Search Results

For Model J6-126, J6-136:
The Dental Handpiece is intended for removing carious material, excess filling material, cavity and crown preparation, finishing tooth preparations and restorations, root canal preparations and polishing teeth.
For Model SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L:
The Dental Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials.

The Dental Handpiece is mainly composed of a machine head, handle, transmission shaft, and cartridge, and is designed to be attached to the drive via standard coupling which complies with ISO 3964 and hose connector which complies with ISO 9168. The head clamp accepts an instrument complying with ISO 1797-1. The handpieces are intended to be powered by air-powered or electric-powered, and they are also intended to provide optic series. They are intended to be provided non-sterile, so they must be sterilized prior to first use and sterilized after each subsequent use using steam sterilization (moist heat sterilization).

The provided document is a 510(k) Premarket Notification for a Dental Handpiece. This type of submission is focused on demonstrating substantial equivalence to a previously cleared device, rather than proving efficacy through clinical studies or setting and meeting specific acceptance criteria for performance as would be done for a novel device or a device requiring a PMA.

Therefore, the document does not contain the information requested regarding acceptance criteria and studies that prove the device meets those criteria in the context of diagnostic or actionable performance (e.g., accuracy, sensitivity, specificity for a diagnostic AI). The "acceptance criteria" discussed in this document refer to adherence to established safety and performance standards for dental handpieces, and "study" refers to non-clinical tests verifying compliance with these standards.

Here's why the requested information isn't available in this document:

• Device Type: A "Dental Handpiece" is a physical tool used for mechanical dental procedures (cutting, grinding, polishing). It's not a diagnostic device, an AI algorithm for image analysis, or a device that generates a patient-specific "result" that would require performance metrics like sensitivity or specificity.
• Regulatory Pathway (510(k)): The 510(k) pathway demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, technological characteristics, and intended use, and running non-clinical tests to show adherence to relevant performance and safety standards. It generally does not require large-scale clinical trials or MRMC studies that would describe the kind of acceptance criteria you've outlined.
• No Clinical Testing: The document explicitly states: "Clinical testing was not included in the submission." This immediately tells us that there will be no data on human reader improvement with AI assistance, standalone algorithm performance, or ground truth established from clinical outcomes.
• "Ground Truth" irrelevant: For a dental handpiece, the concept of "ground truth" (e.g., for a diagnosis) is not applicable. Its "performance" is measured by its physical characteristics, safety, and ability to perform its mechanical function according to engineering standards.
• No AI component: There is no mention of an AI component in this device.

Based on the available document, I cannot fulfill your request as it pertains to a diagnostic/AI device. The document describes a traditional medical device (dental handpiece) and its regulatory clearance via a 510(k) pathway, which focuses on substantial equivalence and compliance with engineering and safety standards, not clinical performance metrics relevant to AI or diagnostic accuracy.

However, I can extract information related to the standards and non-clinical tests that were performed to demonstrate the device's adherence to established safety and performance requirements, which are the "acceptance criteria" in this context.

Summary of Acceptance Criteria and Device (Non-Clinical) Performance:

Here's why the other points of your request cannot be answered from this document:

1. Sample size used for the test set and data provenance: Not applicable in the context of diagnostic/AI performance. The "tests" are engineering and safety verification tests on physical units of the device. The provenance of the device under test would be "Guangdong JINME Medical Technology Co., Ltd., China."
2. Number of experts used to establish the ground truth... and qualifications: Not applicable. There is no diagnostic "ground truth" to establish for a dental handpiece.
3. Adjudication method: Not applicable.
4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Explicitly stated "Clinical testing was not included in the submission." Therefore, no MRMC study, no human reader improvement data.
5. Standalone (i.e., algorithm only without human-in-the-loop) performance: Not applicable, as there is no algorithm component.
6. Type of ground truth used: Not applicable.
7. Sample size for the training set: Not applicable, as there is no AI or machine learning component that requires a training set.
8. How the ground truth for the training set was established: Not applicable, as there is no training set.

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The Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.

Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) consists of a Main Body, connectable Contra Angle, Charging Cradle, and AC/DC Adapter. The Main Body of the handpiece is used for transmitting rotational force required in general dental treatment. The torque transmitted from a wireless electric micro-motor gets further transmitted to the joint part of the device. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.

Based on the provided FDA 510(k) summary, the device in question is a Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study of AI performance. Therefore, many of the typical acceptance criteria and study details for AI/ML-driven medical devices (e.g., Sensitivity, Specificity, MRMC studies, ground truth establishment for images) are not applicable here.

This device is not an AI/ML-driven diagnostic or therapeutic device. It is a traditional medical device (a dental handpiece). The "acceptance criteria" and "study" described in the document relate to engineering and performance testing to ensure the device meets established safety and performance standards for dental handpieces, and demonstrates substantial equivalence to predicate devices.

Here's an attempt to answer your questions based on the provided text, while noting where AI/ML-specific criteria are not relevant:

Acceptance Criteria and Device Performance for the Dental Handpiece, Wireless Endodontic Handpiece, endoit (Model EH-C500)

This device is a dental handpiece, and its acceptance criteria are primarily related to its mechanical, electrical, and material safety and performance, rather than diagnostic accuracy as would be the case for an AI/ML algorithm. The "study" described is a series of engineering design verification and validation tests, along with biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a non-AI device, the acceptance criteria are not typically expressed as traditional metrics like sensitivity, specificity, or AUC. Instead, they are related to compliance with recognized standards and successful completion of pre-defined engineering tests. The document states that "The favorable test results of the proposed device which confirmed to meet the FDA recognized standards as well as ISO standard demonstrate that the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) retains the substantially equivalent profile in safety and essential performance of medical electrical equipment as the predicate (K220577) Dental Handpiece model CA160L and predicated (K123582) Endo A Class."

Here's a summary of the types of criteria and the general performance statement:

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

• Sample Size: Not explicitly stated as a number of "cases" or "patients" as would be for an AI study. The testing for this device involves:
  • Biocompatibility: Likely conducted on samples of device materials, not a "test set" of patients. The document references testing done on a previous predicate device (K192809) which results were applied.
  • Design Verification and Validation: This typically involves testing a certain number of manufactured units of the device (e.g., several units tested for rotational speed, noise, durability, etc.). The exact number is not specified in the summary but would be detailed in the full test reports.
  • Electrical/EMC Testing: This would be conducted on device units in specialized labs.
• Data Provenance: Not applicable in the sense of patient data origin. The testing is laboratory and bench testing of the physical device and its materials. This is effectively "prospective" testing of the new device's engineering performance.

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

• Not applicable. For this type of device, "ground truth" is established by engineering specifications, recognized industry standards (e.g., ISO, IEC), and scientific principles, not by expert interpretation of clinical data or images. The "ground truth" is that the device must meet the specified performance parameters (e.g., a certain rotational speed, torque, noise level) and safety requirements (e.g., electrical safety, material biocompatibility). These are verified through objective measurements and accepted testing methodologies.

4. Adjudication Method for the Test Set

• Not applicable. As there are no human interpretations of data (e.g., images) that require consensus, there is no need for an adjudication method. Test results are objective measurements against established engineering and safety thresholds.

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

• No. This is not an AI/ML diagnostic device, so an MRMC study comparing human reader performance with and without AI assistance is not relevant or performed for this type of 510(k) submission.

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

• No. This is a hardware medical device with an electromechanical function, not a software algorithm. Therefore, "standalone algorithm-only performance" is not a relevant concept for this product. The device's "standalone performance" is its ability to meet its engineering and safety specifications on its own, which is what the various design verification tests confirm.

7. The Type of Ground Truth Used

• Engineering Specifications and Recognized Standards: The "ground truth" is defined by the requirements outlined in the relevant ISO and IEC standards (e.g., ISO 14457 for handpieces and motors, IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility) and the manufacturer's own pre-defined design requirements for functional performance (e.g., rotational speed range, noise limits). Successful completion of tests against these standards constitutes meeting the "ground truth."

