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1060nm laser body slimming machine is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flank, back, and thighs.

The 1060nm laser body slimming machine is an ultra-thermal laser fat decomposition system that uses the latest technology for non-invasive body shaping. It uses 1060mm wavelength laser penetration to target adipose tissue, selectively heats fat cells, and reduces the number of fat cells in the area through blood and lymph metabolism to achieve shaping the purpose of body contouring. It is a new generation of safe and effective way to lose weight.

The provided text is a 510(k) Summary for the "1060nm laser body slimming machine" (Model: RZ-01). This document assesses the substantial equivalence of a new medical device to a legally marketed predicate device.

It's important to understand that a 510(k) summary for a substantial equivalence determination often does not include detailed clinical study results, particularly regarding acceptance criteria for device performance in terms of patient outcomes or AI model accuracy. Instead, it focuses on demonstrating that the new device is as safe and effective as a predicate device, often relying on non-clinical tests (electrical safety, EMC, laser safety, etc.) and comparisons of technical specifications and intended use.

In this specific document, there is no information about acceptance criteria or a study proving the device meets performance criteria in the context of an AI/algorithm-driven device meeting specific accuracy metrics. The device in question is a laser body slimming machine, not an AI diagnostic or assistive tool.

Therefore, I cannot provide the requested information for an AI/algorithm-based device's performance study based on the provided text. The document states:

• "No clinical study is included in this submission." (Page 7)
• The comparison is based on technical specifications (laser type, wavelength, irradiance, etc.) and adherence to international safety standards (IEC, ISO).

If the request were about the safety and technical performance of this laser device, the "acceptance criteria" would relate to its compliance with the listed IEC and ISO standards, and the "study" would be the non-clinical tests conducted to prove this compliance. However, these are not the types of performance metrics or studies typically associated with AI/algorithm validation (e.g., accuracy, sensitivity, specificity, MRMC studies, ground truth establishment methods).

Therefore, I must state that the provided text does not contain the information requested for an AI/algorithm-driven device, as the device described is a physical laser machine, and the submission explicitly states no clinical study was included.

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The ReBorn device is an LED technology-based system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less.

The ReBorn system is a non-invasive, LED-based system intended for non-invasive lipolysis and indicated for non-invasive lipolysis of the abdomen and flanks. The Lightfective ReBorn System is a Light Emitting Diode (LED) system, generating optical energy at 1050mm. The ReBorn's cooling and electrical systems maintain safe and comfortable skin surface temperatures. The Lightfective ReBorn system delivers power of up to 49 Watts (per each applicator) in continuous wave (CW) mode. The device consists of hardware and software. These elements are integrated in the ReBorn console and applicator/handpiece. The ReBorn system is supplied as a console and 4 identical applicators. The device is portable and was specifically designed to be utilized in clinic environments. The console is floor-standing and portable. It is controlled by a touch screen and consists of the following subsystems: Power Supply, Main Controller unit (CPU), Water cooling system (Chiller), Touchscreen display monitor, System on Module (SOM) and proprietary software, Applicator docking panel (cradle), Four designated applicator connector ports.

The provided text details a 510(k) premarket notification for the ReBorn device, an LED-based system for non-invasive lipolysis. However, it does not include information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML performance.

The document primarily focuses on establishing substantial equivalence to a predicate device (Venus Bliss, K190743) based on shared indications for use, technological characteristics, and performance data from non-clinical (bench) testing. There is no mention of an AI/ML component, a test set for AI performance, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as the provided text does not contain this information.

To directly answer your specific points based on the provided text:

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

   • Not applicable. The document does not describe acceptance criteria for an AI/ML device's performance, nor does it report performance metrics relevant to AI/ML. It focuses on demonstrating substantial equivalence to a predicate device through shared characteristics and bench testing. Bench tests performed include:
     • Temperature Control Test
     • Cooling Capacity Test
     • Applicator Power Performance Test
     • Applicator Contact Sensor Test
     • Lifetime Rationale
     • Ex-vivo Animal Study

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

   • Not applicable. There is no mention of a test set for AI/ML performance. The "ex-vivo animal study" is mentioned, but details on sample size or specific "data provenance" (e.g., country) are not provided beyond it being ex-vivo porcine abdominal skin and adipose tissue.

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

   • Not applicable. No experts or ground truth establishment relevant to AI/ML performance is described.

