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The DOLORCLAST Focused Shock Waves System is intended to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The DOLORCLAST Focused Shock Waves system is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.

The DOLORCLAST Focused Shock Waves system is composed of the DolorClast console, a handpiece, interchangeable gel pads (3 different sizes) and optional cart. EMS DolorClast Gel, previously approved under P050004 and K220538, is also provided for transmitting shock waves between the piezoceramic elements to the gel pad and coupling the treatment gel pad to the patient's skin.

The DOLORCLAST Focused Shock Waves system generates acoustic pressure waves generated using piezoelectric technology. A high-voltage impulse, controlled by the console, is used to stimulate the piezoceramic elements arranged across a concave surface in the emission source (the handpiece), causing the elements to expand simultaneously and briefly by a few micrometers, thus generating a focused shock wave. The shock waves are delivered to the patient's body via the handpiece, through a gel pad in a focused manner, and the treatment depth varies in line with the gel pad used.

The provided 510(k) clearance letter and summary for the DOLORCLAST Focused Shock Waves device do not describe a study involving acceptance criteria for an AI/ML-based medical device performance benchmark (e.g., accuracy, sensitivity, specificity). Instead, the document focuses on demonstrating substantial equivalence to a predicate device through physical and electrical performance testing, and biocompatibility, as well as characterization of its acoustic properties and software validation.

The acceptance criteria mentioned in the document are related to:

• Acoustic Pulse Characterization: Comparing the pressure field output to publicly available information on the predicate device.
• System Functional Performance Testing: Confirming correct operation of the console and handpiece at all treatment settings.
• Lifetime Testing: Confirming the console and handpiece function and meet performance specifications for their claimed useful lifetimes.
• Software Validation: Compliance with IEC 62304.
• Electrical Safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2.
• Biocompatibility Testing: Compliance with various ISO 10993 standards.

Since the request asks for information relevant to AI/ML device performance (like acceptance criteria related to accuracy, sample size for test sets, expert ground truth, MRMC studies, etc.), and the provided text does not contain this information for the DOLORCLAST Focused Shock Waves device, I cannot fulfill the request as written.

The DOLORCLAST Focused Shock Waves device is a physical therapeutic device, not an AI/ML diagnostic or assistive device. Therefore, the types of studies and acceptance criteria typically associated with AI/ML devices (like sensitivity, specificity, MRMC studies, and expert adjudication of ground truth) are not applicable or described in this 510(k) submission.

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The AIRFLOW Prophylaxis Master combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The AIRFLOW Prophylaxis Master is intended for use in the following dental applications:

• · Removing supra and subgingival calculus deposits and stains from teeth
• · Periodontal pocket lavage with simultaneous ultrasonic tip movement
• · Scaling and root planing
• · Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha
• Plugging for amalgam condensation
• Amalgam burnishing
• · Preparing, cleaning and irrigating root canals
• · Cavity preparation
• · Cementing inlays and onlays
• · Retrograde preparation of root canals

The AIRFLOW Prophylaxis Master is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.

The AIRFLOW Prophylaxis Master can be used for the following cleaning procedures:

• · plaque removal for placement of sealants
• · surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
• · surface preparation prior to placing composite restorations
• · effective plaque and stain removal for orthodontic patients
• · cleaning prior to bonding ortho brackets
• cleaning implant fixture prior to loading
• · stain removal for shade determination
• · plaque removal prior to fluoride treatment
• · plaque and stain removal prior to whitening procedure

The AIRFLOW Prophylaxis Master is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW Prophylaxis Master is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The AIRFLOW One is intended for use in the cleaning and polishing of teeth by the projection of water, air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.

The AIRFLOW One can be used for the following cleaning procedures:

• · plaque removal for placement of sealants
• · surface preparation prior to bonding/cementation of inlays, crowns and veneers
• · surface preparation prior to placing composite restorations
• effective plaque and stain removal for orthodontic patients
• · cleaning prior to bonding ortho brackets
• · cleaning implant fixture prior to loading
• · stain removal for shade determination
• · plaque removal prior to fluoride treatment
• · plaque and stain removal prior to whitening procedure

The AIRFLOW One is also intended for use as an air-polisher in patients suffering from periodontal disease. The AIRFLOW One is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The EMS AIRFLOW Prophylaxis Master is a dental device that combines the functions of an ultrasonic scaler and air-polishing unit within a single chassis. The proposed device consists of a control unit, hoses, handpiece cords for the two handpieces and a foot pedal which can be wired or wireless. There are two repositories on the control unit: one for the irrigation liquid container or the waterline cleaner container and the other one for one of both air-polishing powder chambers supplied with the device.

