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 acid etching, and Modification or Etching of Dentin prior to acid etching.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification for the Centauri Er:YAG Laser System, seeking FDA clearance for marketing. While it contains performance data and claims regarding the device's efficacy, it does not outline specific, pre-defined acceptance criteria for regulatory approval in the way modern AI device submissions do. Instead, the document presents study results to demonstrate substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide a table of "acceptance criteria" and "reported device performance" in the strict sense requested, because explicit, quantitative acceptance criteria for this type of medical device in 1997 are not detailed in this document. The document describes studies aiming to show the device performs safely and effectively for its intended use, comparable to existing methods.

However, I can extract the reported device performance and infer the implicit "acceptance criteria" based on the presented results and the claims made for "substantial equivalence."

Here's an analysis of the provided information, framed as closely as possible to your request:

Analysis of Centauri Er:YAG Laser System Performance and Supporting Studies

1. Table of (Inferred) Acceptance Criteria and Reported Device Performance:

Feature/Metric	(Inferred) Acceptance Criteria	Reported Device Performance
Pulpal Temperature Increase	≤ 5.5 °C (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 in Air: 0.25°C - Drill in H2O: 0.05°C (All well below the 5.5°C threshold)
Pulpal Vitality (Long-term)	No deleterious effect / no compromise in pulp vitality / no significant difference compared to control (drill)	- H&E histological evidence showed no deleterious effect for laser or control treatment. - Pulp vitality measurements over 1.5 year follow-up showed no compromise. - No difference in pulp vitality pre-surgery, post-surgery, and over 3 months in 33 patients (laser vs. drill in same patient). - No significant difference between laser and control over 3 months in 125 randomized teeth.
Caries Removal Effectiveness	Complete removal of all classes of caries	100% of caries (all classes I-V) completely removed in 125 randomized human adult teeth.
Cavity Preparation & Restoration	Adequate preparation and restoration after 3 months	100% of cavity preparations and restorations still adequate after 3 months in 125 randomized human adult teeth.
Surface Morphology (SEM)	No changes except at the treatment site; equivalent to drill at treatment site; no fissures/cracks, no thermal damage	- Animal and human studies demonstrated no changes in surface morphology except at the treatment site. - Equivalent surface changes to drill at treatment site. - Ideal etched tooth presented roughened dentin/enamel, no cracking/fissuring/charring, open dentinal tubules, vaporized organic material. - Hibst and Keller reported no fissures/cracks, scaled/roughened surface without thermal damage.
Adjacent Structures Damage	Less damage than drill when inadvertent lasing occurs	Damage due to inadvertent lasing of adjacent structures is "usually less than the drill," as the laser does not cut effectively when defocused.
Overall Efficacy (Expert Opinion)	More effective than drill for caries removal; equal to drill for cavity preparation; more effective than acid etching for etching; equivalent to standard treatment overall.	- Investigators rated caries removal more effective than the drill. - Investigators rated cavity preparation with the laser equal to the drill. - Investigators rated laser etching much more effective than acid etching. - Animal and human studies demonstrated equivalence to standard treatment.

2. Sample Sizes and Data Provenance:

Pulpal Temperature Study: Not explicitly stated as a "test set" with human or animal subjects, but rather an experimental measurement of the device's physical effect. The data provenance is not specified beyond being "a benchmark publication" and subsequent substantiation.
Pulp Vitality Studies:
- Study 1 (H&E): Not specified.
- Study 2 (1.5 yr follow-up): Not specified.
- Study 3 (33 patients): 33 human patients ("two teeth in each of 33 patients"). Prospective. Country of origin not specified.
- Study 4 (125 teeth): 125 randomized human adult teeth. Prospective. Country of origin not specified.
Caries Removal & Cavity Preparation Studies: 125 randomized human adult teeth for each study. Multi-site study. Prospective. Country of origin not specified.
Surface Morphology (SEM) Studies: "Animal and human studies" - sample sizes not specified.
Structural Morphology Studies: Refers to published literature by Hibst and Keller, and Paghdiwala. These are not explicitly device-specific studies for this submission but rather foundational science.
Efficacy (Investigator Ratings): "Investigators" - number not specified.

3. Number of Experts and Qualifications for Ground Truth for Test Set:

The studies described do not involve a "test set" of images for diagnostic purposes requiring expert consensus in the way AI/ML device submissions typically do. Instead, they refer to clinical outcomes, histological analysis, and direct measurements.

Pulp Vitality (H&E histological evidence): Implies a pathologist's evaluation. Qualifications not specified.
Pulp Vitality (measurements): Objective clinical measurements.
Caries Removal & Cavity Prep: Implies clinical assessment by dental professionals (investigators). Qualifications not specified.
Surface Morphology (SEM): Interpretation by experts in electron microscopy. Qualifications not specified.
Efficacy (Investigator ratings): The "investigators" are implicitly dental/medical professionals performing the procedures and making subjective assessments. Qualifications not specified.

4. Adjudication Method for the Test Set:

Not applicable in the context of this device submission. The studies involve direct clinical outcomes, measurements, or expert assessments rather than a diagnostic adjudication process. "All blinded" is mentioned for pulp vitality and surface morphology studies, indicating blinding of outcome assessors to treatment arm, which is a form of bias mitigation, but not an adjudication method for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This is a laser system for dental procedures, not an AI diagnostic device. There is no mention of human readers or AI assistance in the context of diagnostic interpretation. The comparisons are between the laser and a traditional drill.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a physical laser device, not an algorithm. Its performance is evaluated by its physical effects and clinical outcomes, not as a standalone software algorithm.