4. Adjudication method for the test set:

   • Not applicable. No test set for AI/ML performance is described, so 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:

   • No. An MRMC study was not done, as this is not an AI/ML device for diagnostic assistance. The device is for non-invasive lipolysis.

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

   • Not applicable. This isn't an AI/ML algorithm-only device. The "software" mentioned refers to control software for the device's operation.

7. The type of ground truth used:

   • Not applicable. There is no AI/ML component for which ground truth would be established. The "ex-vivo animal study" used the thermal effect on tissue as a measure, compared to the predicate device.

8. The sample size for the training set:

   • Not applicable. There is no mention of an AI/ML training set.

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

   • Not applicable. There is no mention of an AI/ML training set or its ground truth establishment.

In summary, the provided document pertains to the regulatory clearance of a medical device (ReBorn) based on substantial equivalence to an existing predicate, not on a study demonstrating AI/ML performance against specific acceptance criteria.

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The DEKA PHYSIQ 360 is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs, in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.

The PHYSIQ 360 is a diode laser device. The device is provided with:

• Up to 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers).
• An LCD control panel with touch-screen technology provides information on the status and settings of the PHYSIQ 360 device to input commands into the system.
• One wavelength, 1060 ±20 nm (infrared)
  The PHYSIQ 360 electrical specifications are: 115-230V~ single phase, 50/60Hz, 1200VA (max)

This document is a 510(k) summary for the DEKA PHYSIQ 360 device, a diode laser intended for non-invasive lipolysis. It focuses on demonstrating substantial equivalence to a predicate device (Sculpsure K171992) rather than presenting a study proving that the device meets specific acceptance criteria related to a diagnostic or AI-driven performance.

Therefore, the requested information, such as acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for a diagnostic device), clinical study data to demonstrate that the device meets these criteria, sample sizes for test sets, expert involvement in ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, is not available in this document.

This document primarily relies on the comparison to a predicate device and non-clinical performance data (electrical safety, EMC, software validation) to demonstrate substantial equivalence, rather than new clinical efficacy or performance studies with specific acceptance criteria that would typically be associated with AI/diagnostic devices.

Here's why the requested information isn't present in this specific type of document:

• Device Type: The DEKA PHYSIQ 360 is a laser for aesthetic use (non-invasive lipolysis). Its clearance is based on demonstrating that it is substantially equivalent to an existing legally marketed predicate device, not on demonstrating a specific diagnostic performance or AI-driven capabilities.
• 510(k) Pathway: The 510(k) premarket notification pathway often relies on comparison to a predicate device and non-clinical testing rather than extensive new clinical studies, especially if the new device has the same technological characteristics and similar indications for use as a cleared predicate.
• "Clinical Performance Data: None": As explicitly stated in the document, no clinical performance data was submitted. This confirms that a study of the type you're asking about (with performance metrics against acceptance criteria) was not part of this submission.
• Focus on Substantial Equivalence: The primary objective of this 510(k) summary is to argue that the DEKA PHYSIQ 360 is "as safe, as effective, and performs as well as the legally marketed predicate device." This is achieved by showing identical or substantially similar technological characteristics and indications for use, and by providing non-clinical safety testing.

In summary, based on the provided document, I cannot fulfill your request for acceptance criteria and a study proving the device meets them, because this type of information is not included in this 510(k) summary for the DEKA PHYSIQ 360.

The document details:

• Non-Clinical Performance Data:
  • Electrical safety and electromagnetic compatibility (EMC) testing based on ANSI AAMI ES60601-1 and IEC 60601-1-2.
  • Software Validation and Verification Testing as per FDA guidance.
  • Additional non-clinical testing per IEC 60601-2-22 and IEC 60825-1.

These non-clinical tests ensure device safety and functionality but are not "performance data" in the sense of diagnostic accuracy or clinical efficacy against specific statistical acceptance criteria for a human performance or AI-driven system.

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This product is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.

The BL-A10 is a 1060nm Diode Hyperthermic Laser Lipolysis system and is the latest technology for non-invasive body contouring. It applies a 1060nm wavelength laser to target the adipose tissue to reduce fat in areas such as flank and abdomen. The purpose of the device is to breakdown the fat cells in the target area and in doing so contour the body and reduce the number of fat cells in that area. It is designed to meet international safety and performance standards.

