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The T-SHAPE 2 and its hand pieces are indicated for the relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation and temporary reduction in the appearance of cellulite.

T-SHAPE 2 treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted radio frequency (RF) energy and the mechanical manipulation is derived from massage and/or vacuum.

The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Applications are pre-set by the machine or the operator in relation to intensity, frequency, length of session, degree of tissue suctioning, and allow to address the issues of each individual in an targeted manner.

T-SHAPE 2 is also equipped with:

• Two light sources type inside some handpieces (see below) with the following wavelengths: 650 and l 980 nm.
• -Electrodes for bipolar RF energy (500 kHz/ 1 MHz / 1,5 MHz).

Through the display, the light sources and RF energy can be fully deactivated or activated.

The light sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).

For the RF energy the user can select frequency between 2 MHz, 1 MHz, 500 kHz and intensity between the 10 levels available.

T-SHAPE 2 comprises a main console unit and several handpieces.

A microprocessor-based system controller is used to monitor and direct all the system function and the graphic user interface.

The main console can be connected to the following handpieces (two different hand piece can be connected at the same time):

• -Large multipole handpiece with 6 diode laser and 6 RF plates;
• -Medium multipole handpiece with 4 diode laser and 4 RF plates;
• -Small multipole handpiece 4 RF plates and 1 red LED;
• -Thermal imaging camera;
• -Roll handpiece with 4 diode laser and 2 motorized roller with RF;
• -Mesosphere handpiece with 45 motorized rotating spheres.

The provided text describes a medical device called T-SHAPE 2 and its substantial equivalence to predicate devices, but does not contain information about specific acceptance criteria, quantitative performance metrics, or a study design with sample sizes, expert qualifications, or ground truth establishment.

The document states that "T-SHAPE 2 has been tested in accordance to consensus standard to demonstrate safety and Performance," and lists general performance data categories:

• Biocompatibility testing: Evaluated according to "biocompatibility flow chart for the selection of toxicity tests for 510(k)s."
• Safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1, IEC 60825-1, IEC 60601-1-2, and IEC TR 60601-4-2 standards.
• Software Verification and Validation Testing: Documentation provided per FDA guidance.
• Performance Bench Testing: "Evaluated to verify the skin tolerance, effect and cosmetic properties of a professional treatment through evaluations and instrumental analysis performed by professionals under medical supervision and consumer self-assessments."

Without quantitative performance data, it is not possible to create a table of acceptance criteria and reported device performance. Also, all other requested details regarding sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are missing from the provided text.

The closest the document comes to performance metrics for the T-SHAPE 2 is under "Performance Bench Testing," which mentions "evaluations and instrumental analysis performed by professionals under medical supervision and consumer self-assessments" for "skin tolerance, effect and cosmetic properties" and safety mechanisms for RF heating. However, no specific metrics, targets, or results are provided.

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ICOONE Laser med (also referred to as ICOONE Medical laser) is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

Icoone Medical Laser (also referred to as Icoone Lase med) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading tissue by hand. Applications are pre-set by the machine or the operator in relation to intensity, frequency, length of session, degree of tissue suctioning, and allow to address the issues of each individual in an absolutely targeted manner. Icoone Medical Laser (model ref 650EC24) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: - Led @ 650mm (50mW) - Laser @ 915mm (1W) Through the display, the light sources can be fully deactivated, or only LED activated. The sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW). Once selected, by turning on the Robosolo hand piece, both suctioning and light emission are activated at the same time. The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.

The provided text is a 510(k) summary for the ICOONE Laser med device. It details the device's substantial equivalency to a predicate device, its indications for use, technological characteristics, and performance data related to electrical safety, EMC, and software validation.

However, the document does not contain information about a study that proves the device meets specific performance acceptance criteria related to its clinical efficacy (e.g., reduction in cellulite, relief of muscle aches). Instead, the performance data presented focuses on safety and technical compliance standards.

