(9 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Palomar Aspire™ Laser Platform (K080567) | The modified Palomar Aspire™ Laser Platform is reported as "substantially equivalent to its predicate device." Shared indications for use, similar technological characteristics and principles of operation are cited as the basis for this determination. |
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.