(217 days)
The BioSonic Suvi ultrasonic scaler is intended for use in dental applications such as supra and subgingival scaling, periodontal therapy, endodontic procedures, cavity preparation, and restorative dentistry.
The BioSonic Suvi Air Polisher is intended for use in the cleaning, surface preparation 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 BioSonic Suvi Air Polisher is also indicated for the nonsurgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
The BioSonic Suvi Piezoelectric Scaler and Air Polisher (BioSonic Suvi) is a combination scaler and polisher device for use in dental care. It combines the functions of an ultrasonic scaler and dental air polisher into a single device.
The scaler is used for removal of tartar or calculus on teeth and other dental work where ultrasonic vibration is beneficial. The polisher unit is used for removal of plaque, cleaning discolored teeth and other dental work where air polishing is beneficial.
The BioSonic Suyi will be offered in (4) four different models. These are the BioSonic Suvi Premier, BioSonic Suvi Premier Plus, BioSonic Suvi Elite and the BioSonic Suvi Elite Plus. The Premier and Premier Plus are scalers only. The Elite and Elite Plus are combination scaler and polisher units
The Premier and Plus versions differ in whether they include a standard tap water supply attachment or an optional medicament dispenser system. The standard tap water versions connect directly to a tap water supply using a hose connection. The medicament dispenser system provides either medicine or clean water using a medicament bottle which connects to the side of the unit.
The medicament versions utilize an internal air compressor to pressurize the medicament. During use, compressed air forces fluids from the bottle, through the hose, to the hand piece and the tip/nozzle. Thus medication can be provided if desired.
The provided document is a 510(k) summary for the BioSonic Suvi Piezoelectric Scaler and Polisher. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through a clinical or non-clinical performance study with defined metrics.
Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth establishment for a performance study are not available in this type of regulatory submission. The document primarily describes the device, its intended use, and compares it to a legally marketed predicate device.
However, I can extract the information that is present and indicate where the requested information is not provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance (as per non-clinical testing) |
|---|---|
| Compliance with general requirements for basic safety and essential performance of medical electrical equipment. (IEC 60601-1/EN 60601-1) | Meets the requirements of: IEC 60601-1/EN 60601-1 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance |
| Compliance with electromagnetic compatibility (EMC) requirements for medical electrical equipment. (EN 60601-1-2) | Meets the requirements of: EN 60601-1-2 Medical electrical equipment, Parts 1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility - Requirements and tests |
| Substantial equivalence to predicate device (EMS Air-Flow Master Piezon K110173). | Conclusion: The BioSonic Suvi Piezoelectric Scaler and Polisher is substantially equivalent to its predicate device. It has the same indications for use, is constructed from the same basic materials and incorporates the same operational principles. |
Missing Information:
- Specific quantitative or qualitative acceptance criteria beyond compliance with the listed standards.
- Detailed performance metrics (e.g., scaling efficiency, polishing effectiveness, plaque removal percentage, etc.) are not provided. The document focuses on safety and general functional equivalence.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. This document describes non-clinical testing for compliance with general safety and EMC standards, and a comparison to a predicate device for substantial equivalence. It does not refer to a test set in the context of a clinical performance study involving human or biological samples. The testing appears to be bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable/Not provided. There is no mention of experts establishing ground truth for a test set in the context of a clinical/performance study.
4. Adjudication Method for the Test Set
Not applicable/Not provided. No test set or adjudication method is 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/Not provided. This device is a medical instrument (scaler and polisher), not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study related to AI assistance is not relevant or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable/Not provided. This device is a physical instrument for dental procedures, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. For the non-clinical testing, the "ground truth" would be the successful demonstration of compliance with the specified IEC and EN standards, which are engineering and safety standards, not clinical ground truth.
8. The Sample Size for the Training Set
Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. This device is not an AI/ML algorithm.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.