The AIRFLOW Prophylaxis Master is supplied with the Piezon Handpiece LED for performing ultrasonic scaling functions. The proposed device is compatible with EMS instruments legally marketed for ultrasonic scaling procedures.

The AIRFLOW Prophylaxis Master is also supplied with the AIR-FLOW Handpiece and optionally with the PERIO-FLOW Handpiece and the PERIO-FLOW Nozzles marked for performing air-polishing procedures. The proposed device is compatible with the AIR-FLOW CLASSIC new formula (sodium bicarbonate), AIR-FLOW SOFT (glycine), AIR-FLOW PERIO (glycine) and AIR-FLOW PLUS (Erythritol) prophylaxis powders.

The AIRFLOW Prophylaxis Master is supplied with accessories for attaching and removing instruments and nozzles from the handpieces.

The EMS AIRFLOW One is the same device as the EMS AIRFLOW Prophylaxis Master without the ultrasonic scaling function. Therefore, the description of the AIRFLOW Prophylaxis Master is also applicable to the AIRFLOW One, except the part related to the ultrasonic scaling function.

This document describes the non-clinical performance testing for the EMS AIRFLOW Prophylaxis Master and EMS AIRFLOW One devices to establish substantial equivalence to a predicate device.

Here's the requested information:

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

The document does not explicitly provide a table of acceptance criteria with corresponding performance results. Instead, it refers to compliance with a list of regulatory standards. The reported device performance is that the devices passed these compliance tests, thereby confirming they are "safe and effective for the indications for use."

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 size for any test sets. The tests are non-clinical performance tests, likely involving units of the device rather than patient data. No information on data provenance (country of origin, retrospective/prospective) is provided, as these are not relevant for non-clinical device performance testing against engineering standards.

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 is not applicable as no clinical studies with expert ground truth establishment are reported. The "ground truth" here is compliance with established engineering and safety standards.

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

This is not applicable as no clinical studies requiring adjudication are reported. The testing involves standardized procedures for demonstrating compliance with engineering 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. This device is a physical dental instrument, not an AI-assisted diagnostic tool involving human readers.

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 dental instrument, not an algorithm.

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

The "ground truth" for the non-clinical performance testing is compliance with the requirements outlined in the listed international and national standards (e.g., ISO 14971, ANSI/AAMI ES60601-1, IEC 60601-1-2, etc.).

8. The sample size for the training set

This is not applicable. The device is a physical dental instrument, not an AI/machine learning model that requires a training set.

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

This is not applicable, as there is no training set for this type of device.

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Scaling:

• Removal of supragingival and subgingival calculus
• Removal of stains

The proposed devices, PIEZON BUILT-IN KIT and the PIEZON BUILT-IN KIT LED, represent a change in presentation from the stand alone PIEZON 150 (predicate) to a device which is built in to the dental chair (OSSTEM K3 (K152830) ). The proposed device and the predicate device are both manufactured using the same internal componentry, the only difference is that instead of housing the device for stand alone use, the componentry is installed into a dental chair.

The difference between PIEZON® BUILT-IN KIT LED and PIEZON® BUILT-IN KIT is that the handpiece of the first features integrated light (LED) while the second does not. All other aspects are identical. Each system consists of the wireless module and handpiece cord and is provided with a wire harness for installation as well as the appropriate accessories. Additionally, spare parts are available.

As with other ultrasonic scalers, the ultrasonic generator component of the PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED (Piezon® Module EJ-110, installed in a dental chair) generates piezo-electric vibrations (ultrasonics) for water or dry work instruments. The PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED are supplied with the Piezon Handpiece EN-061/OS and Piezon Handpiece LED EN-060/OS, respectively. Instruments mounted in the Piezon Handpiece or Piezon Handpiece LED vibrates with a controlled oscillatory movement when activated.

Instruments A is supplied as part of all kits. Instruments P and PS are additionally included in the kits with OS1 suffix. The appropriate instrument for the particular application is screwed onto the handpiece prior to beginning the procedure. The treatment is carried out by placing the instrument tip onto the tooth surface according to the Operating Instruction for the instrument selected.