The provided text is a 510(k) summary for the "Diode Laser Body Sculpture Systems," a medical device intended for non-invasive lipolysis. While it details the device and its equivalence to a predicate device, it explicitly states, "Clinical Testing: It is not applicable."

Therefore, I cannot provide information on acceptance criteria or a study that proves the device meets those criteria from this document. The manufacturer has determined that clinical testing is not necessary to demonstrate substantial equivalence to the predicate device for this submission.

The document discusses non-clinical testing, including electrical safety, electromagnetic compatibility, and biocompatibility, but these do not involve proving the device meets specific performance criteria for its intended clinical effect through human trials.

To summarize, for your specific request:

1. A table of acceptance criteria and the reported device performance: Not provided in the document as clinical testing was deemed "not applicable."
2. Sample sized used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this device is a physical laser system, not an AI diagnostic tool).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on demonstrating substantial equivalence to an existing legally marketed device (SculpSure K182741) based on similar indications for use, technological characteristics (laser type, wavelength, lipolysis method), and compliance with electrical safety and biocompatibility standards.

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The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index of 30 or less.

EON aesthetic laser system is 1064nm diode laser device that is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. This wavelength is used to affect the appearance of visible fat bulges in the abdomen and flanks.

Both laser energy and cooling air are delivered concurrently through the same treatment head that is positioned and moved over the skin at a fixed height by a robotic arm. The treatment head is never in contact with the skin.

During treatment, the desired area will be defined by the physician and will be treated with the 1064nm laser over a 20-minute timeframe. The mechanism of action is to preferentially heat the adipose tissue to temperatures that will induce apoptosis (>42°C). The cooling system will maintain the skin at comfortable temperature (

The provided text describes a 510(k) premarket notification for the EON aesthetic laser system. The submission, K222226, seeks to expand the indications for use of the EON device to include the thighs and back, in addition to the previously cleared abdomen and flanks.

The documentation focuses on demonstrating substantial equivalence to a predicate device (K211681), which is also the EON system but with a more limited indication for use.

Based on the provided text, the information regarding acceptance criteria and the study proving the device meets these criteria is very limited and primarily relies on literature support rather than a de novo clinical study with specific acceptance criteria.

Here's an attempt to extract the requested information, highlighting what is provided and what is not provided:

Acceptance Criteria and Study for EON (K222226)

The EON device is a low-level laser system intended for non-invasive lipolysis. The current submission (K222226) is an update to a previously cleared device (K211681 and K180511), seeking to expand its indications to include the thighs and back.

The primary method used to demonstrate device performance and substantial equivalence for the expanded indications is via literature review and justification, rather than a new, dedicated clinical study with pre-defined acceptance criteria for the new treatment areas. Therefore, explicit "acceptance criteria" in the traditional sense of a clinical trial (e.g., statistical thresholds for efficacy endpoints) are not presented for this specific submission for the new treatment areas. Instead, the "acceptance" is based on inferring equivalent safety and effectiveness from existing data and the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria for clinical efficacy for the new indications (thighs and back) are not provided in this document, the table reflects the regulatory claim of substantial equivalence and relies on the performance of the predicate.

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The DioSculpt laser system is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less.

The DioSculpt laser lipolysis system is a diode laser system, Electrically efficient semiconductor generate optical radiation (1060nm) which is used to deliver laser energy to subcutaneous tissue layers. DioSculpt's cooling and electical systems assist in maintaining safe and comfortable skin surface temperatures.

The provided text describes the 510(k) premarket notification for the DioSculpt laser system, which is intended for non-invasive lipolysis. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of diagnostic performance or clinical outcomes.

The document focuses on demonstrating substantial equivalence to predicate devices through:

• Technological characteristics comparison: Showing similar technology, wavelength, pulse width, cooling, and patient attachment methods.
• Non-clinical testing: Biocompatibility, electrical safety, EMC, and performance testing (specifically temperature testing to ensure safety despite slightly higher energy density/peak power).
• Software verification and validation.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth used for clinical efficacy or diagnostic accuracy. These types of studies are not typically part of a 510(k) submission that relies on demonstrating substantial equivalence to a legally marketed predicate device through technological similarity and non-clinical safety/performance.

The only "performance" discussed is related to safety (temperature testing) and compliance with electrical and laser safety standards.

