Search Results

The PRO MAX system is a Radiofrequency device intended for use in dermatologic procedures with separate indications for each handpiece.

The TC Handpieces (Shaper Max, Mini Shaper Max, iFine Max) are intended for:
• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation

When used up to 65W, the Mini Shaper Max and Small Max handpieces are also intended for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

The FSR Max Handpiece is intended for dermatological procedures requiring ablation and resurfacing of the skin.

The Intensif MAX Handpiece is intended for use in dermatologic procedures for electrocoagulation and hemostasis.

The EndyMed Contour MAX Handpiece is intended for the treatment of the following medical conditions; using the Contour MAX applicator for delivery of non-thermal RF combined with massage:
• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
• Temporary reduction in the appearance of cellulite

ENDYMED PRO™ MAX is a computerized system that generates pulses of radio frequency (RF) energy that are emitted onto patient skin. The device consists of a console and seven handpieces that emit either ablative or non-ablative radiofrequency.

The provided document is a 510(k) clearance letter for the EndyMed PRO MAX device. It indicates that the device has been cleared by the FDA, but it primarily focuses on establishing "substantial equivalence" to predicate devices rather than directly presenting the results of a clinical study designed to prove the device meets specific acceptance criteria based on performance endpoints.

The document describes performance testing but does not provide a table of acceptance criteria alongside detailed "reported device performance" in the context of a clinical study or specific performance metrics for the indications for use. Instead, it justifies substantial equivalence through comparison of specifications and generic performance testing.

Here's an attempt to extract the requested information based on what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state quantitative acceptance criteria for each indication (e.g., a specific percentage reduction in pain, or a defined improvement in wrinkles). Instead, it focuses on demonstrating that the device can achieve and maintain a therapeutic temperature similar to its predicate devices, which is presumed to lead to the intended effects. Therefore, the "Acceptance Criteria" here are inferred from the safety and performance testing described.

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

• Sample Size for Test Set:
  • For Tissue Heating Testing: "3 subjects with 3 anatomical sites each." (Total of 9 test sites across 3 subjects).
  • For other tests (Electrical Safety, EMC, Software, Biocompatibility, etc.): The document does not specify sample sizes in terms of human subjects or data sets. These are typically engineering or lab-based tests on the device itself or materials.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective for the Tissue Heating Testing. Given the context of a 510(k) summary, these tests are typically part of a prospective verification and validation effort by the manufacturer.

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

The document does not mention the use of experts to establish ground truth for the "test set" in the traditional sense of clinical endpoints for the indications. The tissue heating test measures temperature, which is an objective physical parameter.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method like 2+1 or 3+1. This is expected as the described performance testing (tissue heating, electrical safety) involves objective measurements rather than subjective expert assessment.

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

No, an MRMC comparative effectiveness study was not done according to the provided document. The submission focuses on substantial equivalence based on technical specifications and bench/performance testing, not clinical comparative effectiveness with human readers.

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

The device described is a physical medical device (Radiofrequency system with handpieces). While it contains software, the "performance testing" described (e.g., tissue heating) refers to the device's physical output characteristics, not an AI algorithm's standalone diagnostic or detection performance. Therefore, the concept of "standalone performance" for an AI algorithm is not applicable in the context presented.

7. The Type of Ground Truth Used

For the "Tissue Heating Testing," the "ground truth" is the measured temperature (39-45°C) achieved and maintained on the tissue. This is an objective, physiological measurement, not expert consensus, pathology, or outcomes data in a clinical trial sense for efficacy.

8. The Sample Size for the Training Set

The document does not mention a training set. This is because the device is a physical RF energy delivery system, and the "performance testing" described is for verification of its physical properties and safety, not for training a machine learning or AI algorithm.

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

Since no training set is mentioned, this question is not applicable.