Therefore, I cannot fulfill all parts of your request based on the provided text. I will address the parts that are extractable and clearly state when the information is not present.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance Study (as per document context)

The document primarily focuses on establishing substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and compliance with safety and technical standards, rather than proving direct clinical performance against specific numerical acceptance criteria for its claimed therapeutic effects (e.g., a measured reduction in cellulite appearance, or pain relief scores).

The "Performance Data" section specifically lists compliance with electrical safety, EMC, and software verification/validation standards. It does not present data from studies measuring the device's efficacy for its stated indications (e.g., a clinical trial demonstrating cellulite reduction or pain relief).

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document's content, the "acceptance criteria" are compliance with relevant safety and technical standards, and the "performance" tabulated is demonstrating that compliance. There are no clinical efficacy metrics or associated acceptance thresholds provided.

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

This information is not present in the provided document. The document describes technical testing (electrical safety, EMC, software, biocompatibility), which typically does not involve "sample sizes" in the sense of clinical study participants. No clinical efficacy study data is described.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not present in the provided document. As no clinical efficacy study is described, there's no mention of experts establishing ground truth for such a test.

4. Adjudication Method for the Test Set

This information is not present in the provided document. Since no clinical efficacy test set is detailed, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

This information is not present in the provided document. The document does not describe any MRMC study or any study comparing human readers with and without AI assistance, as this is a physical device, not an AI diagnostic tool.

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

This information is not applicable to the device described. The ICOONE Laser med is a physical therapeutic massager with laser and vacuum functions, operated by a human. It's not an algorithm or AI system for which standalone performance would be measured.

7. The Type of Ground Truth Used

Based on the document, the "ground truth" demonstrated is compliance with established international safety and performance standards for medical electrical equipment, laser products, and biocompatibility. For instance, the ground truth for electrical safety is that the device passes specific tests under EN 60601-1. There is no mention of clinical outcome data, pathology, or expert consensus being used as a ground truth for efficacy.

8. The Sample Size for the Training Set

This information is not applicable and not present in the document. The device is not an AI/ML model that requires a training set.

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

This information is not applicable and not present in the document. The device is not an AI/ML model that requires a training set.

In summary, the provided FDA 510(k) summary focuses on demonstrating that the ICOONE Laser med device is substantially equivalent to a predicate device primarily through adherence to established safety and performance standards (electrical, EMC, software, laser, biocompatibility), rather than through a clinical study demonstrating its efficacy against specific, quantitative acceptance criteria for its indications for use.

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ICOONE h is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

The Icoone-h device is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient's body.
lcoone-h Laser is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths:
LED @ 650nm (50Mw) Laser @ 915nm (1W)
The light sources can be activated through the display, either combined or independently (only one of the two or both).
The sources are neither adjustable in intensity (always output at nominal value, as per specifications) nor in frequency (always continuous - CW).
Once selected, by turning on the Robosolo hand piece, both suctioning and light emission are activated at the same time.
The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.

This FDA 510(k) summary for the ICOONE h device does not include acceptance criteria or a study proving that the device meets those criteria. Instead, it argues for substantial equivalence to predicate devices based on indications for use, technological characteristics, and conformance to safety standards.

Therefore, I cannot provide the requested table or describe a study that proves the device meets acceptance criteria based on the provided text.

However, I can extract information related to the device's characteristics and the basis for its substantial equivalence claim, which may be relevant to regulatory acceptance:

Information available from the provided text:

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

As stated previously, explicit acceptance criteria and corresponding performance metrics are not provided in the document. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria. The table below summarizes the comparison to predicate devices, which serves as the basis for regulatory acceptance in this context.

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 explicitly states "Clinical tests- brief discussion: Not applicable." This indicates that no clinical studies were performed to establish the device's safety or effectiveness as part of this 510(k) submission. Therefore, there is no test set, sample size, or data provenance to report from this document in this context. The acceptance is based on substantial equivalence to predicate devices, which were assessed through non-clinical technical characteristics and compliance with recognized standards.

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 tests were performed, and therefore, no "ground truth" for a test set was established using experts in this submission.

