(426 days)
Compothixo is indicated for modeling of composite, occlusal modeling, fissures and removal of excess composite, layer application technique, bulk technique in small cavities, and for direct veneering. Compothixo represents the next generation composite placement and modeling instrument suitable for all classes of restorations. Compothixo technology utilizes the thixotropic properties of composites by only changing viscosity, without altering the chemical or mechanical characteristics of the material.
The Compothixo is a vibration instrument intended for composite modeling by dental professionals.
Compothixo is a hand-held, battery-operated, vibration composite modeling instrument. When the device is turned on the unit begins to vibrate at 140 Hz. It functions in the same way as a hand-operated composite modeling instrument, and also has interchangeable tips which are similar to the tips on manual composite modeling instruments. The main difference is the use of a battery-operated motor which activates vibrations in the tip, at frequencies which cannot be achieved by hand manipulation alone. Intermittent hand motion can achieve up to 4 Hz of vibration. Compothixo can also be hand operated when it is turned off. The rated voltage is 1.3V and rated current is 85 mA. Therefore, motor power consumption is 110 mW. Compothixo is composed of the changeable tips, a chuck and the handle. The DC motor M is connected to the negative polarity of the battery housed in the handpiece, on the other side of the on/off switch. The latter connect the positive polarity of the battery to the motor depending on the status. The handpiece is composed of an over molded elastomeric plastic, which encompasses the over molded plastic case.
Here's an analysis of the provided text regarding the Compothixo device's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on functional characteristics and safety, comparing the Compothixo to a predicate device. Acceptance criteria are implicitly defined by establishing substantial equivalence based on these comparisons.
| Acceptance Criteria Category | Specific Criteria | Predicate Device Performance / Reference | Compothixo Performance / Reference |
|---|---|---|---|
| Intended Use Equivalence | Intended Use | Composite modeling by dental professionals (Hu-Friedy Composite Instrument) | Composite modeling by dental professionals (vibration instrument) |
| Technological Characteristics Equivalence | Tip Shapes | Same as predicate | Same as predicate |
| Operation Method | Manual movement of tip across surface with intermittent hand motion (up to 4 Hz) | Movement of tip across surface with integrated vibration element (140 Hz) or hand-operated when off | |
| Biocompatibility | Material Safety | Not explicitly stated for predicate in this document, assumed to be safe. | Passed ISO 10993 testing. |
| Electromagnetic Compatibility (EMC) | EMC Compliance | Not explicitly stated for predicate in this document, assumed to be compliant. | Passed IEC 60601-1-2 testing at an independent laboratory. |
| Bench Testing (Performance) | Frequency of Hand Movement | Up to 4 Hz (intermittent) | 140 Hz (vibration element) |
| Activation Frequency | Not applicable (manual) | 140 Hz | |
| Maximal Radial Amplitude of Modeling Tip | Not explicitly stated for predicate in this document. | Evaluated against predicate, but specific values not provided in summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document states, "Clinical testing has not been conducted on this product." The testing performed was bench testing and biocompatibility testing.
- Data Provenance: Not applicable for a clinical test set. Bench testing data provenance is from the manufacturer's own evaluation or independent labs for EMC.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable as clinical testing was not performed; therefore, no "ground truth" derived from expert assessment of patient data was established for a test set.
4. Adjudication Method for the Test Set
- Not applicable as clinical testing was not performed.
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 dental hand instrument, not an AI-powered diagnostic 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 is a physical hand tool, not an algorithm or software. The "standalone" performance refers to the device's functional characteristics (vibration frequency, amplitude) as evaluated in bench testing, separate from human use for final substantial equivalence determination.
7. The Type of Ground Truth Used
- For biocompatibility, the ground truth is established by adherence to documented international standards (ISO 10993).
- For electromagnetic compatibility, the ground truth is established by adherence to documented international standards (IEC 60601-1-2).
- For bench testing of performance characteristics (Frequency of hand movement, Activation frequency, Maximal radial amplitude of the modeling tip), the "ground truth" for comparison was the performance characteristics of the predicate device (Hu-Friedy Composite Instrument) or the inherent physical properties of the device itself (e.g., its designed vibration frequency of 140 Hz). This involved direct measurement and comparison.
8. The Sample Size for the Training Set
- Not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as this is a physical medical device, not an AI/machine learning model.
§ 872.4565 Dental hand instrument.
(a)
Identification. A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures. The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.(b)
Classification. Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.