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The Pellevé GlideSafe™ Non-Ablative Wrinkle Treatment System is intended for non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV.

The device is a hand-held, non-ablative wrinkle treatment handpiece available with various size electrode end effectors and a detachable cord. The electrode is spring mounted into the handle. All materials used in the manufacture of the device are suitable for the use in the device and are the same materials used in the predicate product. As with the predicated device, the device is activated using a hand or footswitch based on user preference and is intended for use with the Ellman Radio-Frequency generators (K082834) labeled for the treatment of wrinkles and rhytides.

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

This 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices. It does not contain detailed information about specific acceptance criteria, comprehensive performance outcomes, or a dedicated clinical study report in the way one might expect for a novel device undergoing extensive clinical trials. The provided document is a regulatory submission demonstrating similar safety and effectiveness to already cleared devices.

Given the nature of the document, much of the requested information about a specific "study proving acceptance criteria" is either not explicitly stated or not applicable in the context of a substantial equivalence claim for a minor technological improvement.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document emphasizes substantial equivalence, meaning the acceptance criteria are implicitly met by demonstrating that the new device is as safe and effective as the predicate devices, sharing similar indications for use and technological principles. Specific quantitative acceptance thresholds (e.g., "90% reduction in wrinkles") and their corresponding measured performance are not provided in this summary.

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

The 510(k) summary does not provide details on a specific "test set" sample size or data provenance (country of origin, retrospective/prospective). It only states that "All appropriate testing has been performed." For substantial equivalence based on minor technological changes, the testing might have been limited to engineering, bench, and potentially animal testing, rather than a large-scale human clinical trial with a defined "test set" for performance evaluation in the usual sense.

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

This information is not available in the provided 510(k) summary. The document does not describe a clinical study that required expert consensus for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not available in the provided 510(k) summary. Given the absence of a described clinical test set, an adjudication method is not mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done/described in this 510(k) summary. This type of study is not relevant for a non-AI, energy-based medical device like the Pellevé GlideSafe™ System.

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

No, a standalone algorithm performance study was not done/described. This device is not an AI algorithm but a physical electrosurgical system.

7. The Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically applied to diagnostic algorithms or imaging interpretation is not directly applicable or mentioned in this 510(k) summary for this device. The evaluation focuses on engineering specifications, intended function, and comparison to predicate devices, rather than a diagnostic output requiring ground truth validation.

8. The Sample Size for the Training Set

This information is not available in the provided 510(k) summary. This device is not a machine learning model, so there is no "training set."

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

This information is not applicable as there is no training set for this device.

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Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes I-IV
Non-ablative treatment of mild to moderate facial wrinkles for skin phototypes I-IV

The purpose of this submission is to modify the Cleaning / Disinfection methods of the Non-Ablative Wrinkle Treatment Handpiece cleared as Ellman Non-Ablative Wrinkle Treatment Handpiece under K101967. The device is identical to the device cleared under K101967 Ellman International Non-Ablative Wrinkle Treatment Handpiece except for the modified Cleaning/Disinfection method.

This 510(k) summary describes a modification to a medical device, specifically changes to its cleaning and disinfection methods, rather than an AI-powered diagnostic or treatment device. Therefore, many of the requested categories related to AI performance, such as sample sizes for test sets and training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth types, are not applicable in this context.

The document discusses the device's cleaning and disinfection methods and a study conducted to demonstrate their effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size (e.g., number of test devices or samples) for the test set used in the cleaning/disinfection study. The data provenance is described as "test protocol as part of this submission" and "SGS Protocol # 09A1006547 and demonstrated in SGS Report# 09A1006548," indicating an internal or contracted laboratory study rather than clinical data from a specific country or retrospective/prospective collection.

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

Not applicable. The study is a laboratory test of cleaning and disinfection efficacy, not an assessment of diagnostic performance requiring expert interpretation.

4. Adjudication method for the test set

Not applicable. This is a laboratory test, not a diagnostic assessment with human readers.

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 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 medical device for non-ablative wrinkle treatment, not an algorithm. The study focuses on the efficacy of a cleaning and disinfection protocol.

7. The type of ground truth used

For the cleaning and disinfection study, the "ground truth" would be the direct measurement of bacterial/microbial reduction on the test devices after applying the proposed method. This is laboratory-derived quantitative data, not expert consensus, pathology, or outcomes data in the typical sense of AI-driven diagnostics.

8. The sample size for the training set

Not applicable. This document describes a traditional medical device and its cleaning protocol validation, not an AI/ML system requiring a training set.

