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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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The Palomar Aspire™ Laser Platform is 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. It does not describe an AI/ML device or a study with acceptance criteria in the way typically associated with performance metrics like sensitivity, specificity, or F1-score. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, the requested information elements related to AI/ML device performance, ground truth, expert review, and sample sizes for training/test sets are not applicable or cannot be extracted from this document.

Here's the breakdown based on the available information:

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

Not applicable in the context of typical AI/ML acceptance criteria. This submission is for demonstrating substantial equivalence. The "performance" aspect is framed around meeting the criteria for substantial equivalence to a predicate device, not on quantitative metrics against a defined acceptance threshold for specific clinical outcomes or AI model output.

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

Not applicable. This is not an AI/ML device clinical trial with a test set of data. The submission is based on engineering and design characteristics, intended use, and comparison to a legally marketed predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This document does not describe a study involving expert consensus or ground truth establishment for a test set.

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

Not applicable. There is no test set or adjudication method 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

Not applicable. This document does not describe an MRMC comparative effectiveness study or an AI-assisted workflow.

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

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

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

Not applicable. The concept of "ground truth" as applied to AI/ML performance data is not relevant to this medical device submission. The basis for approval is substantial equivalence to a predicate device.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not applicable. There is no training set or ground truth establishment pertinent to AI/ML described.

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The Palomar Aspire™ Laser Platform is 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.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting study for the Palomar Aspire™ Laser Platform:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the Palomar Aspire™ Laser Platform. Instead, it relies on the concept of substantial equivalence to predicate devices.

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

The document does not specify a classic "test set" sample size for a clinical study in the way one might expect for a diagnostic or treatment efficacy device. The primary approach for demonstrating equivalence appears to have been through a comparison of the device's technical specifications and intended use against existing predicate devices.

• Sample Size: Not applicable in the context of a comparative clinical trial for this specific 510(k) submission. The "data" refers to the technical specifications and functional capabilities compared to predicates.
• Data Provenance: The document does not provide information about the country of origin or whether the data for the new device was retrospective or prospective. The "performance data" mentioned is generalized and suggests technical testing rather than a clinical trial with patient data.

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

This information is not provided and is likely not relevant to this type of 510(k) submission, which focuses on substantial equivalence rather than establishing a new clinical benefit or diagnostic accuracy against a ground truth standard via clinical experts.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable to the substantial equivalence framework used here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence to predicate devices, not on demonstrating an improvement in human reader performance with or without AI assistance. The device in question is a medical laser system for lipolysis, not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Study Was Done:

No, a standalone (algorithm only) study was not done. The Palomar Aspire™ Laser Platform is a physical medical device (laser system), not a software algorithm or AI. Its performance is evaluated based on its physical and functional characteristics for performing laser-assisted lipolysis.

7. The Type of Ground Truth Used:

The concept of "ground truth" as typically used in diagnostic AI evaluation (e.g., pathology, outcomes data) is not directly applicable here. The "ground truth" in this context is implicitly the established safe and effective performance of the predicate devices for laser-assisted lipolysis. The new device demonstrates its equivalence to these known safe and effective devices.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The device is a hardware system, not a machine learning model, so there is no "training set" in the conventional sense.

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

This information is not applicable/not provided as there is no training set for a machine learning model.

Summary of the Study:

The "study" referenced in the 510(k) summary is not a traditional clinical trial or performance study with acceptance criteria in the sense of a new technology proving its efficacy. Instead, it is a technical and functional comparison of the Palomar Aspire™ Laser Platform against existing, legally marketed predicate devices. The "performance data" provided was sufficient to demonstrate that the new device shares:

• The same intended use (laser-assisted lipolysis).
• Similar technological characteristics.
• Similar principles of operation.

This demonstration led the FDA to conclude substantial equivalence to its predicate devices, implying that it is as safe and effective without requiring a full-scale clinical trial to prove new safety or efficacy. The predicates listed are other laser systems for lipolysis (e.g., Cynosure SmartLipo, Biolitec Ceralas, Sciton Profile ProLipo, New Star Lasers CoolLipo).

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