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

Not applicable, as no clinical tests were performed.

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 not an AI-assisted diagnostic tool, and no MRMC study was conducted.

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

Not applicable. This is a physical therapeutic device, not an algorithm, and no standalone performance study was conducted in the context of an algorithm.

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

Not applicable, as no clinical data or ground truth related to patient outcomes or diagnoses were generated for this 510(k) submission. The "ground truth" for regulatory clearance is based on the substantial equivalence argument, particularly alignment with the established safety and efficacy profiles of predicate devices and compliance with relevant safety standards.

8. The sample size for the training set:

Not applicable, as no algorithm or machine learning model was developed or trained for this device.

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

Not applicable, as no algorithm or machine learning model was developed or trained for this device.

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The HONKON-Slimming I+/HONKON-Slimming III+ are indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.

The HONKON-Slimming I+ and HONKON-Slimming III+ are the non-invasive body shaping product to combine four different technologies including IR (infrared), Bi-Polar RF (radio-frequency) and mechanical tissue manipulation using pulsed vacuum and massage rollers. The combination of the IR and vacuum coupled RF technologies causes deep heating of the connective tissue including the fibrous septae which in turn promotes an increase in local cellular reduction. The additional mechanical tissue manipulation of the device causes an immediate increase in circulation and lymphatic drainage, both essential components for healthy skin structure.

The HONKON-Slimming I+ and HONKON-Slimming III+ can output infrared light with wavelength 700-2000nm, the infrared light can penetrate whole skin tissue. The infrared light has the effect to expand blood vessels, temporary improvement of local blood circulation; At the same time, this spectrum has a good efficacy for temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences..

The HONKON-Slimming I+ and HONKON-Slimming III+ can output 1MHz frequency, produce RF energy from X, Y and Z directions in the subcutaneous tissue. Temperature of skin tissues becomes higher, Enzyme activity was enhanced so that fat cells can be fully released within the triglyceride; Triglycerides in the fat under the action of enzymes, cracking into fatty acids and glycerol.

Massage rollers has obvious mechanical compression to skin tissues. Meanwhile, deep negative pressure gives skin and muscles full relaxation and rest. Maximum 8kg negative pressure can absorb all skin tissues into the gap between the bipolar RF tips, ensure RF energy can reach fat layers.

Based on this,the HONKON-Slimming I+/HONKON-Slimming III+ are indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences..

This document is a 510(k) Summary for a medical device called the "Slimming Treatment Device" (models HONKON-Slimming I+ and HONKON-Slimming III+). It seeks to demonstrate substantial equivalence to previously cleared predicate devices.

The document does not describe a study that proves the device meets specific acceptance criteria related to its clinical efficacy (e.g., reduction in cellulite or thigh circumference). Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technical specifications, safety, and regulatory compliance.

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 not explicitly defined as pass/fail thresholds for clinical performance but rather as demonstrating substantial equivalence to the predicate devices across various technical and safety parameters. The "Reported Device Performance" in this context refers to the device's technical specifications and the results of non-clinical safety tests.

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

The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no test set sample size or data provenance (country, retrospective/prospective) for clinical effectiveness. The "tests" mentioned are non-clinical (electrical safety, EMC, biocompatibility) and comparisons to existing predicate device specifications.

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 study or test set with expert-established ground truth was performed for this submission. The "ground truth" for the substantial equivalence claim relies on regulatory standards and the specifications of the predicate devices.

4. Adjudication method for the test set

Not applicable, as no clinical study or test set requiring adjudication was performed.

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 therapeutic device, not an AI-assisted diagnostic or interpretive tool that would involve human readers or MRMC studies.

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

Not applicable. This device is a physical therapeutic device, not an algorithm. Its operation involves human application.

7. The type of ground truth used

For the purpose of this 510(k) submission, the "ground truth" is largely:

• Regulatory Standards: Compliance with established international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993-5, -10) for safety and performance.
• Predicate Device Specifications: The accepted safety and effectiveness profiles of the legally marketed predicate devices (Reaction™ System K090221 and VelaShape K122579). The proposed device's specifications are compared to these predicates to demonstrate similarity.