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

Not applicable. As there is no training set mentioned, the ground truth establishment is irrelevant in this context.

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The device has the following "Indications For Use"

• Non-ablative treatment of mild to moderate facial wrinkles and rhytides for skin phototypes . I-IV

Accessory handpiece electrode is intended for use with the Ellman Surgitron IEC120 / 4.0 Dual Radio-Frequency generator. The device is considered as an accessory to the RF generator. The generator has been cleared by the FDA under 510(k) K082834 Ellman International Non-Ablative Technique for Surgitron IEC.

The provided text describes a 510(k) submission for a "Non-Ablative Wrinkle Treatment Handpiece," specifically for a change in cleaning/disinfection methods. It does not contain information about clinical studies evaluating the device's performance in treating wrinkles or rhytides, nor does it define performance-based acceptance criteria for such a clinical application.

The sole "study" mentioned is related to the cleaning and disinfection methods of the device:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated in the provided text for the disinfection study. The text mentions "test devices" (plural) but does not give a specific number.
• Data Provenance: The study was "successfully executed test protocol as part of this submission" by "Ellman International" and reported by "SGS Protocol # 09A0908673 and demonstrated in SGS Report# 09A0908675." This suggests it was an in-house or contracted laboratory study, likely retrospective to the submission date. The country of origin of the data is not specified, but Ellman International Inc. is located in Oceanside, NY, USA.

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

• Not applicable. The study focuses on microbiological efficacy of disinfection, not clinical outcomes requiring expert interpretation. The "ground truth" here would be the measured reduction of microbial load.

4. Adjudication Method for the Test Set:

• Not applicable as this was a laboratory study of disinfection efficacy; no human subjective assessment for ground truth was involved.

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

• No. This submission is for a change in cleaning/disinfection methods for an accessory handpiece. No MRMC study was conducted or mentioned for the device's primary clinical indication (wrinkle treatment). The document explicitly states: "As there are no technological, structural, design or intended use changes for the subject device, Ellman International believes that no further data or clinical study is required to support the position that the device is safe and effective to use with the changes delineated in the instructions for use."

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

• Not applicable. This device is a physical handpiece and not an algorithm. The disinfection study assessed the physical and chemical process.

7. Type of Ground Truth Used:

• For the disinfection study: "Measured reduction of inoculated challenge organisms." This is an objective, quantitative laboratory measurement.

8. Sample Size for the Training Set:

• Not applicable. This submission is about a change to existing instructions for use for a medical device accessory, not the development of a predictive model or algorithm, so there is no "training set."

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

• Not applicable for the reasons stated above.

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• O Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV
  The device is also indicated for:
• O Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, lumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
• O Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, verrucae, basal cell carcinoma, nevi, fistulas, epithelioma, cosmetic repairs, cysts, abscesses, and development of skin flaps.
• O Hemostasis: control of bleeding, epilation, telangiectasia.
• O Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, hemostasis.
• O Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.

The Ellman Surgitron is a compact source of high power RF energy to be employed for a variety of radiosurgical procedures. This action is achieved by front panel selection of waveforms and power levels. All selections are activated by push buttons with lights that give the operator feedback of operative status. The power level for each mode is indicated by the front panel digital display, which also identifies the status of self-test and monitoring. This display is interlocked with the controls to prevent operation when fail is displayed. The final output power control is made through foot and/or hand switches. Both monopolar and bipolar electrodes are provided.

The Ellman Surgitron is an electrosurgical unit and accessories device that was evaluated for an expanded indication for use: "non-ablative technique" for the treatment of mild to moderate facial wrinkles and rhytids.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantifiable acceptance criteria (e.g., a specific percentage reduction in wrinkles, a particular safety threshold, or a statistical non-inferiority margin). Instead, it relies on a substantial equivalence argument to a predicate device for its performance.

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

The document does not provide details on the sample size used for any specific test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective) for the "studies" mentioned. It merely states that "Studies comparing the subject device to the predicate device" were conducted.

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

The document does not provide any information regarding the number of experts used, their qualifications, or how ground truth was established for any test set.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. There is no information about human readers, AI assistance, or effect sizes.

6. Standalone (Algorithm Only) Performance Study

The device described is an electrosurgical unit, a physical medical device, not an algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable in this context.

7. Type of Ground Truth Used

Given that the device is an electrosurgical unit for treating wrinkles, the "ground truth" for its effectiveness would typically involve clinical assessments, such as improvement in wrinkle severity scores (e.g., using standard scales like the Glogau or Fitzpatrick wrinkle scale), photographic evidence of changes, and patient satisfaction. However, the document does not explicitly state the type of ground truth used in the supporting studies. It only broadly claims "safe and effective."

