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This Highspeed Airturbine Handpiece is intended for removal of carious material, cavities and crow preparations, removal of filings, processing of tooth, restoration of surfaces and as a surgical tool for third molar removal procedures It is designed for use by a trained professional in the field of general dentistry.

The Highspeed Airturbine Handpiece is air driven dental handpieces for the use by a trained professional in the field of general dentistry. The devices are air-powered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the pre-vacuum Autoclave methods. Through the coupling connected to a dental unit, the proposed dental handpiece receive air for functionality of the high speed turbine.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the device's performance in the typical sense of a diagnostic or predictive algorithm. Instead, it focuses on compliance with established international standards for dental devices and comparison to predicate devices, demonstrating substantial equivalence. The "performance" section for the proposed device cites compliance with these standards.

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

Not applicable. This is a submission for a physical medical device (dental handpiece), not a software or AI device that typically uses test sets or data. The "tests" mentioned are non-clinical studies evaluating physical and biological properties.

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

Not applicable. This is a physical device submission. Ground truth, in the context of expert consensus, is not a relevant concept here.

4. Adjudication method for the test set

Not applicable. This is a physical device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical device submission, not an AI or diagnostic imaging device.

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

Not applicable. This is a physical device submission.

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

Not applicable. For this physical device, "ground truth" would be the objective measurements and adherence to specified performance standards as evaluated in non-clinical laboratory settings.

8. The sample size for the training set

Not applicable. This is a physical device submission; there is no "training set" in the context of an algorithm.

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

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

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" proving the device meets acceptance criteria is a series of non-clinical tests conducted to demonstrate the proposed Highspeed Airturbine Handpiece's compliance with established international standards and its substantial equivalence to legally marketed predicate devices.

• Non-Clinical Test Conclusion (Section 6): The submission states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
• Standards Complied With: The tests demonstrated compliance with:
  • ISO 10993-5:2009 (Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)
  • ISO 10993-10:2010 (Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
  • ISO 9168:2009 (Dentistry - Hose Connectors For Air Driven Dental Handpieces)
  • ISO 14457:2012 (Dentistry - Handpieces And Motors)
  • ASTM D4169:2016 (Standard Practice For Performance Testing Of Shipping Containers And Systems)
  • FDA Reprocessing Guidance Document (Cleaning and Sterilization Validation)
• Biocompatibility: For biocompatibility, the proposed device's patient-contact materials (brass and aluminum) were considered identical to those in reference device K172543. The document states that "The biocompatibility testing for K172543 was evaluated and the tests results complied with ISO 10993 standards." This essentially leverages prior testing on a similar, already cleared device from the same manufacturer.
• Performance (Speed in RPMs): "the performance test has been conducted on proposed device according to ISO 14457 and the test results meet the acceptable criteria."
• Sterilization: The sterilization parameters tested "comply with ISO 17665 standard."

Overall: The acceptance criteria are essentially defined by compliance with recognized international and national standards for dental handpieces, and "performance" is demonstrated through non-clinical testing against these standards, often referencing predicate devices for establishing substantial equivalence. No clinical studies were included in this submission (Section 7).

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ND lowspeed airmotor, MP-50M, is used to power prophy angle attachment that helps dental clinician perform the hygiene dentistry work such as cleaning. The device is autoclavable.

ND low speed airmotor, MS-10M / MS-55M, are used to power attachment that helps dental clinician perform various dental work such as cleaning, tooth carving, others. The device is autoclavable.

ND star-type straight nosecone attachment, STS-30H, is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable.

ND star-type contra angle attachment, STC-20L / STU-20ML / STU-30BLP, are powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable

ND highspeed airturbine handpiece, TCP-70QM / TCP-70QB / TC-80QB, are air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teeth. The device is autoclavable.

Not Found

This document is a 510(k) premarket notification from the FDA, determining substantial equivalence for dental handpieces and accessories. It does not describe an AI/ML-driven medical device or a study proving its performance against acceptance criteria.

The information you are asking for, such as acceptance criteria, sample sizes for test/training sets, expert qualifications, ground truth establishment, or multi-reader multi-case (MRMC) studies, is not present in this type of regulatory document. This document is related to traditional medical devices (dental handpieces) and their substantial equivalence to previously marketed devices based on their intended use and technological characteristics, not on software performance or clinical study results for novel AI algorithms.

Therefore, I cannot provide the requested information based on the provided text.

