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The EXELO2 with the fractional scanning unit is indicated for ablative skin resurfacing in people with skin types 1, 2 or 3 based on Fitzpatrick skin type scale.

The EXELO2 is a CO2 laser device designed for dermatological use. It produces a coherent monochromatic radiation at the wavelength of 1.6 microns. The system is composed of a base which encloses the power supply and control interface, an articulated mirror arm, and a scanner handpiece.

The provided text is a 510(k) summary for the EXELO2 Scanned CO2 Laser System for Dermatology. It describes the device, its specifications, indications for use, and performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative "acceptance criteria" for the EXELO2 device's performance in terms of specific metrics like sensitivity, specificity, or accuracy. Instead, the study aims to demonstrate "substantial equivalence" to a predicate device, which is a regulatory standard rather than a specific performance metric.

The reported device performance is qualitative, focusing on histological findings.

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

• Sample Size: 5 human subjects.
• Data Provenance: The study was conducted on "human subjects." The country of origin is not explicitly stated, but the contact information for Quantel USA (Bozeman, MT) suggests the study may have been conducted in the US. The study is prospective, as punch biopsies were taken at specific time points after exposure (10 min, 3 days, 14 days, 21 days, and 28 days).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications used to establish the ground truth for the histological analysis. It only states "Quantitative histology demonstrated substantial equivalence."

4. Adjudication Method for the Test Set

The adjudication method for the histological analysis is not specified in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What War the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The EXELO2 is a medical device (CO2 laser), not an AI-powered diagnostic or assistive tool, so this type of study is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. The EXELO2 is a CO2 laser device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used was quantitative histology. This means that tissue samples (punch biopsies) were analyzed to assess the effects of the laser treatment.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is a laser system, not a machine learning model. There is no mention of any machine learning component requiring a training set.

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

As there is no training set for a machine learning algorithm, no ground truth needed to be established in this context.

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The LEDA System with the Applicator LEDA SCR 585 yellow is indicated for the treatment of periorbital wrinkles and rhytides.

The LEDA System with the Applicator LEDA SCR 635 red is indicated for the treatment of superficial, benign vascular and pigmented lesions.

The LEDA System with the Applicators LEDA EPI 808 and LEDA EPI 980 is indicated for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.

The system is composed of a table-top base unit that includes the power supply, software and cooling system. Different applicators containing the light sources can be plugged into the base unit. The device is controlled by a touch-screen graphic user interface. There are three kinds of applicators each of which is available with several wavelengths. For details see the following section.

The LEDA is a device designed for dermatological use. Depending on the applicator selected wavelength in the range of 550-1,000 nm are produced either by Light Emitting Diodes (LED) or Diode Lasers. For each applicator and thus each wavelength there is a specific set of medical indications.

The provided text is a 510(k) Summary for a medical device called LEDA. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving the device meets specific acceptance criteria with quantifiable performance metrics.

However, I can extract information related to the device's indications for use and the basis for its substantial equivalence claim.

Here's an analysis based on the provided text, structured to address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a table of acceptance criteria with quantifiable performance metrics that a study aimed to prove. Instead, the submission relies on demonstrating substantial equivalence to already cleared predicate devices. The "performance" being reported is the similarity in technological characteristics and intended use.

Therefore, I cannot create such a table directly from this document. The "criteria" are implicitly met if the device's technology and indications are sufficiently similar to approved predicates, implying comparable safety and efficacy.

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

The document does not describe a specific clinical study with a test set of patients or data. The submission relies on a comparison of device specifications and indications for use with established predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

As there is no clinical test set described, there is no information about experts used to establish ground truth. The submission hinges on the regulatory agency's assessment of substantial equivalence based on technical specifications and established indications of predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission's focus is on demonstrating substantial equivalence through technological comparison rather than a human-in-the-loop performance study.

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

This refers to a device that is inherently an algorithm-only device, such as AI-based diagnostic software. The LEDA device is a physical light-based therapeutic device. Therefore, the concept of a "standalone" algorithm-only performance test is not applicable in this context. The performance is inherent to the physical device's operation.

7. The Type of Ground Truth Used

The "ground truth" implicitly used in this 510(k) submission is the established safety and effectiveness of the predicate devices based on their prior regulatory clearance. The LEDA device aims to demonstrate that it is sufficiently similar to these predicates that it shares their established safety and efficacy profiles. There is no new ground truth established via pathology, outcomes data, or expert consensus specifically for the LEDA device in this document.

8. The Sample Size for the Training Set

Not applicable, as this is a traditional medical device submission for a light-based therapy device, not an AI/machine learning device that would require a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set mentioned or implied.

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