Search Results

The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA consists of the following components: Electrosurgical Unit - Main body, Two different handpieces ( motor and AC), Six different electrode tips for the motor handpiece and three needle tips for the AC handpiece; provided as single use, sterile products, Neutral electrode pad and neutral electrode pad cable, cleared under K092761, Handpiece stand, Foot switch, Power cord. The POTENZA generates radiofrequency (RF) energy by means of high RF at 1MHz or 2MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The POTENZA has two operating modes: monopolar mode and bipolar mode.

The provided text describes the 510(k) premarket notification for the POTENZA device, specifically for the addition of four new electrode tips. The document details the performance data collected to demonstrate that the expanded device meets acceptance criteria and is substantially equivalent to its predicate.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides tables of acceptance criteria and results for biocompatibility and sterilization residual testing. Other tests mention conformance to specified standards as their acceptance criteria.

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

The document does not explicitly state sample sizes for specific tests with numerical values like "N=X". For biocompatibility testing, it mentions "the electrode tips were tested as shown in Table 1," implying a sufficient sample was used for each test type according to the standard. Similarly, for bench testing, it states "Jeisys conducted bench testing to assure that the four new electrode pins operate safely and within the predefined design specifications," suggesting testing was performed on the new electrode tips.

The data provenance is from Jeisys Medical, Inc. (South Korea), as the submitter is based in Seoul, Korea. The studies are retrospective in the sense that they are conducted by the manufacturer for the specific purpose of demonstrating substantial equivalence to a predicate device, rather than actively collecting new clinical data on human patients in a prospective manner.

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

This information is not provided in the document. The studies described are primarily in vitro (biocompatibility, sterilization), in silico (software), and benchtop engineering tests, not studies that require expert-established ground truth from clinical images or patient data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving expert review of data (e.g., medical images). The tests described here are technical performance tests, not clinical evaluations 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

This information is not provided and not applicable. The device is an electrosurgical cutting and coagulation device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

This information is not applicable. The POTENZA is a hardware device with associated software, not a standalone algorithm/AI for diagnostic interpretation. Its performance is evaluated through its physical and electrical characteristics as well as its software's functionality. The bench testing and electrical safety tests demonstrate the device's standalone performance.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the various tests is based on recognized consensus standards and predefined design specifications. For example:

• Biocompatibility: Standards like ISO 10993 and USP provide the "ground truth" for acceptable biological response.
• Electrical Safety & EMC: IEC 60601 series standards define the ground truth for safe electrical operation and electromagnetic compatibility.
• Software Verification: FDA guidance provides the framework for acceptable software validation.
• Bench Testing: The device's own predefined design specifications, safety mechanisms, and performance ranges (e.g., needle depth range of the predicate device) serve as the ground truth.
• Sterilization & Shelf-life: ISO standards (e.g., 10993-7, 11135), ASTM standards (e.g., F1980-16, F1929-15), and USP standards provide the ground truth for acceptable sterilization residuals, sterility assurance level, and packaging integrity.

8. The Sample Size for the Training Set

This information is not provided and not applicable. The described tests are for device validation and verification, not for training an AI or machine learning model.

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

This information is not provided and not applicable. No training set for an AI/ML model is mentioned or relevant to this device's submission.

Ask a specific question about this device

The LIPOcel delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt the Subcutaneous Adipose Tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. The LIPOcel is specifically indicated for non-invasive waist circumference reduction.

LIPOcel, the Subject Device, is a medical device indicated for non-invasive waist circumference reduction. It consists of a control unit, Touch LCD monitor, power supply unit, and driver unit for irradiation and for setting parameters after the main power and key switch is turned on. The ultrasound energy that is generated from the pulse generator operates the HIFU transducer, and is irradiated from the cartridge when the footswitch or the finger switch on the handpiece is pressed in the READY state and the energy is delivered into the target tissue. HIFU energy is irradiated based on linear scanning method through the hand-piece depending on irradiation energy, irradiation spacing and irradiation distance, that are set in advance by the user. The Subject Device's L13 Cartridge uses the focused ultrasound energy to focus from the transducer onto the fat layer at a depth of 13mm from the surface of the skin. As a result, tissue temperature rises over 55°C and thermal coagulation occurs. Using thermal effects generated by the HIFU transducer, cellular disruption of the subcutaneous adipose tissue occurs. This thermal coagulation results in the contraction of the collagen and subsequently results in destruction of the adipose tissue. The destroyed adipose tissue is cleared via an inflammatory response.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device's performance in terms of waist circumference reduction. It does not explicitly state pre-defined acceptance criteria in a quantitative format for the primary effectiveness endpoint (waist circumference reduction). However, it reports the study outcome, which implicitly serves as the performance achieved.

