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The Palomar Aspire™ Laser Platform is intended for coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, and subcutaneous tissue. The device is further indicated for laser assisted lipolysis.

The Palomar Aspire™ Laser Platform is a small transportable system which includes a cart, power supply, software, user interface panel, footswitch, cooling system and handpiece.

The provided text is a 510(k) summary for the Palomar Aspire™ Laser Platform, a medical device intended for coagulation of soft tissue and laser-assisted lipolysis. This document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study on the device's performance against those criteria. As such, much of the requested information regarding specific acceptance criteria, study methodologies, and performance metrics is not explicitly present in the provided text.

Here's an attempt to answer the questions based on the available information, noting where details are not provided:

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

The document does not specify quantitative acceptance criteria or detailed reported device performance in a structured table. The primary assessment is for "substantial equivalence" to predicate devices, implying that its performance is considered comparable.

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

The document does not describe a specific test set or clinical study with patient samples. The performance assessment is based on a review of "technical characteristics, indications for use, risk analysis information, and verification and validation information," rather than clinical trial data detailed in this summary.

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

Not applicable. The document does not describe a study involving human experts establishing ground truth for a test set.

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

Not applicable. There is no mention of a test set or adjudication method.

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 platform for medical procedures, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

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

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

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

Not explicitly stated for performance evaluation against specific criteria. The "ground truth" implicitly used for demonstrating safety and effectiveness is based on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. The document does not describe a "training set" in the context of an algorithm or AI development.

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

Not applicable. The document does not describe a "training set" or its ground truth establishment.

Summary of what is available from the document regarding performance and acceptance:

The primary "acceptance criteria" appear to be meeting the standard for substantial equivalence to legally marketed predicate devices.

• Substantial Equivalence Statement: "The review of the technical characteristics, indications for use, risk analysis information, and verification and validation information provided demonstrate that the modified Palomar Aspire™ Laser Platform is substantially equivalent to its predicate devices."
• Performance Claim: "The Palomar Aspire™ Laser Platform is as safe and effective as its predicate devices."
• Basis for Equivalence: "The information provided in this application demonstrates the Palomar Aspire™ Laser Platform shares the same indications for use, similar technological characteristics and principals of operation. Therefore, the Palomar Aspire™ Laser Platform is substantially equivalent to its predicate devices."

The "study that proves the device meets the acceptance criteria" is implicitly the 510(k) submission itself, which provides "technical characteristics, indications for use, risk analysis information, and verification and validation information" to support the claim of substantial equivalence. However, the details of these "verification and validation information" (e.g., specific tests, their methodologies, and quantitative results) are not elaborated upon in this summary document.
It is common for 510(k) summaries to present the conclusion of substantial equivalence without detailing all the underlying testing and data that led to that conclusion, as the full submission would contain such details.

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