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Dermablate System with its accessories is indicated for coagulation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).

Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

Dermablate is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, detachable handpieces, and a footswitch. The device can be operated with micro beam and non-micro beam handpieces. The system incorporates a suction unit for the safe removal of laser plume. The laser is fired with a foot-operated switch (footswitch).

This document, a 510(k) Premarket Notification summary for the Dermablate laser system, primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information (acceptance criteria table, sample sizes, ground truth details, MRMC study, standalone performance) cannot be extracted directly from this document.

The document outlines that "Dermablate passed all the required testing and is in compliance with all applicable sections of the abovementioned performance standards," which implies that the device did meet acceptance criteria related to these standards, but the specific performance results or acceptance thresholds are not detailed.

Here's an analysis of the information available:

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

The document does not provide a table of specific acceptance criteria (e.g., target energy output with an allowable deviation) and the device's reported performance against these criteria. Instead, it lists harmonized standards that the device passed. Compliance with these standards is the reported performance in this context, demonstrating that the device meets safety and electromagnetic compatibility requirements, among others.

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

This information is not provided in the document. The testing described (performance testing, software V&V, biocompatibility) typically involves engineering tests, hardware verification, and software validation rather than patient-level clinical studies with test sets in the context of AI/diagnostic devices.

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)

This information is not applicable/provided. The Dermablate is a laser surgical instrument, and its performance evaluation documented here revolves around technical and safety specifications rather than diagnostic accuracy established by expert consensus on a test set.

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

This information is not applicable/provided. As explained in point 3, the evaluation of this device does not involve expert adjudication of a test set in the way a diagnostic AI would.

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

An MRMC comparative effectiveness study is not applicable here. The Dermablate is a therapeutic laser device, not a diagnostic AI system designed to assist human readers.

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

This concept is not applicable to a therapeutic laser device. The device's function is direct treatment, not an algorithmic standalone performance for diagnosis or image analysis.

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

The document does not detail "ground truth" in the context of clinical outcomes or diagnostic accuracy. For a laser device, "ground truth" would relate to its physical output parameters (wavelength, energy, fluence, etc.) matching specifications, and its safety compliance with international standards. The document states that the device "passed all the required testing and is in compliance with all applicable sections of the above-mentioned performance standards," implying that these standards' requirements serve as the "ground truth" for technical and safety performance.

8. The sample size for the training set

This information is not applicable/provided. The Dermablate is not an AI/machine learning device that requires a training set.

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

This information is not applicable/provided. As above, the device does not use a training set.

Summary of available information regarding compliance and efficacy (as per the document):

The document focuses on demonstrating substantial equivalence of the modified Dermablate device (increased max pulse energy to 3J and addition of a "DeepSpot" microbeam handpiece) to its predicate devices (MCL 31 Dermablate and Erise). The "study" proving the device meets acceptance criteria is implied through its successful passage of various harmonized standard tests and software verifications and validations.

The key statement is: "Based on the nature of the changes implemented, the device underwent and successfully passed performance testing and software verifications and validation according to the relevant standards." and "Dermablate passed all the required testing and is in compliance will all applicable sections of the abovementioned performance standards."

The listed standards that the device passed are:

• IEC 60601-1-6:2010/AMD1:2013: Medical electrical equipment Part 1: General requirements for safety and essential performance
• IEC 60601-1-2:2015: Medical electrical equipment – Part 1-2: General requirements for safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
• IEC 62304: Medical Device Software – Software life cycle processes
• IEC 62366-1:2015: Medical devices – Application of usability engineering to medical devices
• IEC 60601-2-22:2019: Medical electrical equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment
• IEC 60825-1:2014: Safety of laser products - Part 1: Equipment classification, and requirement
• ISO 14971: Medical devices - Application of risk management to medical devices
• FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (for software V&V)
• EN/ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10: Biological evaluation of medical devices - Part 10 Tests for irritation and skin sensitization
• ISO 10993-23: Biological evaluation of medical devices - Part 23 Tests for irritation

The "acceptance criteria" are compliance with these standards, and the "reported device performance" is that it did comply. The document does not elaborate on the specific test results or the criteria defined within each standard that the device had to meet (e.g., maximum electromagnetic emissions or specific laser output tolerances).

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The MCL 31 Dermablate System with its accessories is indicated for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry, and Ophthalmology (skin around the eyes).
The MCL 31 Dermablate System, when used with its micro beam handpieces, is intended for use in Dermatological procedures and Skin resurfacing procedures.

The MCL 31 Dermablate System is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, detachable handpieces, and a footswitch. The MCL 31 Dermablate System can be operated with micro beam and non-micro beam handpieces. The system incorporates a suction unit for the safe removal of laser plume. The laser is fired with a foot-operated switch (footswitch).

