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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 Er:aser™ laser is intended for coagulation, ablation, vaporization, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and skin resurfacing.

The Epulse laser is an erbium:YAG laser which emits its energy at 2.94 um.

The provided text is a 510(k) summary for the Epulse Er:aser™ Laser System. It states that performance data was not required because the specifications and intended uses of the Epulse laser are considered "the same or very similar (substantially equivalent)" to legally marketed predicate devices. Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them.

The relevant section states:

"None. The specifications and intended uses of the Epulse laser are the Performance Data: same or very similar (substantially equivalent) to those of the claimed predicate devices. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."

As such, I cannot populate the table or answer the specific questions about the study, sample sizes, ground truth, or expert involvement, as this information is explicitly stated as "not required" and therefore not provided in the document.

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Use of the device is indicated for the incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing. Use of the device is further indicated for the incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue disection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coadulation may be indicated

The DermaLase ™ laser system consists of two main components: the laser module and the delivery system. The Laser Module contains the laser resonator cavity, power supplies, closed loop internal cooling system and TTCS™ tissue irrigation and cooling module. Microelectronics circuits and system Control Panel are housed inside the laser console as well. The Control Panel provides access to all system controls. Actions are initiated through a touch sensitive membrane keypad. The display screen is back lighted for easy viewing. BioLase currently offers two options for laser energy delivery: a fiber optic based delivery system and an articulated arm based delivery system. The fiber optic system utilizes either a contact or non-contact hand piece. The articulated arm based delivery system utilizes either a contact or non-contact point delivery hand piece.

The provided text is a 510(k) summary for the DermaLase™ laser system, which focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance metrics in the way a clinical trial for a new drug or a novel AI diagnostic device would.

Therefore, the requested information cannot be fully extracted as there is no detailed study described that measures the device's performance against pre-defined acceptance criteria with specific metrics like sensitivity, specificity, or inter-rater reliability. The 510(k) process for this device relies on demonstrating that the DermaLase™ is as safe and effective as other legally marketed devices, primarily the Elmer™ laser system (K952118), and other similar erbium lasers.

Here's a breakdown of what can be inferred or directly stated from the provided document, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. A 510(k) summary for a device like a surgical laser typically focuses on comparing its technical specifications and intended use to predicate devices, rather than establishing numerical performance metrics against acceptance criteria.

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

This information is not applicable/not available. The document does not describe a "test set" in the context of evaluating the device's performance against a gold standard for a specific medical outcome. The submission relies on a comparison of device specifications and indications for use with predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable/not available. The document does not describe a study involving human readers or experts establishing ground truth for a test set.

4. Adjudication Method:

This information is not applicable/not available. There is no adjudication method described as no study involving human assessment of results is mentioned.

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

This information is not applicable/not available. The document does not describe a MRMC study or any study comparing human readers with and without AI assistance. The DermaLase™ is a surgical laser, not an AI diagnostic device.

6. Standalone Performance:

This information is not applicable/not available in the sense of an algorithm's standalone performance. The document describes the device itself and its equivalence to other lasers. Its "standalone performance" is inherent in its technical specifications (wavelength, power, frequency) which are deemed equivalent to predicate devices.

7. Type of Ground Truth Used:

This information is not applicable/not available in the context of a performance study. For this type of 510(k) submission, the "ground truth" is essentially established by the safety and effectiveness profile of the predicate devices. The claim is that the new device operates similarly and therefore achieves similar clinical outcomes as the predicates.

8. Sample Size for the Training Set:

This information is not applicable/not available. Training sets are relevant for machine learning algorithms. The DermaLase™ is a physical surgical laser, not an AI system that requires a training set.

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

This information is not applicable/not available as there is no training set for this type of device.

Summary derived from the provided text regarding Substantial Equivalence:

The DermaLase™ laser system's acceptance criteria are implicitly defined by its substantial equivalence to existing, legally marketed devices. The study proving this involves a comparison of its technical specifications and intended uses to those predicate devices.

Predicate Devices:

• CB Erbium/2.94 (Continuum Biomedical, Inc.) - K961748
• Trilase 2940™ Erbium laser system (Schwartz Electro-Optics) - K954013
• MCL 29 Dermablate™ (Aesculap-Meditec) - K964128
• Elmer™ (BioLase Technology, Inc.) - K952118 (mentioned as almost identical)

Key Aspects of Comparison (implicitly the "study" for 510(k)):

• Wavelength, Power, and Frequency: The DermaLase™ produces laser light at the exact same wavelength, power, and frequency as the Elmer™ (K952118). This is a primary technical equivalence point.
• Tissue Irrigation and Cooling System: The DermaLase™ includes BioLase's Target Tissue Cooling System™ for tissue cooling and irrigation, which is equivalent to that found in the Elmer™ (K952118).
• Indications for Use: The DermaLase™ is indicated for "incision, excision, ablation, vaporization and hemostasis of soft tissue." The submission states that similar indications for use are shared with predicate devices like those from Schwartz Electro-Optics, Continuum Biomedical, and Aesculap-Meditec. The specific expanded indications listed in the FDA's "Indications For Use" form include dermatologic tissues and general surgical applications (incision, excision, vaporization, coagulation of soft tissue, etc.).
• Safety and Effectiveness: The conclusion drawn is that because the DermaLase™ shares similar performance specifications, design, and indications for use with legally marketed predicate devices, it is considered as safe and effective.

