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The AEU-700L-70V is a drive system for instruments and tools used in dentistry for implants / surgical and endodontic procedures. The system includes an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement, or endodontic therapy.

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This document is a 510(k) premarket notification from the FDA for a dental handpiece and accessories, the AEU-7000L-70V Implant/Endodontic Dental System. It primarily addresses the substantial equivalence of this device to previously marketed predicate devices under the 510(k) pathway.

The 510(k) pathway focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This typically involves performance testing to show that the new device meets the same or similar specifications as the predicate. It does not generally involve clinical trials or extensive studies to establish acceptance criteria for novel clinical endpoints in the same way a PMA (Pre-Market Approval) would for high-risk devices.

Therefore, many of the specific questions about acceptance criteria for AI/ML devices, such as sample sizes for test sets, expert adjudication methods, MRMC studies, and detailed ground truth establishment, are not applicable to this type of device and submission.

Here's a breakdown based on the provided document:

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

   • The document does not explicitly state specific quantifiable acceptance criteria (e.g., accuracy, sensitivity, specificity) in the way one would see for an AI/ML diagnostic device.
   • For a device like a dental handpiece, acceptance criteria would typically revolve around engineering specifications, safety standards (e.g., electrical safety, biocompatibility, sterilization efficacy), and performance characteristics (e.g., motor speed, torque, irrigation flow, noise levels, vibration) that are compared to the predicate device.
   • The document states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This implies that Aseptico, Inc. provided data (likely bench testing, engineering reports, and comparisons to predicate device specifications) to demonstrate this substantial equivalence, and the FDA found that data acceptable. However, the details of these tests and their specific acceptance criteria are not included in this FDA letter.

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 in this document. As this is a 510(k) for a dental handpiece, testing would primarily involve bench testing of the device's mechanical and electrical components, not a "test set" of patients or data in the AI/ML context.

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 in this document. There is no "ground truth" in the clinical imaging interpretation sense for this device. Ground truth for mechanical devices would be established by validated measurement techniques and engineering standards.

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

   • Not applicable / Not provided in this document. This applies to clinical interpretation studies, not mechanical device performance.

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 in this document. This is a mechanical device, not an AI/ML 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 / Not provided in this document. This device does not have an "algorithm only" component. It is a physical dental system.

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

   • Not applicable / Not provided in this document. For a dental handpiece, "ground truth" for performance would be based on engineering specifications, validated measurement methods, and compliance with recognized standards (e.g., ISO standards for dental equipment).

8. The sample size for the training set:

   • Not applicable. This device does not use machine learning or require a "training set."

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

   • Not applicable. This device does not use machine learning or require a "training set."

In summary: The provided FDA 510(k) letter confirms substantial equivalence for a dental handpiece. It does not contain the detailed performance data, acceptance criteria, or study methodologies that would be typical for an AI/ML device submission because the device itself is a mechanical-electrical system, not a software algorithm. The FDA's determination means they were satisfied with the comparisons made to predicate devices and the data supporting those comparisons, which would primarily be engineering and bench testing data.

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The AEU-6000-70V and AEU-6000 are drive systems for instruments and tools used in dentistry for implants/surgical procedures and endodontic procedures. The systems include an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement or endodontic therapy.

drive systems for instruments and tools used in dentistry for implants/surgical procedures and endodontic procedures. The systems include an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement or endodontic therapy.

This document is a 510(k) premarket notification from the FDA regarding the Aseptico AEU-6000-70V and AEU-6000 Implant/Surgical & Endodontic Dental Systems. It is a clearance letter, not a study report, and therefore does not contain the requested information about acceptance criteria or study details proving device performance.

The document states that the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices, meaning it performs similarly and has the same intended use. This determination is based on the information provided by the manufacturer in their 510(k) submission, which would have included testing data. However, the clearance letter itself does not detail that testing data.

To answer your questions, one would need to review the original 510(k) submission (K142124) submitted by Aseptico, Incorporated, which is not provided in the prompt.

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To be used for endodontic and general dentistry applications.