The provided text is a 510(k) summary for the MCL 31 Dermablate System, a pulsed Er:YAG laser. It details the device's technical characteristics, intended use, and compares it to legally marketed predicate devices. However, this document primarily focuses on demonstrating substantial equivalence to predicate devices through technical specifications and compliance with various safety and performance standards. It does not present a study with specific acceptance criteria related to a device's diagnostic or therapeutic performance, nor does it report on a device's performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as such a study is not part of this 510(k) summary. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than conducting new clinical performance studies to establish new performance metrics.

Specifically, the document does not contain:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes, data provenance, or ground truth for test sets.
3. Details on the number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on a standalone algorithm performance study.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

The "Nonclinical Performance Data" section lists various engineering and biocompatibility standards the device complied with, such as:

• EN 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
• IEC 60601-1-2 (Electromagnetic compatibility)
• IEC 60601-2-22 (Particular requirements for laser equipment)
• EN/IEC 60825-1 (Safety of laser products)
• IEC 62304 (Medical Device Software - Software life cycle processes)
• ISO 14971 (Risk management)
• EN/ISO 10993-1, -5, -10, -23 (Biocompatibility testing for cytotoxicity, sensitivity, and irritation)

These are standards that the device must meet for safety and basic performance, not metrics measuring its effectiveness in treating patients or its diagnostic accuracy. The compliance with these standards is considered sufficient for substantial equivalence in this context, aligning with the "General controls provisions of the Act" mentioned in the FDA letter.

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Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes).

The MCL 31 Dermablate is a pulsed Er:YAG laser emitting a wavelength of 2940 nm. The system comprises a main console unit, a handpiece and is triggered by means of a footswitch. The MCL 31 is operated with a handpiece of larger spotsize. The system incorporates a suction unit for the safe removal of laser plume.

This document is a 510(k) summary for the MCL 31 Dermablate laser system. It does not describe a study to prove the device meets specific acceptance criteria in the context of AI/ML device performance. Instead, it demonstrates substantial equivalence to predicate devices through technical characteristics and adherence to recognized standards.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment (which are typically relevant for AI/ML device evaluations) are not applicable to this document.

However, I can extract the relevant information regarding performance and testing that is available:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with numerical targets for metrics like sensitivity, specificity, etc. Instead, acceptance is implied by demonstrating substantial equivalence to predicate devices, focusing on:

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. This is a non-clinical submission based on comparison to predicate devices and adherence to standards. No "test set" of clinical data for AI/ML performance is mentioned.

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. No ground truth establishment for a test set of clinical data is mentioned.

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

Not applicable. No test set requiring expert adjudication is mentioned.

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

Not applicable. This is a laser surgical instrument, not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a physical medical device (laser system), not an algorithm.

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

Not applicable. The basis for safety and effectiveness is substantial equivalence to legally marketed predicate devices and compliance with recognized standards, not a specific ground truth for a performance study.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a training set.

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

Not applicable.

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The Dermablate Effect Er:YAG laser with handpiece of larger spot sizes is intended for use for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery, oral surgery and ophthalmology (skin around the eyes).

The Dermablate Effect Er:YAG laser with fractional handpiece is intended for dermatological and skin resurfacing procedures.

The Dermablate Effect can be equipped optionally with the following modules: Asclepion Pulsed Light (APL) and Acoustic Wave (AW).

The Asclepion Pulsed Light is intended for permanent hair reduction, treatment of vascular and pigmented lesions and inflammatory acne.

The Acoustic Wave is intended for the activation of connective tissue.

The Dermablate Effect is a pulsed Er:YAG laser emitting a wavelength of 2940 nm, that can optionally be equipped with a pulsed light module (APL) and an acoustic wave module (AW).

Unfortunately, I cannot directly help you with your request. The provided text is a 510(k) summary for a medical device (Dermablate Effect). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Key issues preventing me from fulfilling your request are:

• Absence of Acceptance Criteria and Performance Data: The 510(k) summary explicitly states "Nonclinical Performance Data: None" and for "Clinical Performance Data," it only mentions a "Fractional Er:YAG histological report of Prof. D. Cassuto" without providing any specific criteria, metrics, or measured performance values. This means there's no information about acceptance criteria or how the device's performance was quantitatively evaluated against them.
• Lack of Detailed Study Information: The brief mention of a "histological report" is not a detailed study description. It doesn't contain the essential information you're asking for, such as sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set specifics.
• Focus on Substantial Equivalence, Not De Novo Performance: The 510(k) process is about demonstrating substantial equivalence to pre-existing devices, not necessarily proving novel performance against a predefined set of acceptance criteria in a detailed clinical trial like a PMA (Pre-Market Approval) submission might require.

