(3 days)
combi touch incorporates, within a single device, the functions of an ultrasonic scaler and of an air-polishing prophylaxis unit.
Ultrasonic scaler function:
combi touch, by using the appropriate associated inserts and the ultrasonic handpiece, is intended for use in the following dental applications:
- Removing supra and subgingival calculus deposits and stains from teeth
- Periodontal therapy and debridement for all types of periodontal disease, including 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 roots canals
- Cavity preparation
- Cleaning restorations and implant surfaces
Air-polishing prophylaxis function:
By using the appropriate air polishing handpiece, combi touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment.
The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis 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.
combi touch is intended for the following oral prophylaxis 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 fixtures prior to loading
- Stain removal for shade determination
- Plaque removal prior to fluoride treatment
- Plaque and stain removal prior to whitening procedure
combi touch is also intended for use as an air-polisher in patients suffering from periodontal disease. combi touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
The combi touch combines, in a single appliance, a multi-purpose piezoelectric scaler and water jet, air, and powder polisher, intended for complete supra- and subgingival dental prophylaxis.
In regards to the various possible ultrasonic treatments, combi touch can be used either connected directly to the main water supply in the dental practice, or with independent irrigation through the special liquid container, which can hold different types of medical solutions.
The appliance is equipped with an automatic tuning circuit which compensates the wear of the inserts, thus always allowing operation in conditions of maximum efficiency.
The operating principle of the polisher is based on the mechanical action obtained from a jet of various crystal types accelerated by a flow of compressed air. The kinetic energy thus imprinted at the particles, dissipates almost completely due to impact against the surface of the enamel, producing a gentle but effective cleaning action. The action is completed by a jet of water which, using the vacuum created around the air-polishing handpiece, has a bellshape around the main flow, thus producing a double effect: to prevent much of the rebound and the leakage of the cloud of powder and perform continuous washing of the treated area, dissolving the powder.
The provided documentation describes the acceptance criteria and a study demonstrating that the Mectron S.p.A. "Combi Touch" device meets these criteria. The device is an ultrasonic scaler and air-polishing prophylaxis unit.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by the comparison to the predicate device and the adherence to various non-clinical performance standards. The "reported device performance" is essentially that the "combi touch" meets or is comparable to the predicate device in all measured aspects and complies with the listed standards.
| Item for Comparison | COMBI TOUCH (Subject Device) | EMS AIRFLOW PROPHYLAXIS MASTER (Predicate Device - K190124) | MULTIPIEZO (Reference Device - K140965) | Acceptance Criteria / Indication of Performance |
|---|---|---|---|---|
| Intended Use | Ultrasonic scaler function: removing calculus, periodontal therapy, scaling, root planing, releasing crowns, condensing gutta percha, amalgam condensation/burnishing, root canal prep/cleaning/irrigating, cavity prep, cleaning restorations/implants. Air-polishing function: complete supra- and sub-gingival prophylaxis (plaque/stain removal for sealants, surface prep before bonding, orthodontic patients, implant fixtures, shade determination, fluoride treatment, whitening procedures). Non-surgical removal of subgingival plaque in pockets up to 5mm after initial periodontal treatment. | Ultrasonic scaler function: removing calculus, periodontal pocket lavage, scaling, root planning, releasing crowns, condensing gutta percha, amalgam condensation/burnishing, root canal prep/cleaning/irrigating, cavity prep, cementing inlays/onlays, retrograde prep of root canals. Air-polishing function: cleaning/polishing of teeth (plaque/stain/soft deposit removal). Non-surgical removal of subgingival plaque in pockets up to 5mm after initial periodontal treatment. | Piezoelectric ultrasonic dental scaler for: Scaling (supra/subgingival, interdental calculus/plaque). Periodontology (periodontal therapy, debridement, pocket irrigation). Endodontics (root canal reaming, irrigation, revision, filling, gutta-percha condensation, retrograde prep). Restorative/Prosthetics (cavity prep, prosthesis removal, amalgam condensation, crown prep finishing, inlay/onlay condensation, implants/restorations cleaning). | Similar to PD1 (except for cementing inlays and onlays which Combi Touch cannot perform). Similar to RD for ultrasonic scaler function. The device is considered substantially equivalent for its intended use. |
| Technological Characteristics | Piezoelectric ultrasonic technology (mechanical micro-vibration of insert tips via piezoceramic disks). Air-polishing: pressurized air mixed with water and powder projected onto tooth surface. | Piezoelectric ultrasonic technology (mechanical micro-vibration of insert tips via piezoceramic disks). Air-polishing: pressurized air mixed with water and powder projected onto tooth surface. | Piezoelectric ultrasonic technology (mechanical micro-vibration of insert tips via piezoceramic disks). | Similar to PD1 and RD for ultrasonic scaler function. No new questions regarding safety or effectiveness. |