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The provided document is a 510(k) premarket notification letter from the FDA regarding a Portable Dental System (K130693). This type of document confirms that a device is substantially equivalent to a legally marketed predicate device, a process that typically does not involve new clinical studies to prove effectiveness against specific acceptance criteria in the same way a new drug or novel high-risk device might.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. Specifically:

• It does not list any acceptance criteria.
• It does not describe any specific study conducted by the manufacturer to demonstrate the device's performance against such criteria.
• It does not mention sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The 510(k) pathway relies on demonstrating substantial equivalence to pre-existing, legally marketed devices. This often involves performance data demonstrating safety and effectiveness similar to the predicate device, but not necessarily against newly established, quantitatively defined acceptance criteria that would require a detailed study as outlined in your request. The "Indications for Use Statement" simply states the intended clinical applications: "To be used for endodontic and general dentistry applications."

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For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.

Model Number: AEU-26L

Classification Name: 872.4200 Dental handpiece and accessories

Product Code: EKX handpiece, direct drive, ac-powered

Primary accessories exclusive to the AEU-26L system:

• a) AEU-26L Consol (Controller)
• b) AE-250L-30 Low Voltage Electric Motor
• c) On/Off Foot Pedal
• d) Motor holder attaching bracket

The AEU-26L is software controlled and has the following features:

• a) Allows adjustment of the motor speed from 300 to 30,000 RPM
• b) Allows setting the torque applied to the motor in gram/cm
• c) Allows selection of gear ratios for different geared E-Type handpieces
• d) Allows selection of forward or reverse drive rotation
• e) Allows reciprocating drive (forward/reverse cycling)
• Allows use of a foot pedal control to operate the attached handpiece motor
• Allows the user to define their own presets for speed (RPM) and torque (gram g)
• h) Allows for attaching geared handpieces that include optics for a light.

The AEU-26L device is a software-controlled dental handpiece system. The acceptance criteria and the study proving the device meets these criteria are detailed below, primarily through a comparison with predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the functional characteristics of the predicate devices. The reported device performance for the AEU-26L demonstrates its equivalence or superior performance to these predicates.

Notes on Performance Comparison:

• Torque Control: The AEU-26L claims improved torque accuracy compared to the AEU-925.
• Gear Ratios: The AEU-26L offers a different set of reduction ratios compared to the AEU-925, but still provides a range for various handpieces.
• Reciprocating Drive & Lighted Handpieces: These are new features to the AEU-26L compared to the AEU-925, and their performance is shown to be equivalent to the respective predicate devices (ATR TECNIKA and AEU-5000).

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

The document does not specify a separate "test set" in the context of a clinical trial or a dataset for AI evaluation. Instead, the performance evaluation relies on "bench testing" and "comparative design verification methods" against predicate devices. This implies that the 'test set' consists of the AEU-26L device itself being tested against established industry standards and specifications of its predicate devices.

• Sample Size: Not explicitly stated as a numerical sample size of patients or images. The testing was performed on the AEU-26L device itself.
• Data Provenance: Not applicable in the traditional sense of patient data. The provenance is the performance characteristics of the device and its comparison to known predicate devices from Aseptico (AEU-925, AEU-5000) and ATR TECNIKA. The testing was likely conducted in a controlled laboratory or engineering environment. The study is retrospective in the sense that it compares features and performance to already cleared predicate devices.

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 a way that aligns with establishing ground truth for a test set, as this is a device performance study rather than an AI diagnostic study. The "ground truth" for the device's technical specifications and functionality would be the design requirements and the specifications of the predicate devices, established through engineering and regulatory processes.

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication process described for a test set in the context of diagnostic interpretation. The evaluation involved verifying the device's functional characteristics and compliance with technical standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance

No MRMC comparative effectiveness study was done, as this is a medical device (dental handpiece) and not an AI-assisted diagnostic tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.

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

Not applicable. The AEU-26L is a hardware and software controlled dental handpiece system, not an algorithm being evaluated for standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for the AEU-26L's performance is established by:

• Technical Specifications and Design Requirements: The device's own design specifications setting out its intended functionality (e.g., speed range, torque control, drive types).
• Predicate Device Specifications: The established and cleared performance characteristics of the Aseptico AEU-925, AEU-5000, and ATR TECNIKA devices with which the AEU-26L claims substantial equivalence for specific features.
• Industry Standards: Compliance with recognized international standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2) and dental handpieces (ISO 11498).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning study, so there is no training set in the conventional sense.

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

Not applicable, as there is no training set mentioned or implied.

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The AMC-20 is a self-contained mobile dental cart that is used for general dentistry and endodontic applications.

AMC-20 Mobile Dental Cart

This document is a 510(k) premarket notification from the FDA regarding the "AMC-20 Mobile Dental Cart." It is a regulatory approval letter and does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the device was approved based on its substantial equivalence to existing devices, not on a new study demonstrating its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information as it is not present in the provided text.

