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The Palomar QYAG Laser Handpiece is indicated at the 1064 nm wavelength for dark ( i.e. dark blue or black) ink tattoo removal, removal of pigmented lesions, including but not limited to, lentigines, nevi, melasma, Becker Nevus-of-Ota and Café-au-Lait birthmarks. The 532 wavelength is indicated for the removal of light (red, orange, yellow or green) ink tattoos and most pigmented lesions (- e.g. lentigines, ephlides). The 1064/532 blended wavelength is indicated for tattoo removal.

The QYAG Laser handpiece is an accessory to the Palomar ICON System, which is composed of a system console, cooling system, power supply and handpiece. Laser energy is produced in the handpiece and delivered directly to the tissue.

Based on the provided text, the QYAG Laser Handpiece is not a device that would typically have acceptance criteria focused on diagnostic accuracy or performance metrics like sensitivity, specificity, or image quality, which are common for AI/ML-based medical devices.

Instead, this document describes a 510(k) Pre-Market Notification for a laser handpiece, which is a regulatory submission demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices. The "performance data" section explicitly states:

"The specifications and indications for use of the QYAG Laser are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information."

This indicates that Palomar Medical Technologies, Inc. did not conduct a new study to prove specific performance criteria for the QYAG Laser Handpiece beyond demonstrating its substantial equivalence to previously approved predicate devices. They are asserting that because it's substantially equivalent, it meets the safety and effectiveness standards already established by those predicates.

Therefore, many of the requested points regarding acceptance criteria, study details, expert review, and AI performance are not applicable or cannot be extracted from this document, as the submission relies on substantial equivalence rather than new performance studies with specific metrics.

Here's a breakdown based on the information provided and the regulatory context of a 510(k):

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not Applicable. The document explicitly states that the device's specifications and indications for use "do not result in additional safety or effectiveness information" beyond what is established for the predicate devices. This implies that no new clinical or performance test set (in the sense of a diagnostic study) was conducted for this 510(k) submission. The evidence for "performance" is based on the substantial equivalence to existing, approved devices.

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

• Not Applicable. No new test set for evaluating specific performance metrics was described or required for this substantial equivalence claim.

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

• Not Applicable. No new test set requiring adjudication was 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:

• No. This device is a laser handpiece, not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant to its type of function.

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

• No. This device is a physical laser handpiece, not an algorithm.

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

• Not Applicable. No new ground truth for performance evaluation was established for this submission. The "ground truth" for its safety and effectiveness is implicitly derived from the existing approvals of the predicate devices.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

• Not Applicable. As above, no training set for machine learning is relevant here.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the Palomar QYAG Laser Handpiece meets "acceptance criteria" is essentially the 510(k) Pre-Market Notification process itself, where Palomar Medical Technologies, Inc. demonstrated substantial equivalence to four legally marketed predicate devices:

1. Palomar Q-YAG 5 ND: YAG LASER SYSTEM (K061436)
2. HOYA ConBio, Inc. RevLite Q-Switched Nd:YAG Laser System (K083899)
3. Quanta System SPA Q-PLUS T+ IPL LASER SYSTEM (K123168)
4. Lutronic Corporation Spectra Laser System (K113588)

The document explicitly states under "6. PERFORMANCE DATA" that "The specifications and indications for use of the QYAG Laser are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information."

Under "7. SUBSTANTIAL EQUIVALENCE," it further clarifies: "The QYAG Laser Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this application demonstrates that the QYAG Laser also shares the same technological characteristics as its predicates."

This means that the "proof" is the successful comparison of the new device's technological characteristics, intended use, indications for use, and potential risks to those of the already approved predicate devices. The FDA, by issuing the 510(k) clearance (K130250), concurred with this assessment of substantial equivalence.

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The Palomar Vectus Laser is intended for all Fitzpatrick skin types, including tanned skin for use in aesthetic, dermatology, general and plastic surgery applications for the treatment of

• · The treatment of vascular lesions, such as angiomas, telangiectasia and other benign vascular lesions.
• Treatment of leg veins.
• · The treatment of benign pigmented lesions.
• · Hair removal and permanent hair reduction.
• · Treatment of pseudofolliculitis barbae.

The Skintel™ Reader is intended as an objective measurement tool for examining skin. melanin content for determining and setting a test spot starting fluence.

The Palomar Vectus Laser consists of a diode-powered handpiece, Skintel Reader, base module, coolant reservoir, and chiller module. The handpiece connects to the base module via the umbilical.