8. Sample Size for the Training Set

The document does not mention a training set sample size. As it is a physical device and not an AI/machine learning model, the concept of a "training set" in that context is not applicable. The device's performance relies on its physical and electrical characteristics.

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

As explained above, the concept of a "training set" with established ground truth is not applicable to this device's submission type (electrosurgical unit, not an AI/ML model). The "studies" likely refer to pre-clinical testing, engineering verification, and potentially clinical trials that demonstrated equivalence to existing predicate devices.

Summary of Study Information:

The provided 510(k) summary relies heavily on demonstrating substantial equivalence to existing predicate devices rather than presenting detailed performance data from a de novo study against specific acceptance criteria.

• Primary Argument: The subject device (Surgitron) is identical in materials and technology to a previously cleared Surgitron (K013255). The only difference is the addition of the "non-ablative technique" for wrinkles, which is similar to the indications for use of another predicate device, Thermage ThermaCool (K040135).
• Performance Data Statement: "Studies comparing the subject device to the predicate device demonstrate that the subject device is safe and effective for use in non-ablative procedures such as the treatment of mild to moderate facial wrinkles and rhytids."
• Lack of Detail: The document is remarkably sparse on specific details regarding these "studies," including methodologies, sample sizes, patient demographics, endpoints, statistical analyses, or the specific "acceptance criteria" met beyond the general claim of "safe and effective" based on substantial equivalence. This level of detail is common in 510(k) summaries where the primary argument is substantial equivalence to a well-understood predicate.

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Orthopedic, arthroscopic, spinal, and neurosurgical

For resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal and neurological procedures. For soft tissue resection and ablation during arthroscopic surgical procedures of knee, shoulder, ankle, elbow, hip and wrist.

Cutting

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags, Blepharoplasty.

Blended Cutting and Coagulation

Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, skin tags, papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of skin flaps.

Hemostasis and Nonablative Coagulation

Control of bleeding, Epilation, Telangiectasia

Bipolar

Pinpoint, Precise Coagulation, Pinpoint Hemostasis, in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage.

The Surgi-Max Electrosurgery Generator is a compact source of high radio-frequency RF energy to be employed for a variety of radiosurgery procedures. This action is actieved by front panel selection of waveforms and power level. All selection is effected through push buttons and lamps, which give the operator feedback of status.

Power level for each mode is indicated by front panel digital displays, which also show the status of self-test and monitoring. The display is interlocked with controls to prevent operation when FAILS is displayed. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are offered.

The power output in the CW (Cut) mode is 120 watts into (500 ohms) a matched load. The output frequency is maintained at 4.0 MHz +/- 400Hz over all service and loading conditions includingshort and open for monopolar mode.

Three output waveforms are provided:

CW CUT -- Continuous wave output with average power equal to the maximum with no deliberate modulation.

CUT / COAG – Deeply modulated envelope with average to peak power ratio approximately 50%. Modulation occurring at 120 or 100 Hz rate.

HEMO - Deeply modulated wave with average to peak ratio approximately 50%. Modulation occurring at 120 or 100 Hz rate of square wave.

The provided text is a 510(k) Summary for the Ellman Surgi-Max electrosurgical generator. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not detail a study proving the device meets specific performance acceptance criteria. Instead, it relies on compliance with general safety standards and comparison to a predicate device.

Here's an analysis based on the information provided, and where information is missing for your specific request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the way one might expect for a new performance study. Instead, it lists the output characteristics of the device and states compliance with general safety standards.

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

This information is not provided in the document. The document refers to compliance with standards (IEC 60601-1 and IEC 60601-2-2) and a comparison to a predicate device (Ellman Surgitron IEC 120 / 4.0 DU K013255). It does not describe a new clinical or laboratory study with a "test set" in the context of AI/software performance. The data provenance (country of origin, retrospective/prospective) is also not applicable/provided for this type of submission.

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

This information is not provided and is not applicable to this type of device submission. This document describes a hardware medical device (electrosurgical generator) and its electrical output characteristics and intended uses, not an AI or software device that would typically involve expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable for the reasons stated above.

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

This is not applicable to this device. The Surgi-Max is an electrosurgical generator, not an AI-assisted diagnostic or treatment planning system that would involve human readers.

