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The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The LaserMe is further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.

LaserME is a non-ablative diode laser. The device is equipped with a diode laser with a wavelength of 1470 nm and a maximum power of 2W, intended for nonablative skin resurfacing. The device works by punctuating the skin (epidermis) with several micro laser beams. The points are evenly spaced with adjustable spacing from 1mm to 4mm. The energy delivered to a single point is regulated from 5mJ to 50mJ.

The provided text is a 510(k) summary for the LaserME device. It details the device's indications for use, specifications, and comparison to a predicate device (Emerge Fractional Laser K111840).

The concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to performance metrics of an AI/ML medical device (e.g., sensitivity, specificity, AUC) is not directly present in this document. This submission is for a laser surgical instrument, not an AI/ML device, and therefore the "acceptance criteria" relate more to safety, performance against engineering specifications, and biological compatibility rather than statistical performance metrics of a diagnostic or assistive AI.

However, I can extract the relevant "testing" components that demonstrate the device meets its intended use and safety standards, and present them in a way that aligns with your request for how the device proves it meets acceptance criteria, even if those criteria are not presented in a tabular format of "performance metrics" in the AI sense.

Here's an interpretation based on the provided document, addressing the closest equivalents to your requested points:

Acceptance Criteria and Device Performance for LaserME

Given that the LaserME is a laser surgical instrument, the "acceptance criteria" are not framed in terms of traditional AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, they are related to its functional specifications, safety standards, and biological effects, demonstrating substantial equivalence to a predicate device.

The "study that proves the device meets the acceptance criteria" refers to the non-clinical and clinical testing performed to satisfy regulatory requirements for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Study Details (As applicable to a laser device submission):

For a laser device, the "study" is primarily focused on demonstrating safety, functional performance, and substantial equivalence to a legally marketed predicate, rather than the statistical performance of an AI model.

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

• Non-Clinical Testing:
  • Ex vivo tissue: Sample size not specified.
  • Provenance: Not specified (but implied to be laboratory-based).
• Clinical Testing:
  • Sample Size: 18 healthy volunteers.
  • Data Provenance: Not specified regarding country of origin, but described as a prospective clinical study.

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

• Non-Clinical (Histological Assessment): The document implies expert assessment of the ex vivo histological samples, but the number of experts and their qualifications are not specified. This would typically be performed by pathologists or dermatopathologists.
• Clinical (Histology Analysis from Human Subjects): Histology analysis was performed, implying expert review (likely pathologists), but the number of experts and their qualifications are not specified.

4. Adjudication Method for the Test Set

• Not Applicable in the AI/Ground Truth Sense: For this type of device, "adjudication" wouldn't be relevant for a test set in the same way it is for diagnostic AI models (e.g., resolving discrepancies in expert labels). The histological and clinical assessments provide direct evidence of tissue response.

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

• No: This type of study (comparing human readers with and without AI assistance) is not applicable as the LaserME is a therapeutic/surgical device, not a diagnostic AI.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

• Yes, by nature of the device: The non-clinical and certain aspects of clinical testing assess the performance of the device itself (its laser output, tissue interaction, safety, healing properties) independently of direct human interpretive "performance" in a diagnostic context. The device performs its function directly.

7. Type of Ground Truth Used

• Non-Clinical: Histological assessment in ex vivo tissue provided "ground truth" regarding the extent of laser-induced damage.
• Clinical: Histology analysis from human subjects provided "ground truth" on in vivo thermal effects and tissue healing. "Behaved as intended" serves as the primary outcome.

8. Sample Size for the Training Set

• Not Applicable: This is a physical device, not an AI/ML model that requires a "training set" in the computational sense. Development of laser parameters and designs would be based on engineering principles and prior scientific understanding, not a data-driven training set.

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

• Not Applicable: See point 8.

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PLASMA IQ is used in the removal and destruction of skin lesions and coagulation of tissue.

PLASMA IQ utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.

Here's an analysis of the provided text regarding acceptance criteria and study information for the Plasma IQ device:

Based on the provided text, the Plasma IQ device (K223222) is stated to be the exact same device as the predicate device (K212329), with the only change being an amendment to the labeling to remove a contraindication. Therefore, the device meets the acceptance criteria by being identical to a previously cleared device.

The document explicitly states: "No performance testing data was provided in this submission other than what was provided in the predicate (K212329) to establish substantial equivalence." and "The Plasma IQ that is subject to this submission is the same device that was cleared in K212329. No changes have been made to this device."

This means that all acceptance criteria and study details would be found in the K212329 submission, not in this current K223222 document. Since the K223222 document merely refers to the predicate for performance data, the details you've asked for related to clinical studies are not present here.

Therefore, many of your requested points cannot be answered from this specific document.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

As stated, no new performance testing data was provided in this submission (K223222). The device's performance is accepted by virtue of its substantial equivalence to the predicate (K212329), which would have had its own acceptance criteria and performance data. The table below presents the comparative technical specifications provided for substantiating equivalence, which implies the acceptance of these specifications being met.

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 available in the provided K223222 document, as no new performance testing was conducted for this submission. This data would be found in the K212329 submission.

