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The Emerge Fractional Laser is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The Emerge Fractional Laser is further indicated for treatment of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.

The Emerge Fractional Laser consists of a fractional laser handpiece attached to a base unit. The base unit includes a power supply, control electronics, and user interface LCD screen.

This 510(k) summary (K111840) for the Emerge Fractional Laser does not contain a study that proves the device meets specific acceptance criteria with reported performance metrics.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices. Substantial equivalence is established by comparing the technological characteristics, mechanism of action, intended use, and previously provided clinical and histology data (not detailed in this summary).

Therefore, I cannot populate the requested table and information points as they relate to a clear acceptance criteria study with defined performance. The provided document states that "the review of the technological characteristics, mechanism of action, indications for use, clinical data, histology data, and verification as well as validation information provided in the 510(k) Premarket Notification demonstrates that the Emerge Fractional Laser is substantially equivalent to its predicate device." This implies that data exists elsewhere in the complete 510(k) submission, but it is not included in this summary.

Based on the provided text, the following points cannot be addressed:

• 1. A table of acceptance criteria and the reported device performance: No specific acceptance criteria or performance results are listed in this summary.
• 2. Sample sized used for the test set and the data provenance: Not mentioned.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• 4. Adjudication method: Not mentioned.
• 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: This device is a laser system, not an AI-assisted diagnostic tool, so this question is not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a laser system.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not described for the context of a performance study. Clinical and histology data are mentioned as having been provided elsewhere.
• 8. The sample size for the training set: Not mentioned.
• 9. How the ground truth for the training set was established: Not mentioned.

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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 Palomar Lux1440 handpiece is intended for use in dermatological procedures requiring: coagulation of soft tissue and skin resurfacing procedures.

The Lux1540 Handpiece & Lux1440 Handpiece each attach to the StarLux Pulsed Light and Laser Systems. The complete StarLux System console consists of a power supply, chiller, electronics, portable cart, and a footswitch.

The provided document is a 510(k) summary for the Palomar Lux1540 and Lux1440 Fractional Laser Handpieces. It details the device's intended use and claims substantial equivalence to predicate devices. However, it does not describe specific acceptance criteria or an analytical study proving the device meets those criteria in the way typically expected for performance claims like sensitivity, specificity, or reader study results.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This means that, rather than conducting new performance studies against pre-defined acceptance criteria, the manufacturer argues that their device is as safe and effective as devices already on the market.

Therefore, many of the requested details cannot be extracted from this specific document.

Here's an attempt to answer based on the available information, noting what cannot be found:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission hinges on "substantial equivalence" rather than quantitative performance against specific acceptance criteria. The document states: "The specifications and indications for use of the Lux1540 Handpiece &Lux1440 Handpiece are substantially equivalent to its predicate devices based on the data provided in the 510(k) Premarket Notification."

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

This information is not provided in the document. As the submission relies on substantial equivalence and a comparison to predicate devices rather than a de novo performance study, details about a test set and its provenance are not included.

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

This information is not provided in the document. There is no mention of a test set with established ground truth by experts.

4. Adjudication method for the test set

This information is not provided in the document.

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

There is no mention of an MRMC study. This device is a laser handpiece, not an AI-assisted diagnostic tool, so such a study would not be relevant in this context.

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

This information is not applicable/not provided. The device is a physical laser handpiece, not an algorithm.

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

This information is not provided as there is no specific performance study against a defined ground truth mentioned in the document.

8. The sample size for the training set

This information is not provided. As the submission is for substantial equivalence of a physical device, a "training set" in the context of an algorithm or AI is not relevant.

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

This information is not provided and is not applicable for this type of device and submission.

Summary based on the document:

The device's acceptance criteria and proof of meeting them are established through the process of substantial equivalence to existing predicate devices (Lux1540 Fractional Laser Handpiece K080244, Lux 1440TM Fractional Laser Handpiece K073583, and Fraxel Re:store™ Laser System (Formerly SR1500) K070284). The manufacturer asserts that "The Lux1540 Handpiece and Lux1440 Handpiece are 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 and Lux1440 Handpiece also share the same technological characteristics, mechanism of action, intended use and physical properties to its predicates."

This means that the "study" proving the device meets its "acceptance criteria" is the 510(k) Premarket Notification submission itself, which argues that the new device is as safe and effective as the predicate devices based on a comparison of their characteristics, rather than new, independent performance studies with detailed acceptance metrics.

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Power settings in the range of 5-50 Watts is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the ThermaPulse may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Not Found

This document is a 510(k) clearance letter for the Palomar Medical Technologies Inc. ThermaPulse™ device, an infrared lamp. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Such information would typically be found in the 510(k) summary or the original submission itself, which are not provided here.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on regulatory approval and substantial equivalence to a predicate device.

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The LOI System is an over-the-counter device intended for treatment of periorbital wrinkles.

