalent to the predicate devices based on its intended use and technological characteristics, particularly the prior safe use of its components and biocompatibility data. This type of submission does not involve a clinical study with performance metrics against acceptance criteria, but rather a regulatory review of equivalence.

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MTA ROOT CANAL SEALER is indicated for use for the permanent sealing of root canals of teeth and may be used in combination with root canal obturation materials.

The MTA ROOT CANAL SEALER is a powder and liquid root canal sealer system. The combination of the powder and liquid creates a colloidal gel that solidifies to form a strong impermeable barrier to seal off pathways of communication between the root canal system and external surfaces of the tooth.

The provided text describes a medical device, MTA Root Canal Sealer, and its FDA clearance. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device, not necessarily a study proving performance against defined acceptance criteria for a new clinical endpoint.

Therefore, many of the requested sections cannot be filled based on the provided text.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

• Cannot be created. The document describes the device's intended use and technological characteristics, and states it passed biocompatibility testing, but it does not provide quantitative acceptance criteria for clinical performance (e.g., success rates, sealing effectiveness metrics) or results from a clinical study demonstrating such performance. The clearance is based on substantial equivalence, not a direct performance study against criteria.

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

• Not applicable. No clinical "test set" in the context of performance metrics is described. The clearance relies on biocompatibility testing and demonstration of substantial equivalence.

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

• Not applicable. No clinical "test set" and ground truth establishment by experts is described.

4. Adjudication method for the test set

• Not applicable. No clinical "test set" and adjudication method is 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. This device is a root canal sealer, not an AI-powered diagnostic tool. MRMC studies are irrelevant here.

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

• Not applicable. This device is a medical material, not an algorithm.

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

• Not applicable. No ground truth in the context of clinical performance evaluation against specific criteria is mentioned for the 510(k) submission itself. The "ground truth" for a 510(k) is typically the predicate device's established safety and effectiveness.

8. The sample size for the training set

• Not applicable. No training set for an algorithm described.

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

• Not applicable. No training set for an algorithm described.

Summary of available information:

• Device Name: MTA ROOT CANAL SEALER
• Intended Use: Permanent sealing of root canals of teeth, possibly with obturation materials.
• Technological Characteristics: All components have been used in legally marketed devices or were deemed safe for dental use.
• Biocompatibility Testing: The device has been evaluated and passed biocompatibility testing for cytotoxicity, mutagenicity, sensitization, and endodontic usage. This is a safety assessment, not a clinical performance assessment against specific criteria.
• Substantial Equivalence: The device is considered substantially equivalent to the MTA Advanced Material (K073218), cleared January 7, 2008. This is the primary basis for its clearance, indicating it does not raise new safety or effectiveness concerns compared to a predicate.

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Self-adhesive Resin Cement is intended for the cementation of indirect restoratives including ceramic, composite and metal-based inlays, onlays, crowns, bridges, and posts.

Self-adhesive Resin Cement consists of a base paste and a catalyst paste, mixed to form a dual-curing cement. The Cement is available in five shades and is delivered in double-barrel syringes and unit dose systems.

The provided 510(k) summary for K073173 describes a Self-adhesive Resin Cement and focuses on its substantial equivalence to predicate devices (Unicem, K020256 and MaxCem, K041474). This type of device (dental cement) does not typically involve the kinds of acceptance criteria and performance studies (e.g., diagnostic accuracy, multi-reader multi-case studies) that are common for AI/ML-enabled devices or diagnostic tools.

Instead, the acceptance criteria for a dental cement would revolve around physical and chemical properties, biocompatibility, and adhesive performance as defined by relevant industry standards and comparison to predicate devices. The study to prove it meets acceptance criteria would be a series of laboratory tests demonstrating these properties.

Based on the provided text, here's an attempt to answer the questions, keeping in mind the nature of the device:

Acceptance Criteria and Device Performance for Self-adhesive Resin Cement (K073173)

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for K073173 does not provide specific numerical acceptance criteria or detailed performance data in a tabular format. The review focuses on substantial equivalence based on the use of previously approved components and general performance and biocompatibility claims.

However, based on the text, the implicit acceptance criteria and reported performance are as follows:

Note: Specific quantitative values for properties like bond strength, film thickness, radiopacity, or water sorption, which would typically be part of a dental cement’s performance evaluation, are not present in this summary document. The substantiation is primarily qualitative and comparative to existing devices.

2. Sample Size for the Test Set and Data Provenance

The document does not specify sample sizes for any tests conducted. The "performance data provided" is mentioned but not detailed. Given the nature of a dental cement, a "test set" in the context of an AI/ML device (e.g., patient data) is not applicable here. Instead, it refers to samples of the cement material itself that underwent laboratory testing.

The data provenance is not explicitly stated (e.g., country of origin of data). Such testing is typically conducted in a laboratory setting by the manufacturer or a contracted lab. There is no indication of retrospective or prospective patient data studies.

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

This question is not applicable to this device. Dental cements are evaluated based on physical, chemical, and biological properties, not by expert interpretation of images or clinical outcomes that require a "ground truth" derived from human experts in the way that AI/ML diagnostics do.

4. Adjudication Method for the Test Set

This question is not applicable to this device. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts in diagnostic studies, which is not relevant for a dental cement.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are used to evaluate the diagnostic performance of human readers, with and without AI assistance, typically in medical imaging. This is not pertinent to a dental cement.

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

This question is not applicable to this device. There is no algorithm or AI component in this self-adhesive resin cement. It is a physical material.

7. The Type of Ground Truth Used

The term "ground truth" as it applies to diagnostic or prognostic studies is not applicable here. The "truth" for a dental cement is established through standardized laboratory tests that measure its physical, chemical, and biological properties against established benchmarks or predicate device performance. For example:

• Physical Property Tests: ASTM or ISO standards for bond strength, film thickness, setting time, etc.
• Biocompatibility: In vitro and in vivo toxicology tests (e.g., ISO 10993 series).

8. The Sample Size for the Training Set

This question is not applicable to this device. There is no AI model requiring a training set. The "development" of the cement involves formulation and testing, not machine learning.

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

This question is not applicable to this device, as there is no training set or AI model.

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