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The AIR-FLOW handy 3.0 PLUS Dental Handpiece is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and EMS prophylaxis powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.

The AIR-FLOW handy 3.0 PLUS is intended for patients suffering from periodontal disease.

The AIR-FLOW handy 3.0 PLUS is indicated for the non-surgical removal of subgingival plaque in pockets up to 4 mm after initial periodontal treatment.

The proposed AIR-FLOW handy 3.0 PLUS device is similar in design and materials to the predicates AIR-FLOW handy 3.0 (K132478) and AIR-FLOW handy 3.0 PERIO (K132480). The proposed AIR-FLOW handy 3.0 PLUS device and the predicates connect to a standard turbine connection on a dental operative unit and deliver a mixture of water, air, and prophylaxis powder to a treatment site. The handpiece component of the proposed AIR-FLOW handy 3.0 PLUS (PLUS) is to be commercialized as an additional optional accessory to the predicate AIR-FLOW handy 3.0 PERIO (PERIO) handpiece component. Therefore, the proposed PLUS and the predicate PERIO share the same EMS reference number FT-221#. The purpose for adding this additional PLUS handpiece is so that the patients can have both supragingival treatments and subgingival treatments by the same AIR-FLOW PERIO prophylaxis powder that is previously cleared in AIR-FLOW MASTER (K082791) and thus create more convenience for the users. There are no changes to the powder in this submission.

The AIR-FLOW handy 3.0 (STANDARD) and the proposed device, AIR-FLOW handy 3.0 PLUS (PLUS) handpieces, have the same air and water ports to enable supragingival use.

The difference between the proposed PLUS and the predicate PERIO is the handpiece, which has the same body, powder chamber and handpiece body with the only difference being the nozzle. The geometric shape of the integrated nozzle of the PLUS handpiece is relatively thin and slim which enables the supragingival use and the subgingival use in pockets up to 4 mm after initial periodontal treatment. The integrated nozzle of PLUS handpiece has no direct contact with the subgingival shallow pocket. The separate slim nozzle of PERIO that has direct contract with the subgingival pocket enables the subgingival use in pockets up to 5mm after initial periodontal treatment.

The PLUS handpiece should not be used with the STANDARD powder chamber. To prevent this, a different connector is used so that it can only be used with the PERIO powder and PERIO powder chamber. The PLUS handpiece uses the same PERIO polishing powder as the PERIO handpiece.

The proposed AIR-FLOW handy 3.0 PLUS device is therefore substantially equivalent to the previously FDA-cleared AIR-FLOW handy 3.0 PERIO (K132480) and AIR-FLOW handy 3.0 (K132478).

The provided text describes the regulatory clearance for the "AIR-FLOW handy 3.0 PLUS," a dental handpiece. The information focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the context of an AI/algorithm-based medical device.

Based on the document, here's an analysis of the requested information:

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

The document does not explicitly present a table of predetermined acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) that would be typical for an AI/algorithm-based device. Instead, the "acceptance criteria" are implied by the verification of compliance with established medical device standards and the comparison testing against predicate devices.

• ANSI/AAMI ST79: 2010/A4:2013 (Steam sterilization)
• ANSI/AAMI/ISO 17665-1:2013 (Moist heat sterilization)
• IEC 62366 (2007+AMD1:2014 CSV) (Usability engineering)
• ISO 10993-1 (2009/Cor1:2010) (Biological evaluation)
• ISO 13485 (2003) + CORR. 1: 2009 (Quality Management Systems)
• ISO 14971 (2007) (Risk Management)
• ISO 15223-1 (2012) (Symbols for labels)
• ISO 17664 (2004) (Sterilization information by manufacturer)
• ISTA 2A (2011) (Preshipment packaging tests) |
  | Performance equivalence to predicate devices (AIR-FLOW handy 3.0 and AIR-FLOW handy 3.0 PERIO) in terms of powder flow rate, powder residue, powder working time, and cleaning efficiency. | Comparison testing was performed for the subject device and predicate devices using currently available EMS powders. This test suite included:
• Powder flow rate
• Powder residue
• Powder working time
• Cleaning efficiency
  The document states: "The test suite results passed." and "The results of this testing confirm that the AIR-FLOW handy 3.0 PLUS is as safe and as effective for the intended use described in Section 6." It also concludes that it is "substantially equivalent to the predicates." |
  | Operational characteristics (water/air pressure, operating/storage/transport conditions) match or are within acceptable ranges of predicate. | Table 1 shows identical Function (Air-polishing) and Mechanism of action (Projection of water/air/powder mixture). Operational characteristics (service pressure, operating/storage/transport condition ranges) are listed for the proposed device and are implicitly considered equivalent or acceptable compared to predicates since substantial equivalence is claimed. |
  | Intended Use capabilities (supragingival and subgingival cleaning up to 4mm) are supported. | The device combines functionalities of the two predicates, allowing for both supragingival and subgingival cleaning in pockets up to 4mm. The testing results are used to support this combined indication. |

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

The document does not provide details on the sample sizes for the "comparison testing" of performance metrics (powder flow, residue, working time, cleaning efficiency). It simply states "comparison testing of the subject device and the predicate device as used with currently available EMS powders was performed." There is no mention of data provenance (e.g., country of origin) or whether the data was retrospective or prospective.