To get the information you are looking for regarding acceptance criteria and detailed study data, you would typically need to consult a more comprehensive clinical trial report or a PMA submission for a novel device, rather than a 510(k) summary.

Therefore, I cannot generate the table or answer the specific questions because the necessary data is not present in the provided text.

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Intended for coagulation, vaporization, ablation or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

The smoke evacuator integrated into the handpiece is intended to remove aerosol, a by-product of laser treatment.

MCL 30 Dermablate Er: Y AG Laser System is an Er: Y AG laser system, having an articulated arm and handpiece. It is a laser with a wavelength of approximately 2.94 um. Laser emission activation is by foot switch. Overall weight of the laser is 85 kg, and the size is 970x360x650 cm (HxWxD). Electrical requirement is 230 VAC, 16A, 50-60 Hz, single phase. Smoke evacuation is provided by the evacuator integrated into the handpiece that removes the aerosol, a by-product of laser treatment.

The provided text is a 510(k) summary for the MCL 30 Dermablate Er:YAG Laser System. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the Study (or lack thereof):

The document explicitly states:

• Nonclinical Performance Data: none
• Clinical Performance Data: none

This means there was no specific study conducted and reported in this 510(k) submission to establish acceptance criteria or demonstrate performance directly through testing. The approval is based on substantial equivalence to a legally marketed predicate device.

Given the above, the following information is not applicable or not provided by the document:

2. Sample size used for the test set and the data provenance: Not applicable, as no dedicated test set or clinical/non-clinical performance data was presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a laser system, not an AI-assisted diagnostic tool for 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no specific performance study with ground truth was reported.
8. The sample size for the training set: Not applicable, as this is not a machine learning/AI device.
9. How the ground truth for the training set was established: Not applicable.

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The laser system DERMABLATE ER:YAG LASER SYSTEM is intended for laser assisted site preparation for hair transplantation. This indication is in addition to previously cleared indications.

The laser system DERMABLATE ER:YAG LASER SYSTEM is restricted to sale to or use by licensed professionals in the United States.

The laser system DERMABLATE ER:YAG LASER SYSTEM is an Erbium:YAG laser with a wavelength of 2.94µm.

The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the AESCULAP-MEDITEC GMBH DERMABLATE ER:YAG LASER SYSTEM, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a study.

Specifically, the document states:

• "Performance data: None. The specifications and intended uses of the laser system DERMABLATE ER:YAG LASER SYSTEM are the same or very similar to those of claimed predicate devices. Because that, performance data were not required."

Therefore, I cannot fill out the requested table and information.

If there were performance data, the table would look like this:

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The Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology (skin around the eyes).

The Dermablate laser is an erbium: YAG laser operating at 2.94 microns and with a maximum pulse energy of 2 J.

The provided text describes a 510(k) summary for the DERMABLATE ERBIUM LASER SYSTEM. It explicitly states that no performance data, acceptance criteria, or studies were required for this device.

Here's why, based on the provided text:

• The summary in section {1} states: "None. The specifications and intended uses of the Dermablate laser are the Performance Data: same or very similar to those of the claimed predicate devices, including the MCL 29 Dermablate. There are no significant differences between the devices under conditions of intended use. Because of this, performance data were not required."

Therefore, I cannot populate the requested information regarding acceptance criteria and studies. The device's clearance was based on its substantial equivalence to legally marketed predicate devices without the need for new performance testing.

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The MCL 29 Dermablate laser is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), and in oral and maxillofacial surgery, and ophthalmology (oculoplasty).

The MCL 29 Dermablate laser is an erbium: YAG of power at 2.94um.

This looks like a 510(k) premarket notification for a medical device, specifically a laser system for soft tissue ablation. In the context of 510(k) submissions, the “acceptance criteria” and “study that proves the device meets the acceptance criteria” often refer to the demonstration of substantial equivalence to a predicate device, rather than a clinical trial with specific performance metrics like sensitivity and specificity for an AI algorithm.

Here's an analysis based on the provided text, addressing your questions where applicable within this regulatory framework:

1. Table of Acceptance Criteria and Reported Device Performance

For 510(k) applications demonstrating substantial equivalence, the "acceptance criteria" are typically that the new device shares basic features, intended use, and similar technological characteristics with a legally marketed predicate device, and does not raise different questions of safety and effectiveness.

In this document, the "performance" is assessed by comparing the specifications and intended use of the MCL 29 Dermablate laser with two predicate devices.

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