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Can be used for a wide range of dental procedures including endodontic surgeries, such as drilling into the root canal, and general dentistry, such as removing carious material from the dentin.

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This is a 510(k) clearance letter for a dental handpiece (AEU-5000), which is a Class I device. Class I devices are generally exempt from premarket notification requirements if they meet certain criteria, and this letter confirms substantial equivalence without requiring a detailed performance study like those for higher-risk devices or software.

Therefore, the provided document does not contain the information requested for acceptance criteria and a study proving device performance as it would for a device requiring more rigorous testing. The information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is typically found in premarket submission documents for software or higher-risk devices, not in a 510(k) clearance letter for a Class I dental handpiece.

The letter simply states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a predicate device, or has different technological characteristics but does not raise new questions of safety and effectiveness, and is as safe and effective as a legally marketed device. This equivalence is typically established based on existing standards and performance data for similar devices, rather than a new, comprehensive clinical study specifically detailed in this type of letter.

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The ASC-12 is an ultrasonic scaler that is intended for the following procedures:

Scaling:
Interdentium treatment
Tooth neck and subgingival treatment
Treatment of large dental calculi
Treatment of coatings and tobacco stains
Treatment of periodontal pockets
Interproximal treatment
Loosening of crowns and posts

Endodontics:
Pulp Chamber Cleaning
Canal filling by ultrasonic gutta-percha condensation

The ASC-12 is an AC mains-powered piezoelectric ultrasonic scaler intended for scaling and endodontic procedures. The device consists of a console, a footswitch and an autoclavable handpiece with interchangeable and autoclavable scaling tips.

The provided document K0708166 describes the Aseptico ASC-12 Piezoelectric Scaler. The submission is a 510(k) for substantial equivalence, not a study presenting novel performance data against acceptance criteria. Therefore, much of the requested information regarding sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets is not applicable to this type of document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices (Satelec Suprasson P5 Booster - K961158 and NSK Varios 350 - K031421) by comparing intended use, design, construction, sterility assurance, and performance specifications.

Here's the breakdown of the information provided in the document concerning "acceptance criteria" which, in this context, are the specified performance characteristics for substantial equivalence validation:

1. Table of "Acceptance Criteria" (Performance Specifications) and Reported Device Performance

The acceptance criteria here are derived from the performance specifications of the predicate devices, which the ASC-12 aims to meet or be equivalent to.

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

This is not applicable as the document is a 510(k) summary for substantial equivalence. It does not describe a clinical study with a "test set" in the traditional sense of evaluating diagnostic or treatment efficacy on patients. The "test" mentioned refers to engineering verification of performance specifications against predicate devices.

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

This is not applicable. Ground truth, expert consensus, or clinical outcome data as part of a "test set" is not detailed in this 510(k) summary. The "ground truth" for the engineering performance validation would be the measured physical parameters against the specified ranges.

4. Adjudication Method for the Test Set

This is not applicable. There is no mention of an adjudication method as there's no clinical "test set" with subjective interpretations requiring expert consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If so, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This is not applicable. The device is an ultrasonic scaler, a physical medical device, not an AI-powered diagnostic or decision support tool. Therefore, MRMC studies are irrelevant to this submission.

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

This is not applicable. The device is a physical instrument, not an algorithm. Standalone performance as typically described for AI devices does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the claims in this submission is based on:

• Engineering Specifications and Measurements: The physical properties and performance parameters (e.g., vibration frequency, coolant flow, water pressure, electrical safety) are measured and compared against established benchmarks or the predicate devices' specifications.
• Comparison to Predicate Devices: The primary "ground truth" for substantial equivalence is the documented characteristics and performance of the legally marketed predicate devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not a machine learning or AI device that requires training data.

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

This is not applicable. See point 8.

Study Proving Acceptance Criteria (Substantial Equivalence)

The entire 510(k) submission itself serves as the "study" proving the device meets the "acceptance criteria" (i.e., demonstrating substantial equivalence to predicate devices). The document states:

• "The following intended [uses] were validated by establishing equivalent scaler tip amplitudes and power settings between a predicate device using their prescribed power settings for the exact same scaler tips to be used with the ASC-12. See tip movement compatibility data."

