Search Results

The Edge CO 2 laser when used in traditional non-fractionated scanner mode is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues.

The Edge CO 2 laser when used in fractionated mode is indicated for ablative skin resurfacing.

The Edge CO2 laser has a wavelength of 10,600nm. CO2 fractional laser uses scanning optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments. This system consists of main body, color touch screen, Arm, hand-piece and Foot switch.

The provided 510(k) summary for the Edge CO2 Laser System is for a medical device that uses CO2 laser technology. The device is intended for various dermatological and surgical applications. The summary describes a performance study to demonstrate the device's capabilities, but it does not provide detailed acceptance criteria or results in a format that allows for a direct comparison as requested.

Therefore, I cannot populate the table with specific acceptance criteria and reported performance metrics as this information is not present in the provided text. The summary states: "A study was conducted to show the depth of penetration for each microdot using histology on pigs." This indicates a technical performance test rather than a clinical effectiveness study against predefined criteria.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not specified. The document only mentions "histology on pigs," implying animal cadaver or live animal testing, but no number of samples (e.g., number of microdots, number of pigs) is given.
• Data Provenance: The study was conducted "on pigs," indicating an animal model. The country of origin of the data is not specified, but the applicant is from Seoul, Korea, so it might have been conducted there. It is a prospective study in the sense that the testing was performed specifically to evaluate this device.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It's plausible that a veterinary pathologist or a a medical pathologist familiar with animal histology would have established the ground truth for the histology study, but this is not stated.

4. Adjudication method for the test set:

• Adjudication Method: Not specified. Given this was a histology study to demonstrate depth of penetration, it's likely a single expert (e.g., pathologist) performed the measurements, but a formal adjudication process is not described.

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:

• MRMC Study: No. This device is a CO2 laser system, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in interpretation. The performance study was a technical test of laser penetration depth.

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

• Standalone Performance: Not applicable in the context of an AI algorithm. The performance study described is for the physical device itself (laser penetration).

7. The type of ground truth used:

• Type of Ground Truth: Histology measurements. For the "depth of penetration for each microdot," histological examination of the tissue after laser application would provide the direct physical measurement, serving as the ground truth.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is a physical medical device (CO2 laser), not a machine learning model that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device