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The Palomar Lux1540 handpiece is intended for use in dermatological procedures requiring: Coagulation of soft tissue, skin resurfacing procedures, melasma, acne scars, and surgical scars.

The Lux1540 Handpiece attaches to the StarLux Pulsed Light and Laser Systems. The complete system consists of a cart, system console, chiller, a footswitch, and a handpiece.

Here's an analysis of the provided text regarding the Palomar Lux1540 Handpiece, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, there are no explicit acceptance criteria or reported device performance metrics in terms of numerical thresholds or efficacy rates. The submission primarily focuses on demonstrating "substantial equivalence" to predicate devices.

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

• Sample Size: The document does not mention any specific test set size or details about clinical trials or studies involving human subjects where data was collected.
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. The "PERFORMANCE DATA" section states that equivalence is based on "data provided in the 510(k) premarket notification," but the nature of this data is not described beyond implying comparison to predicate devices.

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

• This information is not provided in the document. Given the nature of a 510(k) for substantial equivalence typically based on technical characteristics and previous approvals, a formal "test set" with expert-established ground truth for performance metrics (e.g., image interpretation, clinical outcomes) is often not required or detailed in this type of submission unless specific new claims are being made.

4. Adjudication Method for the Test Set

• This information is not provided in the document, as there is no mention of a formal test set or a process for establishing ground truth through expert review.

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

• No, an MRMC comparative effectiveness study was not done (or at least, not mentioned in this 510(k) summary). The document focuses on device characteristics and intended use equivalence, not on comparing human reader performance with and without AI assistance.

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

• This information is not applicable as the device is a laser handpiece, not an AI algorithm or software. Its performance is inherent to its physical properties and operation, not an algorithm's output.

7. The Type of Ground Truth Used

• The concept of "ground truth" as typically applied to performance studies (e.g., pathology, expert consensus) is not explicitly mentioned or utilized in this 510(k) summary regarding the device's performance. The primary "truth" being established is that the device is "substantially equivalent" to its predicate devices in terms of technological characteristics, mechanism of action, intended use, and physical properties. This is a regulatory "ground truth" rather than a clinical performance "ground truth."

8. The Sample Size for the Training Set

• This information is not applicable as the device is a hardware component (laser handpiece), not an AI algorithm requiring a training set.

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

• This information is not applicable for the same reason as above; there is no training set for a hardware device.

Summary of the Study (Based on Provided Document):

The "study" described in the 510(k) summary is not a clinical trial or performance study with defined acceptance criteria and quantitative results. Instead, it is a statement of "substantial equivalence" to legally marketed predicate devices (Palomar Lux1540 Handpiece K060301 & K061652, and Reliant Technologies, Inc. Fraxel SR1500 Laser System).

The basis for this declaration of equivalence is that the Lux1540 Handpiece shares the "same technological characteristics, mechanism of action, intended use and physical properties" as its predicates. The "PERFORMANCE DATA" section explicitly states that "specifications and indications for use... are substantially equivalent to its predicate devices based on the data provided in the 510(k) premarket notification." The nature of this "data" is not detailed (e.g., engineering tests, preclinical studies, previous clinical data from predicate devices), but it is sufficient for the FDA to determine substantial equivalence.

Therefore, the "acceptance criteria" and "proof" in this context are tied to FDA's substantial equivalence pathway, not a detailed clinical performance study with specific quantitative endpoints.

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