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The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used.

The 430 SWL 45 and 430 SW 45 air-powered high speed handpieces are used by trained dental professionals for the removal of impacted third molars as well as endodontic and periodontal procedures for which a conventional handpiece would be used.

The 430 SWL 45 and 430 SW 45 High-Speed Handpieces are designed with a 45 degree back angled head to facilitate access to the back of the oral cavity. They are designed so that air that expelled from the head of the handpiece is directed out the side of the handpiece head and not directed onto the work area of the bur. The handpieces are intended for use with a friction grip bur that conforms to ISO 1797-1 standards. Recommended air pressure is 30-34 PSI which results in a bur rotation of approximately 400,000 RPM.

The 430 SWL 45 High-Speed Handpiece is a fiber optic, swivel connector type handpiece with a lubefree, ceramic bearing, push button autochuck turbine. The 430 SW 45 High-Speed Handpiece is a non-fiber optic version of the 430 SWL 45 Handpiece.

The DentalEZ Inc., StarDental Division 430 SWL 45 and 430 SW 45 High-Speed Handpieces are dental devices, not an AI or imaging device. Therefore, much of the requested information, such as sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable.

Here's the available information based on the provided text, focusing on the acceptance criteria and the studies performed to demonstrate equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not list specific numerical acceptance criteria for performance metrics in a table format. Instead, it states that the devices were developed considering applicable technical standards and internal specifications, and their conformance was verified through bench testing. The comparison to predicate devices focuses on similarity in characteristics rather than meeting defined performance thresholds.

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

Not applicable in the context of this device and study type. Clinical data or test sets as typically understood for AI algorithms are not mentioned. The "tests" referenced are bench tests of the device itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The "ground truth" for this device's performance is established by industrial standards, internal specifications, and physical measurements during bench testing, not expert consensus on medical images or patient outcomes.

4. Adjudication Method

Not applicable. This is not a study requiring adjudication of expert opinions.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This type of study is relevant for AI-assisted diagnostic tools. The provided document describes a dental handpiece, not an AI device.

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

No. This describes a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is established by:

• International Standards: e.g., ISO 7785-1, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011, AAMI/ANSI/ISO 14937:2009, ISO14971:2009.
• StarDental Internal Specifications: Used in the development and testing documentation (TR 468, TR 470).
• Physical Measurements and Bench Testing Results: Directly observed performance characteristics during testing.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI or machine learning device.

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

Not applicable, as there is no training set mentioned.

Studies that Prove the Device Meets Acceptance Criteria:

The acceptance criteria are implicitly met through the following non-clinical studies and comparisons:

• Bench Testing (TR 468): This internal test was developed to determine the performance characteristics of the handpieces, considering StarDental internal specifications and ISO 7785-1, 1997-08-01. This demonstrates the device's mechanical and operational performance against established standards.
• Bench Testing (TR 470): This internal test focused on the effectiveness of housing pressure relief slots and the vortex washer, and quantified the air bleed of the handpiece head. It also compared these characteristics with predicate devices. This shows functional design and safety aspects.
• Sterilization Validation Studies: Performed by HIGHPOWER Validation Testing & Lab Services, these studies confirmed the effectiveness of sterilization and dry times. They followed ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 and AAMI/ANSI/ISO 14937:2009, ensuring the device meets critical infection control requirements.
• Risk Analysis (ISO14971:2009): A risk analysis was conducted according to this standard, indicating that potential risks were identified and mitigated, contributing to the device's safety.
• Substantial Equivalence Argument: The core of the 510(k) submission is the argument that the proposed devices are "substantially equivalent" to predicate devices based on similarities in intended use, principles of operation, and functional design. This implies that the performance and safety are comparable to already approved devices. The FDA concurred with this assessment in their letter.

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The NuTorque Programmable Electric System is used by trained dental professionals to perform general dental procedures including crown preparation, cavity preparation, crown finishing, inlay and the filling, polishing, prophylaxis and endodontic treatment.

The NuTorque Programmable Electric System is an electric handpiece system for use in performing various dental procedures including grinding and trimming. post and pin drilling, pin setting, finishing, polishing, endodontic, caries removal and prophylaxis.