Ask a specific question about this device

Indications for use for the Pure Laser diode hair removal system with a 810nm applicator include:

• · Hair removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
• · Treatment of Pseudo folliculitis Barbae (PFB)
• · Use on all skin types (Fitzpatrick I-VI)

The PURE Laser system is a non-invasive diode laser based system used for Hair Removal. The system is based on a single wavelength laser diode built-in a HP, with a 10x10mm spot size and ability to control the pulse width, frequency and power. The Hair Removal Laser is intended for use on all skin types (Fitzpatrick skin types I-VI).

The device is sold with an electroconductive gel with prior FDA clearance – EndyGel (K161715).

This document (K222369) is a 510(k) summary for the PURE Laser, a device intended for hair removal. It does not contain information about the performance of an AI/ML device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Elysion-pro (K193367)) based on technological characteristics and adherence to safety and performance standards for laser equipment. It explicitly states that "No clinical studies were conducted as part of this submission."

Ask a specific question about this device

Endy Gel is an Electroconductive gel media used with external electrode to reduce the impedance to alternating current) of the contact between the electrode surface and the skin.

EndyMed's EndyGel™ is an Electroconductive gel media used with external electrode to enhance electrical conductivity by reducing the impedance (resistance to alternating current) of the radiofrequency signals path from the electrode surface between the electrode surface and the skin.

This document is a 510(k) Pre-Market Notification for EndyGel™, an electroconductive gel media. The purpose is to demonstrate substantial equivalence to a predicate device, Electro-Gel (K111717).

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

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

Study proving device meets acceptance criteria:

The safety and efficacy of the EndyGel™ were established by a series of performance tests, including biocompatibility testing, electrical performance, and stability.

• Biocompatibility testing:
  • Complies with ISO 10993-1, ISO 10993-5 (Cytotoxicity), and ISO 10993-10 (Irritation and Sensitization).
• Electrical Performance testing:
  • The impedance of EndyGel™ (527.68 at 1 MHz) is within 4% of the predicate device (549.71).
• Stability testing:
  • The EndyGel™ has a shelf life of 2 years (compared to 3 years for the predicate).
• pH:
  • The pH of EndyGel™ (7.15-7.33) is within 2.2% of the predicate device (6.99).

The document states that "The difference in total impedance and in pH between the two gels is negligible and do not impact the safety and effectiveness of the EndyGel." Also, "V&V and compliance testing, including: Biocompatibility testing, Electrical Performance testing and Stability testing, were successfully conducted and did not raise any new safety questions or identify any new risks."

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

The document does not explicitly state the sample size for the test set or the data provenance for the performance tests (biocompatibility, electrical performance, stability). It broadly refers to "performance tests" that were successfully conducted.

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. This device is an electroconductive gel, and the "ground truth" for its performance is based on quantifiable physical and chemical properties and standard biological safety tests, not human expert interpretation of data.

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

Not applicable. This is not a study involving human interpretation or 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

Not applicable. This is not an AI/software device that involves human readers.

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

Not applicable. This is not an algorithm-based device. Performance is based on intrinsic physical, chemical, and biological properties.

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

The "ground truth" for the acceptance criteria for this device are established by:

• Industry standards (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 13485, ISO 14971-1).
• Quantifiable physical properties (impedance, pH, shelf life).
• Chemical composition analysis.
• Comparison to an existing legally marketed predicate device with a history of safe and effective use.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Ask a specific question about this device

The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage:

• · Relief of minor muscle aches and pain, relief of muscle spasm
• · Temporary improvement of local blood circulation
• · Temporary reduction in the appearance of cellulite.

EndyMed's EndyMed Contour Handpiece is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (Imagine K08346). The EndyMed Contour Handpiece combines suction module that creates vacuum energy and emits bipolar RF energy that flows between the electrodes to create thermal heating of the tissue.

The Vacuum is used for the massaging of deep tissues by creating mild to deep suction. The vacuum massage contributes to the sub-dermal and adipose tissues shrinkage and improves the contact surface between electrodes and tissue.

