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The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include:

The Super Hair Removal (SHR) Mode is intended for temporary hair reduction.

The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for the Soprano Trio diode laser HR module include: Benign vascular and vascular dependent lesions.

810nm Applicator

Soprano Titanium 810 nm applicator intended use and indications for use:

The indications for use for the 810nm Modified Diode Laser Module 2 cm2 include:

• The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6.9 and 12 months after the completion of a treatment regimen.

Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)

755nm applicator

Soprano Titanium 755 nm applicator intended use and indications for use:

The indications for use for the 755nm Diode Laser Module include:

• The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.

· Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes)

NIR Applicator

NIR Applicator intended use and indications for use

The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating.

The indications for use for NIR Modules are:

• · Elevating the tissue temperature for the temporary relief of minor muscle 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; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The Alma Lasers Soprano Titanium Laser System consists of:

• System console (contains the laser diodes, the system software, power supply and various other electronic and mechanical parts)
• Operator control panel with touch screen technology (GUI)
• 810 nm applicator ●
• 755 nm applicator
• Small NIR applicator
• Trio 4 cm2 applicator ●
• Trio 2 cm2applicator .

This document is a 510(k) premarket notification from the FDA, asserting the Alma Soprano Titanium device's substantial equivalence to a predicate device (K222064). This means that the device is deemed to be as safe and effective as a previously cleared device. Therefore, a separate study to prove the device meets acceptance criteria is not explicitly provided in this document, as the substantial equivalence framework relies on comparison to an already approved device.

However, based on the provided text, we can infer some information about performance testing and clinical data:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state "acceptance criteria" and "reported device performance" in a table format for the newly submitted device. Instead, it refers to performance testing against established safety and essential performance standards for medical electrical equipment and laser products. The implicit "performance" is that the device conforms to these standards.

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 states, "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission." This indicates that there was no new clinical test set for this specific 510(k) submission. The device's safety and effectiveness are established through its substantial equivalence to the predicate device K222064.

Therefore, questions regarding sample size, data provenance (country of origin, retrospective/prospective), number of experts, and adjudication methods for a test set are not applicable to this submission, as no new clinical test data was generated.

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, as no new clinical studies were conducted for this submission.

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

Not applicable, as no new clinical studies were conducted for this submission.

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. The Smart Clinic software is classified as an MDDS (Medical Device Data System), which is focused on data management and display, not AI-assisted diagnosis or interpretation requiring MRMC studies.

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

Not applicable. The document focuses on hardware (laser modules, applicators) and an MDDS software component. There is no mention of a standalone algorithm for diagnostic or interpretative purposes.

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

Not applicable to this 510(k) submission directly, as it relies on substantial equivalence. The "ground truth" for the predicate device (K222064) would have been established through its own clearances and supporting data, which is not detailed here. For the current submission, the "ground truth" is that the device conforms to the relevant performance standards mentioned in Section VII and maintains similar technical characteristics to the predicate.

8. The sample size for the training set:

Not applicable, as no new clinical studies involving training sets for algorithms are mentioned or deemed necessary for this submission. The Smart Clinic software is an MDDS and does not appear to involve a learning algorithm requiring a training set in the context of this document.

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

Not applicable, as no new clinical studies involving training sets for algorithms are mentioned or deemed necessary for this submission.

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The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include: The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode include: Benign vascular and vascular dependent lesions.

810nm Applicator: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)

755nm applicator: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes)

NIR Applicator: The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating. The indications for use for NIR Modules are: Elevating the tissue temperature for the temporary relief of minor muscle 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; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The Alma Lasers Soprano Titanium Laser System consists of: System console (contains the laser diodes, the system software, power supply, and various other electronic and mechanical parts), Operator control panel with touch-screen technology (GUI), Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously, 810 nm applicator, 755 nm applicator, Small NIR applicator, Footswitch and other laser safety accessories.

The provided text describes the acceptance criteria and a human clinical study performed for the Soprano Titanium device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): 30 healthy subjects.
• Data Provenance: The study was a multi-center, prospective, open-label, single-arm human clinical study conducted in the US at two sites.

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

• Number of Experts: 3 blinded evaluators.
• Qualifications of Experts: Not explicitly stated in the document. They were described simply as "blinded evaluators" who physically counted hairs and assessed results.

4. Adjudication method for the test set

• Adjudication Method: Not explicitly detailed beyond stating that "three blinded evaluators assessed the results compared to the baseline for each treatment area." The document reports an "average reduction" based on these evaluations, suggesting a consensus or averaging approach, but the specific adjudication method (e.g., majority vote, independent assessment with average, etc.) is not provided.

