(33 days)
Class I - V cavity preparation
Caries removal
Hard tissue surface roughening or etching
The Millennium™ hydrokinetic tissuc cutting system is a diverse instrument for Pine Millennium - Hydrokins. Millennium™ utilizes advanced laser and performing coverer. comologies to incise, excise and ablate intraoral soft and hard water alonitation totatively. An erbium, chromium, yttrium, scandium, gallium gamet (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, yielding 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.
Based on the provided text, the document describes a 510(k) submission for the Millennium™ hydrokinetic tissue cutting system, where the primary objective is to demonstrate substantial equivalence to existing dental devices, rather than establishing specific acceptance criteria for a new, unique performance metric. Therefore, the "acceptance criteria" discussed are largely qualitative and based on equivalence to predicate devices, and the "study" is a collection of various tests and comparisons to support this equivalence.
Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text for certain categories:
Acceptance Criteria and Device Performance
The document does not specify quantitative acceptance criteria in the form of thresholds for specific performance metrics (e.g., "device must achieve X accuracy"). Instead, the "acceptance criteria" are implied through the concept of "substantial equivalence" to predicate devices for aspects like safety, efficacy, indications for use, materials, and mechanical cutting mode.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as presented for Millennium™) |
|---|---|
| Similar Indications for Use: Caries removal, cavity preparation, surface roughening (shared with predicates). | Millennium™ Indications: Caries removal, cavity preparation, surface roughening, incision, excision, and ablation of soft tissues. (Broader than some predicates, but includes shared indications). |
| Similar Cutting Mode: Mechanical, non-thermal. | Millennium™ Cutting Mode: Mechanical, non-thermal. |
| Similar Materials: Medical grade plastics, steel, stainless steel, aluminum, brass and electronic parts and components. | Millennium™ Materials: Medical grade plastics, steel, stainless steel, aluminum, brass and electronic parts and components. |
| Similar Safety and Efficacy Profile: Demonstrated through various tests and comparisons. | Millennium™ Safety & Efficacy: Demonstrated through multi-phase in-vitro and in-vivo clinical trials (animals and humans), pulp temperature studies, SEM/optical microscopy, equivalent performance specifications. |
| Biocompatible Cutting Medium (advantageous for Millennium™). | Millennium™ Cutting Medium: High speed water droplets (biocompatible). |
| Non-contact operation (advantageous for Millennium™). | Millennium™ Mode of Operation: Non-contact. |
Study Details
The provided text describes a submission for substantial equivalence. It does not detail a single, self-contained study with a specific "test set" or "training set" in the context of an AI/algorithm-driven device as your questions imply. Instead, it refers to various forms of evaluation.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a single numerical value. The document refers to "multi-phase in-vitro and in-vivo clinical trials on animals and humans," but no specific sample sizes for these trials are provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The trials mentioned are "clinical trials," implying human (and animal) subjects, but the location is not specified. They are "retrospective or prospective" for efficacy, but the document does state "Clinical evaluation in randomized, double-blinded trials" which typically implies prospective and controlled studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The document refers to "clinical evaluation" and "clinical judgment and care," implying dentists/clinicians, but no specific number or detailed qualifications of experts establishing ground truth for the test set are given.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated.
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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 physical hydrokinetic tissue cutting system, not an AI or imaging diagnostic tool that would involve "human readers" or "AI assistance" in the sense of a diagnostic interpretation task.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The Millennium™ is a medical device used by a human operator (clinician). The concept of "standalone algorithm performance" does not apply here.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "clinical trials," the ground truth would likely involve clinical assessment of treatment efficacy (e.g., success of caries removal, cavity preparation, tissue excision) and safety outcomes (e.g., pulp temperature, patient comfort/healing). These assessments would be performed by clinicians, potentially with supporting diagnostic information (e.g., imaging, clinical observation).
- For "pulp temperature studies," the ground truth is objective temperature measurement.
- For "Scanning Electron and Optical Microscopy," the ground truth is the observable structural changes in tissue.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device with a distinct "training set." The development would have involved iterative design and testing, but not a formally defined machine learning training set.
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How the ground truth for the training set was established: Not applicable, as there's no "training set" in the context of AI/machine learning. For the development of the device, engineering and clinical validation would be based on established scientific principles and clinical observations.
§ 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.