8. The sample size for the training set

Not applicable. As no clinical study was conducted. There is no "training set" in the context of device efficacy for this 510(k) submission.

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

Not applicable, as no training set was used or described.

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The InMode WMbody device is intended for the treatment of the following medical conditions, using the WMbody applicator for delivering non-thermal RF combined with massage:

• · Relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of blood circulation; and
• Temporary reduction in the appearance of cellulite. ●

The InMode WMbody device is designed to deliver mechanical vacuum skin massaging and nonthermal RF energy to the skin and subdermal fat. RF energy does not cause thermal damage to the treated skin and adipose tissue.

The device provides individual adjustment of non-thermal RF power and vacuum pulse duration to achieve maximum efficiency and safety for each patient. The ergonomic hand piece allows efficient treatment of large tissue surfaces.

The InMode WMbody device consists of an AC/DC power supply unit, RF generator, controller and user interface including a LCD screen and functional buttons. The hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises a vacuum pump, vacuum chamber with two electrodes and a pressure sensor.

Following are the InMode WMbody device specifications: RF Output Power: 10-50 Watt RF Output Frequency: 1[MHz] ± 2% Dimension: 36cm W x 36cm D x 100cm H (14.2" W x 14.2" D x 40'' H) Weight: 30 Kg (66 lbs) Main Line Frequency (nominal): 50-60 Hz Inout Voltage (nominal): 100-240 VAC

The provided document is a 510(k) summary for the InMode WMbody device, seeking substantial equivalence to a predicate device. It primarily focuses on demonstrating that the new device has similar technological characteristics, performance, and safety features as an already cleared device, rather than performing a de novo study with strict acceptance criteria and clinical trials in the way one might expect for a novel device.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with specific performance metrics (like sensitivity, specificity, accuracy) is not directly applicable or explicitly stated in this document.

Instead, the "acceptance criteria" here implicitly refers to demonstrating substantial equivalence to the predicate device, the Viora Reaction System (K090221). The "study" demonstrating this involves non-clinical (bench) performance data and a comparative analysis of specifications and safety.

Here's an analysis based on the information provided, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, explicit performance acceptance criteria in terms of diagnostic accuracy or clinical efficacy are not provided in this 510(k) summary. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device based on technical specifications and safety.

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

• Test Set Sample Size:
  • Clinical Performance Data: "Not Applicable." The document explicitly states that clinical performance data was not used for this submission.
  • Non-Clinical (Bench) Performance Data: The sample size for the bench test is not specified, nor is the number of units tested. It simply states "A bench test was performed."
• Data Provenance:
  • Clinical: Not applicable.
  • Non-Clinical: Performed by the manufacturer (InMode MD Ltd.). Country of origin is likely Israel, where the applicant is located. It is inherently a prospective test performed for the regulatory submission.

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

• Not applicable. Since clinical performance data was deemed "Not Applicable" for this 510(k) submission, there was no clinical test set requiring expert ground truth establishment. The non-clinical bench test involved comparing instrument measurements.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set or subjective assessment requiring an adjudication method.

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

• No. A MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Performance Data: Not Applicable."

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

• Yes, implicitly, for certain aspects. The "standalone" performance here refers to the device's inherent technical capabilities rather than a diagnostic algorithm. The non-clinical bench test assessed the device's RF output parameters (power, frequency) in a standalone manner, comparing them to the predicate device's specifications. This is a technical performance test, not a diagnostic algorithm performance.

7. The Type of Ground Truth Used

• For Non-Clinical Bench Test: The "ground truth" was the specifications and measured performance of the predicate device (Viora Reaction System) and the expected electrical/mechanical engineering specifications for the InMode WMbody device itself. The goal was to show that the InMode device's technical specifications and output were "the same" as or "substantially equivalent" to the predicate.
• For Clinical Efficacy: Not applicable, as clinical data was not submitted.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical medical device (energy delivery system), not an AI algorithm requiring a training set in the machine learning sense.

