The laser is indicated for Incision, Excision, Hemostasis, Ablation of Tissue, and Vaporization of Tissue in the oral cavity. The additional representative indications include Removal of Caries, Cavity Preparation, Modification or Etching of Enamel prior to acidentify, and Modification or Etching of Dentin prior to acid etching.

Device Description

Not Found

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria & Performance Metric	Stated Acceptance Criteria	Reported Device Performance
Pulpal Temperature Rise	Max 5.5°C rise (to avoid irreversible damage)	- 20 mJ: 0.08°C - 50 mJ: 1.07°C - 100 mJ: 0.84°C - 150 mJ: 1.12°C - 200 mJ: 2.3°C - Drill (Air): 0.25°C - Drill (H2O): 0.05°C
Pulpal Healing (H&E Histology)	No deleterious effect	No deleterious effect for laser or control treatment
Pulp Vitality (Long-term)	No compromise in pulp vitality (1.5 year follow-up)	No compromise in pulp vitality over 1.5 year follow-up
Pulp Vitality (Patient-matched, pre/post)	No difference in pulpal vitality post-surgery over 3 months compared to pre-surgery/drill	No difference in pulpal vitality pre-surgery, post-surgery, and over 3 months
Pulp Vitality (Randomized, pre/post)	No significant difference in pulp vitality between laser and control after 3 months	No significant difference between laser and control in pulp vitality pre-surgery and after a 3 month period
Surface Morphology (non-treatment site)	No changes in surface morphology	No changes in surface morphology except at the treatment site
Surface Morphology (treatment site)	Equivalent surface changes to drill	Drill and laser show equivalent surface changes at the treatment site
Structural Morphology (Etched Tooth)	Roughened dentin/enamel, no cracking/fissuring/charring, open dentinal tubules, vaporized organic material (leaving inorganic components), no remaining caries, crater below margin	Effective removal of tooth structure, no fissures/cracks, scaled/roughened surface without thermal damage. At 430 mJ, hydroxyapatite vaporized, pores developed, no visible cracks.
Adjacent Structures Damage	Damage less than drill when defocused	Damage due to inadvertent lasing of adjacent structures usually less than the drill, as laser does not cut effectively when defocused.
Caries Removal Effectiveness	More effective than the drill	Investigators rate caries removal more effective than the drill
Cavity Preparation Effectiveness	Equal to the drill	Investigators rate cavity preparation with the laser equal to the drill
Laser Etching Effectiveness	Much more effective than acid etching	Investigators rate laser etching much more effective than acid etching
Overall Equivalence to Standard Treatment	Equivalent to standard treatment	Animal and human studies demonstrate that the Er:YAG laser is equivalent to standard treatment
Caries Removal Completion Rate	Not explicitly stated but 100% is implied for "completely removed"	100% of teeth treated had all classes of caries (I-V) completely removed
Cavity Preparation & Restoration Adequacy	Not explicitly stated but 100% after 3 months is implied	100% of treated teeth had adequate cavity preparation and restoration after 3 months
Pediatric Use Complications (Primary Teeth)	No reported complications	- Phase I (51 procedures): 12% on primary teeth, no complications. - Phase II (130 procedures): 15% on primary teeth, no complications. - Additional data (219 procedures): 22% on primary teeth, no complications. - Total (400 procedures): 19% on primary teeth, no complications.
Pediatric Use Anesthesia Request	No anesthesia requested by patient	No anesthesia requested by patient in any pediatric primary tooth procedures (Phase I). (Implied for others as well as "no reported complications")