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. This study was a human clinical trial evaluating the device's efficacy for hair removal, not an AI-assisted diagnostic or interpretive study comparing human reader performance.

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

• No, this was a device efficacy study, not an algorithm-only performance study. The "algorithm" here refers to the laser treatment protocol, and the performance was measured by its effect on human subjects, not by an automated algorithm's output.

7. The type of ground truth used

• Type of Ground Truth: Expert assessment of directly observed outcomes. The ground truth for hair reduction was established by "physically counted" hairs and "assessed" results by "three blinded evaluators" compared to baseline.

8. The sample size for the training set

• Training Set Sample Size: Not applicable/not provided. This was a clinical study on a medical device, not a machine learning model requiring a separate training set. The "protocol was reviewed by the FDA in Q181225 prior to its use," suggesting a pre-defined treatment protocol rather than an algorithm developed from a training dataset.

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

• Ground Truth for Training Set: Not applicable. As explained above, this was a clinical efficacy study, not an AI model development study with a training set and corresponding ground truth. The device and its operating parameters would have been developed and refined through engineering and earlier testing, leading to the protocol used in this specific clinical trial.

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The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite, and Opus] is intended for use in dermatologic and general surgical procedures.

The Opus Plasma Applicator and Tips -

The Opus Plasma Tips (Focus and Glide), when used with the unipolar applicator, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

The Opus Colibri Applicator and Tips

The Opus Colibri Tips, when used with the unipolar Opus Collbri applicator, are indicated for dermatological procedures requiring resurfacing of the skin.

The new Colibri handpiece with two tips incorporates the unipolar RF-based technology and delivers radiofrequency energy via the designed tips that creates micro-plasma causing controlled ablation micro-perforations and a thermal injury zone in the skin, surrounding the perforations.

The new Colibri RF fractional tips are made of the same material as the existing cleared RF tips. The purpose of the Colibri tips is to treat very small areas of skin.

The provided text describes a 510(k) premarket notification for "The Alma Opus System, Colibri Applicator and Tips." This is a regulatory submission demonstrating substantial equivalence to a legally marketed predicate device, not a study evaluating specific acceptance criteria for performance with numerical results against a ground truth for a diagnostic AI device.

Therefore, many of the requested elements for an AI device (like reported device performance against acceptance criteria, sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not available in this document.

However, I can extract information related to what was tested and the conclusions drawn for safety and effectiveness.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria with numerical performance targets and reported values for classification or detection tasks, as it's not a diagnostic AI device. Instead, it focuses on demonstrating safety and functionality.

The "acceptance criteria" here are implicitly related to:

• Compliance with electrical safety standards.
• Demonstration of expected tissue effects through histology.
• Absence of unexpected adverse events.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Non-Clinical Performance Testing (Histology): Three (3) Domestic female (Mixed Landrace & Large White) crossbred swine were used.
• Data Provenance: The study was conducted on porcine animals, typically domestic. The document does not specify the country of origin for the animals or if the study was prospective/retrospective, but preclinical animal studies are inherently prospective.

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)

This is not applicable as this is not a diagnostic AI device requiring expert ground truth for classification/detection. The assessment of histology slides (which would typically be performed by a veterinary pathologist) is implied by the "histology results complied with the FDA requirements" statement, but no specific number or qualifications of experts are given.

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

Not applicable, as this is not a diagnostic AI device involving human interpretation of results requiring adjudication.

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 such study was performed or required, as this is not a diagnostic AI device designed to assist human readers. The submission explicitly states: "Based on the similarities in the safety and effectiveness profiles of the subject and the predicate, no clinical studies were deemed needed to support this submission."

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

Not applicable, as this is a medical device for skin ablation and resurfacing, not a standalone diagnostic algorithm.

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

For the non-clinical performance testing, the "ground truth" was established through histology on porcine tissue. This is a direct pathological assessment of tissue changes post-treatment.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that requires a training set.

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

Not applicable.

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The Dye VL Handpiece (500-600 nm) is indicated for:

• The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, and Becker's Nevi.
• The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques.
• The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
• Use on skin types (Fitzpatrick I-V).

The Harmony XL™ continues to be comprised of the identical console unit, footswitch, and a variety of handpieces. The main console of the Harmony XL™ continues to consist of the same control panel, system controller, power supply modules, cooling system, switching module, and isolation transformer.

