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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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