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

• Not applicable. (See point 8).

Summary of Approach:

This 510(k) submission for the InMode WMbody device followed the substantial equivalence pathway, which often does not require new clinical studies if the device's technological characteristics, indications for use, and safety profile are demonstrably similar to a legally marketed predicate device. The primary "proof" relies on non-clinical (bench) testing to show that the device meets the same technical standards and performance as the predicate, along with compliance with recognized safety standards.

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The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.

The VelaShape treatment is based on the simultaneous application of heat and mechanical manipulation to the tissue, wherein the heat is derived from light energy at a controlled infrared wavelength and from conducted radio frequency (RF) energy and the mechanical manipulation is derived from massage and/or vacuum.

The provided document describes a 510(k) summary for the Syneron Medical Ltd's VelaShape System, specifically concerning a modification to its infrared (IR) light source. This is a special 510(k) submission, meaning it's for a modification to a previously cleared device (VelaShape K071872).

Here's an analysis based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of clinical performance metrics (e.g., specific reductions in cellulite or circumference, pain relief scores, etc.). This submission is for a hardware modification, not a new device or a new clinical claim.
The performance data provided focuses on the technical aspects of the modification.

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

• Sample Size for Test Set: Not applicable or not specified. This submission focuses on engineering verification of a hardware change rather than a clinical trial for a new claim. The "performance data" refers to technical testing, not human subject data.
• Data Provenance: Not applicable for patient data. The modification involves a change in a component for an existing device.

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

Not applicable. Ground truth, in the context of clinical studies, typically refers to expert diagnoses or pathology results. This submission describes engineering verification, not a clinical study requiring ground truth establishment by medical experts.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set subject to expert 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

Not applicable. This device is not an AI-powered diagnostic or assistive tool. It is a physical medical device for cosmetic and pain relief treatments.

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

Not applicable. This device does not involve an algorithm with "standalone performance" in the way an AI diagnostic tool would.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this modification is based on the previously cleared specifications and performance of the device before the change. The "performance testing" was to ensure the new component meets those existing specifications and that the overall system still "functions as intended" based on its original design and claims.

8. The Sample Size for the Training Set

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

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

Not applicable. There is no training set for this type of device and submission.

Summary of the Study and Device Proof of Acceptance:

The "study" described is a verification testing process to confirm that a minor hardware modification (changing the infrared light source from a tungsten halogen lamp to an LED) in the VelaShape system does not negatively impact its performance, safety, or effectiveness, and that it remains substantially equivalent to the original cleared device.

The proof the device meets "acceptance criteria" (which are implicit and relate to maintaining the original device's cleared performance and safety profile) is through engineering and performance testing. The document states that "Verification testing was performed to evaluate this modification to ensure the performance of the new light source is compatible with the previously cleared specifications" and that "Performance testing demonstrates that the VelaShape system performs according to specifications and functions as intended."

The core assertion is that "The modification of the IR light source to LED raises no new issues of safety or effectiveness," thereby allowing it to continue to meet its established indications for use related to minor muscle aches and pain, muscle spasm, local blood circulation, temporary reduction in cellulite appearance, and temporary reduction of thigh circumferences. No new clinical trials or human subject data were presented because the modification was deemed to not affect the foundational scientific technology or clinical performance.

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The Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite] is intended for use in dermatologic 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 handpieces.