2. Sample Size Used for the Test Set and Data Provenance

Pulpal Temperature Study:
- Sample Size: Not explicitly stated, but the data is from "teeth in dogs" (Zach and Cohen) and other substantiating studies (Powell, et. Al.). The presented table shows experimental conditions, not a specific number of teeth in a test set. This appears to be a benchmark/foundational study.
- Data Provenance: Implied to be retrospective from existing literature (Zach and Cohen, Powell, et. Al.) for the benchmark, and experimental for the device's specific temperature measurements. Country of origin not specified.
Pulp Vitality Studies:
- Study 1 (Histological): "H&E histological evidence over pulpal healing time". Sample size not specified. Data provenance: "Animal and human studies" in surface morphology suggests this could be both, but not explicitly stated here.
- Study 2 (1.5 year follow-up): Sample size not specified.
- Study 3 (Patient-matched): 33 patients, two teeth each (total 66 teeth). Data provenance: Not specified (but likely prospective clinical study).
- Study 4 (Randomized): 125 randomized adult teeth. Data provenance: Not specified (but likely prospective clinical study).
Surface Morphology Studies:
- Sample Size: Not specified for animal or human studies.
- Data Provenance: "Animal and human studies" (likely retrospective or previously published experimental for establishing general findings, then performed with the device).
Structural Morphology Studies:
- Sample Size: Not specified for Hibst and Keller or Paghdiwala. Laser dosimetries ranged from 50-350 mJ (Hibst and Keller) and 430 mJ (Paghdiwala).
- Data Provenance: Reported by "Hibst and Keller" and "Paghdiwala," suggesting these are from published literature used as reference points, or studies performed by them.
Caries Removal / Cavity Prep / Equivalence Studies:
- Study 1,2,3 (Investigator Ratings): Sample size of investigators not specified.
- Study 4 (Overall Equivalence): Sample size not specified. Data provenance: "Animal and human studies."
- Study 5 (Caries Removal Rate): 125 randomized human adult teeth. Data provenance: "Multi-site study," implies prospective clinical data.
- Study 6 (Cavity Prep & Restoration Adequacy): 125 randomized human adult teeth. Data provenance: "Multi-site study," implies a prospective clinical data.
Pediatric Use Studies (Phase I, II, Additional Patient Data):
- Phase I: 51 laser procedures (6 on primary teeth).
- Phase II: 130 laser procedures (18 on primary teeth).
- Additional Patient Data: 219 laser procedures (48 on primary teeth).
- Total: 400 laser procedures (68 on primary teeth).
- Data Provenance: Clinical data described as "Phase I," "Phase II," and "additional patient data," suggesting prospective clinical trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Pulp Vitality (Histological): Not specified.
Pulp Vitality (Clinical): "Pulp vitality measurements" (Studies 3 & 4). The method of establishing ground truth (e.g., specific tests like electric pulp testing, thermal tests) is implied by "measurements," but the number and qualifications of experts interpreting these are not specified.
Surface Morphology: "Animal and human studies using SEM". Ground truth likely established by expert interpretation of SEM images. Number and qualifications of experts not specified.
Structural Morphology: "Hibst and Keller reported," "Paghdiwala showed." These are likely based on expert interpretation of micrographs. Number and qualifications not specified for these external references.
Caries Removal / Cavity Prep / Etching Ratings: "Investigators rate." Number and qualifications of these "investigators" are not specified.
Caries Removal Completion (125 teeth study): "completely removed in 100%". The method for determining "completely removed" (e.g., visual inspection, excavation to hard dentin, radiographs, pathological examination) and the number/qualifications of experts making this determination are not specified.
Cavity Preparation & Restoration Adequacy (125 teeth study): "still adequate after 3 months in 100%". The criteria for "adequate" and the number/qualifications of experts making this determination are not specified.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). The "all blinded" statements for Pulp Vitality and Surface Morphology suggest efforts to reduce bias, but not a specific consensus or adjudication process. For investigator ratings, it's unclear if there was a consensus process or if individual investigator opinions were aggregated.

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

There is no mention of an AI component in this device. Therefore, no MRMC study involving AI assistance for human readers was conducted or reported.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This device is a physical laser system, not an algorithm. Therefore, no standalone algorithm performance study was reported.

7. The Type of Ground Truth Used

Pulpal Temperature: Objective thermal measurements (°C rise) compared against a physiological benchmark (irreversible damage threshold).
Pulp Vitality:
- H&E histological evidence (pathology).
- Pulp vitality measurements (clinical tests, likely electric, thermal, or visual assessment of health status).
Surface Morphology: SEM (Scanning Electron Microscopy) observations and interpretations.
Structural Morphology: Detailed visual/microscopic observations (etched surface characteristics, cracks, charring, open tubules) and reported findings from scientific literature (Hibst, Keller, Paghdiwala).
Caries Removal / Cavity Prep / Etching Efficacy: "Investigators rate" (expert opinion/clinical judgment).
Caries Removal Completion / Cavity Prep & Restoration Adequacy (125 teeth study): Clinical assessment of presence/absence of caries and adequacy of preparation/restoration. The specific methodology for these assessments and the experts performing them are not detailed beyond "completely removed" and "adequate."
Pediatric Complications: Clinical observation/reporting of complications by healthcare professionals.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable as this is a physical medical device, not an AI/machine learning model. The various studies and experiments described serve as validation/testing.

9. How the Ground Truth for the Training Set Was Established

Not applicable (see point 8).

Summary

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SUMMARY OF SAFETY AND EFFICACY

Temperature A.