The NuTorque Programmable Electric System is composed of a power supply. control unit, cable and brushless micromotor. The control unit controls the torque, speed and directional rotation of the motor. The system is programmed through the use of a color touch screen on the control unit. The motor has a rotational speed of 100- 40,000 rpm's and can be operated in a clockwise or counterclockwise direction. The system also provides variable light intensity to the handpiece.

The provided text is a 510(k) summary for the NuTorque Programmable Electric System, a dental handpiece system. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information regarding detailed acceptance criteria for the device's performance, nor does it describe specific studies with sample sizes, expert involvement, or ground truth establishment relevant to the request.

The text mentions:

• "Performance testing was conducted to validate the safety and effectiveness of the NuTorque Programmable Electric System."
• "This testing included the electrical safety, electromagnetic compatibility and validation and verification of the software."
• "Testing was completed in accordance with recognized consensus standards."

Based on the provided text, I cannot complete the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or MRMC studies, as this information is not present in the given document.

The document focuses on demonstrating substantial equivalence to a predicate device (Ti-Max NL400), which is a regulatory pathway that often relies on comparing technical characteristics and intended use rather than requiring extensive clinical performance studies with specific acceptance criteria and validation metrics as might be found for novel diagnostic AI devices.

Therefore, the table below will reflect the absence of the requested information from the provided document.

Acceptance Criteria and Device Performance

Study Details (Based on provided text)

1. Sample size used for the test set and the data provenance: Not specified in the provided document.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided document.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified in the provided document.
4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable/Not specified in the provided document. This device is a dental handpiece system, not an AI diagnostic tool that would typically involve human reader performance studies.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not specified in the provided document. This device is a physical dental instrument system, not a standalone algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified in the provided document for performance testing. The document states "Performance testing was conducted to validate the safety and effectiveness" but does not detail the methodology for establishing ground truth for mechanical/electrical performance.
7. The sample size for the training set: Not applicable/Not specified in the provided document. This is not an AI/machine learning device that would have a training set in the typical sense.
8. How the ground truth for the training set was established: Not applicable/Not specified in the provided document.

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High speed handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The intended use of this device is identical to the predicate 430 series handpiece currently marketed under 510(k) numbers K960719 and K982593.

The Solara Series High Speed Dental Handpieces are pneumatically driven, handheld devices intended for use by trained dental professionals for drilling in the oral cavity. Procedures include but not limited caries removal, restorative work and crown preparations.

This 510(k) premarket notification for the Solara Series High Speed Dental Handpieces does not contain a study section that describes acceptance criteria or a study proving the device meets said criteria in the way a modern AI/software as a medical device (SaMD) submission would.

The document is for a traditional medical device (dental handpieces) and focuses on demonstrating substantial equivalence to predicate devices rather than providing performance metrics against predefined acceptance criteria from a clinical study. The "study" mentioned here refers to the comparative analysis performed to show that the proposed device is as safe and effective as existing legally marketed devices.

However, based on the provided text, I can infer the context of "acceptance criteria" through the lens of safety and effectiveness equivalence, and describe the "study" as a comparative analysis.

Here's an attempt to structure the information based on your request, with significant caveats that many sections will be marked "Not Applicable" or "Not specified" due to the nature of this particular 510(k) submission:

Acceptance Criteria and Device Performance

This submission for the Solara Series High Speed Dental Handpieces is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices. The "acceptance criteria" are therefore inferred to be that the proposed device is as safe and effective as the predicate devices, with similar technology and design, and the same intended use and means of operation. Device performance is therefore assessed relative to the function and safety profile of the predicate.

Table of Acceptance Criteria and Reported Device Performance

Details of the "Study" (Substantial Equivalence Analysis)

The "study" in this context is the substantial equivalence comparison performed by the manufacturer, Star Dental Products, against their own previously cleared devices and another manufacturer's device. This is not a prospective clinical trial or a performance study with a test set as would be common for AI/SaMD.

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

   • Sample Size: Not applicable. There is no "test set" in the sense of a dataset of cases used to evaluate an algorithm's performance. The comparison is conceptual and based on the design, materials, and intended use of the devices.
   • Data Provenance: Not applicable. The comparative analysis is based on the known specifications and performance characteristics of the proposed Solara Series handpieces and the predicate devices (StarDental 430 Series High Speed Handpiece (K960719 and K982593) and NSK TI-Max Titanium Handpiece). This is a retrospective analysis of device specifications and clinical indications, rather than a prospective study.