The massager component of the Alma Lasers Accent UniForm Handpiece 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 Alma Lasers Accent Elite system similar to Accent™ RF Systems [Accent, Accent XL } is comprised of the following main components:
. Console
a Bipolar RF module
A Unipolar RF module (UniLarge)
A UniForm (RF and Massage) module
. Control panel
Footswitch. .
Modules are used to deliver radiofrequency energy to the treatment site. Each RF module consists of the following components:
. Handle - used for holding the module
. Trigger - activates the radiofrequency energy emission when pressed in Ready mode
Applicator tip establishes contact with the patient's skin .
. Thermoelectric cooler - integrated within the module, provides internal module cooling
. RF emission indicator - blue LED illuminates prior to- and during RF emission
Umbilical cable contains coolant tubes. RF-power cable and the communication . cable that controls the operation of the module
. Module connector - connects the module to its port. It incorporates an integrated impedance matching network (IMN) and a memory chip which stores information about the module and the parameter settings.
The UniForm module additionally employs a massaging mechanism that works in conjunction with the RF energy application.
The Accent Elite is a computerized system with embedded software that controls its operation. The software also runs the graphical user interface, which enables user-friendly control of the system operation.

The provided document is a 510(k) summary for a medical device (Modified Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL, Accent Elite]), seeking substantial equivalence to predicate devices. It does not describe or conduct a study involving acceptance criteria and reported device performance in the way typically associated with clinical trials or AI/algorithm evaluation.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared devices based on technical characteristics and safety performance testing rather than clinical efficacy studies with specific performance metrics against a defined ground truth.

Therefore, many of the requested elements for describing an acceptance criteria study and the methodology behind it (like sample size, data provenance, expert ground-truthing, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.

However, I can extract the information that is present concerning the rationale for substantial equivalence and the listed safety performance testing.

Here's a breakdown based on the provided document:

Acceptance Criteria and Device Performance Study Information

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

The document does not explicitly state "acceptance criteria" in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical outcome. Instead, the "acceptance criteria" for this submission are compliance with recognized safety standards and demonstration of substantial equivalence in technical characteristics.

The results of the performance testing showed compliance with these standards. |
| Clinical Equivalence (Implicit) | Based on the above, the device is considered "safe and effective, and performs at least as safely and effectively as the predicate Alma Lasers Family of Accent™ Radiofrequency (RF) Systems [Accent, Accent XL] for the intended use and indications." (This is a conclusion drawn from the technical and safety equivalence, not from a comparative clinical efficacy study provided in this summary). |

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. This document does not describe a clinical performance study with a test set of patient data. The "performance testing" refers to engineering and electrical safety standards compliance.

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. No clinical ground truth was established for a test set in this submission.

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

• Not Applicable / Not Provided. No clinical test set or adjudication method 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

• Not Applicable / Not Provided. This device is an RF system for dermatologic/surgical procedures, not an AI or imaging diagnostic tool. Therefore, an MRMC study is irrelevant to this submission.

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

• Not Applicable / Not Provided. This device does not feature an algorithm for standalone performance evaluation in the context of AI or diagnostic systems.

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

• Not Applicable / Not Provided. The "ground truth" for this submission relates to compliance with engineering safety standards and established technical specifications, not clinical outcomes or expert consensus on a diagnostic task.

8. The sample size for the training set

• Not Applicable / Not Provided. This device is not an AI/machine learning system, so there is no concept of a "training set" in this context.

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

• Not Applicable / Not Provided. No training set exists.

Summary of the Study (as described in the 510(k) Summary):

The "study" described in this document is a regulatory submission demonstrating substantial equivalence rather than a clinical performance study measuring specific outcomes. The primary "studies" conducted were non-clinical performance testing to ensure safety and compliance:

• Type of Study: Non-clinical performance testing for electrical safety and electromagnetic compatibility.
• Purpose: To demonstrate that the Modified Alma Lasers Family of Accent™ RF Systems [Accent, Accent XL, Accent Elite] is as safe and effective as its predicate devices, primarily through compliance with international standards (IEC 60601 series).
• Methodology: The system was tested against the requirements of IEC 60601-1-2: 2004 (electromagnetic compatibility), IEC 60601-1:1988 with amendments (general safety), and IEC 60601-2-2:2006 (particular requirements for high-frequency surgical equipment).
• Conclusion: The tests demonstrated compliance with these standards, supporting the conclusion of substantial equivalence to the predicate devices. This equivalence is based on the device sharing the same intended use, indications for use, operation principle, and similar technical and functional capabilities, alongside meeting safety criteria.