This indicates that internal engineering verification and comparison testing was conducted. While the detailed "tip movement compatibility data" is not provided in this excerpt, it would constitute the direct evidence of the device's performance against the predicate. The performance claims (frequency, flow, pressure, electrical safety) are typically verified through bench testing and measurements and compared to industry standards or the predicate device's known specifications. The overall conclusion of the FDA (as shown in the subsequent pages granting 510(k) clearance) is that the device is "substantially equivalent" for its intended uses and performance characteristics.

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The AHP-101 fully autoclavable, straight, 1:1 ratio E-Type dental handpiece is intended for use in general dentistry procedures, such as removing carious material from the dentine.

The AHP-101 is a straight, fully autoclavable, 1:1 ratio E-Type dental handpiece intended for use in general dentistry procedures. It accepts standard 2.35mm (3/32") burs and may be used with prophy angles.

This document is a 510(k) summary for a dental handpiece (AHP-101 E-Type Straight Handpiece). As such, it reports on a determination of substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific performance acceptance criteria.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not applicable in the context of this 510(k) submission.

Here's why and what information is provided:

• 510(k) process: A 510(k) submission demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves showing similar technological characteristics and indications for use, often without requiring new clinical studies or the establishment of new, specific performance acceptance criteria in the same way a PMA (Pre-Market Approval) would.
• Reliance on predicate device: The AHP-101 is deemed substantially equivalent to Aseptico's AHP-64 Handpiece [510(k) K020137]. The predicate device would have been evaluated for its safety and effectiveness, and the general understanding is that if the new device is substantially equivalent, it too is safe and effective for its intended use.

However, the document does list features of substantial equivalence which can be reinterpreted as a form of "acceptance criteria" based on similarity to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information:

• 2. Sample size used for the test set and the data provenance: Not applicable. This is not a study that involved a test set in the traditional sense of evaluating performance. The "test" involved demonstrating equivalence to a predicate device. The validation of the sterility assurance level (SAL) of 10⁻⁶ would have involved a specific, industry-standard sterilization validation study, but the details (sample size, provenance) are not provided in this summary.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The 510(k) process relies on demonstrating equivalence, not on establishing a new ground truth through expert consensus for a test set.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental handpiece, not an AI-powered diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a mechanical tool.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the purpose of the 510(k), the "ground truth" is the established safety and effectiveness of the predicate device (Aseptico's AHP-64 Handpiece). The AHP-101 essentially relies on the predicate's established performance based on its original clearance and compliance with recognized standards.
• 8. The sample size for the training set: Not applicable. There is no machine learning or AI training set involved.
• 9. How the ground truth for the training set was established: Not applicable.

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The EXPEDITION offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is suitable for performing general dental procedures anywhere there is a suitable surface to contain and be operated on internal power source. Additionally, the internal power source can be recharged using a detachable solar panel.

The AEU-14CF Expedition is a portable electric dental system intended to provide basic dentistry capabilities in emergency and field situations. The Expedition features an "E" type autoclavable 30,000 RPM brushless micro motor with interchangeable headpieces, a 3-way air/water syringe, a self-contained water system, and an oil-less air compressor. The Expedition is powered by internal 27.6V battery packs, and may be connected to a 120V/230V AC power source or to a 12/24V vehicle battery for extended operation or recharging. A detachable solar panel is also provided for recharging the internal batteries when other sources are not available.

This document is a 510(k) Summary for the AEU-14CF Expedition Field Dental System. It lists the device description, features of substantial equivalence to a predicate device (Aseptico Model AEU-425, K022217), and other features. An FDA letter of substantial equivalence is also provided.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them because the necessary information is absent from the provided document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices in the United States, and does not require explicit performance study data against defined acceptance criteria in the same way a new device with novel technology might.

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The Endopex V is used to estimate the position an endodontic file in the root canal. The devices enhances endodontic surgery by enabling the dentist to reduce the number of required radiographs.

Using two electrodes, electrical impedance is measured between a root canal file positioned inside the tooth and another making contact with the oral cavity along the lip. The software inside the Endopex V compares the impedance values being read between its two electrodes with impedance values stored in its software database. The comparison of impedance values are than converted to readings on the LED to indicate the estimated position of the endodontic file in relation to the inside root canal and the Apical Foramen.

The provided text does not contain detailed information about the acceptance criteria or an analytical study proving the device meets those criteria. The 510(k) summary focuses on the device's operating principles and its substantial equivalence to a predicate device, rather than a performance study with specific metrics.

Therefore, I cannot provide the requested information in the format specified. The document primarily describes the administrative aspects of the 510(k) submission, not the technical performance evaluation.

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