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

   • Not applicable. There is no "ground truth" establishment in the context of expert consensus on a test set of data. The "ground truth" for the predicate devices' safety and effectiveness was established through their original 510(k) clearances and their market history. The manufacturer's engineering team (Contact Person: William Guscott, Engineering Manager) performed the comparison.

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

   • Not applicable. No test set requiring adjudication was used. The substantial equivalence determination is made by the FDA based on the provided submission.

4. 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/SaMD device, and therefore no MRMC study was conducted.

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

   • Not applicable. This is a mechanical dental handpiece, not an algorithm.

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

   • The "ground truth" in this context is the established safety and effectiveness profile of the predicate devices. This
     "ground truth" was initially validated through the FDA's 510(k) clearance process for the predicate devices, which would have involved assessing their design, performance data (e.g., durability, RPM, torque, vibration), and intended use. Outcomes data, while not explicitly detailed in this document for the predicates, would have contributed to their market acceptance and the FDA's initial clearance.

7. The sample size for the training set:

   • Not applicable. This is a traditional medical device, not an algorithm that requires a training set.

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

   • Not applicable. No training set was used.

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The Portable HDX Intraoral X-ray unit is intended for use only by a qualified/trained dentist or dental technician on both adult and pediatric subjects for taking diagnostic extraoral dental x-rays using intraoral image receptors.

Portable HDX Intraoral X-ray is a portable dental x-ray system that operates on 120 VAC (+/-10%), 60 Hz, and 240 VAC (+/-10%), 50 Hz line AC power. The system uses Constant Emission Power (CEP) which allows for minimum exposure time and can be either mounted to a tripod or can be hand held.

The "Portable HDX Intraoral X-ray" device is a portable dental x-ray system. The study for this device primarily focuses on demonstrating substantial equivalence to a predicate device (MinXray HF70D) rather than meeting specific performance criteria through a standalone study. The acceptance criteria and testing are based on regulatory and government performance standards for X-ray systems.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with the listed performance standards and demonstration of comparable performance to the predicate device across various technical specifications. The reported device performance is presented as its specifications, which are compared to those of the predicate device. The conclusion is that the new system is "as safe and effective" as the predicate based on bench and user testing against these standards.

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

The document states that "bench and user testing" was performed. However, the specific sample sizes for the test set (e.g., number of tests, number of users, number of images) are not provided. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified, beyond mentioning "bench and user testing" against US government specifications.

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

This information is not provided in the document. The study design described does not involve a ground truth established by experts in the typical sense of diagnostic accuracy studies (e.g., radiologists interpreting images). Instead, it relies on compliance with engineering and safety standards for the device itself.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. The testing described is against performance standards and specifications, not an assessment of diagnostic performance requiring adjudication of interpretations.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an X-ray imaging system, not an AI-powered diagnostic tool, so evaluation of human reader improvement with AI assistance is not relevant to this filing.

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

A standalone performance evaluation of an "algorithm only" (without human-in-the-loop performance) was not done. This device is a hardware system; there is no mention of an algorithm being evaluated in this context. The standalone performance evaluation referred to here would be the device's adherence to relevant technical standards (e.g., radiation output, exposure accuracy), which was indeed assessed through "bench and user testing."

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

The concept of "ground truth" in the diagnostic accuracy sense (like pathology or expert consensus for image interpretation) is not directly applicable to this submission. The "ground truth" or reference standard used here is the adherence to established technical performance and safety standards for X-ray devices, specifically 21 CFR § 1020.30 (Performance Standards for Diagnostic X-Ray Systems and Their Major Components) and United States Government Specifications SP0200-96-R-8076. These standards define acceptable parameters for the physical operation and safety of the X-ray system.

8. The Sample Size for the Training Set

A "training set" is not applicable to this type of device. The Portable HDX Intraoral X-ray is a physical medical device, not an AI/machine learning model that requires a training set.

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

This question is not applicable as there is no training set for this device.

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The Air Controlled Sterile Irrigation System is used intra-orally by trained dental professionals for delivery of sterile water for oral surgical procedures as a replacement irrigating solution to the dental operative unit's water supply, specifically for cooling a dental rotary instrument.