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The i-lipo™ Ultra Vacuum Massage System is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. The i-lipo™ Ultra Treatment Pads and Probes are indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, and temporary improvement of local blood circulation.

The i-lipo™ Ultra System consists of a main unit, and applied parts (massage head with rollers and various laser diode cluster probes and pads). The Main Unit contains the mains input, fuses, power supply, pump, relay, control circuits, LCD display, membrane function buttons, emergency stop, and key switch. The massage head, and cluster probes and pads, which are placed against the patients skin, contain the rollers, and Laser diodes, Laser light provides topical heating which increases tissue temperature, and the rollers in combination with the vacuum mechanically manipulate the tissue.

The provided text describes a 510(k) submission for the Chromogenex Technologies Limited i-lipo™ Ultra System. However, it does not contain the detailed information requested regarding specific acceptance criteria, study design parameters (like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods), or comprehensive performance results.

The document states:

• Clinical Testing: "Skin temperature measurements were made to support the performance of pads and probes as thermal heating systems for pain relief." This is the only mention of a "study" related to performance. It doesn't elaborate on the specifics of this study, its results, or how these results relate to predefined acceptance criteria.
• Non-Clinical Testing: Safety testing was to be carried out to various IEC, UL, and CSA standards (e.g., IEC 60601-1, IEC 60601-2-22, CSA C22.2, IEC 60601-1-2) for electrical safety and electromagnetic compatibility. These are standards for device safety, not device performance against specific clinical efficacy claims or acceptance criteria.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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): Not specified.
• Data Provenance: Not specified (implicitly clinical data, but no country or retrospective/prospective status).

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

• Not applicable/Not specified, as there is no mention of ground truth established by experts for performance evaluation.

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

• Not applicable/Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC study was mentioned. The device is not an AI-assisted diagnostic tool.

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

• This is a physical medical device, not an algorithm. Standalone performance as typically described for AI/software is not relevant. The device itself operates "standalone" in its intended use.

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

• For the "skin temperature measurements," the implicit ground truth would be the temperature measurements themselves, considered direct evidence of heating. For other indications like pain relief, muscle spasms, blood circulation, and cellulite reduction, the document only mentions "support the performance" but does not detail how efficacy was measured or validated against a ground truth.

8. The sample size for the training set:

• Not applicable/Not specified as no training set for an algorithm is mentioned.

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

• Not applicable/Not specified as no training set for an algorithm is mentioned.

Summary of Device and Study Information:

• Device Name: i-lipo™ Ultra System
• Intended Use: Temporary relief of minor muscle aches and pain, temporary relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
• Key Finding from Document: The device appears to have obtained 510(k) clearance based on substantial equivalence to predicate devices and non-clinical testing for safety (electrical, EMC) and limited clinical support for performance via skin temperature measurements. The document does not provide details of a rigorous clinical trial with defined acceptance criteria for efficacy or comprehensive performance data for each indicated use. The FDA letter confirms the 510(k) clearance based on substantial equivalence.

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The Elemé Medical SMOOTHSHAPES XV system is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

The SMOOTHSHAPES XV System featuring Photomology® technology is designed to temporarily reduce the appearance of cellulite. The proprietary Photomology technology combines heating through dynamic energy (laser and light) with mechanical manipulation (contoured rollers and vacuum) to temporarily reduce the appearance of cellulite.

Photomology is based on the transcutaneous application of a dynamic combination of dual-band laser/light. The Photomology Module combines 650 nm light from LEDs and 915 nm light from laser diodes with mechanical massage (rollers) and vacuum (suction).

The provided text is a 510(k) summary for the SMOOTHSHAPES® XV System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain the detailed information about acceptance criteria or a specific study that proves the device meets those criteria, as requested in your prompt.

Specifically, the document focuses on regulatory approval based on demonstrating substantial equivalence to existing devices (Elemé SmoothShapes (K083629) and Syneron Velashape (K071872)) for the indications of use. It does not provide:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test sets, data provenance, or the number and qualifications of experts for ground truth.
• Information on adjudication methods, MRMC studies, or standalone algorithm performance.
• Specifics about the type of ground truth used or the size and ground truth establishment for a training set.