8. The Sample Size for the Training Set

• Not applicable. This device does not use an AI/ML algorithm that requires a "training set" of data.

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

• Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

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Dental Handpiece with models of CA160, and CA500L are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.

Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

Dental Handpiece with the model CA160, CA160L and CA500L consists of the main body of the handpiece, which is used for transmitting rotational force for the general dental treatments. The torque transmitted from a wired electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.

Model CA160, CA160L and CA500L can be connected to spray adapter (accessory component) which is used for channeling water and air for further applications to the dental treatments. The only difference between model CA160 and CA160L is that the CA160L has lighting function.

The provided text is a 510(k) summary for a dental handpiece. It details the device's equivalence to a predicate device but does not describe an AI medical device or a study involving AI performance metrics like sensitivity, specificity, or reader studies. Instead, it focuses on the engineering and biocompatibility testing of a physical dental instrument.

Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance for an AI model, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the content provided.

The document discusses the following types of tests for the dental handpiece:

Design Verification & Performance Data:

• Appearance Test
• Operation Test
• Rotational Speed Test
• Noise Test
• Spray Test
• Light Test
• Serviceable Year/Shelf-Life Test

Biocompatibility Testing (applicable from the predicate device):

• ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP)
• ISO Guinea Pig Maximization Sensitization Test (GLP 2 Extracts)
• ISO Intracutaneous Irritation Test (GLP 2 Extracts)
• ISO Materials Mediated Rabbit Pyrogen (GLP)
• ISO Acute Systemic Injection Test (GLP 2 Extracts)

The document concludes that the proposed device is substantially equivalent to the predicate device based on these tests and that no new questions of safety or effectiveness are raised.

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Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.

In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures.

Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

Dental Handpiece with models of SG200, SG200L, SA100L, SA100R, CA100L, and CA100R are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.

In addition, Dental Handpiece with models of SG200, SG200L are also intended for implant surgery such as perforating the bone, tapping and threading procedures.

Dental Handpiece is designed for use by a trained professional in the field of general dentistry.

The proposed dental handpiece consists of the main body of a handpiece, which is used for transmitting a rotational force for the general dental treatments as well as accessory components. which are used for channeling water and air for further applications to the dental treatments. The torque transmitted from an electric micro-motor gets further transmitted to the joint part of Dental Handpiece. The rotational force is then decelerated according to the speed reducer of the gear to be transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.

The product is offered as an electrical-powered Dental Handpiece that is reusable and ergonomically shaped. The dental handpiece can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the Dental Handpiece equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the proposed Dental Handpiece per ISO 1797:2017 (Dentistry - Shanks for rotary and oscillating instruments).

Dental Handpiece has been developed with a full range of surgical contra angle intended to be used in implantology. The contra angle-design, size and performance of the proposed Dental Handpiece conform to ISO 14457 (2017) "Dentistry -Handpieces and motors"

The six (6) product codes and models of Dental Handpiece are SG200L, SG200, CA100L, CA100R. SA100L. SA100R.The component names and functional descriptions for critical components of Dental Handpiece are provided in the table below.

The provided text describes a 510(k) premarket notification for a Class I dental handpiece, meaning it is seeking to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a specific performance metric against acceptance criteria. Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert involvement, etc.) is not explicitly available in the provided document in the way it would be for a novel device undergoing clinical trials.

The document focuses on demonstrating that the new dental handpiece is substantially equivalent to existing predicate devices (SMARTmatic (K163239) and ANTHOGYR Contra angles and Handpieces (K093894)). Substantial equivalence is primarily proven by showing similar indications for use and technological characteristics, and by conforming to recognized standards.

Here's an analysis of the provided information relative to your request:

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

The document does not provide a table of acceptance criteria in the sense of specific thresholds for a novel device's performance metrics (e.g., a specific accuracy or sensitivity). Instead, it lists design verification and performance data tests that were conducted to confirm the device meets pre-determined design requirements and conforms to recognized standards. The "reported device performance" is generally stated as "favorable test results" or "demonstrates conformance."