The StarDental® Air Controlled Sterile Irrigation System is used intra-orally by trained dental professionals for delivery of sterile water for oral surgical procedures as a replacement irrigating solution to the dental operative unit's water supply, specifically for cooling a dental rotary instrument. The Air Controlled Sterile Irrigation System consists of a connector assembly and pinch valve assembly which can be autoclaved.

This looks like a 510(k) summary for a medical device called the "StarDental® aXcs Sterile Water System," also referred to as the "StarDental® Air Controlled Sterile Irrigation System." This document is a regulatory submission to the FDA, not a study report. It focuses on demonstrating substantial equivalence to existing devices, not on providing performance data or clinical study results in the way you've described for AI/algorithm performance.

Therefore, most of the information you've requested regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this type of regulatory submission. These elements are typically found in clinical trial reports or validation studies for new technologies, especially those involving AI or complex performance claims.

Here's a breakdown of why the information isn't available and what is available:

This document:

• Is a 510(k) Summary: This is a premarket notification to the FDA to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This process often relies on comparisons of design, materials, intended use, and operational principles, rather than extensive clinical performance studies.
• Focuses on "Substantial Equivalence": The core argument is that the new device is as safe and effective as predicate devices that are already on the market.
• Describes Device Purpose: It clearly states the device's intended use: "delivery of sterile water for oral surgical procedures, specifically for cooling a dental rotary instrument."

Why your requested information is largely absent:

• No Acceptance Criteria Table or Reported Device Performance: This document doesn't typically include specific performance metrics or thresholds the device must meet, nor does it report on a study directly measuring those metrics. Substantial equivalence is often argued based on design similarity and known performance of predicate devices.
• No Sample Sizes, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance: These are all hallmarks of a clinical study or a performance validation for an AI/algorithm-driven device. This irrigation system is a mechanical device, not an AI system. Therefore, these types of studies were not conducted or reported here.
• No Information on Training Set Size or Ground Truth Establishment (for training): Again, this is not an AI/algorithm device, so there is no "training set."

What can be inferred or extracted from the document related to "performance" in a broad sense:

While not formal acceptance criteria as you'd find for AI, the document implies that the device must:

• Deliver sterile water: This is fundamental to its intended use in oral surgical procedures. The design aims to maintain sterility.
• Be air-controlled: This describes its mechanism of operation.
• Be safe and effective for cooling dental rotary instruments: This is the ultimate goal of the sterile water delivery.
• Meet general controls provisions: These are FDA requirements for medical devices (registration, listing, GMP, labeling, etc.) which implicitly ensure a baseline of safety and effectiveness.

In summary, based solely on the provided text, I cannot provide most of the requested information because it describes a regulatory filing for a mechanical device demonstrating substantial equivalence, not a performance study for an AI or complex diagnostic system.

If this were an AI device, the 510(k) summary would typically refer to a separate validation report where these details would be found.

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Low speed dental attachments are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. Furthermore, the intended use extends to disking, cavity and crown preps, polishing, post and pin drilling and pin setting. The intended use is identical to that of the predicate low speed motor attachments.

Dental attachments and accessories to be used by the dental clinician during routine dental procedures. The attachments affix to a low speed dental motor.

This exemption is for a low-speed dental motor attachment, a mechanical device. The provided text doesn't describe a study with acceptance criteria and performance metrics in the way one would for an AI/ML medical device. The 510(k) submission primarily focuses on demonstrating "substantial equivalence" to existing predicate devices, particularly highlighting a design change from lubricated to non-lubricated bearings and bushings.

Therefore, many of the requested fields are not applicable to this type of device and submission.

Here's an attempt to address the prompt based on the available information, noting where information is not present:

Description of Acceptance Criteria and Study for K983574

The device under review, StarDental® LUBE FREE LOW SPEED MOTOR ATTACHMENTS, is a mechanical dental device. The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with quantitative acceptance criteria against a defined ground truth for medical diagnostic accuracy. The core "acceptance criteria" appear to be related to functional equivalence and safety, particularly concerning the change to "non-lubricated bearings and bushings."

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the furnished 510(k) summary. Given the nature of the device (mechanical dental attachment), the "test set" would likely refer to engineering evaluations or bench testing, not a clinical data set in the way AI/ML devices are validated.

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

This information is not provided and is generally not applicable to the substantial equivalence pathway for a mechanical device like this. Ground truth for diagnostic performance, as applies to AI/ML devices, is not a concept used in this submission.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to this type of medical device submission.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially AI/ML) where human reader performance is a key metric, which is not the case for a low-speed dental motor attachment.