The document mostly outlines the administrative and regulatory aspects of the device's clearance.

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The Cutera CMMCD optional infrared/RF device is indicated for the relief of minor muscle aches and pains, relief of muscle spasms, temporary improvement in local circulation. The Cutera CMMCD massage device is indicated for the temporary improvement in the appearance of cellulite.

The Cutera CMMCD infrared(optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

The Cutera CMMCD massage device is intended to provide a temporary reduction in the appearance of cellulite.

The Cutera CMMCD treatment consists a massage device and an infrared light(optional)/RF device. Topical heating for the purpose of elevating tissue temperature is derived from conducted RF energy/optional infrared light. Mechanical manipulation is derived from a vacuum assisted massage with rollers. The pneumatic/mechanical manipulation of the skin is sufficient to provide mild transient erythema and produces a temporary improvement in the appearance of cellulitic skin where applied.

This 510(k) submission for the Cutera CMMCD (K092195) is a Special 510(k), which indicates that it is a modification to a previously cleared device. Special 510(k)s typically do not require new clinical studies if the changes do not affect the fundamental scientific technology or intended use. Instead, they rely on demonstrating that the performance and technical specification changes fall within FDA regulations for such modifications and that the modified device is substantially equivalent to predicate devices.

Therefore, the provided document does not contain a detailed study with acceptance criteria, sample sizes, ground truth establishment, or human reader performance data as would be found in a traditional 510(k) or PMA for an entirely new device or a significant change in indications. The core of this submission is a declaration of substantial equivalence based on the nature of the modifications.

Here's a breakdown based on the information available, and what cannot be answered from this specific document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a study. The "acceptance criteria" for a Special 510(k) primarily revolve around the device's technical specifications and safety profile remaining within acceptable bounds given the modifications, and demonstrating substantial equivalence to predicate devices. The implicit acceptance criterion is that the modified device performs as safely and effectively as its predicate and the original device, for the stated indications.

• Reported Device Performance: The document states:

  • "The pneumatic/mechanical manipulation of the skin is sufficient to provide mild transient erythema and produces a temporary improvement in the appearance of cellulitic skin where applied."
  • The device is indicated for "relief of minor muscle aches and pains, relief of muscle spasms, temporary improvement in local circulation" (for the optional infrared/RF device) and "temporary improvement in the appearance of cellulite" (for the massage device).

  Since this is a Special 510(k) for modifications, these performance claims are likely based on the performance demonstrated by the original device and the predicate devices, rather than new performance data for these specific modifications.

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

• Not Applicable / Not Provided: This document does not describe a new clinical study with a test set. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) is not available.

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

• Not Applicable / Not Provided: As no new clinical study test set is described, there's no mention of experts used for ground truth.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided: No test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No: This document does not mention an MRMC study.

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

• No: This device is a physical medical device (massage and RF/infrared) and does not involve an algorithm in the AI/standalone software sense. Therefore, this is not applicable.

7. The Type of Ground Truth Used:

• Not Applicable / Not Provided: No new clinical study requiring ground truth establishment is described. The "ground truth" for the device's indications (e.g., temporary improvement in cellulite) would have been established through previous clinical studies for the original device and its predicates, usually involving clinical assessments, patient reported outcomes, and potentially photographic documentation.

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided: As there is no AI algorithm involved, there is no training set in this context.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable / Not Provided: No AI algorithm or training set.

Summary for K092195 (Cutera CMMCD):

This submission is a Special 510(k) for modifications to an existing device. It establishes substantial equivalence by demonstrating that the changes do not raise new questions of safety or effectiveness, and that the device's performance and technical specifications align with its predicate. It does not present new clinical study data with explicit acceptance criteria, performance metrics, sample sizes, or ground truth establishment based on a new study for the modified device. The performance claims listed are based on the cleared indications for the original device and predicate devices.

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