The provided document is a 510(k) premarket notification for the EndyMed Contour Handpiece. It details the device's intended use, technological characteristics, and a claim of substantial equivalence to predicate devices. However, this document does not contain the specific information requested regarding acceptance criteria for an AI/ML device study, and the detailed study description you've outlined.

The document discusses performance tests for the EndyMed Contour Handpiece itself (e.g., power output, temperature, vacuum pressure), but this is validation of a physical medical device, not a study proving an AI/ML algorithm meets acceptance criteria.

Here's why the requested information cannot be found in the provided text:

• No AI/ML Component: The EndyMed Contour Handpiece is described as an electrosurgical cutting and coagulation device accessory that uses RF energy and vacuum mechanical manipulation. There is no mention of an AI/ML component or algorithm in its description or intended use.
• Study Type: The "performance data" and "summary of clinical performance data" refer to lab performance tests, design validation, and software verification and validation for the physical device, and a claim that no clinical studies were necessary to show substantial equivalence with its predicate devices because it has the same intended use, clinical indication, and technology. This explicitly states new clinical studies were not performed for this submission.
• Ground Truth: Since no clinical studies were performed, there is no discussion of establishing ground truth, expert consensus, pathology, or outcomes data for a test set.
• Sample Sizes/Experts/Adjudication/MRMC: These are all concepts relevant to clinical or performance studies evaluating an AI/ML algorithm's effectiveness against a ground truth, which were not conducted for this submission.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study proving device meets acceptance criteria, as the provided text does not describe such a study for an AI/ML-driven medical device.

The document is a regulatory submission for a physical medical device (EndyMed Contour Handpiece), focusing on its technical specifications and substantial equivalence to existing devices, rather than the performance evaluation of a novel AI/ML algorithm.

Ask a specific question about this device

The EndyMed Newa™ is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.

The Newa™ is an OTC, home use hand held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of:

• User interface
• Programmable logic controller (PLC)
• RF power module
• Power supply
• RF electrodes

Acceptance Criteria and Device Performance Study for NEWATM

1. Table of Acceptance Criteria and Reported Device Performance

1. Preparing self for treatment (3 tasks): 100% (62/62) completed correctly.
2. Preparing device for treatment (3 tasks): 100% (62/62) completed correctly.
3. Treatment performance (8 tasks): 100% (62/62) completed correctly.
   Result: All tasks performed correctly by 100% of subjects. |
   | Clinical Performance Evaluation: Demonstrate device performs as intended for aesthetic results. | Study: 69 participants (62 completers).
   Effectiveness Criterion: At least 75% of patients show a success (≥1 score reduction on Fitzpatrick Wrinkle Severity Scale agreed by ≥2 of 3 dermatologists).
   Result (at 4-week post-treatment):

• Reviewer #1: 91.93% (57/62)
• Reviewer #2: 91.93% (57/62)
• Reviewer #3: 90.32% (56/62)
• ≥2 agree: 95.16% (59/62)
  Result (at 3-month follow-up):
• Reviewer #1: 91.93% (57/62)
• Reviewer #2: 96.77% (60/62)
• Reviewer #3: 98.39% (61/62)
• ≥2 agree: 100% (62/62)
  Conclusion: Study success criterion for treatment effectiveness was met. |
  | Biocompatibility: Patient-contacting components demonstrated to be biocompatible. | Study: Electrodes and shell (b(4)) are same as Newa™ prescription device (K130793). Tested according to ISO 10993-1 and USP Class VI tests.
  Result: Met requirements for up to 30 days contact with human tissue. |
  | Instructions for Cleaning: Cleaning instructions validated. | Study: Cleaning validation protocol and report provided.
  Result: Cleaning instructions are adequate. Device is non-sterile and reusable, for single user. |
  | Electromagnetic Compatibility (EMC) and Electrical Safety: Performance data provided. | Study: Tested against IEC 60601-1:2005/EN 60601-1:2006, IEC 60601-1-2:2007, IEC 60601-1-11:2010.
  Result: Device passed all relevant testing portions, demonstrating electrical safety for home use. |
  | Software Verification, Validation & Hazard Analysis: Performed per guidelines. | Study: Software is firmware on micro-controller, same as cleared prescription device (K130793). Considered moderate LOC. All elements for moderate LOC devices provided per FDA guidance. V&V testing conducted for system initialization, power button, power down, LEDs, vibration, temperature detection.
  Result: Satisfactory results. Software development procedures provide assurance of intended performance; all software risks adequately mitigated. |
  | Labeling: Include warnings, precautions, contraindications, and clinical summary. | Content: User Manual, Quick Reference Guide, Box Labeling. Includes: When to use (indication), What is Newa, Who can benefit, Using Newa (regimen), Who cannot use (contraindications), What to do to avoid harm (warnings, precautions), Manufacturer details.