What can be extracted from the text related to performance/safety criteria are:

1. A table of acceptance criteria and the reported device performance (focused on safety performance):

The remaining requested information is not available in the provided document:

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of submission which focuses on non-clinical testing and substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the safety tests, the "ground truth" is compliance with established international standards and the measured physical properties (e.g., temperature).
8. The sample size for the training set: Not applicable (no machine learning model for training).
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details the non-clinical testing performed to demonstrate the safety and performance (in a technical compliance sense, not clinical efficacy) of the DioSculpt device for its 510(k) clearance, asserting substantial equivalence to predicate devices. It does not contain information on clinical studies that establish efficacy acceptance criteria or clinical performance outcomes.

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The EON (1064nm laser) is intended for non-invasive lipolysis of the abdomen and flanks to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic effect. It is intended for individuals with a Body Mass Index of 30 or less.

EON aesthetic laser system is 1064nm diode laser device that is intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. This wavelength is used to affect the appearance of visible fat bulges in the abdomen and flanks.

Both laser energy and cooling air are delivered concurrently through the same treatment head that is positioned by a robotic arm. The treatment head is never in contact with the skin.

During treatment, the desired area will be defined by the physician and will be treated with the 1064nm laser over a 20-minute timeframe. The mechanism of action is to preferentially heat the adipose tissue to temperatures that will induce apoptosis (42°C to 50°C). The cooling system will maintain the skin at comfortable temperature (

Here's a breakdown of the acceptance criteria and the study details for the EON device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The Bodysculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic assthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.

The BodySculp is a diode laser system. The main components of BodySculp are a console and four applicators that deliver the laser energy to the patient. Electrically efficient semiconductors generate optical radiation (1060 nm) which issued to deliver laser energy to subcutaneous tissue layers.

The provided document is a 510(k) summary for the BodySculp device, which is a low-level laser system for aesthetic use. It details the device, its intended use, and a comparison to a legally marketed predicate device (PowerSculp) to demonstrate substantial equivalence.

However, the document explicitly states that "A human clinical study was not required as the device is identical to the predicate device." This means there isn't a study proving the device meets specific acceptance criteria for performance related to its intended aesthetic effect in the way you're asking, i.e., through a clinical trial with human subjects.

Instead, the acceptance criteria and performance data provided in this 510(k) are related to safety, electrical compatibility, and software validation, demonstrating that the device itself is safe and functions as intended, and is substantially equivalent to a device already cleared for market. The clinical effectiveness for aesthetic outcomes relies on the predicate device's prior clearance.

Therefore, for your specific request regarding acceptance criteria and performance related to the aesthetic claims of the device (disruption of adipocyte cells, aesthetic affect), the information is not available in this document because a clinical study for these outcomes was not performed for BodySculp.

Here's a breakdown of what is available in the document regarding "acceptance criteria" through non-clinical performance data:

Acceptance Criteria and Reported Device Performance (Non-Clinical)

Since a human clinical study for efficacy was not conducted for the BodySculp device, the "acceptance criteria" and "reported device performance" in this context refer to the non-clinical performance data supporting the device's safety and functional equivalence to the predicate.

Study Details (Based on the provided document)

As previously stated, a human clinical study was not required or conducted for the BodySculp device itself, as per the FDA 510(k) summary, because it was deemed substantially equivalent to a predicate device already on the market. Therefore, most of the following points cannot be answered from this document.

1. Sample size used for the test set and the data provenance: Not applicable, as no dedicated clinical test set was required or used for this device's 510(k) clearance for aesthetic efficacy. The "test set" in the document refers to the device itself being tested against electrical safety and software standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human subject clinical ground truth was established for this device. Ground truth for the non-clinical tests (e.g., electrical safety) is typically established by engineering standards and test procedures, not expert consensus on medical images or outcomes.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as no human subject clinical test set requiring adjudication was used.

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 a laser lipolysis system, not an AI-assisted diagnostic or imaging device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm for diagnostic performance. Its "standalone" performance refers to its ability to meet engineering and safety standards.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical performance data, the "ground truth" implicitly used is compliance with established international and FDA-recognized standards for electrical safety, electromagnetic compatibility, laser safety, and software development. For the intended use and technological characteristics, the "ground truth" for substantial equivalence is the predicate device's cleared status and specifications.

7. The sample size for the training set: Not applicable. This device does not use an AI/machine learning model trained on data for its primary function.

8. How the ground truth for the training set was established: Not applicable.

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The Powersculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.

