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

Centauri Er:YAG Laser System

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study data that demonstrate the device meets those criteria:

Device Name: Centauri Er:YAG Laser System

Indications For Use: Incision, Excision, Hemostasis, Ablation of Tissue, and Vaporization of Tissue in the oral cavity. 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.

Contraindications: Children under the age of 18 years.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for each performance metric with numerical thresholds. Instead, it presents various performance measures and concludes that the device is "equivalent to standard treatment" or "more effective" than drilling/acid etching for certain outcomes. Therefore, I will infer the acceptance criteria from the reported findings, primarily focusing on equivalence to established methods or a lack of deleterious effects.

Acceptance Criteria (Inferred)	Reported Device Performance
Pulpal Temperature Rise: Max pulpal temperature rise of ≤ 5.5°C (to avoid irreversible damage).	Observed Pulpal Temperature Rise: - 20 mJ, 10 Hz, 2 sec H2O cooling: 0.08°C - 50 mJ, 10 Hz, 2 sec H2O cooling: 1.07°C - 100 mJ, 10 Hz, 2 sec H2O cooling: 0.84°C - 150 mJ, 10 Hz, 2 sec H2O cooling: 1.12°C - 200 mJ, 10 Hz, 2 sec H2O cooling: 2.3°C Conclusion: All observed temperature rises are significantly below the 5.5°C threshold.
Pulp Vitality: No deleterious effect on pulp vitality; equivalent to control/drill methods over time.	Observed Pulp Vitality: - H&E histological evidence over pulpal healing time: No deleterious effect for laser or control treatment. - Pulp vitality measurements over 1.5 year follow-up: No compromise in pulp vitality. - In 33 patients, two teeth (laser vs. drill) showed no difference in pulpal vitality pre-surgery, post-surgery, and over three months. - In 125 randomly treated adult teeth, no significant difference in pulp vitality pre-surgery and after three months compared to drill.
Surface Morphology: No changes in surface morphology except at the treatment site; equivalent to drill at treatment site.	Observed Surface Morphology: - Animal and human studies using SEM: No changes in surface morphology except at the treatment site. - Animal and human studies using SEM: Drill and laser show equivalent surface changes at the treatment site.
Structural Morphology: Roughened dentin/enamel, no cracking, fissuring, or charring; open dentinal tubules; no remaining caries.	Observed Structural Morphology: - Ideal etched tooth (description given): "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." - Hibst and Keller: Effective removal of tooth structure with ultrastructural changes; no fissures or cracks; surface scaled and roughened without signs of thermal damage. - Paghdiwala: No visible cracks radiated from craters.
Adjacent Structures: Damage due to inadvertent lasing of adjacent structures is less than or equivalent to the drill.	Observed Adjacent Structures Effects: - Damage due to inadvertent lasing of adjacent structures is usually less than the drill, as the laser does not cut effectively when defocused.
Efficacy (Caries Removal): Effective removal of caries.	Observed Efficacy (Caries Removal): - Investigators rate caries removal more effective than the drill. - In a multi-site study of 125 randomized human adult teeth, 100% of Class I-V caries were completely removed.
Efficacy (Cavity Preparation): Equivalent to drill.	Observed Efficacy (Cavity Preparation): - Investigators rate cavity preparation with the laser equal to the drill. - In a multi-site study of 125 randomized human adult teeth, 100% of cavity preparations and restorations were still adequate after 3 months.
Efficacy (Etching): More effective than acid etching.	Observed Efficacy (Etching): - Investigators rate laser etching much more effective than acid etching.
Overall Equivalence: Equivalent to standard treatment.	Observed Overall Equivalence: - Animal and human studies demonstrate that the Er: YAG laser is equivalent to standard treatment.