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

This is not applicable to this device. The Surgi-Max is a standalone hardware device; the concept of an "algorithm only" performance study typically applies to software/AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is its measured electrical output characteristics (power, frequency, waveform) and its compliance with established international safety standards for electrosurgical units (IEC 60601-1 and IEC 60601-2-2). The ultimate "truth" for its market acceptance is its substantial equivalence to a legally marketed predicate device. This is primarily engineering and compliance data, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not provided and is not applicable as this isn't an AI/machine learning device.

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

This information is not provided and is not applicable as this isn't an AI/machine learning device.

Summary of the Study (as described in the document):

The "study" or justification for market clearance for the Ellman Surgi-Max appears to be based on:

• Compliance with Recognized Standards: The device was tested and found to comply with IEC 60601-1 (general requirements for safety) and IEC 60601-2-2 (particular requirements for the safety of high-frequency surgical equipment). This demonstrates that the device meets established safety and performance benchmarks for its category.
• Performance Specifications: The manufacturer presented the output characteristics (power, frequency, waveforms) for each mode of operation. These specifications are inherently verifiable through engineering testing.
• Substantial Equivalence to a Predicate Device: The core of the 510(k) submission is the claim that the Surgi-Max is "as safe and effective" as the legally marketed predicate device, the Ellman Surgitron IEC 120 / 4.0 DU (K013255), and that any differences are minor. This comparison typically involves comparing technical specifications, materials, intended use, and performance claims to show that the new device does not raise new questions of safety or effectiveness.

The document does not describe a new clinical trial, a comparative performance study against a placebo, or an AI validation study. It is a regulatory submission demonstrating compliance with standards and equivalence to an existing device, a common pathway for many medical devices.

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Cutting: Skin and Mucosal Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, Skin Tags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures; Blended Cutting and Coagulation: Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures, ENT procedures; Hemostasis: Control of Bleeding, Epilation, Telangicctasia; Bipolar: Pinpoint, Precise Cutting and Coagulation, Pinpoint Hemostasis in any field (Wet or Dry)

The @llman Surgitron Radiolase II is a high frequency, medium power output electrosurgical medical device. The design is similar to currently marketed electrosurgical generators and provides the essential operational modes that are most often used in medium power electrosurgical applications. The unit consists of both a nominal 50 Watt maximum output power in monopolar mode and a nominal 55 Watt maximum output power in bipolar mode, providing the capability of precision cutting, coagulation, and hemostasis in a four megacycle frequency electrical current. The unit is designed to comply with the international safety standards.

Here's a breakdown of the acceptance criteria and study information for the ellman Surgitron Radiolase II device, based on the provided 510(k) summary:

This document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It typically does not contain detailed primary study results, acceptance criteria, or comprehensive performance data as would be found in a full clinical study report. Instead, it focuses on demonstrating equivalence to existing devices.

Therefore, the information provided below will be based on what can be inferred from the 510(k) submission, particularly the comparison to predicate devices, rather than explicit statements of acceptance criteria and a detailed study proving performance against them.

Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary does not explicitly state "acceptance criteria" in the typical sense of quantitative performance targets. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and safety standards. The reported device performance is described by its technical specifications and capabilities, which are compared directly to the predicate devices.

Study Information (Based on 510(k) Submission)

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

• Test Set: Not applicable for this type of submission. A 510(k) premarket notification primarily relies on a comparison of technological characteristics and intended use to predicate devices, rather than a new clinical study with a "test set" in the sense of clinical data. The submission indicates that the "indications for use is identical to the Surgitron as a preamendment device".
• Data Provenance: The document does not describe specific clinical data or a test set. The provenance of the comparison data is the existing specifications and regulatory clearances of the predicate devices: ellman Surgitron Radiolase (K992382) and ellman Surgitron 4.0 Dual RF/120 IEC (K013225).

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

• Not applicable. There is no mention of a test set with human-established ground truth in this 510(k) submission. Ground truth would be derived from the established safety and effectiveness of the predicate devices.

3. Adjudication method for the test set:

• Not applicable, as no human expert adjudication of a test set is described.

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

• No. This device is an electrosurgical unit, not an imaging or diagnostic device that would typically involve human readers or AI assistance in interpretation. Therefore, an MRMC study is not relevant here.

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

• No. This device is a physical electrosurgical unit. It does not contain an algorithm or AI component.

6. The type of ground truth used:

• For a 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the established safety and effectiveness of legally marketed predicate devices, as determined by the FDA's original clearance of those devices. This includes adherence to recognized performance standards (e.g., IEC 60601-1, 60601-2-2).

7. The sample size for the training set:

• Not applicable. The device does not contain software or AI that would require a "training set."

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

• Not applicable, as no training set exists for this device.

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