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ND air powered low speed airmotor is used to power various U-type attachment which helps dental clinician perform the hygiene dentistry work. All the devices are autoclavable.
ND air powered low speed airmotor is used to power various attachment which helps dental clinician perform various dental procedures. All the devices are autoclavable.
ND highspeed airturbine handpiece is an air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teeth. All the devices are autoclavable.
ND straight nosecone is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. ES-30A is E-type 1:1 ratio, ESG-30AR is E-type 4:1 ratio, and MWS-30A is Midwest-type 1:1 ratio. All the devices are autoclavable. They accept 2.35mm (3/32") standard burs and can have prophy angles mounted.
ND e-type contra angle is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. EC-20L and EC-30BL are 1:1 ratio, EG-20L is 4:1 ratio, and EGG-20L is 16:1 ratio. All of the devices are autoclavable.
ND u-type prophylaxis angle is used mounted on U-type nose attachment powered by either lowspeed airmotor or electric micromotor for hygiene dentistry work. All the devices are fully autoclavable.

ND air powered low speed airmotor is used to power various U-type attachment which helps dental clinician perform the hygiene dentistry work. All the devices are autoclavable.
ND air powered low speed airmotor is used to power various attachment which helps dental clinician perform various dental procedures.
ND highspeed airturbine handpiece is an air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teeth. All the devices are autoclavable.
ND straight nosecone is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. ES-30A is E-type 1:1 ratio, ESG-30AR is E-type 4:1 ratio, and MWS-30A is Midwest-type 1:1 ratio. All the devices are autoclavable. All the devices accepts 2.35mm (3/32") standard burs and can have prophy angles mounted.
ND e-type contra angle is powered by either lowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations and polishing teeth. EC-20L and EC-30BL are 1:1 ratio, EG-20L is 4:1 ratio, and EGG-20L is 16:1 ratio. All of the devices are autoclavable.
ND u-type prophylaxis angle is used mounted on U-type nose attachment powered by either lowspeed airmotor or electric micromotor for hygiene dentistry work. All the devices are fully autoclavable.

The request asks for specific information regarding acceptance criteria and a study proving a device meets these criteria. However, the provided text consists of several 510(k) summaries for various dental handpieces and attachments. These summaries primarily focus on demonstrating "substantial equivalence" to predicate devices rather than presenting detailed acceptance criteria and performance study results.

The concept of "substantial equivalence" in a 510(k) submission means that the new device is as safe and effective as a legally marketed predicate device. The evidence for this is typically based on comparing the new device's technological characteristics, materials, operating principles, and performance specifications to those of the predicate device. It usually does not involve presenting a specific clinical or performance study with acceptance criteria in the manner requested for an AI/clinical device study.

Therefore, most of the requested information cannot be extracted from the provided text because:

• Acceptance Criteria and Reported Device Performance (Table): The summaries state that the "performance specification is virtually identical" to the predicate devices. There are no specific quantitative acceptance criteria or detailed performance metrics reported for the subject devices.
• Sample size for the test set and data provenance: No new performance studies with test sets are described. The equivalence is based on comparison to existing predicate devices.
• Number of experts and their qualifications: Not applicable as no ground truth establishment for a test set is reported.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is a comparison of physical device characteristics, not an AI efficacy study.
• Standalone (algorithm only) performance: Not applicable, as these are physical medical devices, not algorithms.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How ground truth for the training set was established: Not applicable.

The core argument for acceptance in these documents is based on the similarity of the device's design, materials, and intended use to a previously approved (predicate) device, asserting that this similarity demonstrates equivalent safety and effectiveness.

Here’s a summary of what can be extracted or inferred regarding "acceptance" in the context of these 510(k) submissions:

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate devices. The "reported device performance" is essentially that the device functions identically to the predicate device in its intended use.

2. Study Description and Evidence of Meeting Acceptance Criteria:

The "study" that proves the device meets the acceptance criteria is the 510(k) substantial equivalence comparison against predicate devices. This is not a clinical trial or performance study in the traditional sense, but rather a regulatory submission based on comparative analysis.

• Sample size used for the test set and the data provenance: There is no specific "test set" or explicit data provenance mentioned beyond the comparison to the existing predicate devices already on the market. These are retrospective comparisons to existing approved devices.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the predicate devices' safety and effectiveness was established through their prior market clearance.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
• If a standalone performance was done: No standalone algorithm performance was done as this is a physical device submission.
• The type of ground truth used: The ground truth for the predicate devices is their previous regulatory clearance based on their demonstrated safety and effectiveness in the market. For the subject devices, the "truth" is the argument of their equivalence to these predicate devices.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

In conclusion, the provided documents are 510(k) summaries, which aim to demonstrate substantial equivalence to previously approved devices. They do not contain the type of detailed performance study data, acceptance criteria, test set information, or expert adjudication typically found for AI or clinical performance studies. The "proof" lies in the direct comparison of features and intended use to existing, legally marketed devices.

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