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

Pulpal Temperature: The table (TABLE 1) shows measurements at various energy outputs and repetition rates for "Time with H2O Cooling". No explicit sample size for this specific test is provided beyond listing the parameters. A control "Drill in Air" and "Drill in H2O" are also mentioned, suggesting a comparison study. The study references Zach and Cohen (1965) and Powell et al. (1990) for the temperature threshold, implying the context for these measurements is based on established dental research, likely involving animal models initially.
Pulp Vitality:
- 33 patients (comparison of two teeth per patient: laser vs. drill).
- 125 randomly treated adult teeth (comparison of laser vs. drill, source not explicitly stated but implies human).
- One and a half-year follow-up for general pulp vitality measurements (sample size not specified, but context suggests human patients).
Surface Morphology: Animal and human studies (specific sample sizes not provided).
Efficacy:
- 125 randomized human adult teeth for caries removal.
- 125 randomized human adult teeth for cavity preparation and restoration adequacy.

Data Provenance: The document references investigations from various researchers (e.g., Zach and Cohen, Powell, Hibst and Keller, Paghdiwala, Arcoria, Kumazaki). This suggests a compilation of findings from multiple studies, both animal and human. The "multi-site study" for efficacy suggests data from different clinical locations. The general impression is that this is a retrospective summary of existing research and possibly some newly compiled data to support the 510(k) submission. No specific country of origin is mentioned for the sample data beyond the general context of medical device regulatory submissions in the USA.

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

The document directly mentions "Investigators" rating efficacy for caries removal, cavity preparation, and laser etching. It also mentions "blinded" assessments for Pulp Vitality and Surface Morphology.

Pulpal Temperature: The ground truth for the acceptable temperature rise (5.5°C) is established by publications from Zach and Cohen (1965) and Powell et al. (1990). These would be established dental researchers or pathologists.
Pulp Vitality: "H&E histological evidence" implies assessment by pathologists. "Pulp vitality measurements" would likely be performed and interpreted by dental professionals. The term "blinded" suggests that the assessors were unaware of whether the treatment was laser or control. The number of experts is not specified.
Surface Morphology: "SEM demonstrated" implies interpretation by experts trained in electron microscopy, likely with dental or material science backgrounds. The term "blinded" is used. The number of experts is not specified.
Structural Morphology: This section relies on findings reported by Hibst and Keller (dental researchers) and Paghdiwala (who specifically researched the Er:YAG laser in hard dental tissues). Their qualifications would be in dentistry, laser physics, and material science as applied to dentistry.
Efficacy: "Investigators rate..." suggests multiple dental professionals or clinicians were involved in evaluating the outcomes of caries removal, cavity preparation, and etching effectiveness. Their specific qualifications (e.g., years of experience as a dentist or oral surgeon) are not detailed, nor is their exact number. Given the context of a 510(k), these "investigators" would typically be qualified dentists or oral surgeons.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). For the "blinded" evaluations (Pulp Vitality, Surface Morphology), it implies individual expert assessments, but doesn't describe a formal consensus or tie-breaking process. For the "Investigators rate..." efficacy statements, it suggests a collective judgment rather than individual adjudication results for each case. The "multi-site study" implies that data might have been collected and analyzed collectively rather than through a strict adjudication panel for each individual finding reported.

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

The document does not describe a formal MRMC comparative effectiveness study in the way this term is typically used for AI-assisted image interpretation studies. However, it does present data that can be considered a comparative effectiveness assessment:

Comparison to Drill: Multiple sections compare the laser's performance to the conventional drill for pulpal temperature, pulp vitality, surface morphology, and efficacy in caries removal (laser more effective), cavity preparation (laser equal), and adjacent tissue damage (laser usually less).
Comparison to Acid Etching: The laser is rated "much more effective" than acid etching.
"Investigators rate..." and "Animal and human studies demonstrate..." suggest a collective assessment over multiple cases by multiple readers (investigators/experts) comparing the laser to standard methods.

Effect Size: The document provides qualitative rather than quantitative effect sizes for "human readers improve with AI vs without AI assistance." Instead, it focuses on the device's standalone performance or direct comparison to current standards:

Caries removal: laser "more effective" than drill.
Cavity preparation: laser "equal" to drill.
Laser etching: "much more effective" than acid etching.
Adjacent structures: damage "usually less" than drill when defocused.