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

No, this is not applicable. The device is a mechanical instrument; there is no "algorithm" or standalone "AI" component to evaluate.

7. The Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) as understood for diagnostic AI/ML devices is not applicable here. The "truth" for this device revolves around its functional performance, material compatibility, and intended use matching those of legally marketed predicate devices, which would have been assessed through engineering specifications and potentially bench testing rather than clinical ground truth labels.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" for a mechanical device like this in the context of an AI/ML model.

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

This information is not applicable as there is no "training set" or associated ground truth for a mechanical device.

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High-speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental caries for restoration, such as fillings. The intended use is identical to that of the predicate 430 Series Lube Free High Speed Handpiece. Autochuck turbines are used in place of a bur tool to facilitate bur changing. The intended use of the Star Autochuck Turbine with Vortex Air Seal is to both provide the convenient:e of tool-free bur changing and to eliminate the necessity of lubrication of the turbin a after use and before sterilization.

Lube Free Autochuck Turbine with Vortex Air Seal for use with StarDental 430 Series Lube Free High Speed Dental Handpiece. Autochuck turbines are used in place of a bur tool to facilitate bur changing.

This device, the "Lube Free Autochuck Turbine with Vortex Air Seal for use with StarDental 430 Series Lube Free High Speed Dental Handpiece," is a dental accessory. The provided 510(k) summary and FDA clearance letter do not contain any information about acceptance criteria or a study demonstrating the device meets such criteria.

The 510(k) process for this device relies on substantial equivalence to a predicate device, the "StarDental 430 Series Lube Free High Speed Handpiece." This means the manufacturer argued that their new device is as safe and effective as a device already legally marketed, without needing to perform extensive clinical studies to establish new performance metrics.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

Here's a breakdown of why and what information would typically be needed for such a report:

Why the information isn't available in the provided text:

• Substantial Equivalence: The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a predicate device. This typically involves comparing technological characteristics, intended use, materials, and safety/effectiveness profiles. It does not necessarily require new clinical trials or the establishment of new, specific acceptance criteria for performance, especially for devices like dental handpieces which are well-understood.
• Device Type: A dental handpiece and its components are mechanical devices. Performance is more often assessed through engineering benchmarks (e.g., rotational speed, torque, durability, vibration, noise) rather than complex diagnostic accuracy metrics as seen with AI/imaging devices.
• Date of Submission (1998): Regulatory expectations for device testing, particularly for software/AI components or complex diagnostic devices, have evolved significantly since 1998. The focus for this type of device at that time was primarily on demonstrating equivalence established through technical comparison and compliance with relevant standards.

What would be expected for a device with acceptance criteria and a study:

If this were a device where such information was required and provided, the report would look like this (with hypothetical data for illustration):

Hypothetical Report (as if the information were present in the 510(k) submission):

This report describes the acceptance criteria and the study that proves the device meets these criteria for [Device Name - hypothetical example: "AI-Powered Caries Detection System"].

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: 500 dental radiographs (250 with confirmed caries, 250 caries-free).
• Data Provenance: Retrospective data collected from 3 dental clinics in the United States and 2 in Germany.

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

• Number of Experts: 3
• Qualifications: All were board-certified radiologists specializing in oral and maxillofacial radiology with an average of 15 years of experience in dental imaging interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: 2+1 (Two experts independently reviewed each image. In cases of disagreement, a third senior expert adjudicated the final ground truth).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? Yes.
• Effect Size: Human readers (dentists and dental hygienists) showed an average improvement of 22% in sensitivity and 15% in diagnostic accuracy when using AI assistance compared to reading without AI assistance. The time taken for diagnosis decreased by an average of 20%.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes. The performance metrics in the table above (Sensitivity, Specificity, Accuracy, False Positive Rate) represent the standalone performance of the AI algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: A combination of expert consensus (as described in section 4) and correlative pathology reports where available for a subset of the carious lesions. Patient outcome data (e.g., confirmed restoration due to active caries) was used to validate equivocal cases.

8. Sample Size for the Training Set

• Training Set Sample Size: 20,000 dental radiographs.

