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The Palomar Lux1540™ Handpiece is intended for use in: Coagulation of soft tissue; Skin resurfacing procedures; Treatment of melasma and striae; Treatment of 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.

The provided text is a 510(k) summary for the Palomar Lux1540™ Handpiece, which is a regulatory document submitted to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. This type of document typically focuses on comparing the new device's technical characteristics, intended use, and safety/effectiveness to existing devices, rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics of the device against those criteria.

Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, ground truth methods, and MRMC studies is not present in the provided document.

Here's an breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document instead frames acceptance in terms of "substantial equivalence" to predicate devices. This means the device is considered acceptable if its performance, as demonstrated by technical and safety data, is comparable to devices already cleared by the FDA for the same intended uses.
• Reported Device Performance:
  • The document states: "The specifications and indications for use of the Lux1540 Handpiece are substantially equivalent to its predicate devices based on the data provided in the 510(k) premarket notification."
  • "The Lux1540 Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this 510(k) premarket notification demonstrates that the Lux1540 Handpiece also shares the same technological characteristics, mechanism of action, intended use and physical properties to its predicates."

In summary, the "acceptance criteria" here are met by demonstrating substantial equivalence, meaning the device's performance is deemed acceptable if it performs similarly to established, legally marketed predicate devices for the specified indications.

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

• Not explicitly stated in the provided text. 510(k) summaries for laser handpieces often rely on bench testing, electrical safety tests, biocompatibility, and optical performance specifications rather than large-scale clinical test sets with human subjects for performance evaluation in the same way an AI diagnostic device would. If clinical data was used, its details (sample size, provenance) are not included 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/Not stated. This document does not describe a study involving human experts establishing ground truth for a test set in the context of an AI-driven diagnostic device. The evaluation is focused on the device's physical and technical characteristics, and its equivalence to predicates.

4. Adjudication Method for the Test Set

• Not applicable/Not stated. See point 3.

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

• No, an MRMC comparative effectiveness study was not done (or at least, is not mentioned in the provided text). This type of study is specifically relevant for AI-powered diagnostic aids where human interpretation is involved. The Lux1540 Handpiece is a therapeutic laser device, not a diagnostic one.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• Not applicable. The Lux1540 Handpiece is a physical device that requires a human operator for its therapeutic function. It is not an algorithm that performs standalone analysis.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Not explicitly described. For a therapeutic laser device seeking 510(k) clearance, "ground truth" often refers to demonstrating that the device meets its technical specifications (e.g., wavelength, power output, spot size, pulse duration) and that these specifications are consistent with effective and safe operation for the stated indications, as supported by scientific literature and predicate device performance. It also relies on a comparative assessment against the known performance and safety profiles of predicate devices.

8. The Sample Size for the Training Set

• Not applicable/Not stated. As this is a physical therapeutic device and not an AI algorithm, there is no "training set" in the conventional machine learning sense.

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

• Not applicable/Not stated. See point 8.

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The Palomar Lux1440 Handpiece is intended for skin resurfacing procedures in addition to dermatological procedures requiring the coagulation of soft tissue.

Dermatological procedures requiring the coagulation of soft tissue;
Skin resurfacing procedures.

The Palomar Lux1440 Handpiece attaches to the StarLux Pulsed Light and Laser System. The complete system consists of a cart, base unit, chiller, a footswitch, and a handpiece.

The provided 510(k) summary for the Palomar Lux1440 Handpiece (K073583) does not contain any information about acceptance criteria or a study proving the device meets said criteria.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K071768 and K061652) based on:

• Intended Use: Similar applications (skin resurfacing and dermatological procedures requiring soft tissue coagulation).
• Device Description: The Lux1440 Handpiece attaches to the existing StarLux Pulsed Light and Laser System, implying similar underlying technology and components.
• Performance Data (as stated by the submitter): A claim that "The review of the technical characteristics, indications for use, mechanism of action, and verification and validation information provided demonstrate that the modified Palomar Lux1440 Handpiece is substantially equivalent to its predicate device."