There is no mention of human-in-the-loop performance augmentation by the device. The device is a direct treatment tool, not an AI diagnostic aid for human readers.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

Yes, the studies described are essentially standalone performance studies of the Centauri Er:YAG Laser System as a treatment device. The device performs the action (caries removal, cavity preparation, etching, etc.) directly. The "efficacy" and "safety" evaluations are assessments of the laser's direct effects, not its assistance to a human operator in a diagnostic or interpretive task. The quantitative measurements (e.g., pulpal temperature rise) and qualitative observations (e.g., histological evidence, SEM changes) are direct outputs of the laser's application.

7. Type of Ground Truth Used

The ground truth used is a combination of:

Expert Consensus/Clinical Judgment: For efficacy ratings (caries removal, cavity preparation, etching), "Investigators rate..." suggests expert consensus or clinical judgment.
Histopathology: "H&E histological evidence" for pulpal healing.
Physiological Measurements: "Pulp vitality measurements" (likely using cold/electric pulp tests or similar clinical methods). "Temperature in °C" for pulpal temperature rise.
Imaging/Microscopy: "SEM demonstrated" for surface morphology.
Established Scientific Literature: The 5.5°C pulpal temperature threshold is derived from benchmark publications (Zach and Cohen, Powell et al.). Structural morphology descriptions also rely on existing research findings.
Outcome Data: "100% of Class I-V caries were completely removed" and "100% of cavity preparation and restoration was still adequate after 3 months" are direct outcome measures.

8. Sample Size for the Training Set

The document does not describe a "training set" in the context of an algorithm or AI system. This 510(k) submission is for a physical medical device (laser system) and describes its performance validation, not the development and training of an AI algorithm. Therefore, this question is not applicable to the provided document. The studies referenced are for validating the device's safety and efficacy, not for training a model.

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

As there is no "training set" described for an algorithm, this question is not applicable. The information provided relates to the validation of a physical laser device.

Summary

{0}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the left and has its head turned to the right.

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

{1}------------------------------------------------

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

{2}------------------------------------------------

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)

{3}------------------------------------------------

MAY - 7 1997 K933841

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

Pulp Vitality (all blinded): B.

H&E histological evidence over pulpal healing time demonstrates no deleterious 1. effect for laser or control treatment.
Pulp vitality measurements over 1½ year follow-up demonstrate no compromise 2. 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.
Pulp vitality measurements on 125 randomly treated adult teeth treated by laser 4. and drill show no significant difference between the laser and the control in pulp vitality measurements pre-surgery and after a three month period.

{4}------------------------------------------------

Surface Morphology (all blinded): C.

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. 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.
Investigators rate cavity preparation with the laser equal to the drill. 2.
Investigators rate laser etching much more effective than acid etching. 3.
1. Animal and human studies demonstrate that the Er: Y AG laser is equivalent to standard treatment.

{5}------------------------------------------------

In a multi-site study of 125 randomized human adult teeth, all classes of caries 5. (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 6. and restoration was still adequate after 3 months in 100% of treated teeth.
が・・。

{6}------------------------------------------------

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: Y AG 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.
Hibst, R., and Keller, U. 1990. Heat effect of pulsed Er: Y AG laser radiation. SPIE Vol 3. 1200 II. 379-386.
Hibst, R., and Keller, U. 1992. Erbium:YAG laser in caries therapy: Indication and 4. first clinical results. ICOLD.
Zach, Leo , and Cohen, Gerson. 1965. Pulp response to externally applied heat. O.S., న. O.M., and O.D. 19(4):515-530.
Powell, G.L .; Whisenant, B.K .; Morton, T.H. 1990. Carbon dioxide laser oral safety 6. parameters for teeth. Lasers in Surgery and Medicine 13:548-552.
Arcoria, Charles J. 1994. Hard tissue effects using multiple wavelength lasers. ICOLD. 7.
Paghdiwala, Abid F. 1988. Application of the Erbium: Y AG laser in hard dental tissues: 8. Measurement of the temperatures and depths of cut. ICALEO. 64:192-201.
Paghdiwala. Abid F. 1993. Root resection of endodontically treated teeth by 9. Erbium: Y AG laser radiation. J of Endodontics. 19(2):91-94.
Kumazaki, M. 1992. Results of etching with the Er: Y AG 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.