The provided text describes a 510(k) premarket notification for a medical device, the PIEZON BUILT-IN KIT, which is an ultrasonic scaler intended for dental cleaning. The primary claim for substantial equivalence is that the new device is essentially the same as a previously cleared predicate device (PIEZON 150), with the main difference being that the components are integrated into a dental chair rather than being a standalone unit.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A Table of Acceptance Criteria and the Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" for clinical performance in the sense of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) for an AI/CADe device. Instead, the acceptance criteria are related to engineering performance, electrical safety, electromagnetic compatibility, and functional integration, demonstrating that the reconfigured device performs equivalently to its predicate.

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

The document does not describe a "test set" in the context of a clinical study or AI model validation with patient data. The testing performed is related to engineering verification and validation of the device's physical and electrical properties, and its functional integration.

• Sample Size: Not applicable in the context of patient data. The "sample" for testing would be units of the device (PIEZON BUILT-IN KIT and PIEZON BUILT-IN KIT LED) and their integration within dental chairs. The document states "All tests were successfully performed," implying sufficient physical units were tested to demonstrate compliance.
• Data Provenance: Not applicable in the sense of patient data origin. The "data" comes from engineering tests performed by the manufacturer. It is internal company data.
• Retrospective or Prospective: Not applicable in the sense of patient data. The engineering tests were implicitly prospective (i.e., designed and executed to verify the new product configuration).

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

Not applicable. This device is an ultrasonic scaler, a physical medical device, not a diagnostic AI/CADe system requiring expert-adjudicated ground truth from medical images. The "ground truth" for its performance is derived from engineering standards, functional tests, and comparison to the predicate device's proven performance.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for image interpretation or diagnosis described.

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

Not applicable. This device is an ultrasonic scaler, not an AI/CADe system for diagnostic assistance. Therefore, an MRMC study is not relevant to its clearance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for this device's substantial equivalence claim relies on:

• Engineering Standards: Compliance with electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) standards.
• Functional Verification: Demonstrating that the device operates as intended in its new integrated configuration.
• Predicate Equivalence: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (PIEZON 150). The argument is that since the new device uses the same internal components and technology and only differs in its housing (integrated into a dental chair vs. standalone), its performance is inherently equivalent.
• Risk Analysis: A detailed risk assessment confirming that the change in housing does not introduce new or unacceptable risks.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As above, this is not an AI/ML device.

In summary, the provided document details a 510(k) submission for a traditional medical device (ultrasonic scaler) where the primary evidence for substantial equivalence comes from engineering testing and a comparison to a predicate device, rather than a clinical study involving patient data or AI model performance metrics. The "acceptance criteria" and "proof" relate to the physical and electrical performance of the device and its safe integration into a dental chair.

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The PERIO-FLOW nozzle, used with EMS PERIO-FLOW dental handpieces, is intended for patients suffering from periodontal disease.

The PERIO-FLOW nozzle, used with EMS PERIO-FLOW dental handpieces, is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The PERIO-FLOW nozzle is a flexible, thermoplastic accessory to the PERIO-FLOW handpiece that is used with the EMS AIR-FLOW devices such as AIR-FLOW MASTER, AIR-FLOW MASTER PIEZON and AIR-FLOW handy PERIO and AIR-FLOW handy 3.0 Perio. The PERIO-FLOW nozzle includes printed markings and is molded from an alternate version of the cleared thermoplastic polyester elastomer. The marks are arranged to ensure that the user is aware of the location of the tip with respect to the pocket. There is a mark at 3 mm and 5 mm so that the user can evaluate the location of the tip during a procedure. The 5mm mark is bolder to indicate the depth limit. The line and the square located above the 5 mm line serve to ensure that the user does not insert the nozzle deeper than 5mm in the pocket. The PERIO-FLOW nozzle is provided non-sterile. The nozzle is single use only and is intended for use under clean conditions.

The principle of operation of the proposed PERIO-FLOW nozzle is identical to predicate device nozzle (DT-113) which was cleared with the predicate system AIR-FLOW handy 3.0 PERIO (K132480 cleared on 02/24/2014).

EMS dental handpieces connect to a standard turbine connection on a dental operative unit and deliver a mixture of water, air, and the prophylaxis powder to a treatment site. The air /powder mixture exits the distal end of the PERIO-FLOW handpiece through the PERIO-FLOW nozzle where it meets with a water spray in the pocket.

The PERIO-FLOW nozzle is a Class I dental accessory intended for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment, used with EMS PERIO-FLOW dental handpieces. The device was deemed substantially equivalent to its predicate, the E.M.S. Electro Medical Systems S.A., AIR-FLOW handy 3.0 PERIO (K132480).