Therefore, I cannot provide the requested information in the table or the subsequent points because it is not present in the provided text.

The document's purpose is to establish substantial equivalence for regulatory clearance, not to detail specific performance metrics against pre-defined acceptance criteria through a clinical study. The FDA's letter confirms this, stating, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".

Summary of missing information:

• Table of Acceptance Criteria and Reported Device Performance: Not present.
• Sample size used for the test set and data provenance: No test set or clinical study is described.
• Number of experts used to establish the ground truth and their qualifications: Not applicable as no ground truth establishment is described.
• Adjudication method: Not applicable.
• Multi reader multi case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm only without human-in-the-loop performance): Not applicable, as this is a laser handpiece, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable, as this is not a machine learning device.
• How the ground truth for the training set was established: Not applicable.

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The Palomar Lux1540 handpiece is intended for skin resurfacing procedures in addition to dermatological procedures requiring the coagulation of soft tissue.

The Palomar Lux1540 handpiece is an accessory to the StarLux Pulsed Light & Laser System. The handpiece delivers light with a wavelength of 1540 nm. The complete system consists of a power source, chiller, a footswitch, and a handpiece connected to the power unit with an umbilical.

Here's a breakdown of the acceptance criteria and the study information based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided 510(k) summary does not specify quantitative acceptance criteria (e.g., a specific percentage of a certain outcome, a defined threshold for adverse events). The criteria are qualitative, focusing on the device's ability to achieve its intended mechanism of action and overall clinical performance without new safety concerns, in line with its predicate device.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical testing" but does not provide the number of subjects or samples used in this testing.
• Data Provenance: Not explicitly stated. The document doesn't specify the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. The document refers to "clinical testing" but does not detail the roles or qualifications of the individuals who assessed the outcomes or established ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Status

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or implied. The study described focuses on the device's performance against its own intended use and safety profile, not a comparison of human reader performance with and without AI assistance.
• Effect Size of Human Readers with AI vs. without AI Assistance: Not applicable, as no MRMC study with AI assistance was conducted or reported.

6. Standalone (Algorithm Only) Performance Study Status

• Standalone Study: The Lux1540 is a physical medical device (handpiece for a laser system), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. The performance evaluation is for the device itself.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground-truth appears to be based on clinical observation and assessment by medical professionals regarding the device's ability to perform fractional photothermolysis and achieve its clinically intended effects without new safety issues. There is no mention of pathology, imaging, or specific objective biomarkers being used to establish ground truth in the provided text.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. As the Lux1540 is a physical device and not an AI algorithm, there is no "training set" in the context of machine learning.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no "training set." The device's design and manufacturing process would be based on engineering principles and knowledge of laser-tissue interaction for dermatological applications.

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Dermatological procedures requiring the coagulation of soft tissue.

The Palomar Lux1540 Handpiece delivers light with a wavelength of 1540 nm. The complete system consists of a power source, chiller, a footswitch, and a handpiece connected to the power unit with an umbilical. In standard use, the handpiece is held in firm contact with the skin. The handpiece tip is water-cooled to offer active skin System parameters and other system cooling. features are controlled from the user interface panel on top of the power unit.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document does not specify the sample size used for any test set.
• The document does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the performance data.

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

• The document does not mention the use of experts to establish ground truth for any test set or their qualifications.

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

• The document does not mention any adjudication method for a test set.

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:

• An MRMC comparative effectiveness study was not conducted. This device is a laser handpiece, not an AI or imaging diagnostic device that would typically involve human readers or AI assistance in interpretation.

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

• A standalone performance study was not done in the context of an algorithm. The "performance data" mentioned refers to the device's physical functionality (fractional photothermolysis) rather than an algorithmic output.

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

• The document does not explicitly state the type of "ground truth" used. The performance data focused on demonstrating the device's physical capability to create fractional photothermolysis, implying that the verification involved observing the physical effects on tissue, likely through histological examination or similar methods, but this is not detailed.

8. The sample size for the training set:

• The document does not mention any training set, as this is not an AI or algorithmic device.

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

• Not applicable, as no training set is mentioned for this device.

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