The LOI System is composed of a handpiece, base, power cord, charger, and pretreatment gel.

This document describes the LOI System, an over-the-counter device intended for the treatment of periorbital wrinkles. The provided text is a 510(k) summary and approval letter, which primarily focuses on regulatory submission and substantial equivalence to predicate devices, rather than a detailed study report with specific acceptance criteria and performance metrics. Therefore, some of the requested information, such as precise acceptance criteria values, a detailed breakdown of device performance against these criteria, specific sample sizes for test/training sets, or details on human expert involvement beyond general clinical data collection, is not explicitly present in the provided text.

Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Precise quantitative acceptance criteria for safety and effectiveness (e.g., specific reduction in wrinkle severity, adverse event rates below a certain threshold) are not provided in this regulatory summary.

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

• Sample size for the test set: Not explicitly stated. The document mentions "multiple studies" and "clinical data was collected in multiple studies," but does not provide specific sample sizes for these studies or differentiate between test and training sets.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). It is implied that the data was collected through "clinical studies," suggesting a prospective clinical trial, but no details are given.

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: Not specified.

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 study is not mentioned. This device is a direct-use aesthetic device, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable in the context of this device.

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

• The LOI System is a physical light-based medical device for direct patient use, not an algorithm. Therefore, "standalone (algorithm only)" performance is not applicable. Its performance is inherent in its physical operation.

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

• Given the "treatment of periorbital wrinkles" indication, the ground truth would likely be based on clinical assessment of wrinkle severity (e.g., using a standardized photographic scale, expert-graded visual assessment, or potentially instrumental measurements) and patient-reported outcomes. However, the specific methodology for establishing this ground truth is not detailed.

8. The sample size for the training set

• Not explicitly stated. The document mentions "multiple studies" for "clinical data" but does not differentiate training from test sets or provide specific numbers.

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

• Not explicitly stated. As with the test set, it would likely involve clinical assessments of wrinkle severity, but the specific methodology is not detailed.

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The Erbium Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

The Erbium Fractional 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 510(k) summary regarding the Erbium Fractional Handpiece:

Acceptance Criteria and Device Performance Study for K083900 - Erbium Fractional Handpiece

Based on the provided 510(k) summary, the device's acceptance criteria and performance are established through a claim of substantial equivalence to predicate devices, rather than a new clinical study with specific acceptance criteria metrics.

The document explicitly states:
"The specifications and indications for use of the Erbium Fractional are substantially equivalent to its predicate devices based on the data provided in premarket notification. Thus, it does not result in additional safety or effectiveness information."

And:
"The Erbium Fractional Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this premarket notification demonstrates that the Erbium Fractional Handpiece also shares the same technological characteristics, mechanism of action, intended use and physical properties to its predicates."

This means that no new, independent study was conducted to demonstrate the device's performance against specific, pre-defined acceptance criteria. Instead, the FDA cleared the device based on its similarity to previously approved devices. Therefore, the following information is largely not applicable or not explicitly detailed in the provided document, as a traditional performance study was not conducted for this specific 510(k) filing.

1. Table of Acceptance Criteria and Reported Device Performance

• Palomar Erbium Fractional Handpiece (K071768)
• Palomar Erbium Handpiece (K071152, K063571)
• Palomar Lux1540 Fractional Handpiece (K080244)
• Reliant Technologies, Inc. Fraxel III SR Laser System (Fraxel Re:Pair™) (K080915) |

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

• Sample Size for Test Set: Not applicable. No new test set data was reported for this 510(k) submission. Performance was established via substantial equivalence.
• Data Provenance: Not applicable. The submission relies on data previously reviewed and accepted for the predicate devices.

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

• Number of Experts: Not applicable. No new test set requiring expert ground truth establishment was conducted.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No new test set was evaluated.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done for this submission. The device's clearance is based on substantial equivalence.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable. This device is not an AI-assisted diagnostic tool; it is a laser handpiece for dermatological procedures.

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

• Standalone Performance: Not applicable. This device is a medical instrument (laser handpiece), not a software algorithm or AI.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable for this specific 510(k) submission, as performance was demonstrated through substantial equivalence. The predicate devices would have relied on appropriate clinical data (e.g., expert clinical assessment, histopathology) to establish their safety and effectiveness.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a laser handpiece, not an algorithm that requires a training set.

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

• How Ground Truth for Training Set Was Established: Not applicable. This device is a laser handpiece, not an algorithm that requires a training set.

Summary of K083900's Clearance Basis:

The Erbium Fractional Handpiece (K083900) received 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. This means the manufacturer successfully argued that their new device shares fundamental technological characteristics, intended use, mechanism of action, and physical properties with devices already on the market that have been deemed safe and effective. Therefore, no new clinical performance studies, test sets, or training sets were required for this specific submission to prove safety and effectiveness beyond what was already established for the predicates.

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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 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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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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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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