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details:

Since the device is a Class I medical device, the studies primarily focus on demonstrating substantial equivalence to a predicate device through performance testing, rather than extensive clinical efficacy studies typically seen for Class II or III devices or AI-powered diagnostics.

• 2. Sample Size for the Test Set and Data Provenance:

  • The document does not explicitly state numerical sample sizes for the test sets (e.g., number of nozzles tested). It refers to "comparison testing" and "functional testing" performed on the "current material (predicate)" and "new material (this submission)" for the nozzle. This implies a sufficient number of samples were used to perform the specified engineering and material tests, but the exact count is not provided.
  • Data Provenance: Not explicitly stated, however, the testing was conducted to support a submission to the U.S. FDA, indicating adherence to relevant international standards (e.g., ISO 10993-1). The tests are engineering and material-based, not clinical studies involving patient data or specific geographical origin.

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

  • This question is not applicable in the context of this device and its testing. The "ground truth" for these tests relates to engineering specifications, material properties, and functional performance, which are evaluated against established standards and internal design specifications by engineers and material scientists, rather than clinical experts establishing a ground truth for diagnostic accuracy.

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

  • This is not applicable. The tests described are objective, quantitative or qualitative measurements against pre-defined engineering and material specifications. There is no subjective interpretation by multiple readers requiring adjudication in the context of this 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:

  • This is not applicable. The PERIO-FLOW nozzle is a mechanical dental accessory, not an AI-powered diagnostic or therapeutic device. No MRMC study was performed.

• 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 dental accessory, not an algorithm, and does not operate in a standalone algorithmic capacity.

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

  • The "ground truth" for the tests performed is based on established engineering principles, material science standards, and the functional requirements of the device. This includes:
    • Biocompatibility Standards: ISO 10993-1:2009 for biological evaluation of medical devices.
    • Mechanical and Functional Specifications: Internal design specifications for connection force, pressure resistance, nozzle fixation, powder exit hole placement, direction, and marking durability.

• 8. The sample size for the training set:

  • This is not applicable. This device is not an AI/ML algorithm that requires a training set. The "new material" of the nozzle was developed and tested against established engineering and biocompatibility standards.

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

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

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The AIR-FLOW PLUS Prophylaxis Powder is indicated for use with EMS dental handpieces for cleaning and preparation of teeth.

The proposed AIR-FLOW PLUS Prophylaxis Powder is an erythritol powder containing 0.05% Cetyl Pyridinium Chloride (CPC) as a preservative. This prophylaxis powder is intended to be used with all currently available EMS dental handpieces for AIR-FLOW and PERIO-FLOW treatments. The addition of CPC is to preserve the powder from bacterial contamination by humidity and microorganisms when the container is opened. Clinical studies have not been conducted to demonstrate that the presence of CPC in this device results in improved clinical outcomes.

The principle of operation of the proposed AIR-FLOW PLUS Prophylaxis Powder is identical to predicate and reference device powder is mixed with air and water in the dental handpiece nozzle to create a mechanically abrasive stream used in polishing procedures.

The device in question is the AIR-FLOW PLUS Prophylaxis Powder. It is an erythritol powder containing 0.05% Cetyl Pyridinium Chloride (CPC) used with EMS dental handpieces for cleaning and preparation of teeth. The provided document is a 510(k) summary for this device, determining its substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list specific numerical acceptance criteria in a table. Instead, it describes functional testing and biocompatibility assessments, concluding that "All tests were successfully performed and all acceptance criteria were met". Based on the descriptions, the implicit acceptance criteria are:

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

The document does not specify the exact sample sizes (e.g., number of test specimens, number of repetitions) for any of the performance tests.

• Shelflife testing: Not specified.
• Biocompatibility testing: Not specified (e.g., number of cell culture replicates, number of animal subjects if applicable).
• Comparison testing (Subgingival and Supragingival): Not specified (e.g., number of metal plates, number of PEEK samples, number of cleaning cycles).

The data provenance is from E.M.S. Electro Medical Systems S.A. (Switzerland), the manufacturer. The studies appear to be prospective in nature, as they were conducted specifically to support the 510(k) submission for the new device.

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

This device is not an AI/ML device that generates diagnoses or predictions. Therefore, the concept of "ground truth" established by experts in the context of clinical interpretation (e.g., radiologists interpreting images) does not directly apply. The "ground truth" in this context refers to the defined objective outcomes of the physical and chemical tests.