In a benchmark publication on temperatures which cause pulpal damage, Zach and Cohen showed that 15 % of teeth in dogs where pulpal temperature was raised to 10°F (5.5°C) had irreversible damage. These findings have been substantiated by Powell, et. Al. Therefore, if the pulpal temperature rises on only 5.5°C, one may conclude that there is no permanent damage to the pulp of the tooth due to the laser treatment.

Energy Output	Repetition Rate	Time with H2OCooling	Temperature in °C
20 mJ	10 Hz	2 sec	.08
50 mJ	10 Hz	2 sec	1.07
100 mJ	10 Hz	2 sec	.84
150 mJ	10 Hz	2 sec	1.12
200 mJ	10 Hz	2 sec	2.3
Drill in Air	Not Applicable	10 sec	.25
Drill in H2O	Not Applicable	10 sec	.05

TABLE 1 - PULP TEMPERATURES

B. Pulp Vitality (all blinded):

H&E histological evidence over pulpal healing time demonstrates no 1. deleterious effect for laser or control treatment.
1. Pulp vitality measurements over 1½ year follow-up demonstrate no compromise in pulp vitality.
Pulp vitality measurements on two teeth in each of 33 patients treated by laser and 3. drill from the save patient show no difference in pulpal vitality pre-surgery, postsurgery and over three months.
1. Pulp vitality measurements on 125 randomly adult teeth treated by laser and drill show no significant difference between the laser and the control in pulp vitality measurements pre-surgery and after a three month period.

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C. Surface Morphology (all blinded):

Animal and human studies using SEM demonstrated no changes in surface 1. morphology except at the treatment site.
Animal and human studies using SEM illustrated that the drill and laser show 2. equivalent surface changes at the treatment site.

Structural Morphology D.

The ideal etched tooth presents a roughened dentin or enamel surface and no 1. evidence of cracking, fissuring or charring. The dentin demonstrates open dentinal tubules. Organic material has been vaporized leaving the inorganic components of the tooth - leaving greater tooth surface area. In addition, a cavity preparation should show no remaining evidence of caries and a crater created by removal of tooth structure below the margin of the preparation.
Hibst and Keller reported on the effective removal of tooth structure with 2. ultrasructural changes in enamel and dentin. There were no fissures or cracks. The surface was scaled and roughened without signs of thermal damage. Laser dosimetries ranged from 50 - 350 mJ.
Paghdiwala showed at 430 mJ, hydroxyapatite has vaporized, developing pores 3. and surrounded by elevated fused inorganic tissue. No visible cracks radiated from the craters.

Adjacent Structures E.

Adjacent structures to the treated tooth surface include soft tissue, proximal teeth 1. and underlying bone. The damage due to inadvertent lasing of adjacent structures is usually less than the drill, since the laser does not cut effectively when defocused.

F. Efficacy

Investigators rate caries removal more effective than the drill 1.
Investigators rate cavity preparation with the laser equal to the drill. 2.
1. Investigators rate laser etching much more effective than acid etching.
Animal and human studies demonstrate that the Er: Y AG laser is equivalent 4: to standard treatment.

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In a multi-site study of 125 randomized human adult teeth, all classes of caries (I-ડ. V) were completely removed in 100% of the teeth treated.
In a multi-site study of 125 randomized human adult teeth all cavity preparation 6. and restoration was still adequate after 3 months in 100% of treated teeth.
In Phase I, 51 laser procedures were performed on children 18 years of age and 7. under. Six procedures or approximately 12% of these were performed on primary teeth with no reported complications, and no anesthesia was requested by the patient in any of these procedures.
In Phase II, 130 laser procedures were performed on children. Eighteen 8. procedures or approximately 15% were performed on primary teeth with no reported complications.
1. In the additional patient data submitted, 219 laser procedures were performed on children. Forty-eight procedures of approximately 22% were performed on primary teeth with no reported complications.
A total of 400 laser procedures were performed on children 18 years of age and 10. under with no reported complications. Sixty-eight of these procedures or approximately 19% were performed on primary teeth with no reported complications.

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Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of an eagle with three lines representing its body and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUM. SERVICES. USA" in a circular arrangement.

OCT 9 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Mojica Premier Laser Company 3 Morgan Irvine, California 92618

Re: K983211 Centauri Er:YAG Laser Systems Trade Name: Regulatory Class: ı i Product Code: GEX Dated: September 08, 1998 Received: September 14, 1998

Dear Ms. Mojica:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਮੁ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Lisa Mojica

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,

Cella 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

510(k) Number (if known): K983211

Device Name: Er:YAG Laser System

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K98321/

Prescription Use(Per 21 CFR 801.109)	X
------------------------------------------	---

Over-The-Counter Use
----------------------	--

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.