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The CoolTouch®, CoolTouch® II, and CoolTouch® CT3 ND:YAG Laser Systems are indicated for the treatment of mild to moderate inflammatory acne vulgaris.

The CoolTouch® Nd: YAG Laser Systems are ND: YAG lasers producing laser emission at 1320nm. The lasers consist of three interconnected section: a) The cabinet, which houses the power supply, cooling system , microcontroler and the laser, b) the fiber optics and c) the handpiece.

The provided text is a 510(k) premarket notification for three CoolTouch® Nd:YAG Laser Systems. It establishes substantial equivalence to a predicate device for the treatment of mild to moderate inflammatory acne vulgaris.

However, the document explicitly states "Performance Data: None" for the CoolTouch® Nd:YAG Laser Systems. Therefore, there is no information in this document to populate most of the requested fields regarding acceptance criteria and study details.

Based only on the provided text, here's what can be answered:

1. Table of Acceptance Criteria and Reported Device Performance:

No acceptance criteria or reported device performance for the CoolTouch® Nd:YAG Laser Systems are provided in this document. The submission states "Performance Data: None".

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

Not applicable. No performance study data is presented.

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

Not applicable. No performance study data is presented.

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

Not applicable. No performance study data is presented.

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:

Not applicable. This device is a laser system, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported.

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

Not applicable. This device is a laser system, not an algorithm.

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

Not applicable. No performance study data is presented.

8. The sample size for the training set:

Not applicable. No training set is mentioned as this is a laser device, not a machine learning model.

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

Not applicable. No training set is mentioned.

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The CoolTouch Nd:YAG Laser Systems are indicated for use in Dermatological and Plastic Surgery applications including use in the treatment of fine lines and wrinkles.

The CoolTouch Nd:YAG Laser Systems are ND:YAG lasers producing laser emission at 1320 nm. The lasers consist of three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optic, and the handpiece.

The provided document is a 510(k) summary for the CoolTouch Nd:YAG Laser System, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel acceptance criteria. As such, it does not contain the specific information required to complete all sections of your request.

Here's an analysis of the available information:

• Acceptance Criteria and Reported Device Performance: The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it mentions that "Clinical trials produced results that indicated that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of periorbital and perioral wrinkles." This is a qualitative statement about effectiveness, not a specific performance metric. Since no explicit criteria are provided, a table cannot be constructed.

• Sample size for the test set and data provenance: The document states "Clinical trials produced results...", but it does not specify the sample size for these trials, nor does it mention the country of origin or whether the data was retrospective or prospective. It refers to "previous related 510(k) submissions for clinical results," implying the data was presented elsewhere.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the summary.

• Adjudication method: This information is not provided in the summary.

• Multi-reader multi-case (MRMC) comparative effectiveness study: The document does not describe an MRMC study or any comparison of human readers with and without AI assistance. The device is a laser system, not an AI diagnostic tool.

• Standalone (algorithm only without human-in-the-loop performance) study: This is not applicable as the device is a laser system used by a clinician, not an algorithm.

• Type of ground truth used: Given the indication for "treatment of fine lines and wrinkles," the ground truth likely would have involved expert assessment of wrinkle reduction (e.g., photo-grading scales, patient-reported outcomes), but this is not explicitly stated.

• Sample size for the training set: This is not applicable, as the document describes a medical device, not an AI algorithm requiring a training set.

• How the ground truth for the training set was established: This is not applicable.

Summary of Available Information from the Provided Text:

This 510(k) summary primarily serves to establish substantial equivalence with a predicate device (New Star Lasers, Inc. Model 130 Nd: YAG Surgical Laser System K962791) rather than to present detailed results of a clinical study designed to meet specific performance acceptance criteria for a novel technology. The "Nonclinical Performance Data" is stated as "None," and for "Clinical Performance Data," it refers to "previous related 510(k) submissions," indicating that the detailed clinical evidence was likely submitted and reviewed in those prior applications and not reiterated in this summary.

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The CoolTouch Nd:YAG Laser Systems are indicated for the treatment of periorbital and perioral wrinkles.

The CoolTouch Nd:YAG Laser Systems are ND:YAG lasers producing laser emission at 1320 nm. The lasers consist of three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optics, and the handpiece.

Here's an analysis of the provided text regarding the CoolTouch Nd:YAG Laser System's acceptance criteria and study information:

Based on the provided documents, there's no detailed information available about specific acceptance criteria or a comprehensive study report that would typically include the requested metrics for an AI/device performance evaluation. The document is a 510(k) premarket notification summary for a medical device (laser system), not an AI algorithm.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, as required for medical device clearance in the US. It mentions "Clinical Performance Data," but only as a general statement: "Clinical trials produced results that indicate that that CoolTouch Nd:YAG Laser System is effective in the treatment of periorbital and perioral wrinkles." This is a summary and does not contain the specifics of a clinical study report.

Therefore, many of the requested details about acceptance criteria, study design for AI, sample sizes, ground truth, and expert involvement are not present in the provided text.

However, I can extract the available relevant information and present it in the requested format, clearly indicating where information is absent.

Acceptance Criteria and Device Performance

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:
   This information is not provided in the given document. The document only states that "Clinical trials produced results," implying a test set was used, but details on size and provenance are absent.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the given document. The context of a physical laser device for wrinkle treatment suggests that "ground truth" would likely be clinical assessments of wrinkle reduction, possibly by physicians, but no specifics are given.

3. Adjudication method for the test set:
   This information is not provided in the given document.

4. 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 to the described device. The CoolTouch Nd:YAG Laser System is a physical laser device for treatment, not an AI algorithm, and therefore an MRMC study comparing human readers with and without AI assistance is not relevant to its function.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This information is not applicable to the described device, as it is a physical laser system, not a standalone algorithm.

6. The type of ground truth used:
   The document implicitly suggests the ground truth was based on clinical assessment of wrinkle reduction, as it states the device is "effective in the treatment of periorbital and perioral wrinkles." More specific details (e.g., objective measurements, subjective ratings, standardized scales) are not provided.

7. The sample size for the training set:
   This information is not provided in the given document. For a clinical trial of a laser device, there would be participants, but the term "training set" is typically used for machine learning models and is not directly applicable here.

8. How the ground truth for the training set was established:
   This information is not provided in the given document. Similar to point 7, the concept of a "training set" with established ground truth is more relevant to AI. For a medical device trial, the "ground truth" (i.e., the outcome measure of wrinkle reduction) would be established through clinical protocols, but the specifics are not detailed.

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