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The PROPHYflex 4 Handpiece and Accessories is a dental handpiece intended for perform supragingival and subgingival prophylaxis treatments. The prophylaxis treatments are obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the treatment site. PROPHYflex 4 Handpiece and Accessories in supra-gingival configuration is intended for use in the cleaning and polishing of teeth by removal soft deposits and areas of discoloration as well as preparing teeth for fillings or veneers and cleaning fixed bands and brackets on orthodontic appliances. PROPHYflex 4 Handpiece and Accessories in subgingival configuration is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

The PROPHYflex 4 is an air polishing device/powder jet handpiece that projects a mixture of water and air with sodium bicarbonate, calcium carbonate or fine glycine power onto tooth surfaces. The device includes the handpiece main body with adjustable spray feature, two cannulas, a wrench for installing the cannula, two interchangeable gripping sleeves, powder container with cover, a cleaning burr and nozzle pin, and a set of spare o-rings. An optional adapter and perio tip can be installed for subgingival treatments.

The powder is filled into the powder container by the user. When activated through foot control, air is pushed into the powder container, swirling the powder and pushing it through the device and out of the cannula. The spray is only mixed with the air and powder at the very tip of the cannula, providing an even and gentle cleaning effect. The amount of powder can be regulated via three different spray settings by the adjusting ring, helping the users to perform individual treatments such as subgingival biofilm removal, removal of discoloration and bacterial plaque, orthodontics, cleaning prior to fissure sealing, prosthetics, conservative and aesthetic dentistry by providing the possibility to adjust the cleaning effects to the clinical situation of the patient at hand.

The components of the PROPHYflex 4, including the powder container, is to be completely reprocessed after each use.

The three powder levels are as follows:

• Highest Level: Suitable for supragingival treatment and offers full cleaning power .
• Medium Level: Suitable for sub- and supragingival treatment and enables . gentle cleaning at a reduced powder quantity
• . Lowest Level: Helps rinsing the powder off the tooth and blowing the powder from the system after the treatment

During supraqinqival treatments (e.g. stain removal), the device doesn't touch the patient but will be placed 3 – 5 mm from the area that is to be cleaned. During subgingival treatments (biofilm management) with the perio tip, the tip is inserted into the pocket up to 5mm and angled towards the tooth.

The provided text is a 510(k) summary for a dental handpiece, the PROPHYflex 4. It focuses on demonstrating substantial equivalence to predicate devices through technological characteristic comparison and non-clinical performance testing.

Crucially, this document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

Therefore, a study demonstrating the device meets acceptance criteria via clinical performance (which would involve human readers, ground truth established by experts, MRMC studies, etc.) was explicitly not performed and is not required for this type of device according to the provided FDA submission.

However, I can extract the acceptance criteria and reported performance based on the non-clinical (bench) testing, and other relevant information from the document, framing it within the context of a "study" as requested, even if it's a bench study rather than a clinical one.

Here's a breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the PROPHYflex 4 are implicitly defined by its ability to perform as well as, or better than, its predicate devices across various technical specifications and to comply with relevant international standards. The study proving these criteria are met consists of non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are essentially demonstrated equivalence or improvement over the predicate device (AIR-FLOW Handy 3.0 Plus (K151912)) and compliance with specified ISO standards.

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

• Sample Size: The document does not specify exact "sample sizes" in terms of number of devices tested for each bench test. These are typically covered under the manufacturer's internal quality system documentation and test protocols, which are summarized rather than detailed in a 510(k). The tests are performed on representative units of the device.
• Data Provenance: The testing was non-clinical (bench testing).
  • Country of Origin: The manufacturer is Kaltenbach & Voigt GmbH, located in Biberach, Germany. Therefore, the testing would likely have been conducted in Germany or by approved testing facilities.
  • Retrospective or Prospective: This refers to the collection of patient data, not bench testing. Bench testing is inherently prospective in its execution, demonstrating performance against specifications.

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

• This question is not applicable as the study was purely non-clinical bench testing. There were no "experts" establishing a clinical "ground truth" for a test set, as no clinical test set involving human subjects was used. The "ground truth" for bench testing is derived from engineering specifications, established medical device safety and performance standards (e.g., ISO standards), and comparative performance against legally marketed predicate devices.

4. Adjudication Method for the Test Set

• This question is not applicable as there was no test set requiring human expert adjudication (e.g., image interpretation). Bench testing results are typically objectively measured against defined criteria.

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

• No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product." Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.