The subject change is to add a version of the 515-950 nm SVL515 Module AFT handpiece ("SVL515") provided in the company's cleared Harmony XL™ (K072564) to the Harmony XL™ system. The modified handpiece has a narrowed wavelength range of 500-600 nm as compared to the SVL515 handpiece that has a wavelength of 515-950 nm. In addition, the modified handpiece is named the "Dye VL handpiece." Further, the identification color of the distal end of the handpiece is being changed from turquoise to light green.

The provided text is a 510(k) summary for the Alma Lasers Harmony XL™ Multi-Application Platform with the Dye VL Handpiece. This document is a regulatory submission to the FDA for demonstrating substantial equivalence to a predicate device, not a detailed scientific study on device performance against specific acceptance criteria. Therefore, the information required to fully answer your request regarding acceptance criteria and a study proving the device meets them is limited and largely not present in the provided text.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific acceptance criteria (e.g., in terms of clinical efficacy metrics like lesion reduction percentage, or safety metrics like adverse event rates) and reported device performance against those criteria.

The "Performance Data" section states:

• "Software verification and validation was performed, and demonstrates that the software performs as intended."
• "Electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) was established."
• "Biocompatibility of patient-contacting components was established per ISO 10993."
• "In all instances, the subject device functions as intended and meets all the same acceptance criteria as the predicate devices."

This indicates that the acceptance criteria are based on fulfilling engineering and safety standards, and that device functions as intended. However, the specific quantitative or qualitative criteria are not detailed.

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 clinical test set, sample size, or data provenance (country of origin, retrospective/prospective). The performance data cited refers to engineering verifications and validations (software, electrical safety, EMC, biocompatibility), which typically do not involve human subjects or clinical data in the same way as a clinical trial.

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)

This information is not applicable and not available in the document, as no clinical test set requiring expert ground truth establishment is described.

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

This information is not applicable and not available, as no clinical test set requiring adjudication is 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

There is no mention of an MRMC comparative effectiveness study, nor is there any AI component described in the device. The device is a laser/light platform, not an imaging analysis or diagnostic AI device. Therefore, this question is not applicable to the provided document.

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

This question is not applicable. The device is a physical laser/light therapy platform, not an algorithm.

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

For the engineering performance data mentioned, the "ground truth" would be established by the relevant engineering standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and the functional specifications of the device. There is no mention of clinical ground truth (like pathology or outcomes data) because the document focuses on demonstrating substantial equivalence based on technological characteristics and safety, rather than presenting new clinical efficacy data.

8. The sample size for the training set

The document does not mention any training set. This device is not described as an AI/ML device that would require a "training set" in the context of machine learning.

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

Not applicable, as no training set for an AI/ML component is mentioned.

Summary of what is present:

The document is a 510(k) summary for a medical device (Harmony XL™ Multi-Application Platform with Dye VL Handpiece). It aims to demonstrate substantial equivalence to existing predicate devices, not necessarily to prove new clinical efficacy.

• Acceptance Criteria (Implied): The device is stated to meet the "same acceptance criteria as the predicate devices" for software, electrical safety, electromagnetic compatibility, and biocompatibility. These criteria are based on established engineering and safety standards (IEC 60601-1, ISO 10993) and the device's functional specifications. Specific quantitative or qualitative performance targets are not listed.
• Study: The "studies" conducted are non-clinical:
  • Software verification and validation.
  • Electrical safety testing (IEC 60601-1).
  • Electromagnetic compatibility testing (IEC 60601-1-2).
  • Biocompatibility testing (ISO 10993).
• Sample Size/Data Provenance/Experts/Adjudication/MRMC/Standalone Performance/Ground Truth (for clinical data or AI): These details are not provided because the 510(k) submission primarily relies on demonstrating that the modified device's technological characteristics and intended use are substantially equivalent to a cleared predicate, and that it conforms to relevant engineering and safety standards. It does not describe a clinical performance study using patient data and expert review.

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Intended Use: The device is intended for use in dermatologic and general surgical procedures.
Indications for Use:
The Soprano trio Diode Laser Module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio Diode Laser Module include:

• Benign vascular and vascular dependent lesions removal.
  The indications for use for the Soprano1064nm Diode Laser Module include:
• The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
• Treatment of Pseudo folliculitis Barbae (PFB)
• Use on all skin types (Fitzpatrick I-VI), including tanned skin.
  The indications for use for the 810nm Modified Diode Laser Module 1.2 cm' include:
• . The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
• The treatment of benign vascular and pigmented lesions.(The Laser Blanch (LB) Mode)
• Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and LB Modes)
  Optional Tapered Light Guide: It is intended for the same use as the device.
  The indications for use for the 810nm Modified Diode Laser Module 2 cm include:
• The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
• Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)
  The indications for use for the 755nm Diode Laser Module include:
• The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
• The treatment of benign vascular and pigmented lesions.(The Laser Blanch Mode)
• Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and Laser Blanch Modes)
  NIR Modules
  The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating.
  The indications for use for NIR Modules are:
• Elevating the tissue temperature for the temporary relief of minor muscle pain 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; may also help muscle spasms, minor sprains and minor muscular back pain.

