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The LipoLite (eLipo) is intended for dermatological procedures requiring incision, excision, vaporization, ablation and coagulation of soft tissue. The LipoLite (eLipo) is further indicated for laser-assisted lipolysis.

The LipoLite (eLipo) is a microprocessor-controlled 1064 nm Nd: YAG laser system. It is composed of the following main units: high voltage power supply, laser assembly, control panel and cooling unit. The LipoLite (eLipo) delivers pulsed energy to pre-determined anatomical areas via an optical fiber.

I am sorry, but the provided text describes a 510(k) submission for a laser surgical instrument (LipoLite/eLipo) and focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as typically found for software or AI/ML-based medical devices.

Therefore, I cannot extract the requested information regarding device performance, sample sizes, expert qualifications, ground truth, or comparative effectiveness studies. This type of information is not present in the provided context, which is primarily a regulatory clearance document for a hardware device, not an AI/ML device.

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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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