• Shelflife: Determined by laboratory testing following established protocols (e.g., stability assays over time).
• Biocompatibility: Determined by standardized laboratory tests conforming to ISO 10993-1, interpreted by qualified toxicologists or biocompatibility experts. The number of such experts is not specified.
• Comparison Testing: The "ground truth" for cleaning efficiency and abrasivity is based on objective laboratory measurements (e.g., visual assessment of paint removal, weight loss of PEEK, calculated cleaning efficiency). The "experts" in this case would be the laboratory personnel conducting and analyzing the tests, ensuring adherence to protocols and accurate data collection. Their specific qualifications and numbers are not mentioned.

4. Adjudication Method for the Test Set

Given that the studies are primarily about physical and chemical performance, and not diagnostic or interpretive tasks, a formal "adjudication method" like 2+1 or 3+1 by multiple clinical experts is not applicable. The results are based on objective measurements and established laboratory protocols. Any potential "adjudication" would involve internal quality control processes to ensure test validity and reliability.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices that assist human readers in diagnostic tasks, where the impact on human performance is measured. This device is a dental prophylaxis powder, and its performance is evaluated based on physical and chemical properties, not diagnostic accuracy or human interpretation.

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

No, a standalone AI/ML algorithm performance study was not done. This device is a physical product (prophylaxis powder), not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the AIR-FLOW PLUS Prophylaxis Powder is based on objective laboratory measurements and established physical/chemical standards:

• Shelflife: Measured degradation or stability of the product over time.
• Biocompatibility: Results of standardized toxicology and irritation assays.
• Cleaning efficiency: Quantifiable removal of a paint layer from a metal plate using an automated test bench.
• Abrasivity: Measurable erosion of a standard material (PEEK).

This is not expert consensus, pathology, or outcomes data in the traditional clinical sense, but rather factual, measurable outcomes from controlled experiments.

8. The Sample Size for the Training Set

This question is not applicable. The AIR-FLOW PLUS Prophylaxis Powder is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The product's formulation and manufacturing processes are likely developed through research and development, but this is distinct from training an algorithm.

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

This question is not applicable, as there is no training set for an AI/ML algorithm.

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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 PIEZON® 707 BIK and PIEZON® BIK LED is intended for use for the following indications:

Scaling

• Removal of supragingival calculus
• Removal of stains

Endo

• Preparation, cleaning and irrigation of root canals
• Condensing gutta-percha
• Removal of crowns, bridges and restorations

Restorative

• Preparation of cavities
• Cementation of restorations
• Condensing of amalgams

Periodontics

• Scaling and root planing
• Periodontal therapy

The PIEZON® 707 BIK and PIEZON® BIK LED is an ultrasonic scaling unit consisting of an ultrasonic generator supplied with a Piezon Handpiece and scaling instruments. The PIEZON® 707 BIK and PIEZON® BIK LED are supplied with the Piezon Handpiece EN-061 and Piezon Handpiece LED EN-060, respectively. The PIEZON® 707 BIK and PIEZON® BIK LED ultrasonic generator is designed for installation into a dental chair.

The ultrasonic generator produces piezo-electric vibrations (ultrasonics) for water or dry work instruments. The appropriate instrument for a particular application is screwed onto the handpiece supplied with the scaling unit prior to beginning the procedure. The power control is handled via the potentiometer or the chair main control. The water control is handled via the handpiece or the chair main control. The treatment is carried out by placing the instrument tip onto the tooth surface according to the Operating Instruction for the instrument selected.

The provided text describes the regulatory clearance for the PIEZON® 707 BIK and PIEZON® BIK LED ultrasonic scaler. It states that no clinical testing was conducted to support this submission, and therefore, an AI/algorithm-specific acceptance criteria and study proving its meeting of those criteria in a MRMC or standalone manner are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (Satelec SP Newtron Module, K033764) through non-clinical performance testing.

Here's the information parsed from the document based on your request, with an emphasis on what is not applicable due to the nature of the submission (device, not AI/ML):

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

The document does not explicitly state "acceptance criteria" in a quantitative, threshold-based manner typical for AI/ML performance. Instead, it indicates that "all design inputs... were satisfied by the design outputs" and that "the device met the predetermined acceptance criteria" based on non-clinical tests.