The subject device, Alma Lasers Soprano Trio Diode Laser Module is an additional hand piece intended to be used with previously cleared Soprano platforms. Consistent with the previous clearance the system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas, and its major components are still the main console unit, foot switch, and individual modules. No change has been made to the main console unit except for incorporation of the software needed to run the new module and adding a new device name (Soprano 100 Platinum) to the Soprano family name for marketing purposes. The footswitch and pre-existing modules are also unmodified from those cleared in K140009 and K170626.
The module's operation involves emission of laser (diode) energy through the hand piece to the patient's skin. The materials that could contact the patient during device use are as cleared in the predicate. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.

The provided text describes a 510(k) premarket notification for a medical device, which is primarily a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to prove acceptance criteria in the typical sense of a clinical trial for a novel device. Therefore, much of the requested information (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, specific ground truth for training data) is not applicable or not provided in this type of regulatory document.

However, I can extract the relevant information regarding performance testing and the conclusion of safety and effectiveness.

Acceptance Criteria and Device Performance

The acceptance criteria here are implicitly tied to demonstrating substantial equivalence to predicate devices, ensuring that the modified device functions as intended and does not raise new safety or effectiveness concerns.

Detailed Study Information (as applicable to this 510(k) submission):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • No specific "test set" in the context of clinical data for algorithmic performance is mentioned. The performance testing described includes adherence to international standards and animal histology.
   • For animal histology, the sample size is not specified, nor is the country of origin or whether it was retrospective/prospective. The text only states "animal histology testing was performed".

2. 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. The ground truth for device performance here is based on compliance with engineering standards and direct observation of tissue effects in animal models by the manufacturer or testing facility, not expert consensus on diagnostic interpretations.

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

   • Not applicable. No diagnostic interpretation or human reader-based assessment requiring adjudication is described.

4. 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 surgical instrument, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is a medical device, not a standalone algorithm. Its performance is assessed through compliance with standards and tissue effects, not an algorithmic output.

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

   • For the animal histology study, the "ground truth" would be the observed histological changes and tissue effects, likely evaluated by a histopathologist, although this is not explicitly stated. The comparison was to the effects of individual wavelengths.
   • For compliance with standards, the ground truth is the engineering specifications and safety requirements defined by the standards themselves.

7. The sample size for the training set:

   • Not applicable. No machine learning training set is mentioned as this is a laser device.

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

   • Not applicable.

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The Alma LipoFlow System is used in the aspiration, harvesting, filtering and transferring of autologous adipose tissue and infiltration for aesthetic body contouring. If the harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.

The Alma LipoFlow System is a wheeled cart (also called as console) that contains a peristaltic irrigation pump and an adjustable vacuum source. The peristaltic pump (120 VAC, 50-60 Hz and 220-230 VAC, 50-60 Hz) is intended for continuous and/or intermittent delivery of tumescent liquid into a patient's body. The vacuum source is a rocking piston oil-less pump that delivers an adjustable vacuum pressure intended for subsequent aspiration of localized subcutaneous fatty deposit.

The console has a control panel that is the user interface for operating the system. The control panel has a peristaltic knob that allows a flow-rate selection of up to 535ml/min. The control panel also has a vacuum knob that allows the delivery of vacuum pressure of up to 27 in Hq (90 kPa). The device operates using a Peristaltic Pump Mode or a Vacuum Pump Mode. Only one mode can be activated at a time using the footswitch.

The system also includes an AC Power Cord, isolation transformer, wires and connectors. Other third party components of the system include: canister-style filters, tubing, syringe for potential re-injection, infiltration cannulas, aspiration cannulas, HEPA filter tubing, tumescent tubing, suction canister holder and waste canisters,

The canister filter (fat canister) is a closed loop tissue collection system with a volume capacity of up to 2500 mL. It includes a vacuum port, tissue port, tissue port and lid. It is used with the aspiration system to separate and filter adipose tissue for possible reimplantation. The aspiration system provides the vacuum suction source to the canister. As the tissue is harvested from the patient, it enters the canister via the collection port in the canister lid. The physician removes unwanted waste materials from the collection system via the vacuum port by closing the valve. This process leaves the fatty tissue that can be transferred to syringes via the tissue port for autologous fat re-injection.