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

• This question is not applicable in the context of a dental handpiece. The device is a physical instrument, not an AI algorithm. Its "performance" is its mechanical, fluidic, and material characteristics demonstrated through bench testing.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance validation is based on:
  • International Standards: Compliance with ISO standards (e.g., ISO 7785-1, ISO 14457, ISO 9168, ISO 10993 series, ISO 20608).
  • Predicate Device Performance: Demonstrating that the PROPHYflex 4's performance characteristics (dimensions, noise, pressure, flow, etc.) are comparable to or improved over the legally marketed predicate device (AIR-FLOW Handy 3.0 Plus (K151912)) and other reference devices.
  • Engineering Specifications: Internal design specifications and performance targets set by the manufacturer for the device.

8. The Sample Size for the Training Set

• This question is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

• This question is not applicable as this is a physical medical device, not an AI/ML algorithm; therefore, there is no "training set" or "ground truth" establishment for it in this context.

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The Pelton & Crane P50 series Dental Operative Units and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The Pelton & Crane P50 series Dental Operative Units and Accessories are designed for use by a trained professional in the field of dentistry.

The P50 series Dental Operative Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, patient dental chair, foot control, and a junction box that houses a power supply and air/water regulators. The unit may also include a dental operating light and a monitor. Various handpieces, instruments, and accessories can be added to the P50 series Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them to the P50 series Dental Operative Units. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments. Water quality is maintained automatically by the preprogramed cleaning functions for the water lines, cuspidor spouts, and instrument hoses including motors and syringes. Instructions are provided for waterline treatment and suction cleaning agents. Water supply is available by either the municipal water supply or a self-contained water bottle.

The retrieved document is a 510(k) Pre-Market Notification for the Pelton & Crane P50 series Dental Operative Unit and Accessories. This notification focuses on demonstrating substantial equivalence to a predicate device rather than providing a study proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable or available in this type of submission.

However, I can extract the relevant information that is present:

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

The document does not present specific acceptance criteria in the form of a table with numerical thresholds for performance metrics. Instead, it provides a comparison table (Table 5.3) outlining technological characteristics between the proposed device (P50 series Dental Operative Unit and Accessories) and the predicate device (ESTETICA Dental Treatment Unit and Accessories, K161488). The document states that "The performance testing results provided in this submission supports that the proposed device performs as well as the predicate devices for its intended use" and that "Hence, the device is deemed to be substantially equivalent to the ESTETICA Dental Treatment Unit and Accessories (K161488)."

Here is a summary of the comparative characteristics, serving as the basis for "performance" as described in this 510(k) submission:

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

This information is not provided in the document. The submission relies on "Non-Clinical Test Data" to demonstrate substantial equivalence, which primarily involves performance bench testing against international standards and comparative performance testing of integrated accessories versus cleared stand-alone devices. There is no mention of a traditional "test set" in the context of clinical data for performance evaluation.

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 there was no clinical test set requiring ground truth establishment by experts for a specific performance metric.

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

This is not applicable as there was no clinical test set requiring adjudication.

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

This is not applicable. The device is a "Dental Operative Unit and Accessories" and is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Its primary function is to provide power, air, water, and vacuum for other dental instruments.

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 unit, not an algorithm.

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

For the non-clinical performance testing, the "ground truth" was adherence to established international standards (e.g., AAMI ES60601-1, IEC 60601-1-2, ISO 10993-1, etc.) and comparative performance to cleared stand-alone predicate devices for integrated accessories. Specific outcomes data or expert consensus on clinical findings are not mentioned as "ground truth" in this context.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device requiring a training set.

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

This is not applicable as this is not an AI/ML device requiring a training set.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-Clinical Test Data" and primarily involves:

• Performance bench testing: Conducted according to international standards for dental operative units to determine conformance in regards to basic safety and essential performance. Relevant standards cited include:
  • AAMI ES60601-1:2005 +AC1; A2
  • IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)
  • IEC 60601-1-2 Edition 3: 2007-03 (EMC)
  • IEC 80601-2-60 Edition 1.0 2012-02 (Dental equipment specific)
  • ISO 9168 Third edition 2009-07-15 (Hose connectors)
  • ISO 14457 First edition 2012-09-15 (Handpieces and motors)
  • ISO 7494-2 Second edition 2015-04-01 (Air, water, suction)
  • ISO 7494-1 Second edition 2011-08-15 (General requirements)
• Biocompatibility testing: Completed for applicable components, referencing ISO 10993-1 and ISO 7405. Reference devices (Spirit - K143696 and ELECTROmatic - K163317) were used due to identical patient contacting parts.
• Software documentation: For moderate level of concern per FDA Guidance Document for Software Contained in Medical Devices, referencing IEC 62304.
• Comparative performance testing: The functions of the integrated accessories were compared to "cleared stand-a-lone device[s]."
• Risk Management: Compliance with ISO 14971:2007, with the Risk Management File reviewed by Intertek for 60601-1 certification.

The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

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