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

• Test Set Sample Size: The document does not explicitly state the number of subjects in the clinical study. It refers to "the subjects" and "the treated population" but doesn't give a specific 'n'.
• Data Provenance: Prospective, single-center study conducted at UltraLaser Center, Monterrey, Mexico.

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

The document describes a clinical study for waist circumference reduction, which uses objective physical measurements (waist circumference) as the primary endpoint. This generally does not involve "experts" establishing a subjective ground truth in the same way an imaging study would require radiologists. The measurements would typically be taken by trained clinical staff. No specific number of experts or their qualifications are mentioned for establishing the ground truth of waist circumference measurements.

4. Adjudication Method (for the test set):

Since the primary endpoint is waist circumference reduction, which is an objective measurement, an adjudication method for subjective interpretation (like 2+1 or 3+1 for imaging reads) is not applicable or described. Data collection and analysis would follow standard clinical trial protocols.

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

No, an MRMC comparative effectiveness study was not done. The study described is a clinical trial evaluating the device's effectiveness in reducing waist circumference and its safety, not comparing human readers' performance with and without AI assistance.

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

This question is not applicable to the LIPOcel device. The LIPOcel is a medical device that delivers High-Intensity Focused Ultrasound (HIFU) energy to disrupt subcutaneous adipose tissue for non-invasive waist circumference reduction. It is not an AI algorithm or software that performs diagnostic or interpretive tasks. The study evaluates the physical device's direct therapeutic effect on patients.

7. The Type of Ground Truth Used:

The ground truth used for effectiveness was objective physical measurements (waist circumference reduction) from patients treated with the device. Safety was assessed through the reporting of adverse events and participant pain scores.

8. The Sample Size for the Training Set:

This question is not applicable. The LIPOcel is a physical medical device, not an AI algorithm that requires a "training set." The clinical study evaluated the device's performance directly on patients.

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

This question is not applicable, as there is no "training set" for an AI algorithm.

Ask a specific question about this device

The INTRAcel Premium Fractional RF Micro Needle is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

The INTRAcel Premium consists of the following components:

• INTRAcel Premium (Main Frame)
• Active Accessory
• : 10xINTRAcelTip 1011 1x Power cable 1x Foot switch 1xHandpiece 1xHandpiece hanger 1x User's manual

This document is a 510(k) Premarket Notification for the INTRAcel Premium Fractional RF Micro Needle (FRM) System. It demonstrates the device's substantial equivalence to a legally marketed predicate device (Lutronic – INFINI, K121481) for electrocoagulation and hemostasis in dermatological and general surgical procedures.

Based on the provided text, here is a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to a predicate device and adherence to recognized safety and performance standards. The "performance" often refers to meeting these standards during testing.

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

• Sample Size for Preclinical In-vivo Study: The text mentions "in-vivo micropig model" and "porcine subjects" but does not specify the number of subjects (i.e., the sample size).
• Sample Size for Preclinical Ex-vivo Study: The text mentions "ex-vivo animal tissue testing" but does not specify the number of tissue samples or animals from which they were derived.
• Data Provenance: Not explicitly stated in terms of country of origin for the preclinical studies. However, the manufacturer is in Korea (Jeisys Medical, Inc., Seoul, Korea), and the submission correspondent is in the USA (LK Consulting Group USA, Inc., Fullerton, CA), suggesting international collaboration or trials conducted in either location.
• Retrospective or Prospective: The preclinical studies described (in-vivo micropig model, ex-vivo animal tissue testing) are inherently prospective as they involve conducting new experiments to gather data.

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

• The document does not specify the number or qualifications of experts used to establish ground truth for the preclinical studies. "Histologic evaluation was done by H&E and Trichrome" implies a histopathologist, but no details are provided.
• For the non-clinical testing (Electrical Safety, EMC, Software, etc.), these are typically assessed against pre-defined engineering standards by qualified test engineers/laboratories, but expert details are not provided.

4. Adjudication Method for the Test Set

• The document does not describe an adjudication method for the preclinical test sets. Histological evaluation is typically performed by a pathologist, and sometimes a second review is done for quality control, but this is not mentioned.
• For the non-clinical (engineering) tests, adjudication is usually not applicable; rather, the results are objectively measured against defined criteria.

