(70 days)
For use on adult and pediatric patients for the following:
Class I, II, III, IV and V cavity preparation
Caries removal
Hard tissue surface roughening or etching
Enameloplasty, excavation of pits and fissures for placement of sealants
The Millennium™ hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Millennium™ utilizes advanced laser and water atomization technologies to incise, excise and ablate intraoral soft and hard tissues safely and effectively. An erbium, chromium, yttrium, scandium, gallium garnet (Er, Cr:YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result.
The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, vielding quick and clean mechanical tissue removal.
A flexible fiberoptic handpiece delivers the Millennium™s unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.
This document describes the BioLase Technology, Inc. Millennium™ hydrokinetic tissue cutting system, intended for various dental applications.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative "acceptance criteria" for the Millennium™ device in terms of specific performance metrics (e.g., specific percentages for accuracy, sensitivity, or specificity). Instead, substantial equivalence to existing predicate devices (dental handpieces, microetchers) is demonstrated through a feature comparison table and qualitative statements regarding safety and efficacy.
| Feature | Acceptance Criteria (Implied by Predicate Devices) | Reported Millennium™ Performance | Meets Criteria? |
|---|---|---|---|
| Indications for Use | Caries removal, cavity preparation, surface roughening (for microetchers), incision, excision, and ablation of soft tissues (implied by combined predicates) | Caries removal, cavity preparation, surface roughening, incision, excision and ablation of soft tissues | |
| Specifically for adult and pediatric patients for Class I-V cavity preparation, caries removal, hard tissue surface roughening or etching, enameloplasty, excavation of pits and fissures for placement of sealants. | YES | ||
| Cutting Mode | Mechanical, non-thermal | Mechanical, non-thermal | YES |
| Cutting Medium | Rotating bur (dental handpiece), High speed aluminum oxide (microetcher) | High speed water droplets | YES |
| Biocompatible Cutting Medium? | N/A (Yes for standard handpieces; No for microetchers) | Yes (advantage over microetchers) | YES |
| Spray Flow Control? | Yes (dental handpiece) | Yes | YES |
| Mode of Operation | Contact (dental handpiece), Non-contact (microetcher) | Non-contact | YES |
| Safety | Safe for dental applications, no undue risks | Demonstrated through multi-phase in-vitro and in-vivo clinical trials on animals and humans, including pulp temperature studies. | YES |
| Efficacy | Effective for stated indications | Demonstrated through multi-phase in-vitro and in-vivo clinical trials on animals and humans. | YES |
The basis for acceptance is stated as "substantially equivalent" to predicate devices, which implies that the device performs with comparable safety and efficacy for its intended use.
2. Sample Sizes Used for the Test Set and Data Provenance
The document states: "reported results from multi-phase in-vitro and in-vivo clinical trials and Feature Comparison Table demonstrate that Millennium™ is substantially equivalent..." and "Safety and efficacy have been demonstrated through in-vitro, in-vivo and clinical trials on animals and humans."
- Test Set Sample Size: The specific sample sizes for the in-vivo human clinical trials are not provided in the summary.
- Data Provenance: The document does not specify the country of origin for the data. The studies performed include both in-vitro and in-vivo (on animals and humans), indicating a mix of pre-clinical bench testing and prospective clinical investigation. The term "reported results" suggests the studies were already completed at the time of submission (retrospective for the submission itself, though the trials were prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The summary broadly refers to "clinical evaluation in randomized, double-blinded trials" but does not detail the process or experts involved in establishing ground truth for the clinical outcomes.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable to this type of device (a dental cutting system). The device itself performs a physical action, not an interpretative task requiring human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
This is not applicable as the Millennium™ is a physical surgical device, not an AI algorithm. Its performance is always a "human-in-the-loop" scenario, as a dentist or dental professional operates it.
7. Type of Ground Truth Used
The ground truth for the performance of the Millennium™ device appears to be based on:
- Clinical Evaluation: Outcomes from "randomized, double-blinded trials" on humans, assessed by clinicians to determine safety and efficacy (e.g., caries removal, cavity preparation success, patient comfort, extent of tissue removal).
- Pulp Temperature Studies: Objective physiological measurements to ensure safety (e.g., avoiding thermal damage).
- Scanning Electron and Optical Microscopy: Objective imaging to assess the quality of tissue cutting and surface preparation, and potentially to corroborate efficacy.
- Equivalent Performance Specifications: Comparison to established predicate devices based on their known performance.
8. Sample Size for the Training Set
This is not applicable as the Millennium™ is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the Millennium™ is a physical device, not an AI/ML algorithm.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.