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

Not applicable. This was non-clinical performance and safety testing of a physical device, not an AI/ML algorithm's performance on a data test set. The testing was performed on the device itself, integrated with a dental chair and handpiece.

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. Ground truth as typically defined for AI/ML performance evaluation (e.g., derived from expert consensus on medical images) is not relevant here. The "ground truth" for this device's performance would be engineering specifications and safety standards.

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

Not applicable. No expert adjudication process for a data test set was described.

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. No clinical testing, and specifically no MRMC comparative effectiveness study was performed or described. This device is an ultrasonic scaler, not an AI-assisted diagnostic tool. The submission explicitly states: "No clinical testing was conducted to support this submission."

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

Not applicable. This device is a physical medical device (ultrasonic scaler), not an AI algorithm. Its performance is measured by its physical operation and adherence to engineering and safety standards, not as a standalone algorithm.

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

For the non-clinical performance testing of the ultrasonic scaler, the "ground truth" was based on:

• Engineering specifications: The design inputs and predetermined performance specifications for the device's electrical, mechanical, and functional characteristics.
• International standards: Compliance with standards like IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility).

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.

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

Not applicable. As there is no training set, this question is not relevant.

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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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The PIEZON 250 is a device for delivering ultrasonic movement and irrigant to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:

• Periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planing
• Removal of supra and subgingival calculus and stains from teeth

The proposed PIEZON 250 ultrasonic scaler is a modification of the previously cleared miniPiezon (K953026). The working instrument for the scaling function is the handpiece, which is connected to the control unit via a handpiece cord and mounted in a holder on the side of the control unit. In the proposed PIEZON 250, irrigating liguid is pumped to the handpiece from a 350ml (or 500ml) irrigating bottle by a peristaltic pump rather than from an external water supply. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit. The PIEZON 250 is supplied with two handpieces - the Piezon handpiece LED (lightemitting diode) and the Piezon handpiece. The Piezon handpiece LED is identical to the Piezon handpiece LED described in K093000 for the Piezon Master 700 ultrasonic scaler (K093000) and contains 6 LEDs in the body of the handpiece and a light guide that is positioned under the nozzle. The Piezon handpiece is identical to the Piezon handpiece LED, except that the Piezon handpiece does not have LEDs or the light guide. All instruments compatible with the PIEZON 250 have been previously cleared (see 510(k) numbers referenced in Section 3).

The provided document describes a 510(k) submission for a device modification of the PIEZON 250 ultrasonic scaler. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical studies and acceptance criteria as would be the case for novel devices. Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically understood for new device validation, is largely not applicable in this context.

However, I can extract information related to the "non-clinical performance testing" which serves a similar function for device modifications.

Here's a breakdown of the available information:

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

The document does not explicitly state "acceptance criteria" in a quantitative table format with corresponding "reported device performance" as would be seen for a clinical trial or algorithm validation study. Instead, it refers to fulfilling "design inputs" and meeting "functional and performance requirements" through non-clinical testing.

The basis for substantial equivalence is listed as:

• Intended Use: Identical to predicate (dental and periodontal applications, scaling, root planing, removal of calculus and stains).
• Treatment Site: Identical to predicate (subgingival and supragingival).
• Function: Identical to predicate (ultrasonic scaling).
• Mechanism of Action: Identical to predicate (ultrasonic energy).
• Components: Mostly identical, with modifications in the control unit, handpieces, and irrigation system being the primary differences.

Implicit Acceptance Criteria (derived from the substantial equivalence claim and non-clinical testing summary):

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

• Sample Size for Test Set: Not applicable. The document states "No clinical testing was conducted for this submission." The evaluation relied on non-clinical performance testing and comparison to predicate devices, not a clinical test set.
• Data Provenance: Not applicable for a clinical test set. The non-clinical testing would typically be performed in a lab setting by the manufacturer (E.M.S. ELECTRO MEDICAL SYSTEMS S.A. in Switzerland).

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 as no clinical test set was used and no ground truth was established by experts in the context of a clinical study. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices.

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

• Not applicable as no clinical test set was used.

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 not an AI device, and no MRMC comparative effectiveness study was conducted.

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

• Not applicable. This is not an AI device.

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

• The "ground truth" in this context is the regulatory determination of safety and effectiveness for the predicate devices (miniPiezon and Piezon Master 700). The PIEZON 250 demonstrates substantial equivalence to these already cleared devices through non-clinical testing and comparison of technological characteristics.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device, so there is no "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 submission.

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