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 device is an electrocoagulation and hemostasis system, not an AI-assisted diagnostic or therapeutic device that involves human readers interpreting medical images or data. Therefore, this type of study is not relevant to this device.

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

• This question is not applicable as the device is a medical instrument for electrocoagulation and hemostasis, not an AI algorithm. Its performance is evaluated through physical and electrical characteristics, and its effect on tissue.

7. The Type of Ground Truth Used

• Preclinical In-vivo Study: The ground truth for the wound healing response was histopathological examination (H&E and Trichrome staining) after varying time points. This is a direct biological and histological ground truth.
• Preclinical Ex-vivo Study: The ground truth for comparing power delivery characteristics was also histopathological examination (H&E and Trichrome staining) of the tissue after immediate treatment. This serves as a direct, objective measure of the device's effect on tissue.
• Non-Clinical (Engineering) Testing: The "ground truth" for these tests is adherence to established international and national standards (e.g., IEC 60601 series for electrical safety and EMC, IEC 62304 for software).

8. The Sample Size for the Training Set

• This device is not an AI/machine learning device that requires a "training set." Therefore, this concept is not applicable.

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

• As the device does not employ AI/machine learning requiring a training set, this concept is not applicable.

Ask a specific question about this device

INTRAgen is intended for dermatologic and general surgical procedures for electro coagulation and hemostasis.

The INTRAgen uses the principle that coagulation of cellular tissue is caused using the heat generated by the load or contact resistance by carrying high frequency current to the body. Active electrodes of INTRAgen have 2 types according to effective area: model KT-07 (7 mm x 7 mm) and model KT-15 (15 mm x 15 mm). Electrical current flows through the tip of the electrode, through the target tissue and to the patient plate. The active electrodes are for single use. Patient contacting materials are PCB (Polychlorinated Biphenyl) and ABS (Acrylonitrile-Butadiene-Styrene Copolymer). The INTRAgen consists of the following components: INTRAgen (Main Frame), Active Accessory : Active Electrode(KT-07 (7 mm x 7 mm), KT-15 (15 mm x 15 mm)), Handpiece Hanger and Hand-piece, Miscellaneous Accessories : Foot Switch and Power Cable.

The provided document describes the INTRAgen, an electrosurgical cutting and coagulation device and its accessories. The document focuses on demonstrating its substantial equivalence to a predicate device (Thermage ThermaCool System) for dermatologic and general surgical procedures requiring electrocoagulation and hemostasis.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed as a separate table but are implied by the types of tests performed and the statement "The INTRAgen met all the acceptance criteria." The performance is reported in the summary tables and discussed in the text.

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

• Test Set Sample Size:
  • Pre-clinical Study: "a porcine tissue model." The exact number of animals or tissue samples is not specified.
  • For Electrical Safety, Biocompatibility, Bench Data, and Sterilization, the "sample size" refers to the tested device units/materials. The document states "The tests were performed on the INTRAgen" and "The active electrodes... Biocompatibility test has been conducted..." without indicating the number of units.
• Data Provenance: The document does not specify the country of origin for the data collection, but the manufacturing company is based in Korea. The studies are described as "pre-clinical" and "bench tests", implying controlled laboratory settings rather than patient data.

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

• Pre-clinical Study:
  • Number of Experts: Not specified.
  • Qualifications: "Histology evaluation" and "immune histochemical and PCR studies" would imply evaluation by qualified scientists or pathologists. However, specific qualifications (e.g., "radiologist with X years of experience") are not provided.
• For other tests (Electrical Safety, Biocompatibility, Bench Data, Sterilization), ground truth is established by meeting recognized standards (e.g., IEC, ISO) and internal specifications, which are assessed by qualified engineers/testers rather than external domain experts in the clinical sense.

4. Adjudication Method for the Test Set

• No adjudication method is described. For the pre-clinical study, the evaluation was stated as "histologically and by RT-PCR," implying objective lab analyses rather than expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

• No MRMC comparative effectiveness study was done. This device is an electrosurgical unit, not an AI-assisted diagnostic or therapeutic tool that involves human readers interpreting data. The study primarily focuses on the device's technical specifications and biological effects in a pre-clinical model.

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

• This question is not applicable. The INTRAgen is a hardware electrosurgical device, not an algorithm or AI. Its performance is inherent to its physical operation, not an algorithm's output.

