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NaturaLase CO2 laser operating in tractionated mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery.

NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.

The NaturaLase CO2 is an RF excited CO2 laser. The main console of the NaturaLase CO2 laser system contains the following components:

• CO2 laser tube
• Power Supply
• Optical bench assembly
• Articulated Arm
• Hand-pieces: scanning and surgical
• Touch screen controller/user interface

The laser source is a sealed CO2 laser tube that is mounted vertically within the main cabinet and the laser beam is passed from the laser tube into the articulated arm. The NaturaLase CO2 laser unit is equipped with a switching-mode power supply, which converts the input line voltage to the high voltage required for laser operation. The optical bench assembly consists of the articulated arm mount, the aiming beam diode laser (3mW @ 650nm) and optics to align the laser beam and the aiming beam to the articulated arm. The laser energy is delivered through an articulated arm to a hand-piece (scanner or surgical) that distributes the laser energy on the target in a controlled and uniformed way. The user-interface microprocessor-based touch screen allows operator to control all operating functions.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "NaturaLase CO2 Laser System." This document aims to demonstrate the substantial equivalence of the new device to previously cleared predicate devices, rather than proving its performance against specific acceptance criteria for a new clinical indication or a new type of device requiring complex performance studies (like AI/ML-driven diagnostic devices).

Therefore, many of the typical acceptance criteria and study elements listed in your request (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, ground truth types for training data) are not applicable to this type of regulatory submission. This document focuses on showing that the NaturaLase CO2 Laser System operates similarly to predicate devices and does not introduce new questions of safety or effectiveness.

Here's how to address your request based on the provided document:

Acceptance Criteria and Device Performance

For a device like the NaturaLase CO2 Laser System seeking 510(k) clearance, the primary "acceptance criterion" is demonstrating substantial equivalence to existing predicate devices. This is achieved by showing that the new device has the same intended use and technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

The document demonstrates this through:

• Comparison of Technical Specifications: The core method of proving substantial equivalence is through direct comparison of the new device's technical specifications and operating principles with those of the predicate devices.
• Performance Testing (Bench Testing): The document refers to engineering verification and validation tests to ensure the device performs according to its own specifications and functions as intended, and conforms to relevant safety standards. This is not clinical performance testing against a disease state, but rather engineering and safety performance.

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

The "acceptance criteria" here are implicitly the parameters of the predicate devices a new device must match or fall within to demonstrate substantial equivalence, alongside compliance with relevant safety standards. The "reported device performance" are the specifications of the NaturaLase CO2 Laser System.

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The NaturaLase CO2 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue.

The NaturaLase CO2 is an RF excited CO2 laser. The laser energy is delivered through an articulated arm and with a scanner that distributes the laser energy on the skin in a controlled way with uniform distribution. The scanner design allows the system to ablate small micro spots of tissue. The system has the ability to deliver micro spots with a size of 120 microns and up to 45 mJ of optical energy per micro spot.

The NaturaLase CO2 Laser is a medical device, and this document does not contain information on acceptance criteria or a study that proves the device meets specific performance criteria in the way artificial intelligence models are typically evaluated.

Instead, this is a 510(k) summary for premarket notification to the FDA, demonstrating substantial equivalence to a predicate device (Lutronic Mosaic eCO2 Laser System). For such devices, the "acceptance criteria" are generally that the device has the same intended use and fundamental technology as a legally marketed predicate device, and that it raises no new issues of safety and effectiveness.

Here's an analysis based on the provided text, addressing the points where information is available or relevant:

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

Since this is a medical device submission for substantial equivalence rather than an AI model evaluation, "acceptance criteria" are not reported as quantitative metrics with specific thresholds and device performance results in the same way. Instead, the "acceptance" is based on demonstrating equivalence to an existing, legally marketed device.

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

• Sample Size: The document mentions "laser treatment of human skin" for histology data, but does not specify the number of human subjects or punch biopsies in the study.
• Data Provenance: The data is from "human skin," implying it's prospective ("treated" human skin). The country of origin is not specified, but the applicant (Focus Medical) is based in Bethel, CT, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not applicable to this document. The study described focuses on objective histological measurements (spot size, treatment depth, healing process) of laser effects on tissue, not on subjective interpretations requiring expert consensus for ground truth.

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

This information is not applicable. The study involves objective measurements of tissue response, not interpretive assessments that would require adjudication.

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 is not applicable. This document describes a medical device (laser system), not an AI algorithm. Therefore, an MRMC study related to AI assistance for human readers was not performed.

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

This is not applicable. This describes a physical medical device, not an algorithm.

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

The ground truth for the "histology data" study was based on objective measurements derived from punch biopsies, which falls under pathology/histology. These measurements included "spot size, treatment depth and the healing process."

8. The sample size for the training set

This is not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

This is not applicable for the same reasons as point 8.

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