The Alma LipoFlow System is a Suction Lipoplasty System used in the aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. If the harvested fat is to be re-implanted, it is to be used without any additional manipulation.

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

1. A table of acceptance criteria and the reported device performance

Based on the provided document, the acceptance criteria are implicitly met by successful completion of various performance tests. The document does not provide specific numerical criteria for each test or detailed quantitative performance metrics. Instead, it states that the device "functioned as intended" or that "results were passing."

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

The document does not specify the sample size for any of the tests, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The phrasing "adipose viability testing" and "bench/laboratory testing" suggests laboratory experiments rather than human clinical trials.

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 the test set. The tests appear to be related to the technical and biological performance of the device rather than diagnostic accuracy or subjective interpretation.

4. Adjudication method for the test set

The document does not describe any adjudication method as it does not involve human interpretation or subjective measurements that would typically require adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The Alma LipoFlow System is a medical device for fat aspiration and transfer, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there is no AI component or effect size relevant to human reader improvement discussed.

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

This question is not applicable to the Alma LipoFlow System. The device is a physical system with integrated software and mechanical components for a medical procedure, not a standalone algorithm. Its "performance" is based on its physical operation and biological outcome (adipose viability).

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

The concept of "ground truth" as typically used in the context of diagnostic AI algorithms is not explicitly detailed for this device. However, inferring from the tests performed:

• For software verification and validation, the ground truth would be the pre-defined functional specifications and expected outputs of the software.
• For electrical safety and electromagnetic compatibility, the ground truth would be compliance with the specified IEC standards.
• For biocompatibility, the ground truth would be the established safety profiles of the materials in contact with the patient.
• For sterility validation, the ground truth would be the absence of viable microorganisms as per defined sterility assurance levels.
• For adipose viability testing, the ground truth would be the assessment (e.g., cellular integrity, metabolic activity) of fat cells after processing by the device, likely compared to a control or accepted standard for viable adipose tissue. This would be a biological ground truth.
• For bench/laboratory testing, the ground truth would be the expected functional parameters and physical outputs of the device components and the combined system.

8. The sample size for the training set

The document does not mention a training set. The Alma LipoFlow System is a hardware device with associated software, not a machine learning model that requires a training set in the typical sense.

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

Not applicable, as a training set for a machine learning model is not mentioned or relevant to this device's description.

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Intended Use: The additional Soprano 1064nm Diode Laser Module is intended for use in dermatologic and general surgical procedures.

Indications for Use: The indications for use for the Soprano1064nm Diode Laser Module include:

• The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6.9 and 12 months after the completion of a treatment regimen.
• Treatment of Pseudo folliculitis Barbae (PFB)
• Use on all skin types (Fitzpatrick I-VI), including tanned skin.

The subject device, Alma Lasers Soprano 1064nm Diode Laser Module is an additional hand piece intended to be used with previously cleared Soprano 100 platform. Consistent with the previous clearance the system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas, and its major components are still the main console unit, footswitch, and individual modules. No change has been made to the main console unit except for incorporation of the software needed to run the new module; the footswitch and pre-existing modules are also unmodified from those cleared in K140009.

The module's operation involves emission of laser (diode) energy through the handpiece to the patient's skin. The materials that could contact the patient during device use are sapphire, aluminum, and plastic; these would all have limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.

This document describes the marketing authorization for a medical device and does not include information about specific acceptance criteria or performance studies of the kind typically associated with AI/ML-driven devices.

The device in question, the "Modified Alma Lasers Soprano XL Family Of Multi-application & Multi-technology Platform, Soprano Yag Hand Piece" (specifically, the additional 1064nm Diode Laser Module), is a laser surgical instrument. The FDA review is for a 510(k) premarket notification, which establishes substantial equivalence to existing legally marketed predicate devices.

Therefore, most of the requested information (like performance metrics, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable to this document as it pertains to a traditional medical device approval based on technological equivalence and established safety standards rather than AI/ML performance.

However, I can extract the relevant information from the provided text:

1. A table of acceptance criteria and the reported device performance:

This document does not specify "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, AUC) for an AI/ML device. Instead, the "acceptance criteria" for this 510(k) clearance are based on substantial equivalence to predicate devices in terms of:

• Intended Use: Dermatologic and general surgical procedures.
• Indications for Use: Permanent reduction in hair regrowth (HR and SHR modes), treatment of Pseudofolliculitis Barbae (PFB), and use on all skin types (Fitzpatrick I-VI), including tanned skin.
• Technological Characteristics: Wavelength (1064nm), laser media (Solid State), mode (HR, SHR), spot size, pulse width, pulse repetition rate, energy density, user interface, delivery device type, and compatible laser system.
• Safety and Effectiveness: Demonstrated through compliance with recognized device standards and comparison to predicate devices, without raising new questions of safety or effectiveness.