Ask a specific question about this device

The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

EndyMed's Intensif Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346) (EndyMed Pro). The Intensif Applicator has a custom grid array of micro electrodes that is used to deliver the energy into the tissue. The Intensif Applicator tip emits bipolar RF energy that flows between electrodes to create thermal heating of the tissue for hemostasis and coagulation. The Intensif Applicator consists of: . Disposable treatment element (tip) . RF electrodes on a disposable tip . Operation trigger.

Here's a breakdown of the acceptance criteria and study information for the Intensif Applicator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information

This device did not involve a clinical study with human subjects. The supporting studies are entirely preclinical and ex vivo.

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

• Test Set Sample Size: Not specified. The document mentions "a few Ex Vivo laboratory studies and Ex Vivo animal studies tests" but does not quantify the number of samples or animals used.
• Data Provenance: The studies were "Ex Vivo laboratory studies and Ex Vivo animal studies tests." The location where these studies were performed is not explicitly stated, but the company is based in Israel. This is a preclinical type of data.

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

• This information is not applicable as the studies were preclinical (ex vivo laboratory and animal) and did not involve human interpretation or expert evaluation to establish ground truth in the context of clinical outcomes. The "ground truth" was based on measurable physical and biological effects in the lab.

4. Adjudication Method for the Test Set

• Not applicable. There was no human expert adjudication of a test set as the studies were preclinical.

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, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This device is not an AI-assisted diagnostic tool; it's an electrosurgical applicator.

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

• While the device itself operates without human intervention post-activation, this question is typically relevant for diagnostic algorithms or AI. For this medical device, the "standalone" performance refers to its ability to achieve its intended physical effect (electrocoagulation and hemostasis) as demonstrated in the ex vivo studies. It is not an "algorithm only" type of device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance was established through measurable physical and biological effects in ex vivo laboratory settings and animal tissues. This included:
  • Evaluating thermal and biological effects.
  • Measuring power control and accuracy.
  • Testing safety features functionality.
  • Validating needle depth.

8. The Sample Size for the Training Set

• Not applicable. This device is a medical device for electrocoagulation and hemostasis, not an AI/machine learning algorithm requiring a "training set" of data in the conventional sense. Its design and performance are based on engineering principles and physical testing.

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

• Not applicable, as there was no "training set" in the context of AI/machine learning for this device.

Ask a specific question about this device

The Glow by EndyMed is a noninvasive device intended for use in Dermatologic and General Surgical procedures. The TC applicator is indicated for mild to moderate facial wrinkles and rhytides. The FSR applicator is indicated for Dermatological procedures requiring ablation and resurfacing of the skin.

The EndyMed Glow is a non-invasive unit consists of a user interface, programmable logic controller (PLC), an RF power module, internal electronics, and treatment handpieces. The user interface allows the selection of treatment parameters by pressing on the treatment buttons; A LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety functions of the system. The system is connected to one or two out of 2 TC handpieces with different size electrode areas for different treatment sites, or to a FSR handpiece. The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at 1MHz frequency.