Conclusion:

The provided 510(k) summary does not contain the detailed performance study information with explicit acceptance criteria, sample sizes, and ground truth methodologies typically associated with clinical trials or AI device evaluations. Instead, the "study" is a demonstration of substantial equivalence through a comparison of the DermaLase™'s design, technical specifications, and intended uses to those of predicate devices already cleared for market.

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Schwartz Electro-Optics, Inc. is not requesting any additional indications or changing the indications as previously cleared in K954013 received 1/31/96. As previously cleared, the Schwartz Electro-Optics, Inc. CLR 2940 will be indicated for use in small and large joint Arthroscopy, including laparoscopic procedures, general and all surgical procedures for cutting (incision/excision), vaporizing, ablating and coagulating soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Specialties are: General Surgery, Plastic Surgery, Podiatry, Urology, Gynecology, Pulmonary Surgery, Dermatology, Gastroenterology, Ophthalmology, ENT, Thoracic Surgery, Oral and Maxiliofacial Surgery. These indications have been cleared for marketing by the Food and Drug Administration for the cited predicated laser. Schwartz Electro-Optics, Inc. seeks no new indications for the CLR 2940 and is only requesting a modification.

From a technology perspective, theory of operation the predicate device is the same as the Schwartz Electro-Optics, Inc. CRL 2940 Erbium CrystaLase. The laser mediums are the same, the systems are similar both mechanically and electronically. Schwartz Electro-Optics, Inc. believes that the technological characteristics of the TriLase 2940 Erbium Laser are similar to the predicate device (Premier Centauri Erbium). The Premier Centauri Erbium has the ability to deliver laser energy at 2.94 microns (2940nm), average power of 5 watts at repetition rates of up to 50 pulses per second. These characteristics are very similar to the Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser.

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided document, the device described, the Schwartz Electro-Optics, Inc. TriLase 2940 Erbium Laser (referred to as CLR 2940 elsewhere), is being submitted for 510(k) clearance based on substantial equivalence to a predicate device, not through a performance study against specific acceptance criteria in the traditional sense of a clinical trial for a novel device.

The core of the submission relies on demonstrating that the new device has "similar" technological characteristics and that "slight differences in the performance characteristics of these devices raises no concerns." This is a key aspect of 510(k) submissions where a direct comparison to a legally marketed predicate device is made rather than de novo clinical studies establishing specific performance metrics.

Therefore, many of the requested categories for a new device's acceptance criteria and study information are not explicitly present in this type of submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/not provided. The submission is based on a comparison to a predicate device's specifications and existing indications for use, not a clinical study on a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/not provided. Ground truth in this context would refer to the established performance characteristics and safety profile of the predicate device, which is already legally marketed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/not provided. There was no test set requiring adjudication in the context of this 510(k) submission.

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

This information is not applicable/not provided. This device is an erbium laser for surgical procedures, not an AI-assisted diagnostic or imaging tool.

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

This information is not applicable/not provided. This device is a surgical laser, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) submission is the established safety and effectiveness profile and performance characteristics of the legally marketed predicate device (Premier Centauri Erbium and CRL 2940 Erbium CrystaLase), as determined by their prior FDA clearance. The company asserts that the new device's characteristics are "similar" to these predicate devices, making them substantially equivalent.

8. The sample size for the training set

This information is not applicable/not provided. There was no "training set" in the context of this 510(k) submission.

9. How the ground truth for the training set was established

This information is not applicable/not provided.

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For use in dermatology for the incision, excision, ablation, vaporization and hemostasis of soft tissue.

The Medlite\Erbium Laser is an erbium laser producing laser emissions at 2.94 $\mu$ . The laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench. At 5 pulses per second and a pulse energy of 2 Joules, the average power from the laser is 10 watts.

This 510(k) summary for the K961748 Medlite Erbium Laser System does not contain the detailed acceptance criteria or a study proving the device meets those criteria, as it explicitly states:

• Nonclinical Performance Data: none
• Clinical Performance Data: none

Therefore, I cannot provide the information requested in your prompt based solely on the provided K961748 document. The device was deemed substantially equivalent to a predicate device (SEO Medical TriLase 2940 Erbium Laser System; K954013) without specific performance studies detailed in this summary.

Here's a breakdown of why each requested item cannot be answered:

1. A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are reported.
2. Sample sized used for the test set and the data provenance: No test set data or provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment or experts are mentioned.
4. Adjudication method for the test set: No test set or adjudication method is mentioned.
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: Not applicable. This is a laser system, not an AI-assisted diagnostic device, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a laser system, not an algorithm, and no such performance study is mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance study with ground truth is mentioned.
8. The sample size for the training set: Not applicable, as no algorithm training or training set is mentioned.
9. How the ground truth for the training set was established: Not applicable, as no algorithm training or training set is mentioned.

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