The provided 510(k) summary for the Palomar Vectus™ Laser and Skintel™ Reader focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics, indications for use, and verification/validation. It includes a general statement about clinical data supporting the Skintel Reader. However, the document does not explicitly detail specific acceptance criteria for the Skintel Reader's performance, nor does it describe a dedicated study designed to prove the device meets established acceptance criteria for its objective measurement of skin melanin content.

Therefore, based only on the provided text, I cannot complete a table of acceptance criteria and reported performance, or provide detailed information about a study that proves the device meets those criteria.

Here's a breakdown of what can and cannot be extracted from the provided text regarding your request:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information (Not available in the provided text):

Since the document does not describe a study to explicitly prove acceptance criteria, the following information is also not available:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified.
• 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 specified.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not specified. A multi-reader study is generally not relevant for a melanin reader; this type of study is more applicable for diagnostic AI interpretation.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not specified. The Skintel Reader itself is a standalone objective measurement tool, distinct from an "algorithm only" in the sense of a software-based AI interpreting images. Its performance would inherently be "standalone." However, its specific validation is not detailed.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not specified. For a melanin reader, ground truth would likely involve a reference spectrophotometer or other validated melanin measurement technique.
• 8. The sample size for the training set: Not specified (if a machine learning model were involved, which isn't explicitly stated for the Skintel Reader).
• 9. How the ground truth for the training set was established: Not specified.

Conclusion based on provided text:

The provided 510(k) summary for the Palomar Vectus™ Laser and Skintel™ Reader primarily focuses on demonstrating substantial equivalence to predicate devices and states that clinical data for the Skintel™ Reader was included. However, it does not explicitly define acceptance criteria for the Skintel™ Reader's performance, nor does it describe the details of any study that specifically proves the device meets such criteria, as would typically be presented with performance metrics. The information needed to complete the requested table and detailed study description is absent from this document.

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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 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions.

The 2940 Fractional Ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.

The 1540 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

The 1440 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

The IR Handpiece is intended for photocoagulation of soft tissue in dermatologic applications. In addition, it is intended 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, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; verrucae, skin tags, seborrheic keratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments; treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (PFB).

The Max Series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae; removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.

The Skintel™ Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence.

The Palomar Icon Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces individually connect to the system via the console connection port.

This 510(k) submission (K110907) is for the Palomar Icon™ Aesthetic System, a light and laser system intended for various dermatological and surgical applications. The submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing detailed performance studies with acceptance criteria for a new AI/software device.

Therefore, most of the requested information cannot be extracted directly from this document. The document states:
"The review of the technical characteristics. indications for use, clinical data, verification and validation information provided in the 510(k) Premarket Notification demonstrates that the Palomar Icon Aesthetic System is substantially equivalent to its predicate i device." and "The Palomar Icon Aesthetic System is substantially equivalent to its predicate devices when used according to its intended use. This is based on the information provided in this 510(k) Premarket Notification which demonstrates that the Palomar Icon Aesthetic System shares the same technological characteristics, mechanism of action, intended use and physical properties when compared to its predicates."

This indicates that the focus was on demonstrating similar technological characteristics and intended use to existing devices, rather than presenting new performance data against specific acceptance criteria for a novel AI or software component.

However, I can extract information related to the Skintel™ Reader, which is a component of the system and has a specific function:

Skintel™ Reader Information:

• Intended Use: "The Skintel™ Reader is intended as an objective measurement tool for examining skin melanin content for determining and setting a test spot starting fluence."

Based on the provided text, the following information cannot be determined:

• A table of acceptance criteria and reported device performance (for the overall system or the Skintel™ reader, as this is a substantial equivalence submission)
• Sample size used for the test set
• Data provenance
• Number of experts used to establish ground truth
• Qualifications of experts
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• Effect size of human readers improvement with AI vs without AI assistance
• If a standalone (algorithm only) performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Missing Information/Why it cannot be provided from the text:

The provided 510(k) summary is a high-level overview focused on demonstrating substantial equivalence to predicate devices, as is typical for many medical device clearances. It does not contain the detailed performance study results, acceptance criteria, or methodological specifics that would be required for an AI/software device. For instance, the "Performance Data" section simply states that the review "demonstrates that the Palomar Icon Aesthetic System is substantially equivalent," without providing specific metrics or criteria.