The "reported device performance" is essentially that the device functioned as intended and the results observed were as expected during performance testing against established electrical safety, electromagnetic compatibility, and laser safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60601-1-6, IEC 60825-1).

Table Summarizing Equivalence:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No clinical studies (test sets on patients) were deemed necessary for this 510(k) submission. "Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission." Therefore, this information is not applicable.

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, as no clinical test set was required.

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

Not applicable, as no clinical test set was required.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

Not applicable, as no new clinical ground truth data was generated for this submission. The "ground truth" for the device's functionality is its adherence to established engineering and safety standards and its equivalence to already cleared predicate devices for the specified indications of use.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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The Modified Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatological and general surgical procedures.

The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is indicated for the non-invasive treatment of wrinkles and rhytids using a combined treatment with Unipolar and Bipolar hand pieces.

The massage component of the Alma Lasers Accent Uniform Hand piece is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
-Temporary reduction in the appearance of cellulite.

Simultaneous application of the RF energy and mechanical manipulation of the skin is intended for use with the Modified Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite] to provide:
-Temporary reduction in the appearance of cellulite.

The Unipolar and Bipolar hand pieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids.

The Pixel RF Tips (stationary and rolling), when used with the unipolar hand piece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

Ultrasound Module provides ultrasonic diathermy intended for:

• Relief of pain
• Muscle spasms
• · Joint contractures
• · NOT for the treatment of malignancies

The hand pieces above are intended to be used with the console cleared in K101147 Alma Lasers Family of Accent RF Systems [Accent, Accent XL, Accent Elite].

The Alma Lasers Accent XL is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

The provided document describes the Accent XL with the Alma Ultra hand piece and its substantial equivalence to predicate devices, primarily for its ultrasonic diathermy function. The document does not contain information on clinical studies involving human patients, human readers, or a multi-reader multi-case (MRMC) comparative effectiveness study with or without AI assistance. The focus is on technical performance bench testing and regulatory equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the performance bench testing conducted and comparison to predicate devices, ensuring it meets similar specifications and safety standards.

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

The document describes bench testing, not a clinical study on a patient test set. The sample size for the bench tests is not specified, but it refers to physical testing of the device's electrical, thermal, and mechanical properties. The data provenance is from bench laboratory testing conducted by the manufacturer, not from human subjects or retrospective/prospective clinical data.

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

Not applicable. This was regulatory submission based on technical compliance and substantial equivalence, not a study requiring expert-established ground truth for a clinical dataset.

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

Not applicable. This was bench testing against predefined technical standards and predicate device specifications, not a study requiring adjudication of clinical findings.

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. This document does not describe a study involving human readers or AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical device (ultrasonic diathermy) and does not involve AI algorithms.

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

For the technical performance bench testing, the "ground truth" was established by engineering and safety standards (e.g., IEC standards for electrical safety, EMC, and ultrasonic physiotherapy equipment) and comparison to the specifications of legally marketed predicate devices. For the temperature performance, the criteria (e.g., raising skin temperature to 40-45°C in less than 15 minutes) served as the ground truth.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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

Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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Intended Use: The Alma Lasers Family of Accent RF Systems [Accent XL, Accent Elite] is intended for use in dermatologic and general surgical procedures.

Indications for Use: The Unipolar and Bipolar handpieces, when used as a combined treatment, are indicated for the non-invasive treatment of wrinkles and rhytids. The Pixel RF Tips (stationary and rolling), when used with the unipolar handpiece, are indicated for dermatological procedures requiring ablation and resurfacing of the skin.

The Accent Pixel RF Tips include cleanable, sterilizable, multiple use radiofrequency (RF) energy delivery devices (accessory) intended for use with the Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite]. These Pixel RF Tips are also available as single use, disposable products. The Accent Pixel RF Tips are comprised of the following main components: Pixel Stationary Tip, Pixel Roller Tip.

The provided text is a 510(k) Summary for the Alma Lasers Accent Pixel RF Tips. It describes the device and its intended use, and argues for substantial equivalence to predicate devices, supported by animal and human clinical data. However, the document is a regulatory submission for substantial equivalence rather than a detailed study report proving the device meets specific acceptance criteria.

