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The SMARTmatic handpieces are intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

The SMARTmatic electrical-driven handpieces listed in the table below are dental handpieces for the use by a trained professional in the field of general dentistry. The devices are electricalpowered handpieces that are reusable and ergonomically shaped. The devices can be sterilized by the steam autoclave method. Through the tube and the electrical motor connected to a dental unit, the SMARTmatic handpieces equipped with a handpiece connection according to ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors - ISO 3964:1982) receive the energy for the gear, the cooling water and air for cutting treatment. Dental burs and other attachments will be used with the SMARTmatic handpieces per ISO 1797-1:2011 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals).

The request asks for a detailed description of acceptance criteria and the study proving the device meets these criteria. However, the provided document is a 510(k) premarket notification for a dental handpiece (SMARTmatic), which focuses on demonstrating substantial equivalence to a predicate device rather than on specific acceptance criteria and a detailed study proving performance against those criteria.

The document primarily highlights the substantial equivalence of the SMARTmatic handpieces to the MASTERmatic LUX handpieces (K143465) based on intended use, technological characteristics, and performance data. It relies on conformance to various ISO standards and a guiding document for dental handpieces. The document does not contain information on:

• A specific table of acceptance criteria with reported device performance against numerical targets.
• Sample sizes for a test set or data provenance (as it's not a clinical study on diagnostic accuracy).
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance (as it's a mechanical device, not an AI algorithm).
• Sample size for a training set or how ground truth for a training set was established.

Therefore, many of the requested points cannot be extracted from this document as they are not relevant to a 510(k) submission for a dental handpiece.

However, I can extract information related to the performance data and "acceptance" from the perspective of substantial equivalence and adherence to recognized standards.

Here's the information that can be extracted and a clear indication of what is not present:

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

The document doesn't provide a table of acceptance criteria in the sense of specific numerical thresholds for performance metrics. Instead, it relies on conformance to international standards. The "Summary of the Technological Characteristics" table ([page 7] and [page 8]) compares the new device (SMARTmatic) to the predicate device (MASTERmatic LUX) across various design and technical specifications. The "acceptance criteria" here are effectively that the new device's characteristics are either the same as the predicate or, if different, that these differences do not raise new questions of safety or effectiveness, as demonstrated by non-clinical testing to relevant standards.

Summary of Technological Characteristics and Performance (as presented in the document):

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

• None stated directly. The document refers to "Performance bench testing according to international standards." This typically involves testing a defined number of device units or components, but the specific sample sizes are not provided in this summary.
• Data Provenance: Not explicitly stated, but the manufacturer is Kaltenbach & Voigt GmbH, based in Biberach, Germany. The tests are "Non-Clinical Test Data," indicating lab/bench testing, not data from human subjects. This would be considered prospective bench testing.

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. This information is for clinical studies or AI algorithm validation, not for a mechanical dental handpiece undergoing bench testing for substantial equivalence.

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

• Not applicable. This is for clinical studies/AI algorithm validation.

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

• Not applicable. This device is a mechanical dental handpiece, not an AI-assisted diagnostic tool.

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

• Not applicable. This is a mechanical device, not an algorithm. Bench testing was done for the device itself.

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

• For biocompatibility: Conformance to ISO 10993-1. The "ground truth" is that the materials used meet the specified biocompatibility standards.
• For mechanical performance (e.g., bur retention force, speed range, coupling dimensions): Conformance to relevant ISO standards (e.g., ISO 14457, ISO 1797-1, ISO 3964). The "ground truth" is whether the physical measurements and operational parameters of the device meet the requirements of these standards.
• For sterilization: Conformance to ISO 17665-1 and AAMI ANSI ST79. The "ground truth" is that the sterilization process specified for the device achieves the required sterility assurance levels.

8. The sample size for the training set

• Not applicable. This refers to AI/machine learning models.

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

• Not applicable. This refers to AI/machine learning models.

Summary of the Study (as described in the document):

The "study" described is a non-clinical performance bench testing program to demonstrate substantial equivalence to a legally marketed predicate device (MASTERmatic LUX K143465).

• Methodology: Performance bench testing according to international standards (listed below) and biocompatibility and sterilization studies.
• Standards utilized for performance verification:
  • ISO 3964 (Dentistry - Coupling dimensions for handpiece connectors)
  • ISO 1797-1 (Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals)
  • ISO 7405 / ISO 10993-1 (Dentistry - Evaluation of biocompatibility of medical devices used in dentistry / Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system)
  • ISO 14457 (Dentistry - Handpieces and motors)
  • ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1)
  • AAMI ANSI ST79 (Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities)
  • Guidance for Industry and FDA Staff - Dental Handpieces - Premarket Notification [510(k)] Submissions.
• Conclusion: The tests demonstrated that despite some differences in technological characteristics (e.g., external vs. internal spray, presence/absence of fiber optics, speed range, specific chuck types, and minor dimensions), these differences do not raise new concerns regarding substantial equivalence to the predicate device. The SMARTmatic handpieces are deemed substantially equivalent based on intended use, indications, technological characteristics, principle of operation, features, and performance data derived from these non-clinical tests.
• Clinical Data: 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."

Ask a specific question about this device

KaVo QUATTROcare is a unit intended for internal cleaning, i.e, purging of old lubricant, for the maintenance of rotating dental and surgical instruments. The KaVo QUATTROcare spray can is a component of the KaVo QUATTROcare unit and is specifically designed to fit this unit only. The lubricant spray can is unable to be used manually. NOTE: The Kallo QUATTROcare should be used with only pre-cleaned dental handpieces and before they are sterilized.

The KaVo QUATTROcare Modified is a unit that uses an aerosol product based upon hydrocarbon propellants with a lubricant for use in the routine maintenance (cleaning and lubrication) of dental handpieces prior to sterilization. The lubricant is housed within a spray can and is a component of the unit. The KaVo QUATTROcare Modified device was modified to enhance the secure fit of the lubricant spray can to the unit through the utilization of two independent sealing systems - the screw can sealing and an additional O-ring sealing in the connector.

This looks like a 510(k) premarket notification for a dental handpiece lubricant/cleaner device. The provided text does not contain any information regarding acceptance criteria, study design, or performance metrics for the KaVo QUATTROcare Modified device. It primarily focuses on the device's description, intended use, and claim of substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory submission focused on substantial equivalence, not a performance study report.

If you have a different document that details the performance study for K071288, please provide it, and I would be happy to analyze it for the requested information.

Ask a specific question about this device