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 and not provided in the document. The device is a dental handpiece, not an AI/algorithm that requires expert adjudication for ground truth. The testing performed was related to physical device performance and compliance with standards.

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

This information is not applicable and not provided in the document. Adjudication methods are typically associated with expert review of medical images or data for AI/algorithm validation, not for the physical performance testing of a dental handpiece.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic or clinical decision support tools. The device described is a physical dental handpiece.

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

No, a standalone (algorithm only) performance study was not done. This concept is not applicable to a physical dental handpiece.

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

The concept of "ground truth" as typically applied to AI/algorithm development (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. The "ground truth" for the performance testing would be the measured physical and operational characteristics of the device and its predicates, compared against engineering specifications and industry standards, as well as the observed cleaning efficiency, powder flow, etc.

8. The sample size for the training set

This information is not applicable and not provided. The device is not an AI/algorithm that requires a training set.

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

This information is not applicable and not provided. The device is not an AI/algorithm that requires a training set or ground truth for training.

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The AIR-FLOW handy 3.0 Dental Handpiece is a dental handpiece intended for use in the cleaning and polishing of teeth by the projection of a mixture of water, air, and EMS prophylaxis powder onto the tooth surface. The device removes soft deposits and areas of discoloration and can be used to prepare teeth for dental procedures such as the placement of composite fillings, porcelain inlays, and laminate veneers. The device can be used to clean implant abutments and to clean teeth prior to treatments such as shade matching, fluoridation, and bleaching. The device can also be used to degrease crowns and bridges prior to placement and clean fixed bands and brackets on orthodontic appliances.

The proposed AIR-FLOW handy 3.0 is a modification of the AIR-FLOW handy 2 Dental Handpiece previously cleared under K022119. This device modification has been submitted as a Special 510(k) Premarket Notification because the indications for use for the proposed AIR-FLOW handy 3.0 are identical to the parent AIR-FLOW handy 2. The fundamental technology and design of the proposed AIR-FLOW handy 3.0 are essentially identical to the AIR-FLOW handy 2 dental handpiece.

Both the proposed AIR-FLOW handy 3.0 and the predicate AIR-FLOW handy 2 connect to a standard turbine connection on a dental operative unit and deliver a mixture of water, air, and dental powder to a treatment site.

Modifications made to the AIR-FLOW handy 2 Dental Handpiece to produce the AIR-FLOW handy 3.0 were limited to minor design changes to enhance the ergonomics of the design, including:

• Location of the powder chamber is modified to improve the visibility of the mouth of patient by the practitioner during the treatment.
• Slimmer shape of the powder chamber to be in-line with the body of the device to improve the visibility of the mouth of patient by the practitioner during the treatment.
• Diameter of the powder chamber cap is reduced to be in-line with new design of the powder chamber.
• The powder chamber capacity has been slightly decreased to 21g from 23g to fit new ergonomic design.
• The body of the handy 3.0 is made of 2 glued molded part instead of 1 molded part.
• The handpiece is shorter and slimmer to improve ergonomics.

Accessories were included to aid in filling the powder chamber and removing residual powder from the handpiece channels.

In addition, the AIR-FLOW CLASSIC COMFORT prophylaxis powder has been added to the panel of available prophylaxis powders. The chemical composition of the AIR-FLOW CLASSIC COMFORT Powder is identical to the AIR-FLOW CLASSIC that was described in the 510(k) Premarket Notification for the AIR-FLOW MASTER (K073284). The grain size was slightly reduced from a median particle size of

This document describes the AIR-FLOW handy 3.0 dental handpiece. The submission for this device is a Special 510(k) Premarket Notification, indicating that it is a modification of a previously cleared device (AIR-FLOW handy 2, K022119) and shares the same indications for use, fundamental technology, and design. Therefore, the device proves substantial equivalence to its predicate device rather than meeting specific quantifiable performance criteria as would be required for a novel device.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a Special 510(k) based on substantial equivalence to a predicate device due to minor modifications (ergonomics, slightly reduced powder chamber capacity, and a new powder with smaller grain size for comfort), there are no specific quantifiable acceptance criteria for device performance in terms of metrics like sensitivity, specificity, accuracy, or other clinical outcomes.