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 available in the provided K223222 document.

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

This information is not available in the provided K223222 document.

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 available in the provided K223222 document. The device is for physical tissue treatment, not AI-assisted reading.

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

This information is not available in the provided K223222 document. The device is a physical electrosurgical unit, not an AI algorithm.

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

This information is not available in the provided K223222 document. Clinical ground truth for electrosurgical devices often involves direct observation of treatment effectiveness (e.g., lesion removal, tissue coagulation) and safety endpoints.

8. The sample size for the training set

This information is not available in the provided K223222 document.

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

This information is not available in the provided K223222 document.

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Laser EpilME with EpilME applicator is indicated for use in surgical and aesthetic applications in the medical specialties of general and plastic surgery, and dermatology.

The EpilME is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

The EpilMe with EpilME Applicator is intended for:

• · Treatment of benign vascular lesions, including angiomas, telangiectasia and other benign vascular lesions and leg veins
• · Treatment of pseudofolliculitis barbae (PFB)
• · Hair removal, permanent hair reduction *
• · Treatment of benign pigmented lesions

*Permanent hair reduction is defined as the 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 regime.

The Laser EpilME with EpilME applicator is an electro-optical device consisting of a laser console and applicator. The laser console provides a graphical user interface and software for control of the system, the needed electronics to control and power the accessories, handpiece connection port and cooling system.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the EpilME device:

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not present a detailed study proving the device meets specific acceptance criteria through clinical trials in the way you might expect for a new performance claim. Instead, it relies on comparison to a legally marketed predicate and adherence to recognized standards.

Here's an attempt to answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for clinical performance in a quantifiable manner as you might see in a clinical study. Instead, it demonstrates substantial equivalence to a predicate device based on comparable intended use, indications for use, and technical specifications. The "performance" is implied by meeting recognized standards and having similar technical characteristics to the predicate.

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

The document does not describe a clinical "test set" with a specific sample size and data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating technical equivalence to a predicate device and adherence to recognized performance standards (e.g., IEC, ISO). This indicates that the primary "testing" for this 510(k) involves engineering bench testing and a comparison of specifications, not a clinical study on a patient cohort for the EpilME itself.

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

Not applicable. As described above, there is no clinical "test set" or ground truth established by experts in this 510(k) summary for the EpilME device's performance. The ground truth for the predicate device's efficacy would have been established during its original clearance/approval process.

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

Not applicable, as there is no described clinical "test set" with expert 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. The EpilME is a laser device, not an AI-assisted diagnostic or interpretative tool. Therefore, an MRMC study related to human reader improvement with AI is not relevant to this device.

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

Not applicable. The EpilME is a physical laser device, not a standalone algorithm.

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

For the EpilME device itself, the "ground truth" for its safety and functional performance is based on engineering standards (IEC, ISO) and the demonstrated technical equivalence to the predicate device, which has established clinical efficacy for its stated indications. There is no new clinical ground truth generated for the EpilME beyond these comparisons and standards adherence.

8. The sample size for the training set

Not applicable. This device is a laser system, not an AI/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 this type of device.

In summary:

This 510(k) submission for the EpilME laser system primarily demonstrates substantial equivalence to a previously cleared predicate device (LightSheer Desire Laser System K170179) and compliance with recognized safety and performance standards. It does not present a de novo clinical study with specific acceptance criteria, a test set, expert adjudication, or MRMC/AI performance data for the EpilME itself. The "proof" the device meets acceptance criteria is derived from its similar technical specifications and intended uses to a device already deemed safe and effective by the FDA, and its adherence to relevant electrical and biological safety standards.

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PLASMA IQ is used in the removal and destruction of skin lesions and coagulation of tissue.

PLASMA IQ utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.

This document is a 510(k) Premarket Notification from the FDA regarding the Plasma IQ device. It primarily focuses on demonstrating "substantial equivalence" to previously cleared predicate devices, rather than presenting a performance study for a novel AI or diagnostic device.

Therefore, many of the requested elements for describing the acceptance criteria and study that proves a device meets acceptance criteria (especially those related to AI algorithm performance, human reader studies, and ground truth establishment for image analysis) are not applicable to this document. This document describes a device for direct physical interaction (removal and destruction of skin lesions, coagulation of tissue) using electrosurgery, not an AI or diagnostic tool.

However, I can extract information relevant to the device's technical specifications and the basis for its clearance.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (as inferred from Substantial Equivalence)

For a device like Plasma IQ, "acceptance criteria" for FDA clearance through the 510(k) pathway are primarily demonstrating substantial equivalence to a previously cleared predicate device. This means the new device is as safe and effective as the predicate. The "study" proving this largely involves comparing technical specifications and intended use.

Inferred Acceptance Criteria for Substantial Equivalence:

• Identical Intended Use: The device must have the same indications for use as the predicate.
• Similar Technological Characteristics: Key physical and operational characteristics must be substantially similar.
• No New Questions of Safety/Effectiveness: Any differences must not raise new safety or effectiveness concerns.