To answer the requested questions comprehensively for a device like the Skintel™ Reader (an "objective measurement tool"), one would typically need a much more detailed technical report or clinical study report, which is not part of this 510(k) summary. This report would describe validation studies showing the accuracy and precision of the melanin content measurement, comparison to a gold standard, and how these measurements correlate with "setting a test spot starting fluence."

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The 2940 Ablative Laser Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions.

The 2940 Ablative Laser 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, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

The 1440 Fractional Non-ablative Laser Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.

The 1540 and 2940 Fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, fine lines, textural irregularities, dyschromia and pigmented lesions.

he 1440 and 2940 Fractional combined treatment is intended for dermatological procedures quiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin surfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, schromia and pigmented lesions.

The IR Handpiece is intended for photocoagulation of soft tissue in dermatologic applications. In addition, it is intended 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 culation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The 1064 Laser Handpiece is intended for the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction; treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; verrucae, skin tags, seborrheic keratosis; tattoos (significant reduction in the intensity of black and/or blue-black tattoos); pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; coagulation and hemostasis of soft tissue; treatment of wrinkles and pseudofolliculitis barbae (PFB).

The Max Series Intense Pulsed Light Handpieces are intended for the treatment of inflammatory acne (acne vulgaris) and for the treatment of benign pigmented epidermal and cutaneous lesions, including warts, scars and striae; removal of unwanted hair from skin types I-VI, and to effect stable long-term, or permanent, hair reduction; treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.

The Palomar Icon Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces individually connect to the system via the console connection port.

This document is a 510(k) summary for the Palomar Icon™ Aesthetic System, indicating substantial equivalence to predicate devices. It does not contain acceptance criteria for specific performance metrics or detailed study results proving the device meets such criteria. Instead, it relies on the assertion of "substantial equivalence" to previously cleared devices.

Therefore, most of the requested information cannot be extracted from this document, as it outlines the regulatory submission, intended uses, and device description, rather than clinical performance data against pre-defined acceptance criteria.

Here's an attempt to answer what can be gathered, with clear indications where information is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not available in this document. The submission relies on "performance data" but does not detail studies with specific sample sizes for a 'test set'.
• Data Provenance: Not available in this document. The document mainly discusses regulatory equivalence and does not specify the country of origin of any data, nor whether it was retrospective or prospective.

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

• Number of Experts: Not applicable/Not available. This document does not describe the establishment of ground truth by experts for a test set, as no specific clinical performance study is detailed against newly established ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not available. No specific test set performance study or adjudication process is described.

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

• MRMC Study Done: No, based on the information provided. The document does not describe any MRMC study or the effect size of human readers with vs. without AI assistance. The device is a laser/light system, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study Done: Not applicable/Not available. This device is a physical system (laser/light handpieces) for aesthetic and surgical procedures, not an algorithm. Therefore, "standalone algorithm performance" is not relevant in this context.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable/Not available in the context of a performance study against specific ground truth. The submission relies on the concept of "substantial equivalence" to predicate devices, meaning its safety and effectiveness are deemed similar to devices already on the market and legally used. No new ground truth establishment is described for proving efficacy of the Icon system itself as a novel device.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not available. This document pertains to a physical medical device, not an AI/ML algorithm that would typically involve a "training set."

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

• How Ground Truth for Training Set Was Established: Not applicable/Not available. As above, this document does not describe an AI/ML algorithm that uses a training set with established ground truth.

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The Lux1540 and Lux2940 fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.

The Lux1440 and Lux2940 fractional combined treatment 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, dyschromia and pigmented lesions.

The complete platform consists of a cart, console with an internal power supply and electronics, chiller, and a footswitch. Each handpiece individually attaches to the console via a connection port.

Here's an analysis of the provided text regarding acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary (K101506) does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, or quantitative measures of wrinkle reduction) that need to be met for the device to be considered effective.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. The "performance data" section states:

"Clinical studies were conducted to evaluate safety and effectiveness when combining either the Lux1540 and Lux2940 or the Lux1440 and Lux2940 for treatment of wrinkles, dyschromia and pigmented lesions. The specifications and indications for use of the handpieces are substantially equivalent to the predicate devices based on the data provided in Premarket Notification and comparison of the technical characteristics. Thus, these handpieces do not result in additional safety or effectiveness information."

This implies that the acceptance criteria are met if the device's technical characteristics, specifications, and observed safety and effectiveness (as determined in the clinical studies) are deemed comparable to the legally marketed predicate devices. The study's purpose was to support this claim of substantial equivalence.