The "acceptance criteria" here are implicitly that the modified device performs at least as well as the predicate device for its intended use, and that the modifications do not introduce new questions of safety or effectiveness.

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The AIR-FLOW handy 3.0 PERIO is intended for patients suffering from periodontal disease.

The AIR-FLOW handy 3.0 PERIO is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The proposed AIR-FLOW handy 3.0 PERIO is a modification of the AIR-FLOW handy PERIO Dental Handpiece previously cleared under K092289. This device modification has been submitted as a Special 510(k) Premarket Notification because the indications for use for the proposed AIR-FLOW handy 3.0 PERIO are identical to the parent AIR-FLOW handy PERIO. The fundamental technology and design of the proposed AIR-FLOW handy 3.0 PERIO are essentially identical to the AIR-FLOW handy PERIO dental handpiece.

Both the proposed AIR-FLOW handy 3.0 PERIO and the predicate AIR-FLOW handy PERIO connect to a standard turbine connection on a dental operative unit and deliver a mixture of water, air, and dental powder to a treatment site.

Modifications made to the AIR-FLOW handy PERIO Dental Handpiece to produce the AIR-FLOW handy 3.0 PERIO were limited to minor design changes to enhance the ergonomics of the design, including:

• Location of the powder chamber is modified to improve the visibility of the mouth of the patient by the practitioner during the treatment
• Slimmer shape of the powder chamber to be in-line with the body of the device to improve the visibility of the mouth of the patient by the practitioner during the treatment.
• Diameter of the powder chamber cap is reduced to be in-line with new design of the powder chamber.
• The powder chamber capacity has been slightly decreased to 21g from 23g to fit new ergonomic design.
• The body of the AIR-FLOW handy 3.0 PERIO is made of 2 glued molded parts instead of 1 molded part
• The handpiece is shorter and slimmer to improve ergonomics.

Accessories were included to aid in filling the powder chamber and removing residual powder from the handpiece channels.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AIR-FLOW handy 3.0 PERIO device:

The provided document (K132480) is a 510(k) Premarket Notification for a dental handpiece, the AIR-FLOW handy 3.0 PERIO. This is a Special 510(k), indicating a modification to a previously cleared device (AIR-FLOW handy PERIO, K092289). The focus of this submission is on demonstrating substantial equivalence to the predicate device, primarily through non-clinical performance testing.

Acceptance Criteria and Reported Device Performance

The document states that the modifications were "limited to minor design changes to enhance the ergonomics of the design," and that "The fundamental technology and design...are essentially identical to the AIR-FLOW handy PERIO dental handpiece." This implies that the key acceptance criteria revolve around maintaining the functional performance of the predicate device while incorporating ergonomic improvements.

Since this is a Special 510(k) for minor design changes, the acceptance criteria are not explicitly numerical targets for performance metrics like accuracy or sensitivity, as would be common for diagnostic AI devices. Instead, they are more about demonstrating that the changes do not adversely affect the device's original intended function and safety, and that the ergonomic improvements are indeed effective.

Study Details

The primary "study" described is a non-clinical performance testing effort.

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

   • The document does not specify a numerical sample size for the devices tested. It refers to "functional verification of the hardware modifications at the component and finished device level." This likely involved testing a certain number of manufactured units, but the exact count is not provided.
   • Data Provenance: The testing was "Non-clinical," meaning it was conducted in a laboratory or simulated environment, likely at the manufacturer's facility (E.M.S. ELECTRO MEDICAL SYSTEMS S.A. in Switzerland). It is retrospective in the sense that the testing was performed after the design changes were made to verify them.

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

   • The document explicitly mentions "user evaluations to validate the design improvements." However, it does not specify the number of users/experts involved in this evaluation, nor their qualifications (e.g., dentists, dental hygienists, or engineering evaluators). The "ground truth" here would be subjective user feedback on ergonomics and ease of use.

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

   • No formal adjudication method is mentioned. The "user evaluations" would likely involve collecting feedback, but there's no indication of a structured multi-expert consensus process.

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:

   • No MRMC study was done. This device is a dental handpiece, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

   • No standalone algorithm performance study was done. This device does not incorporate AI or algorithms in its function.

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

   • For the functional verification, the "ground truth" was engineering specifications and performance targets (i.e., verifying that the device still sprayed correctly, held powder, etc.).
   • For the user evaluations, the "ground truth" was subjective user feedback regarding ergonomic improvements (visibility, handling, ease of use).

7. The sample size for the training set:

   • Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

   • Not applicable. As above, no training set exists for this type of device.

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