Here's a table based on the information available, interpreting "acceptance criteria" as meeting the relevant standard and "reported device performance" as the outcome of the testing:

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 specify the sample sizes for the "design verification and performance data" tests (e.g., for rotational speed, noise, water supplying, etc.). It only states that these tests were performed.

For Biocompatibility, it states the testing was conducted in 2019, implying prospective testing for the proposed device. The country of origin for the data is not explicitly stated for individual tests, but the manufacturer is Micro-NX Co., Ltd. from the Republic of Korea, suggesting the testing likely occurred there or was contracted to testing facilities globally.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the type of submission described. This is a 510(k) for a dental handpiece, not an AI/imaging device requiring expert interpretation for ground truth establishment. The "ground truth" here is adherence to engineering and safety standards, not diagnostic accuracy.

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

Not applicable. Adjudication methods are typically used in clinical trials or studies where human interpretation of medical data is being evaluated, particularly with AI. This document pertains to the physical and functional characteristics of a medical device.

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 for a dental handpiece, not an AI or imaging diagnostic device.

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

Not applicable. This is for a dental handpiece, not an AI algorithm.

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

For this device, the "ground truth" is defined by established engineering standards, material safety standards, and functional performance benchmarks (e.g., specific rotational speeds, noise limits, water flow rates). These are objective measurements against recognized international and national standards (ISO, FDA recognized standards).

8. The sample size for the training set

Not applicable. This is for a dental handpiece, not a machine learning model.

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

Not applicable. This is for a dental handpiece, not a machine learning model.

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Karam STD, Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are airpowered highspeed dental handpieces with intended use of preparing dental cavities for restorations, such as fillings, reducing hard tooth structure, and cleaning teeth. Karam STD, Karam Mini, AeroBreeze STD, and AeroBreeze Mini can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling. Karam ECN model connects directly to either Type A or Type B hose connectors and does not require a coupling.

Karam45 and Dexor45 are air-powered highspeed dental handpieces with intended use of being a surgical tool for impacted third molar removal and periodontal procedures for which a conventional handpiece would be used. Both models can be used with either Type B (Karam 4B) or Type A (Karam 2A) coupling.

The devices are an air-powered dental handpieces intended for use with a friction-grip bur that conforms to ISO 1797-1 standard. Recommended air pressure is 29 ~ 36 psig (gage pressure) to produce high-speed bur rotation ranging between 380,000 and 450,000 RPM. Karam Mini, Karam ECN, AeroBreeze STD, and AeroBreeze Mini models are straight-headed. Karam45 and Dexor45 models are designed with a 45-degree back angle. The devices include a water line that directs water mist/jet to the cutting area for cooling and irrigation.

Aerobine line of handpieces employs a cartridge type air turbine with a common core design across the product line. All models employ a friction-grip push button chuck, a drive air line, a discharge air egress line, a water delivery line to supply cooling water. With the exception of Karam ECN, all models can be used with either Karam 4B or Karam 2A coupling. Karam ECN connects directly to Type A or Type B hose connectors without a coupling.

The provided text describes Aerobine Line of Dental Handpieces and compares them to predicate devices for a 510(k) submission. It does not contain a detailed study with acceptance criteria and reported device performance in the format requested. The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics.

Therefore, many sections of your request cannot be fully answered.

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

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

The document lists "Minimum Performance requirements" as a technological characteristic and states that the Aerobine devices are "Identical" to the predicate devices for these requirements. However, it does not specify the quantitative acceptance criteria or the actual reported performance values for the Aerobine devices.

2. Sample sized 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 document refers to "engineering analysis results obtained in support of the sterilization validation effort (section 14)," but section 14 is not included, and no details about specific test sets, sample sizes, or data provenance are mentioned for performance criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. The document does not describe a study involving expert assessment or ground truth establishment.

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

This information is not provided.

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 information is not applicable/not provided. The device is an air-powered dental handpiece, not an AI-assisted diagnostic tool.

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

This information is not applicable/not provided.

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

This information is not applicable/not provided. The document indicates that substantial equivalence was determined based on "technological profile comparisons (Table 1) and engineering analysis results."