7. Type of Ground Truth Used:

Pulpal Temperature: Direct physical measurement of temperature increase in °C.
Pulpal Vitality:
- Histological evidence (pathology).
- Objective clinical measurements of pulp vitality.
Caries Removal: Clinical assessment of complete removal by treating dentists/investigators.
Cavity Preparation & Restoration: Clinical assessment of adequacy by treating dentists/investigators.
Surface Morphology: SEM imaging and expert interpretation (morphological assessment).
Efficacy: Subjective ratings by clinical investigators.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

Summary Interpretation:

This 510(k) submission for the Centauri Er:YAG Laser System provides data from a series of studies (some device-specific, some referencing existing literature) to demonstrate that its performance aligns with established safety thresholds (e.g., pulpal temperature increase) and clinical effectiveness when compared to the traditional dental drill for carving/ablation. The "acceptance criteria" are implied by the safe and effective performance demonstrated, particularly the lack of harm and comparable or superior efficacy to existing methods.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

( olette Cozean, Ph.D. MAY 5 1007 I'resident, CEO Premier Laser Systems, Inc. . . ...... 3 Morgan I vine, California 92618

l- e: K932683 and K933841 Trade Name: Centauri Er:YAG Laser System Regulatory Class: II Product Code: GEX Dated: April 28. 1997 Received: April 30, 1997

l )ear Dr. Cozean:

We have reviewed your Section 510(k) notifications 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 ( osmetic Act (Act). You may, therefore, market the device, subject to the general controls rrovisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and rohibitions 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, I'arts 800 to 895. A substantially equivalent determination assumes compliance with the ( inod Manufacturing Fractice for Medical Devices: General (GMP) regulation (21 CFR Part { 20) and that, through periodic

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Page 2 - Colette Cozean, Ph.D.

JMP 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, 17DA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submissions does not affect any >bligation you might have under sections 531 through 542 of the Act for devices under the Blectronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notifications. The FDA finding of substantial equivalence of your device to a egally marketed predicate device results in a classification for your device and thus, permits vour 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 1dvertising of your device, please contact the Office of Compliance at (301) 594-4639. 41so, 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 vours.

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 - I. .

& K933841 51Cik) Number (if known) K932683

Centauri Er:YAG Laser System Device Name:

Indical ons For Use:

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 Er amel prior to acid etching, and Modification or Etching of Dentin prior to acid eichi ig.

The contraindications are for children under the age of 18 years.

:P:EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDE DI

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices K932.683
510(k) Number: 1933841

Press: iphon lise tire: 21 CFR 801.109! റ്റു

Over-The-Counter Use

(Optional Format 1-2-96)

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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):

1. H&E histological evidence over pulpal fiealing time demonstrates no deleterious effect for laser or control treatment.
1. Pulp vitality measurements over 1½ year follow-up demonstrate no compromise in pulp vitality.
1. Pulp vitality measurements on two teeth in each of 33 patients treated by laser and drill from the same patient show no difference in pulpal vitality pre-surgery, postsurgery and over three months.
1. Pulp vitality measurements on 125 randomly treated 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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ડ. In a multi-site study of 125 randomized human adult teeth, all classes of caries (I-V) were completely removed in 100% of the teeth treated.
In a multi-site study of 125 randomized human adult teeth all cavity preparation ર. and restoration was still adequate after 3 months in 100% of treated teeth.

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C. Surface Morphology (all blinded):

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

D. Structural Morphology

1. The ideal etched tooth presents a roughened dentin or enamel surface and no 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.
1. Hibst and Keller reported on the effective removal of tooth structure with ultrastructural 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.

E. Adjacent Structures

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.
1. Investigators rate cavity preparation with the laser equal to the drill.
Investigators rate laser etching much more effective than acid etching. 3.
Animal and human studies demonstrate that the Er:YAG laser is equivalent to র্বা standard treatment.

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BIBLIOGRAPHY

Walsh, J.T.; Flotte, T.J.; Deutch, T.F. 1989. Er:YAG laser ablation of tissue: Effect of 1. pulse duration and tissue type on thermal damage. Lasers in Surg and Med. 9:314-326.
Hibst, R., and Keller, U. 1989. Experimental studies of the application of the Er.YAG 2. laser on dental hard substances: I. Measurement of the ablation rate. II. Light microscopic and SEM investigations. Lasers in Surg and Med. 9:38.
1. Hibst, R., and Keller, U. 1990. Heat effect of pulsed Er: Y AG laser radiation. SPIE Vol 1200 II. 379-386.
Hibst, R., and Keller, U. 1992. Erbium:YAG laser in caries therapy: Indication and 4. first clinical results. ICOLD.
1. Zach, Leo, and Cohen, Gerson. 1965. Pulp response to externally applied heat. O.S., O.M., and O.D. 19(4):515-530.
ર્. Powell, G.L .; Whisenant, B.K .; Morton, T.H. 1990. Carbon dioxide laser oral safety parameters for teeth. Lasers in Surgery and Medicine 13:548-552.
1. Arcoria, Charles J. 1994. Hard tissue effects using multiple wavelength lasers. ICOLD.
1. Paghdiwala, Abid F. 1988. Application of the Erbium: YAG laser in hard dental tissues: Measurement of the temperatures and depths of cut. ICALEO. 64:192-201.
1. Paghdiwala, Abid F. 1993. Root resection of endodontically treated teeth by Erbium: YAG laser radiation. J of Endodontics. 19(2):91-94.
Kumazaki, M. 1992. Results of etching with the Er:YAG laser. ISLD. 141-142. 11.

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.