Therefore, direct answers to many of your questions, particularly those related to detailed study methodologies, sample sizes for training/test sets, ground truth establishment methods, expert qualifications, adjudication, and MRMC studies, are not explicitly stated or available in the provided text.

Here's an analysis of what can be extracted and what is missing:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this document is primarily centered around demonstrating substantial equivalence to existing predicate devices. This means the device performs similarly to devices already cleared by the FDA for similar indications. The document doesn't outline specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet against a predefined threshold. Instead, the "performance" discussed relates to the device's functional characteristics and its ability to achieve the stated indications for use.

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Information (Based on available text):

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

   • Not explicitly stated for either animal or human clinical data. The document only mentions "animal and human clinical data were submitted." The exact numbers of subjects or cases in these studies are not provided.
   • Data Provenance: Not specified (e.g., country of origin). "Animal histology data - section 19 - and human clinical data - section 20" are referenced as supporting the indications for use, suggesting prospective collection for the purpose of the submission, but details are absent from this summary.

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

   • Not stated. The document refers to "animal histology data" and "human clinical data." For clinical data, the assessment of "ablation and resurfacing" or "wrinkles and rhytids" would typically involve expert assessment (e.g., dermatologists, plastic surgeons), but the number or qualifications of these experts are not provided in this summary.

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

   • Not stated. The methods for evaluating the clinical data (e.g., how efficacy was determined, or how disagreement among evaluators, if any, was resolved) are not detailed.

4. 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 an energy delivery system (RF tips), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to "human readers improving with AI" would not be relevant.

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

   • Not applicable. As noted above, this device is a medical instrument (RF tips) used in dermatological procedures, not an algorithm. Performance is assessed through its physical effects on tissue and clinical outcomes, not through an algorithm's standalone output.

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

   • Inferred: For the "animal histology data," the ground truth would typically be pathology (histopathology from tissue samples). For the "human clinical data," the ground truth would likely be clinical assessment / outcomes data by medical professionals, potentially supported by photographic evidence or other objective measurements of skin ablation, resurfacing, or wrinkle reduction.

7. The sample size for the training set:

   • Not applicable/Not stated. This device does not use machine learning in the conventional sense where a "training set" of data is used to teach an algorithm. The "data" mentioned (animal and human clinical data) is for validation or substantiation of the device's performance, not for training a model.

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

   • Not applicable. See point 7.

In summary, the provided document is a 510(k) submission focused on demonstrating substantial equivalence. It confirms that animal histology and human clinical data were submitted to support the device's performance and indications for use, but it does not provide the detailed study protocols, participant numbers, or specific methodological information that would be found in a clinical study report.

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The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are intended to be used with the Harmony XL™ Multi-Application Platform for use in aesthetic, cosmetic, and surgical applications requiring the ablation, vaporization, excision, incision, and photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of dermatology, general and plastic surgery, endoscopic/laparoscopic surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), general neurosurgery, oculoplastics, oral surgery, ophthalmology (skin around the eyes), orthopedics, podiatry, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.

Indications for Use:
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:

• Matrixectomy
• Periungual and subungual warts
• Plantar warts
• Radical nail excision
• Neuromas

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (Long Pulsed and Q-Switched) are intended for use with the Harmony XL™ Multi-Application Platform for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

The 1064 nm Nd:YAG Laser Module handpieces (Long Pulsed and Q-Switched with and without contact-cooling) are indicated for treatment and clearance of:

• Benign vascular lesions such as, but not limited to treatment of: Port wine stains, Hemangiomas, Warts, Superficial and deep telangiectasias (venulectasias), Reticular veins (0.1-4.0 mm dia.) of the leg, Rosacea, Venus lake, Leg veins, Spider veins, Poikiloderma of Civatte, Angiomas
• Benign cutaneous lesions, such as, but not limited to: Warts, Scars, Striae, Psoriasis
• Benign pigmented lesions such as, but not limited to: Lentigos (age spots), Solar lentigos (sun spots), Cafe-au-lait macules, Seborrheic keratoses, Nevi and nevus of Ota, Chloasma, Verrucae, Skin tags, Keratoses, The removal of black, blue or green tattoos (significant reduction in the intensity of black and for blue/black tattoos), Plaques
• 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 treatments.
• The non-ablative treatment of facial wrinkles, such as, but not limited to: Periocular wrinkles, Perioral wrinkles
• Laser skin resurfacing procedures for the treatment of: Acne scars, Wrinkles
• Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The 1064 nm Nd: YAG lasers (Long Pulsed only, with and without contact-cooling) is indicated for:

• Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles.
• Removal or lightening of unwanted hair (with and without adjuvant preparation)
• Treatment of pseudofolliculitis barbae (PFB)

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules for use in podiatry and for the temporary increase in clear nail in patients with onychomycosis is a laser handpiece that contains the optical bench that emits the high power Nd: YAG laser beam. The Modified Alma Lasers Harmony 1064nm (Nd: YAG) Modules are designed to be used with the Harmony XL™ Muli-Application Platform [Accent, Accent XL, Accent Beauty] for the delivery of long-pulse or O-switched laser energy. The patient contact portion of the Modified Alma Lasers Harmony 1064nm (Nd. YAG) Modules is a removable, cleanable, sterilizable stand-off tip.

The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules are comprised of the following main components:

• Handpiece Housing
• Incorporates the optical head (laser)
• Handpiece trigger.
• Standoff-Tip (cleanable/ sterilizable)
• Laser emission indicator illuminates prior to- and during laser energy emission
• Umbilical cable houses the wiring to the Harmony XLTM Muli-Application Platform
• Module (handpiece) connector - connects the handpiece umbilical cable to its port on the Harmony XLTM Muli-Application Platform.

This document is a 510(k) Premarket Notification for the "Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules". This type of submission to the FDA focuses on establishing substantial equivalence to existing legally marketed devices (predicates), rather than proving safety and efficacy through clinical trial data with specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) submission would.

Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical performance evaluation against predefined endpoints. Instead, it asserts substantial equivalence based on technological characteristics and intended use.

Here's a breakdown of why the requested information isn't present in this type of submission and what the document does provide:

1. A table of acceptance criteria and the reported device performance: This document does not provide a table of acceptance criteria or specific device performance metrics from a clinical study. The tables in the document (pages 3-4) compare the technological characteristics of the subject device (Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules) to those of predicate devices, not clinical performance. The "acceptance criteria" here is implicitly reaching substantial equivalence in technological characteristics and intended use to the predicates.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not provided. No "test set" in a clinical performance sense is referenced. The submission relies on a comparison of device specifications to predicates.

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/Not provided. There is no clinical "test set" requiring ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. No clinical "test set" requiring adjudication is detailed.

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/Not provided. This device is a laser system, not an AI diagnostic tool. MRMC studies are not relevant to this type of submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. This is a hardware laser device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. There is no clinical ground truth established or used for performance evaluation in this 510(k). The clinical experience of the predicate devices is implied validation for the similar new device.

8. The sample size for the training set: Not applicable/Not provided. This is a hardware device; machine learning "training sets" are not part of its development or submission.

9. How the ground truth for the training set was established: Not applicable/Not provided. As above, no training set for machine learning is involved.

Summary of what the document does provide regarding "acceptance criteria" for substantial equivalence:

The "acceptance criteria" in a 510(k) context are that the new device has the same intended use and technological characteristics as a predicate device, or that any differences in technological characteristics do not raise new questions of safety and effectiveness.

• Intended Use & Indications for Use: Pages 1, 2, 8, 9, 10 clearly list the intended use and extensive indications for use in various medical specialties, including podiatry for temporary increase in clear nail in onychomycosis, benign vascular lesions, benign cutaneous lesions, benign pigmented lesions, non-ablative treatment of facial wrinkles, laser skin resurfacing, reduction of red pigmentation in scars, and hair removal. This is compared to the indications for use of the predicate devices implicitly.

• Technological Characteristics Comparison (Tables on pages 3-4): The document provides detailed tables comparing the key technical specifications of the Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (Long Pulsed and Q-Switched) to those of the predicate devices. These characteristics include:

  • Treatment wavelength (1064 nm Nd:YAG)
  • Spot Size
  • Pulse Energy
  • Pulse Duration
  • Laser Power
  • Energy Density
  • Repetition Rate
  • Patient Contact Materials
  • How provided (Reusable, non-sterile, cleanable, sterilizable tip)
  • Electrical Requirements
  • System Dimensions and Weight

• Rationale for Substantial Equivalence (Page 5): The submission explicitly states: "The Modified Alma Lasers Harmony 1064nm (Nd:YAG) Modules (used with the Harmony XL™ Muli-Application Platform) share the same indications for use, device operation, overall technical and functional capabilities, and therefore are substantially equivalent to the predicate devices."

In conclusion, this 510(k) submission does not present a clinical study with acceptance criteria and performance data as requested in the prompt. Instead, it demonstrates substantial equivalence to predicate devices based on a comparison of intended uses and technological characteristics.

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