8. The sample size for the training set

This information is not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not provided. There is no mention of a "training set" or ground truth establishment in this context.

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High Speed Air Turbine Handpiece series: This device is an air-powered hand-held device, intended to prepare dental cavities for restorations, such as tooth body treatment, tooth drilling and tooth grinding of stomatology.

Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece Series: This device is an air-powered hand-held device. intended for removing curious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and polishing teeth for use by a trained professional in general dentistry.

High Speed Air Turbine Handpiece series: There are two series (total 12 models) handpieces in this high speed hanhpiece series as A and B series. A series means the initial of model is "A", which include Quick Coupling, B series means the initial of model is "B", which doesn't include Quick Coupling. The High Speed Air Turbine Handpiece series device is reusable device, but they should be sterilized before use. In the A series, there are 2 models (AZL-4 and ADZ-4) device have one especial different from other model. These two model device have illumination function implemented via LED, the power supply of which is 3.3V d.c. and supplied by Therapy Machine. All the variant types follow the same principle with the same intended use and are made of same materials. The applicant device is not for life-supporting or life-sustaining, not for implant. The device is for prescription. The device does not contain drug or biological product. The device are not provided as sterile, they can be reusable and re-sterilized by the user. The device is not software-driven device.

Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece series: This series devices is the low speed handpiece device which includes 2 air motors (model 0222 is two hole motor; model 0224 is four hole motor), one straight head (model 043) and one contra angle head (model 058E). the two air motor can be matched with the straight or contra angle head discretional for different condition. The Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece series device is reusable device, but they should be sterilized before use. All the variant types follow the same principle with the same intended use and are made of same materials. The applicant device is not for life-supporting or life-sustaining, not for implant. The device is for prescription. The device does not contain drug or biological product. The device are not provided as sterile, they can be reusable and re-sterilized by the user. The device is not software-driven device.

This submission details the K093971 Premarket Notification for High Speed Air Turbine Handpiece series and Dental Low Speed Handpiece including Air Motor Straight and Geared Angle Handpiece series. The document asserts substantial equivalence to predicate devices based on safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "The performance of device following [relevant ISO and IEC standards] were conducted."

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

Not applicable. The ground truth was established through compliance with recognized international and national standards for device performance, not through expert human evaluation of outcomes.

4. Adjudication Method for the Test Set

Not applicable. Device performance was assessed against established technical standards, not through a process requiring human adjudication.

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

Not applicable. This device is a dental handpiece, not an AI/imaging diagnostic device that would typically involve an MRMC study comparing human readers with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states that "The performance of device following [relevant ISO and IEC standards] were conducted," implying that the device's technical specifications and functional capabilities were assessed independently against these standards. This is a standalone evaluation of the device's adherence to engineering and safety benchmarks.

7. Type of Ground Truth Used

The ground truth used was compliance with established international and national standards for dental handpieces:

• ISO7785-1:1997
• ISO9168:1991
• IEC 60601-1 (for specific models with illumination)
• IEC60601-1-2 (for specific models with illumination)
• ISO7785-2:1995
• ISO13294:1997

8. Sample Size for the Training Set

Not applicable. This device is a mechanical dental instrument, 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. There is no training set for this type of device.

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AS ALL OTHER DENTAL HANDPIECES, WILL THIS DENTAL HANDPIECE, BE USED INTRA AND EXTRA ORALLY TO CENTAL DEVICES CRIND AND POLISH TEETH, OR ITEMS RELATED TO TEETH AND DENTAL DEVICES THAT MAY BE IN THE MOUTH OR TO BE PLACED IN THE MOUTH.

