(78 days)
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.
Cutting, shaving, contouring and resection of oral osseous tissues (bone).
The Waterlase™ Millennium® hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Waterlase™ 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 laser energized 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 Waterlase™ 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.
The provided FDA 510(k) summary for the BioLase Waterlase Millennium focuses on demonstrating substantial equivalence to predicate devices, primarily traditional dental handpieces. As such, it does not contain the typical information one would expect for a study proving a device meets specific acceptance criteria using quantitative metrics like sensitivity, specificity, or accuracy.
The summary references "clinical results reported in this Premarket Notification," but it does not detail these clinical studies in a granular way that would allow for the extraction of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, or expert adjudication.
Therefore, for almost all of the requested categories, the answer is "Not provided in the document."
Here is the breakdown based on the provided text:
Acceptance Criteria and Device Performance Study (Not Provided in Detail)
The document asserts "Waterlase Millennium is substantially equivalent to the Dental handpiece in terms of safety and efficacy," based on "clinical results reported in this Premarket Notification and Feature Comparison Table." However, specific quantitative acceptance criteria (e.g., minimum percentage of successful cavity preparations, a defined tissue removal rate, or reduction in patient discomfort scores) are not explicitly stated. Likewise, the "reported device performance" against such criteria is also not detailed.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated and quantified in this document. The overarching criterion is "substantially equivalent in terms of safety and efficacy" to predicate dental handpieces. | Not explicitly reported in quantifiable metrics against specific acceptance criteria in this document. |
Additional Study Information:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided in the document. The document mentions "clinical results reported in this Premarket Notification" but does not detail the size or nature of the test set, nor its provenance.
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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 provided in the document. The means by which any clinical study data was evaluated or ground truth established (if applicable to the study type) are not described.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided in the document.
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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 surgical instrument (hydrokinetic tissue cutting system) and not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to readers improving with AI assistance would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device for direct clinical use, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided in the document. The clinical results mentioned are not detailed enough to ascertain the type of ground truth (e.g., direct observation of tissue removal, patient outcomes, success of cavity preparations, etc.).
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The sample size for the training set:
- Not applicable / Not provided in the document. As this is not an AI/machine learning device, there wouldn't typically be a "training set" in the sense of data used to train an algorithm. If "training set" refers to data used for initial development or pilot studies, it is not described.
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How the ground truth for the training set was established:
- Not applicable / Not provided in the document. As per point 7.
§ 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.