The provided text is a 510(k) Summary for the "Glow by EndyMed" device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It does not contain information about a clinical study designed to prove the device meets specific acceptance criteria.

The document primarily focuses on:

• Device Description and Intended Use: Describing what the device is and what it's used for.
• Predicate Devices: Identifying previously cleared devices to which "Glow by EndyMed" claims substantial equivalence.
• Performance Standards: Stating compliance with general safety and EMC standards for medical electrical equipment.
• Technological Characteristics Comparison with Predicates: Asserting that the device has the same technological characteristics as the predicate devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies cannot be extracted from this document as such studies are not described.

The document states:

• "The Glow by EndyMed has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices."
• "The TC applicator has exactly the same RF technology characteristics as the EndyMed Imagine TC Skin Treatment System (K0834610) and the FSR applicator has the same fractional RF technology as the EndyMed Fractional Skin Resurfacing (FSR) Applicator (K101510)."

This indicates that the primary "proof" of meeting acceptance criteria for a 510(k) submission like this is typically through demonstrating substantial equivalence to already cleared devices, rather than through new clinical performance studies with defined acceptance criteria for a novel device. The implicit acceptance criteria are that the device performs as safely and effectively as the predicate devices.

Ask a specific question about this device

The Fractional Skin Resurfacing (FSR) Applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin

EndyMed's Fractional Skin Resurfacing (FSR) Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346). The FSR Applicator tip emits bipolar RF energy that flows between electrodes to create micro-ablation points on the skin, forming superficial ablation with a volumetric non ablative heating effect in the dermis.

The provided text describes the EndyMed Fractional Skin Resurfacing (FSR) Applicator and its 510(k) submission. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and a detailed study.

The document states that a "performance testing" was conducted and its results "clearly indicate that the Fractional Skin Resurfacing (FSR) Applicator offers a non-invasive, effective, safe device for skin resurfacing." It also claims the device "is as safe, as effective, and performs at least as safely and effectively as the legally marketed device" (predicate devices).

Here's a breakdown based on the information provided, highlighting what is missing:

1. Table of acceptance criteria and the reported device performance:

Missing Information: The document does not explicitly state specific quantitative or qualitative acceptance criteria (e.g., minimum percentage improvement in skin texture, reduction in wrinkles, safety endpoint thresholds). It only provides a general statement about the device's performance relative to safety and efficacy.

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

Missing Information: The document states "a performance testing" was conducted but does not provide any details on:

• The sample size of participants or data points used in the test set.
• The country of origin for the data.
• Whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Missing Information: The document mentions "performance testing" but does not describe how ground truth was established, nor does it refer to any experts involved in this process or their qualifications.

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

Missing Information: There is no information provided about any adjudication method used for establishing ground truth or evaluating the test results.

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 (Based on available information): This device is an applicator for dermatological procedures (physical treatment), not an AI-assisted diagnostic device that would involve human readers interpreting results with or without AI. Therefore, an MRMC study related to AI assistance for human readers is not relevant in this context.

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

Not Applicable (Based on available information): Similar to point 5, this is a physical treatment device, not an algorithm. Standalone performance (algorithm-only) is not applicable here. The device's performance inherently involves a human operator.

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

Missing Information: The document does not specify the type of ground truth used for evaluating the device's performance. Given it's a skin resurfacing device, potential ground truths could include clinical assessment scores (e.g., wrinkle scales, skin texture scores), photographic assessment, or potentially histological changes, but none are mentioned.

8. The sample size for the training set:

Missing Information: As the device is not an AI algorithm, there is no "training set" in the conventional sense. The "performance testing" described is likely a clinical trial or study on human subjects, not an algorithm training process.

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

Missing Information: As there is no AI algorithm training set, this question is not applicable.

Ask a specific question about this device