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

• Ground Truth Establishment for Training Set: Ground truth for the training set was established through a combination of:
  • Automated Labeling: Leveraging existing clinical reports and structured data fields from electronic dental records.
  • Expert Review (Subset): A random subset of 10% of the training data was independently reviewed and labeled by 5 dental professionals (dentists and experienced dental hygienists). Discrepancies were resolved by a lead radiologist.
  • Pathology Correlation: For a portion of the confirmed carious lesions, histopathological reports provided definitive ground truth.

Conclusion for the original prompt based on available data:

The provided 510(k) summary for the "Lube Free Autochuck Turbine with Vortex Air Seal for use with StarDental 430 Series Lube Free High Speed Dental Handpiece" does not include details on specific acceptance criteria or a study demonstrating the device meets such criteria. The submission focuses on establishing substantial equivalence to a predicate device based on identical intended use, technology, design, manufacturing, and materials, which is a common pathway for mechanical dental devices.

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Air powered low speed dental motor that powers various dental attachments and accessories to facilitate procedure by the dental clinician during routine dental procedures.

Air powered low speed dental motor that powers various dental attachments and accessories to facilitate procedure by the dental clinician during routine dental procedures.

This document is a 510(k) summary for dental low-speed motors and attachments from Star Dental, submitted in 1996. It does not contain the type of acceptance criteria, study details, performance metrics, or ground truth information that your request is asking for.

The document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Similar materials: "Materials used to manufacture the components are similar."
• Identical means of operation: "Means of operation are identical, compressed air powers a variable speed rotary vane motor to provide power for various dental procedures."
• Virtually identical performance specifications: "The performance specifications are virtually identical."
• Minor differentiations: "The differentiation between the predicate device and the submitted one is more precise speed control, spring pre-loaded bearings."

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from the provided text because it describes a clearance process for a mechanical dental device based on substantial equivalence, not a diagnostic AI/ML device that would undergo the types of studies you've outlined.

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Both the predicate turbines and the proposed Star Dental replacement turbines are intended to be used as components to high speed handpieces, which are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.

Star Dental Pushbutton Autochuck Replacement Turbine.

The provided text is a 510(k) summary for a dental device (Star Dental Pushbutton Autochuck Replacement Turbine). It describes the device, its intended use, and claims substantial equivalence to predicate devices.

However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth, expert opinions, or any of the other specific details requested in the prompt.

Therefore, I cannot provide the requested information. The 510(k) summary focuses on demonstrating equivalence to existing devices rather than presenting detailed performance studies against specific acceptance criteria.

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High speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The intended use of the device is identical to that of the predicate.

High speed dental handpieces are used intraorally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings. The technology, design, manufacturing, and materials are substantially equivalent to those of other handpieces on the market, including that of the current 430 series handpiece.

This 510(k) summary for the STAR DENTAL HIGH SPEED HANDPIECE 9600719 does not contain the information necessary to address your request.

The provided document is a summary for a dental handpiece, which is a physical device used for drilling. Your request, however, is structured around the evaluation of a computational device or algorithm that would produce performance metrics like sensitivity, specificity, or F1-score, and would involve concepts like acceptance criteria, ground truth, and expert adjudication for a "study that proves the device meets the acceptance criteria."

Here's why the provided information is insufficient for each point of your request:

1. Table of acceptance criteria and reported device performance: This document describes a physical dental tool. Acceptance criteria for such a device would typically relate to mechanical properties, durability, speed, torque, vibration, noise, and sterilization compatibility, rather than diagnostic performance metrics (e sensitivity, specificity, accuracy) that an AI or computational device would have. No such performance metrics are provided.
2. Sample size for the test set and data provenance: Not applicable. There is no "test set" in the context of diagnostic data for this physical device.
3. Number of experts used to establish ground truth and qualifications: Not applicable. Ground truth, in the context of diagnostic algorithms, refers to the definitive correct answer for a given case. This concept doesn't apply to a dental handpiece in the way you've defined it.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study compares human reader performance (with and without aid) on diagnostic tasks. A dental handpiece is a tool, not a diagnostic aid.
6. Standalone (algorithm only) performance: Not applicable. There is no algorithm.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable. There is no training set for a machine learning model for this device.
9. How ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device based on "intended use, technology, design, manufacturing, and materials." This is a regulatory pathway for physical medical devices and does not involve the kind of performance studies or data analysis that would apply to AI or diagnostic software.

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