PowerSculp laser lipolysis system is a diode laser system that emits laser radiation centered at 1064nm in order to achieve non-invasive laser lipolysis. Main components of the device include the laser console with display and controls, and four cooled laser applicators that attach to frames and a belt that is attached to the person being treated. The device is powered by an alternating current electrical power source.

The provided document, a 510(k) Premarket Notification summary for the Lotuxs Medtech (Suzhou) Co., Ltd. Powersculp laser lipolysis system, explicitly states:

"No clinical tests were provided for this pre-market notification." (Page 7, Section 9. Clinical Tests)

Therefore, based on the provided text, there is no study that proves the device meets acceptance criteria, as no clinical studies were submitted. The acceptance criteria and the study details requested cannot be extracted from this document because such a study was not performed or submitted as part of this 510(k) application.

The 510(k) clearance for this device was based on non-clinical tests demonstrating substantial equivalence to a predicate device (K191068 Powersculp laser lipolysis system), not on a clinical effectiveness study.

Here's an breakdown of the information that can be extracted from the provided document, in relation to the prompt's requests:

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

• Acceptance Criteria (Implied by Non-Clinical Testing): The acceptance criteria for this 510(k) submission are based on demonstrating that the proposed device performs as intended and is as safe and effective as the predicate device through non-clinical testing. This primarily involved meeting engineering specifications and safety standards.
  • Software verification and validation: Software performs as intended.
  • Power Output: Meets specification.
  • Electromagnetic Compatibility and Electrical Safety: Complies with IEC 60601-1-2, ANSI AAMI ES60601-1, IEC 60601-2-22, and IEC 60825-1.
  • Biocompatibility: Patient contacting materials assessed per ISO 10993-1 and found to be biocompatible.
• Reported Device Performance (from Non-Clinical Tests): The document confirms that the device met these criteria:
  • Software verification and validation performed, demonstrated software performs as intended.
  • Testing confirmed power output meets specification.
  • EMC and electrical safety testing performed, results confirmed the device meets the standards.
  • All patient contacting materials assessed and found biocompatible.

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

• Not applicable as no clinical test set was used. Non-clinical tests would involve specific units of the device and testing materials, but these are not analogous to patient sample sizes for clinical studies.

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

• Not applicable as no clinical test set requiring expert ground truth was used.

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

• Not applicable as no clinical test set was used.

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 no clinical effectiveness study, specifically an MRMC study, was conducted or submitted. This device is not an AI-assisted diagnostic tool.

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

• Not applicable. This is a laser lipolysis system, not an algorithm, so standalone performance in the context of an algorithm is irrelevant.

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

• Not applicable for clinical ground truth as no clinical studies were performed. For the non-clinical tests, "ground truth" would be the engineering specifications and safety standards against which the device performance was measured.

8. The sample size for the training set:

• Not applicable as no AI/machine learning model requiring a training set was involved.

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

• Not applicable as no AI/machine learning model requiring a training set was involved.

In summary, the 510(k) clearance for the Powersculp laser lipolysis system (K211402) was based solely on non-clinical testing and a demonstration of substantial equivalence to a predicate device, not on clinical performance data or studies involving human subjects to establish effectiveness for the indicated use.

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The SLIMUS is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.

Vibrator installed inside each hand-piece and operable only in non-laser output condition is intended for relief from minor muscle aches and pains.

The SLIMUS device incorporates a laser system that emits a 1060 nm wavelength using a diode laser. Laser radiation is emitted from the laser main unit to the device's handpieces through the handpiece fibers. The device is used to noninvasively reduce the size of the waist of overweight patients with a Body Mass Index (BMI) of less than 30 (kg/m²). A vibrator function is installed inside of each hand-piece and operable only in non-laser output mode. The device's handpieces are fixed to a belt which then combined provide mechanical vibration to the patient in order provide relief from minor muscle aches and pains.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) premarket notification summary for the SLIMUS device, primarily demonstrating its substantial equivalence to a predicate device (SculpSure™).

Specifically, the document states in section 8: "No Clinical performance testing was performed." This means there isn't a study proving the device's performance against specific acceptance criteria in a clinical setting provided in this document.

Therefore, I cannot provide the requested information in the table or answer the questions related to clinical study design, as no such study is presented in this document. The provided text focuses on non-clinical testing and technological comparisons to establish substantial equivalence.

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