| Biocompatibility | Biocompatible (materials in direct contact with patient: Stainless steel, Diamond coating, Titanium nitride coating, PEEK, EVA+LPDE, Viton, PPSU, TPX). | Biocompatible (materials in direct contact with patient: Stainless steel, Titanium, COC, PPSU, EPDM, PEEK, Hytrel SC969). | Biocompatible (materials in direct contact with patient: Stainless steel, Diamond coating, Titanium nitride coating, PEEK). | Biocompatible; Similar to PD1 & RD. Differences in materials do not impact safety or performance. |
| Prophylaxis Powders Used | Sodium Bicarbonate based powder, Glycine based powder. | PERIO (Glycine), SOFT (Glycine), CLASSIC (Sodium Bicarbonate), PLUS (Erythritol). | N/A | Tests demonstrated effective plaque removal and no dental surface damage, with erosion comparable to or lower than the predicate device. This indicates the powders are effective and safe for their intended use. |
| Non-Clinical Standards Compliance | Complies with: CEI UNI EN ISO 14971:2019, ISO/TR 24971:2020, IEC 60601-1:2015, AMD1:2012, IEC 60601-1-2:2014; Amendment 1:2020, IEC 60601-1-6:2010 Amendment 1:2013, IEC 62366: 2007/AMD1:2014, IEC 62304:2006 + AMD1:2015, ASTM D4169-16, ISO 7153-1:2016, ASTM F899-20, ASTM F136-13, EN 10088-3:2014, EN ISO 11737-1:2018/AMD 1:2021, EN ISO 11737-2:2020, EN 62353:2015, IEC 62471:2006, EN 62471:2008, IEC 80601-2-60:2019, ISO 10993-1:2018, UNI EN ISO 10993-5:2009, UNI EN ISO 10993-7:2008, ISO 10993-10:2021, ISO 10933-11:2017, ISO 10993-12:2021, ISO 11607-1:2019, ISO 11607-2:2019, UNI EN 1422:2014, EN ISO 15223-1:2021, UNI 556-1:2002/AC:2006, AAMI ST77:2013/®:2018, AAMI ST79:2017, AAMI ST8:2013, ISO 15883-1:2007, ISO/TS 15883-5:2005, ISO 15883-5:2021, AAMI TIR12:2010, AAMI TIR28:2016, AAMI TIR30:2011 (R2016), ISO 17664-1:2021, EN ISO 15883-4:2018, ASTM E1837-96 (Reapproved 2014), AFNOR NF T 72-281, 2014, EN 1276:2019, EN ISO 11135:2014/A1:2019, ISO 11138-1:2017, ISO 11138-2:2017, ISO 11138-3:2017, ISO 11138-7:2017, EN ISO 11737-1:2015, EN ISO 11737-2:2020, UNI EN 868-2:2009, ISO 17665-1:2006, AAMI/ISO TIR 17665-2:2009, EN ISO 5349-1:2001, ISTA 2A :2011, UNI EN ISO 5349-2:2015, EN ISO 20417:2021. | Complies with relevant FDA-recognized standards. | Complies with relevant FDA-recognized standards. | Compliance with all listed non-clinical standards. This ensures the device's basic safety and performance according to established benchmarks. |
Study Proving Acceptance Criteria:
The documentation states that:
"The data presented in this submission demonstrates the identities existing between the combi touch device and the predicate devices, and thus support a finding of substantial equivalence between the subject device and the referenced predicated devices, which are already in commercial distribution in the United States."
And critically, regarding performance testing:
"The results of the tests indicated that combi touch, when used in combination with the commercially-available prophylaxis powders identified above: 1) was effective in the removal of simulated plaque from dental surfaces. 2) did not cause any damages to dental surfaces, as verified by the examination of tooth surfaces morphology after the treatment; 3) proved to be safe and effective for its intended use, producing erosion that is comparable to, or even lower than, the erosion produced by the predicate device."
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 explicitly states: "Animal or clinical testing were not required to prove combi touch's substantial equivalence when compared to the predicate/reference devices." This implies that the testing for the "Combi Touch" device focused on non-clinical performance and engineering standard compliance rather than a traditional clinical study with patient data.
- Sample Size for Test Set: Not specified for any clinical data. For the non-clinical performance involving "simulated plaque from dental surfaces" and "examination of tooth surfaces morphology," the specific sample size of tested dental surfaces or teeth is not provided within this document.
- Data Provenance: Not specified, as it's primarily non-clinical 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, as this was not a clinical study involving human ground truth assessment. The assessment of "simulated plaque" and "tooth surfaces morphology" would likely involve expert evaluation, but the number and qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was not a clinical study requiring adjudication of expert interpretations.
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 an ultrasonic scaler/air-polisher, not an AI-powered diagnostic or assistive tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not feature an AI algorithm for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests mentioned (plaque removal, dental surface damage/erosion), the ground truth appears to be based on:
- Objective measurements of simulated plaque removal.
- Laboratory examination of tooth surface morphology (e.g., microscopy) to assess damage/erosion after treatment.
- Comparison against the performance of the predicate device under similar testing conditions.
8. The sample size for the training set
Not applicable. This device does not appear to employ machine learning or AI that would require a 'training set.'
9. How the ground truth for the training set was established
Not applicable.
§ 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.