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The BeautyStar 532 is intended for Vaporization and Photocoagulation of vascular and pigmented lesions in soft tissue.

The Laser System BeautyStar 532 consists of a laser enclosure. fiber optic delivery system and an computer controlled treatment parameter interface.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the ASCLEPION-MEDITEC AG Laser System BeautyStar 532:

Based on the provided 510(k) summary, no performance data or study information is included. The submission explicitly states:

"Performance data: None. The specifications and intended uses of the laser system BeautyStar 532 are the same as or very similar to those of claimed predicate devices. Because of this, performance data were not required."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details. This device gained clearance based on substantial equivalence to predicate devices, meaning it was deemed as safe and effective as pre-existing devices without new clinical performance data being required.

Here's a breakdown of what can be extracted and why the other details are absent:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The documentation explicitly states "Performance data: None." and that performance data was not required due to substantial equivalence to predicate devices. Therefore, there are no reported acceptance criteria or corresponding device performance metrics from a study in this submission.

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

• Sample size: Not applicable, as no dedicated performance study was conducted.
• Data provenance: Not applicable.

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

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

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

• Adjudication method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was 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 device is a laser system, not an AI-powered diagnostic tool, and its clearance was based on substantial equivalence, not new performance data.

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

• No, a standalone (algorithm only) performance study was not done. This is a physical laser device, not an algorithm, and its clearance was based on substantial equivalence, not new performance data.

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

• Not applicable, as no dedicated performance study was conducted requiring ground truth.

8. The sample size for the training set:

• Not applicable, as this is a physical medical device (laser system) and not an AI/ML algorithm that would typically have a "training set."

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

• Not applicable, for the same reasons as point 8.

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The DermaStar Er: YAG Laser System is intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

The DermaStar Er: YAG Laser System is an Erbium:YAG laser with a wavelength of 2.94um. It consists a laser enclosure and fiber optic delivery system (including hand piece).

The provided text is a 510(k) summary for the ASCLEPION-MEDITEC AG DermaStar Er:YAG Laser System. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting novel performance data from a clinical study with detailed acceptance criteria and expert reviews.

Here's a breakdown based on the request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance metrics in a table. The primary acceptance criterion for a 510(k) is substantial equivalence to a predicate device.
• Reported Device Performance: "None" is explicitly stated. The submission relies on the specifications and intended uses being "the same or very similar" to legally marketed predicate devices.

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

• Sample size: Not applicable. No performance data or test set was used for this submission. The determination of substantial equivalence was based on a comparison of device specifications and intended uses.
• Data provenance: Not applicable.

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

• Not applicable. No test set requiring expert ground truth was utilized.

4. Adjudication method for the test set:

• Not applicable. No test set was utilized.

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, and no MRMC study was performed.

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:

• Not applicable. No ground truth was established as no performance study was conducted. The basis for clearance was a comparison of features and intended use with predicate devices already cleared by the FDA.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device. The determination was based on existing predicate device specifications.

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

• Not applicable. No training set was used.

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The Laser System YellowStar intended for treatment of vascular and pigmented lesions.

The Laser System YellowStar consists of a laser enclosure, fiber optic delivery system and an computer controlled treatment parameter interface.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the ASCLEPION-MEDITEC AG Laser System YellowStar, which focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing performance data from a specific study.

Specifically, the "Performance data" section states: "None. The specifications and intended uses of the laser system YellowStar are the same or very similar to those of claimed predicate devices. Because of this, performance data were not required."

Therefore, I cannot populate the table or answer the questions regarding acceptance criteria and study details based on the provided text.

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Ask a specific question about this device

Ask a specific question about this device