THE DENTAL HANDPIECE, PATENT NUMBER 5575647, WAS DESIGNED TO INTRA-ORALLY, ALIGNED WITH THE LONG AXIS OF EACH TOOTH. THIS EASE OF ALIGNMENT IN ALL AREAS OF THE MOUTH DECIDEDLY GIVES THE HANDPIECE A SAFETY MARGIN OVER ANY EXISTING HIGHSPEED HANDPIECE, UPON WHICH THE SUBSTANTIAL EQUIVALENCE IS BASED. ALL DENTAL HANDPIECES, SINCE THEIR INCEPTION IN THE LATE 1800'S, HAVE BEEN CONSRUCTED OF THE SAME MATERIALS: BRASS AND CHROME,OR STAINLESS, OR A COMBINATION OF BOTH. AALL DENTAL HANDPIECES HAVE BEEN BOTH DURABLE AND SAFE.

The provided text describes a 510(k) submission for a dental handpiece (K971732). However, it does not contain any information regarding acceptance criteria, study methodologies, performance metrics, sample sizes, expert qualifications, or ground truth establishment.

The document is a 510(k) summary/statement and the FDA's response letter indicating substantial equivalence to a predicate device. This type of regulatory submission typically focuses on demonstrating that a new device is as safe and effective as an already legally marketed device, often by highlighting similar design, materials, and intended use, rather than presenting detailed clinical study data with specific acceptance criteria and performance outcomes.

Therefore, I cannot populate the requested table or answer most of the questions based on the provided text.

Here's what I can extract, and why the other information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Quantitative acceptance criteria (e.g., specific thresholds for durability, ergonomic benefits, or any other performance aspect) are not mentioned. Corresponding quantitative performance results are also absent.

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

Missing Information: The document does not describe any specific test set, clinical study, or data.

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

Missing Information: No information about expert involvement in establishing ground truth is provided, as no test set or study is detailed.

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

Missing Information: No adjudication method is mentioned, as there is no description of a 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

Missing Information: This device is a mechanical dental handpiece, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effectiveness are irrelevant and not mentioned.

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

Missing Information: This is not an algorithm or software device. No standalone performance data is relevant or provided.

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

Missing Information: No ground truth information is provided, as no specific study or clinical data is presented. The substantial equivalence relies on the comparison to predicate devices' known safety and efficacy, often inferred from long-standing market use (as implied by the statement "All dental handpieces, since their inception in the late 1800's, have been consructed of the same materials: brass and chrome, or stainless, or a combination of both. AALL dental handpieces have been both durable and safe.")

8. The sample size for the training set

Missing Information: No training set is mentioned or applicable to this device type and submission.

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

Missing Information: No training set or ground truth for such a set is discussed.

Summary of Document Content:

The provided documents are a 510(k) "Substantial Equivalence" submission and the FDA's clearance letter for a dental handpiece (K971732). The basis for substantial equivalence is primarily:

• Similar materials: "Constructed of the same materials: brass and chrome, or stainless, or a combination of both" as other dental handpieces.
• Historical safety: "All dental handpieces... have been both durable and safe."
• Design feature leading to safety margin: The new handpiece's "ease of alignment in all areas of the mouth" is presented as a safety improvement over existing designs.
• Intended use: "To grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth," identical to other dental handpieces.

This type of submission often leverages known safety and performance of predicate devices without requiring new, specific clinical studies with detailed acceptance criteria or performance metrics for the new device.

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Brixton Infection Control Barrier is intended as a single use, transparent plastic, disposable, nonsterile barrier that will help reduce gross contamination and provide equipment surface protection for devices used within the dental/ clinical treatment setting. Brixton Infection Control Barriers are available in an assortment of sizes and shapes, designed to accommodate the following types of equipment: Light Handles, Chairs, Headrests, Air and Water Syringe sleeves (ties included), Stools, X-Ray Heads, Trays

The Brixton Infection Control Barrier manufactured by Filmtech. Inc. is intended as a single use, disposable, transparent, polyethylene plastic equipment cover that will help provide surface protection and reduce cross contamination of equipment used in the dental/ clinical setting. The barriers are available in a variety of sizes and shapes, dispensed in boxes containing 200, 250 or 500 covers,

This document is a 510(k) summary for a medical device called the Brixton Infection Control Barrier. It details its intended use, device description, and claims of substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or training set details.

Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory submission requirements for demonstrating substantial equivalence based on device characteristics rather than reporting detailed performance studies.

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