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Intended Use. For use in oral/dental procedures for the incision, ablation, vaporization and hemostasis of soft tissue.

Specific Indications for Use:

1. Gingivoplasties
2. Ginaivectomies
3. Frenectomies
4. Benign and malignant lesion removal
5. Biopsies
6. Leukoplakia
7. Fibrotomy

Pharos Optics, Inc. offers a dental laser system known as the FutureLase zooo/goo2 Erbiurm Laser System. The device utilizes laser radiation energy produced at a frequency of 2.94น. This laser system is intended for intraoral or dental soft tissue surgery including the marginal and interdental gingiva. The FutureLase zooo/zoo2 Erbium Laser System is used to assist the dentist or oral surgeon with the following general intended use and/or specific indications for use:

The provided text does not contain information about the acceptance criteria and the study that proves the device meets them in the context of performance metrics like sensitivity, specificity, or accuracy. This document, a 510(k) premarket notification for the FutureLase 3000/3002 Erbium Laser System, is focused on demonstrating substantial equivalence to legally marketed predicate devices.

The information primarily discusses:

• Device Name and Classification: FutureLase 3000/3002 Erbium Laser System, Class II, Product Code 79GEX.
• Intended Use and Specific Indications for Use: For oral/dental procedures involving incision, ablation, vaporization, and hemostasis of soft tissue, including gingivoplasties, gingivectomies, frenectomies, benign/malignant lesion removal, biopsies, leukoplakia, and fibrotomy.
• Device Description: Details on the laser head, power supply, cooling system, control system, control panel, and beam delivery.
• Substantial Equivalence: A comparison table showing that the FutureLase 3000/3002 has similar technical specifications (Laser Type, Wavelength, Pulse Rate, Pulse Duration, Max Pulse Energy, Power, Beam Delivery, Fiber Material, Electrical Requirements, and Indications) to predicate devices (TriLase 2940 Erbium Laser System, MedLite Erbium Laser System, and PulseMaster™ Dental Laser System).

Missing Information:

The document does not include:

1. A table of acceptance criteria and reported device performance related to specific clinical outcomes or statistical metrics.
2. Sample sizes for test sets, their provenance, or whether the study was retrospective or prospective.
3. The number or qualifications of experts used to establish ground truth.
4. Adjudication methods.
5. Results of Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or the effect size of AI assistance.
6. Results of standalone (algorithm-only) performance studies.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This is typical for a 510(k) submission, where the primary objective is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, rather than to prove absolute safety and effectiveness through extensive clinical trials with specific performance endpoints. The equivalence is primarily established through technical characteristics and similar intended use.

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The PulseMaster® 1000 ST Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is indicated for use in the following procedures:

• lesion (tumor) removal
• biopsies
• fibroma removal
• frenectomies and frenotomies
• gingivoplasties
• gingivectomies
• leukoplakia
• operculectomies
• oral papillectomies
• aphthous ulcers
• sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility.

The PulseMaster® 1000 ST Dental Laser System is a portable diode laser system intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is software-controlled and utilizes high brightness diode laser technology to provide similar performance characteristics to Nd:YAG lasers.

Here's an analysis of the provided information regarding the acceptance criteria and study for the PulseMaster® 1000 ST Dental Laser System:

This 510(k) pertains to a medical device (a dental laser system) and not an AI/ML device. Therefore, many of the requested fields (such as expert adjudication, MRMC studies, standalone algorithm performance, and training set details) are not applicable as they are specific to AI/ML device evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner as might be seen for a new AI/ML device. Instead, the performance is demonstrated by showing substantial equivalence to a predicate device through comparative testing. The criteria for acceptance are implicitly that the new device performs "the same or slightly better than" the predicate, without detrimental effects.

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

• Sample Size: Not explicitly stated (e.g., number of tissue samples, trials). The study is described as an "in vitro study."
• Data Provenance: In vitro study, comparing the device to a predicate. The specific country of origin or whether it was retrospective/prospective in a clinical sense is not applicable or provided for an in vitro comparison of physical properties.

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

• N/A. This is a hardware device assessment, not an AI/ML diagnostic or prognostic tool requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

• N/A. Not an AI/ML diagnostic or prognostic tool.

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

• N/A. This is not an AI-assisted device.

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

• N/A. This is a standalone hardware device, but the concept of "standalone algorithm" doesn't apply.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance was established through direct physical measurement of tissue effects (width/depth of tissue removed, thermal coagulation, temperature rise) in an in vitro setting, against the performance of a known predicate device.

8. The Sample Size for the Training Set

• N/A. This is not an AI/ML device that undergoes "training."

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

• N/A. This is not an AI/ML device that undergoes "training."

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