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.

AI/ML Overview

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.

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.
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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated.
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.
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.
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.
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.
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.

Summary

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Image /page/0/Picture/4 description: The image shows a handwritten date, "2/24/99". The numbers are written in black ink on a white background. The handwriting is somewhat cursive, with the numbers slightly slanted.

990219

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

REGULATORYAUTHORITY:	Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY:	BioLase Technology, Inc.981 Calle AmanecerSan Clemente, California 92673
CONTACT:	Mr. Andrew I. KimmelBioLase Technology, Inc.981 Calle AmanecerSan Clemente, California 92673(714) 361-1200 (714) 361-0204 Fax
TRADE NAME:	MillenniumTM
COMMON NAME:	Hydrokinetic tissue cutting system
CLASSIFICATION NAME:	Hydrokinetic dental system
CLASSIFICATION CODE:	79 MXF
EQUIVALENT DEVICES:
Dental handpiece	Dentsply
Dental handpiece	Star Dental
Dental handpiece	Siemens
Microetcher Ab	Danville Engineering, Inc.
KV-1	Kreativ, Inc.

DEVICE DESCRIPTION:

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INDICATIONS FOR USE:

Class I - V cavity preparation

Caries removal

Hard tissue surface roughening or etching

CAUTIONS AND CONTRAINDICATIONS:

All clinical procedures performed with Millennium™ must be subjected to the same clinical judgement and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercise caution for general medical conditions that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disease, bleeding disorders, sleep apnea or an immune system deficiency. Medical clearance from patient's physician is advisable when doubt exists regarding treatment.

SUBSTANTIAL EQUIVALENCE:

There are no unique applications, indications, materials or specifications presented herein. This Premarket Notification, reported results from multi-phase in-vitro and in-vivo clinical trials and Feature Comparison Table demonstrate that Millennium™ is substantially equivalent to the Dental handpiece in terms of safety and efficacy.

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	FEATURE COMPARISON TABLE
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FEATURE	Millennium ™	Dental handpiece	Microetcher Ab	KV-1	SE
Input Voltage:	115/230 V~50/60 Hz	N/A	N/A	N/A	YES
Materials:	Medical grade plastics, steel, stainless steel, aluminum, brass and electronic parts and components	Same	Same	Same	YES
Indications for Use:	Caries removal, cavity preparation, surface roughening, incision, excision and ablation of soft tissues	Caries removal, cavity preparation	Caries removal, cavity preparation, surface roughening	Caries removal, cavity preparation, surface roughening	YES
Cutting Mode:	Mechanical, non-thermal	Same	Same	Same	YES
Cutting Medium:	High speed water droplets	Rotating bur	High speed aluminum oxide	High speed aluminum oxide	YES
BiocompatibleCutting Medium?	Yes	N/A	No	No	YES
Spray FlowControl?	Yes	Yes	N/A	N/A	YES
Mode ofOperation:	Non-contact	Contact	Non-contact	Non-contact	YES
Manufacturer:	BioLase Technology, Inc	DentsplyLaers ResearchMidwestStar DentalSiemens	Danville Engineering Inc.	Kreativ Inc.	YES

CONCLUSION:

Millennium™ is substantially equivalent to several available, established dental technologies. Safety and efficacy have been demonstrated through in-vitro, in-vivo and clinical trials on animals and humans. Technically, Millennium™ performs through the same mechanical mechanism as other technologies but has the benefit of using a biocompatible agent as its cutting medium. Evidence of equivalence has been demonstrated through:

Clinical evaluation in randomized, double-blinded trials .
. Pulp temperature studies
Scanning Electron and Optical Microscopy .
Equivalent performance specifications .
Promotional materials for equivalent systems ◆
. Equivalent intended uses
Feature comparison table .

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Page 2 – Mr. Andrew I. Kimmel

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K990219 510(k) Number (if known):

Device Name:

Millennium™

Indications for Use:

Class I, II, III, IV and V cavity preparation

Caries removal

Hard tissue surface roughening or etching

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off
Division of General Restorative Devices
510(k) Number	K990219

Prescription Use (Per 21 CFR 801.109)	X
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Over-The-Counter-Use	_________________
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Regulation Number and Section

§ 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.