Without explicit performance targets, a table would look like this:

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

The provided summary does not specify the sample size used for the clinical studies. It only states that "Clinical studies were conducted."
The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned in the provided document.

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 510(k) summary. The document mentions "Clinical studies were conducted to evaluate safety and effectiveness," but it does not detail the methodology for establishing ground truth, the number of experts, or their qualifications.

4. Adjudication Method for the Test Set

The 510(k) summary does not describe any adjudication method for the test set or clinical study outcomes.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study (comparing human readers with and without AI assistance) was not conducted or described. This device is a laser handpiece, not an AI-driven diagnostic tool that would typically involve human readers interpreting images.

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

This question is not applicable as the device is a medical laser handpiece, not an algorithm or AI system for diagnosis or interpretation. The device's performance is inherently tied to its physical application by a human operator.

7. The Type of Ground Truth Used

While "clinical studies" were mentioned to evaluate "safety and effectiveness," the specific type of "ground truth" used is not explicitly stated. Given the nature of the device (laser for skin treatment), it's likely that the evaluation of effectiveness involved clinical assessments by physicians (e.g., visual grading of wrinkle reduction, assessment of lesion clearance), potentially with objective measures like photography or skin analysis, and safety would be assessed through adverse event monitoring. However, the document does not elaborate on these details.

8. The Sample Size for the Training Set

The provided summary does not mention a training set sample size. This is expected as the device is a physical handpiece, not an AI model that requires a training set.

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

This question is not applicable as the device is a physical handpiece and does not utilize a "training set" in the context of machine learning or AI models.

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The Lux1540 Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars.

The Lux1440 Handpiece is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures.

The Lux2940 Handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications: skin resurfacing, treatment of wrinkles, epidermal nevi, telangiectasia, spider veins, actinic chelitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions. The Lux2940 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 MaxG Handpiece is intended for treatment of benign pigmented epidermal and cutaneous lesions, including but not limited to lentigines, nevi, melasma, café-au-lait warts, scars, striae, and the treatment of vascular lesions including but not limited to port wine stains, hemangiomas, angiomas, telangiectasias, rosecea, facial and leg veins.

The Artisan Aesthetic System consists of a console with an internal power supply, chiller, and electronics. The light and laser handpieces connect to the system via the console connection port.

The provided text is a 510(k) Summary for the Palomar Medical Technologies, Inc. Artisan™ Aesthetic System. It generally focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed clinical study with acceptance criteria and specific performance metrics.

Based on the information provided in the document:

1. Table of acceptance criteria and the reported device performance:
   The document does not report specific acceptance criteria or quantitative device performance metrics from a clinical study. The submission relies on establishing substantial equivalence to predicate devices. The "Performance Data" section states: "The review of the technical characteristics, indications for use, risk analysis, verification and validation information provided in the 510(k) Premarket Notification demonstrates that the Artisan Aesthetic System is substantially equivalent to its predicate device."

   Without specific study results, a table of acceptance criteria and reported performance cannot be generated from this document.

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 mention any specific clinical study data (test set, sample size, or data provenance). The submission focuses on technical characteristics, intended use, and equivalence to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   As no specific clinical study data or test set is described, there is no information provided regarding experts used to establish ground truth or their qualifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Since no clinical study with a test set is described, no adjudication method is 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 document describes a light and laser system, not an AI-assisted diagnostic or therapeutic device that would typically involve human readers. Therefore, no MRMC comparative effectiveness study or related effect size for human readers improving with AI is mentioned or relevant to this submission. The device is a direct treatment system, not an AI-based analysis tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This device is a physical light and laser system for medical procedures, not an algorithm. Therefore, the concept of "standalone algorithm-only performance" does not apply to this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   As no specific clinical study results are presented, no information on the type of ground truth used is available. The substantial equivalence argument relies on the safety and effectiveness of the predicate devices.

8. The sample size for the training set:
   Since this is a physical medical device and not an AI/machine learning algorithm, the concept of a "training set" in that context is not applicable or mentioned in this document.

9. How the ground truth for the training set was established:
   As the concept of a training set is not applicable to this device type and submission, no information is provided on how ground truth for a training set was established.

In summary, the provided 510(k) Summary emphasizes substantial equivalence to predicate devices based on shared technological characteristics, mechanism of action, intended use, and physical properties. It does not contain information about specific clinical study data, acceptance criteria, or performance metrics in the format requested, as it is not a submission for a novel AI/software-driven diagnostic or therapeutic device evaluated through a performance study with explicit ground truth and sample sizes.

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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 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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