7. The Type of Ground Truth Used

• Pre-clinical Trial: The ground truth was based on objective biological markers and histological evaluations:
  • Histological evaluation of wound healing response.
  • Immune histochemical and PCR studies for neocollagenesis and neoelastogenesis.
• Other Tests: Ground truth was based on established industry standards (IEC, ISO), internal engineering specifications, and measurement accuracy.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve an AI algorithm that requires a training set. The "training set" concept is relevant for machine learning models, not for traditional medical devices like electrosurgical units.

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

• Not applicable. As a traditional medical device, there is no training set for which ground truth would be established.

Ask a specific question about this device

To provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain and stiffness, arthritis pain or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

The devices have a control unit that can be programmed utilized for the patient parameters. In addition, they are equipped with manual interface, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters. During operation the devices have an applicator instrument attached to the main unit.

This document is a 510(k) Pre-Market Notification from the FDA regarding the Hilthera 4.0 Therapeutical Laser System. It seeks to establish substantial equivalence to a predicate device, the El En HILT Family Laser (K051537).

Based on the provided document, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific performance metrics for the Hilthera 4.0 Therapeutical Laser System in comparison to detailed criteria. Instead, it relies on demonstrating substantial equivalence to a predicate device. The performance is assessed through non-clinical testing focused on safety and functional specifications, rather than clinical efficacy against defined acceptance thresholds for a specific medical outcome.

The closest comparison of "performance" is in the Comparison of Technological Characteristics (Table 5A), which compares specifications:

Note on Acceptance Criteria: For a 510(k) submission, "acceptance criteria" are typically met by demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through engineering, electrical, and performance testing, rather than direct clinical outcome comparisons with predefined thresholds for efficacy in a novel clinical trial.

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

• Test Set Sample Size: Not applicable in the context of clinical patient data. The non-clinical performance data involved testing of the device hardware and software. The document refers to "test plans" for software and "all testing" for electrical and safety, implying comprehensive unit and integration testing.
• Data Provenance: The testing was carried out by the manufacturer, Jeisys Medical, Inc. The document does not specify the country of origin for the non-clinical testing data beyond the manufacturer's location (Seoul, Korea). The testing is retrospective in the sense that it evaluates the manufactured device against pre-established specifications and standards.

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

Not applicable for this type of submission. The ground truth for the non-clinical tests (hardware, software, electrical safety, EMC) is adherence to engineering specifications, national/international standards, and FDA guidelines. This generally involves standard engineering verification and validation processes and compliance checks, not expert adjudication of medical images or diagnostic outcomes.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation by multiple experts where ground truth is subjective or requires consensus (e.g., radiology diagnoses). For this device, verification and validation testing against technical specifications serve as the "ground truth establishment."

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

Not applicable. This device is a laser system for therapeutic purposes (topical heating), not an AI-powered diagnostic or assistive tool for human readers. 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. This is a physical therapeutic device, not an algorithm. Its performance is inherent in its hardware, software, and physical properties.

7. The type of ground truth used

The ground truth used for the non-clinical performance data (hardware and software testing, electrical safety, EMC) was engineering specifications, established software design specifications, Device Hazard analysis, and national/international voluntary standards (e.g., for Electromagnetic Compatibility and Safety). The device performed as intended based on these specified acceptance criteria.

8. The sample size for the training set

Not applicable. This is a hardware therapeutic device, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for a machine learning model in this submission.

Ask a specific question about this device

The left handpiece (560nm) of the SmoothCool is indicated for the treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benigh vascular lesions (diffuse redness). The right handpiece (700nm) is indicated for hair removal (permanent hair reduction).

SmoothCool

I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria. The text is a letter from the FDA regarding a 510(k) premarket notification for a device called "Smoothcool." It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls provisions and other regulatory information.

However, the letter does not contain any information about specific acceptance criteria for the device's performance, nor does it describe any studies conducted to prove the device meets such criteria. It only lists the "Indications for Use" of the SmoothCool device.

Ask a specific question about this device

The SmoothCool HR System is indicated for hair removal (permanent hair reduction).

Not Found

This document is a 510(k) clearance letter from the FDA for a device called the "SmoothCool HR System," indicated for hair removal (permanent hair reduction). It does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about ground truth establishment.

The letter focuses on the FDA's determination of substantial equivalence to a predicate device, which is a regulatory pathway for market clearance, not a detailed performance study report.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device

Ask a specific question about this device