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The Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers is indicated for use in surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue using laser-generated thermal energy in medical including aesthetic (dermatology and plastic surgery), podiatry, specialties, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery, for the indications for use that the compatible laser system to which attached has been cleared.

Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers is comprised of the following main components:

• Laser waveguide
• Specially-shaped tip
• Coupler connector

The provided text describes a 510(k) premarket notification for the Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers. This document concludes that the device is substantially equivalent to existing predicate devices.

However, the provided text does not contain specific details regarding acceptance criteria and a study that definitively proves the device meets those criteria in the way typically required for AI/ML-based diagnostic devices. The submission focuses on substantial equivalence to predicate devices, which is a different regulatory pathway.

Here's an analysis of the information that is and isn't available in the document, structured according to your request:

1. A table of acceptance criteria and the reported device performance

The document states: "Performance data were provided to demonstrate that the Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers operates in accordance with product specifications."

However, neither the specific acceptance criteria (e.g., minimum laser power output, tip temperature range, durability metrics) nor the quantitative reported device performance are explicitly detailed within the provided text. The submission focuses on substantial equivalence to predicate devices rather than proving a novel performance metric against a set of new acceptance criteria.

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

This information is not provided in the document. The submission does not detail specific clinical or performance studies with test sets in the context of typical AI/ML device evaluations. The performance data mentioned would likely refer to internal engineering tests or bench testing to ensure the device functions as intended, rather than a clinical trial or large-scale data analysis.

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 and not provided. As this is a physical medical device (disposable contact tip for CO2 lasers), not an AI/ML diagnostic system, the concept of "experts establishing ground truth for a test set" in the context of diagnostic interpretation doesn't apply. The device's function is mechanical and thermal, not interpretative.

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

This information is not applicable and not provided for the same reasons as point 3.

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 and not provided. This is a physical surgical accessory, not an AI-assisted diagnostic tool.

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

This information is not applicable and not provided. This is a physical device, and the concept of "standalone algorithm performance" does not apply.

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

As this is a physical device, the "ground truth" would likely relate to objective physical and functional parameters, such as:

• Mechanical integrity: Does the tip remain intact during use?
• Thermal performance: Does it deliver the expected thermal energy at the tip?
• Material compatibility: Are the materials safe and biocompatible?
• Sterility: Is the device sterile as provided?

The document states "Performance data were provided to demonstrate that the Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers operates in accordance with product specifications." This implies that the ground truth for performance was defined by these product specifications, which would cover the physical and functional aspects listed above. Specific details of these specifications are not provided in the document.

8. The sample size for the training set

This information is not applicable and not provided. As a physical device, there is no "training set" in the context of machine learning. The device's design and manufacturing processes are validated, not "trained."

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

This information is not applicable and not provided for the reasons stated in point 8.

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