Table of Acceptance Criteria (as demonstrated by comparison to predicates) and Reported Device Performance:

Study Details (as related to Substantial Equivalence for this type of device)

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

   • N/A. This submission is for an electrosurgical device cleared via the 510(k) pathway, primarily demonstrating "substantial equivalence" to predicate devices. It states: "No performance testing data was provided in this submission other than what was provided in the predicate (K192813) to establish substantial equivalence."
   • The "study" here is a comparison of technical specifications, safety standards compliance, and intended use to predicate devices. The data provenance is implied to be existing documentation and specifications of the predicate devices.
   • The intent of this specific K212329 submission was to amend labeling to remove a contraindication, which was supported by clinical evidence (though not detailed here beyond this statement).

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

   • N/A. This is not an AI/diagnostic device where expert "ground truth" for image data or clinical outcomes is established for a test set in the conventional sense. The "ground truth" for demonstrating substantial equivalence is the existing safety and effectiveness profiles of the cleared predicate devices, confirmed by technical comparisons.

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

   • N/A. Not relevant for this type of 510(k) submission.

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 is not an AI-assisted diagnostic device.

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

   • No. This is a medical device for direct physical treatment, not an algorithm.

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

   • The "ground truth" for this 510(k) clearance is the established safety and effectiveness of the predicate devices (K192813 and K201738) based on their prior FDA clearances and compliance with recognized standards (EN60601-1, EN60601-1-2, EN60601-2-2). The clinical evidence mentioned for the contraindication removal would refer to outcomes data from relevant studies, but these are not presented in this summary document.

7. The sample size for the training set:

   • N/A. This is not an AI/machine learning device that uses a "training set."

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

   • N/A. Not applicable, as there is no training set for this device type.

Conclusion stated in the document: "The Plasma IQ that is subject to this submission is the same device that was cleared in K192813. No changes have been made to this device. The Plasma IQ is substantially equivalent to the predicate device. The intent of this submission is to amend the labeling to remove a contraindication. This removal of the contradiction is supported by clinical evidence. There are no new questions regarding safety or effectiveness raised by the change in the labeling."

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The Sectum control unit is a high frequency generator intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such and muscle spasms, increase in local circulation and provide a temporary reduction in the appearance of cellulite. The Sectum control unit utilizes a BODY and PRECISION applicator for delivering high frequency electrotherapy to tissue.

The Sectum control unit is a radiofrequency energy generator employed for a variety of aesthetic applications. The control unit output is set and monitored via touchscreen and controlled by foot switch. The control unit can be used with corded bipolar Precision and Body applicators.

The Neauvia Sectum System's acceptance criteria and the study proving it meets these criteria are described below. The device in question is a high-frequency electrosurgical generator intended for topical heating to elevate tissue temperature for conditions such as pain and muscle spasms, increased local circulation, and temporary reduction of cellulite.

1. Table of Acceptance Criteria and the Reported Device Performance:

The provided document focuses on substantial equivalence to a predicate device (Venus Legacy CX) through non-clinical evidence and compliance with electrical safety and EMC standards. Therefore, the "acceptance criteria" can be inferred from these compliance requirements and the performance aspects compared to the predicate.

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

The document does not specify a "test set" in the context of human subjects or patient data. The provided evidence is based on non-clinical testing (e.g., electrical safety, EMC, software validation, skin surface temperature testing, and biocompatibility). Therefore, sample size and data provenance in terms of country of origin or retrospective/prospective nature are not applicable for these types of engineering and laboratory tests.

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

Since the evidence is non-clinical testing and not based on human-read interpretations of medical images or diagnoses, the concept of "experts establishing ground truth for a test set" is not applicable in the traditional sense for this submission. The "ground truth" for these tests refers to the established standards and accepted scientific methodologies for proving compliance (e.g., passing electrical safety tests according to IEC standards). These tests would be conducted by qualified engineers and technicians in certified testing laboratories.

4. Adjudication method for the test set:

Not applicable, as there is no test set involving human interpretation requiring an adjudication method.

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. The device is a high-frequency electrosurgical generator, 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:

Not applicable. This device is a medical instrument and not an algorithm. Its performance is demonstrated through its functional capabilities, safety, and biocompatibility, as evaluated through non-clinical tests.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests were established technical standards and validated testing protocols. For example:

• Electrical Safety, EMC, Usability, Alarm Systems: Compliance with specific IEC 60601 series standards.
• Software Validation: Adherence to FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
• Skin Surface Temperature Testing: Defined therapeutic temperature limits.
• Biocompatibility: Adherence to ISO 10993 series standards (ISO 10993-1, -5, -10).

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm 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 this device.

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Plasma IQ is used in the removal and destruction of skin lesions and coagulation of tissue.

PLASMA IQ utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316L stainless steel is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.

I am sorry, but based on the provided text, I cannot provide a table of acceptance criteria and reported device performance related to an AI/ML device, as the document describes a 510(k) submission for a non-AI medical device called "Plasma IQ" for electrosurgical cutting and coagulation.

The document discusses performance testing for electrical safety, tissue testing (thermal spread comparison), and packaging, but not for an AI/ML component. Therefore, there is no information in the provided text to address the following points:

• Acceptance criteria and reported device performance for an AI/ML device.
• Sample size for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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