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The Dr.pen Microneedling System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.

The Dr.pen Microneedling System is a minimally invasive microneedling device that mechanically creates microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The Dr. pen Microneedling System is comprised of a reusable pen body, a sterile, single use microneedling cartridge, a power adapter, and a disposible protective sleeve. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending on the condition of the skin being treated. Charging is accomplished by attaching the Dr.pen pen body to the power adapter.

The provided document is a 510(k) premarket notification for a microneedling device. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, not on proving de novo performance criteria for a novel device. Therefore, the information typically associated with acceptance criteria and a detailed study proving performance against those criteria (especially regarding AI/human reader studies, ground truth, and sample sizes for training/test sets) is not present in this document.

The document primarily discusses bench testing to show that the device meets safety and performance standards equivalent to the predicate device, not a clinical study to prove efficacy in improving acne scars based on image analysis or similar AI-assisted diagnostics.

Here's a breakdown of what can be extracted and what information is missing based on your request:

Information Present in the Document:

1. Acceptance Criteria and Device Performance (in a limited sense related to substantial equivalence):
   The document focuses on comparing technological characteristics to a predicate device and demonstrating equivalence through bench testing. It does not provide a table of acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) because it's a microneedling device for aesthetic use, not an AI diagnostic tool.

   The "acceptance criteria" here are implied by the standards and bench tests performed to show equivalence in physical and electrical characteristics and safety.

   Acceptance Criteria (Implied by Bench Testing & Predicate Equivalence)	Reported Device Performance (Dr.pen Microneedling System)
   Motor Speed Puncture Rate: Match predicate range (6300-7700 RPM, 105-128 stamps/sec)	Reported as "Same" as predicate (6300-7700 RPM, 105-128 stamps/second)
   Needle Penetration Depth and Extension Accuracy: Accurate to selected depth settings and within acceptable tolerances	Bench testing performed; results supported substantial equivalence. Specific accuracy values not listed.
   Needle Bonding Strength: Sufficient for intended use	Bench testing performed; results supported substantial equivalence. Specific strength values not listed.
   Use Life Testing: Device maintains function over expected lifespan	Bench testing performed; results supported substantial equivalence. Specific lifespan not listed.
   Cartridge Life Testing: Cartridge maintains function over expected lifespan	Bench testing performed; results supported substantial equivalence. Specific lifespan not listed.
   Anti-suction Testing: Prevent suction/tissue damage	Bench testing performed; results supported substantial equivalence.
   Microbial Ingress Testing: Prevent microbial contamination	Bench testing performed; results supported substantial equivalence.
   Cleaning and Disinfection Validation: Effective cleaning and disinfection	Passed ISO 11737-1, AAMI TIR-30, AAMI TIR-12.
   Sterilization and Shelf Life: Maintain sterility and integrity for specified shelf life	Passed ISO 11135-2014, ISO 11737-1:2018, ISO 11737-2:2009, ISO 10993-7:2008, ASTM F1980-16, ASTM F1886/F1886M-16, ASTM F1929-2015, ASTM F88/F88M-2015, ASTM D3078-02(2013), ASTM F1140-2013, DIN 58953-6:2016, ISO 11737-2:2019.
   Biocompatibility: Non-toxic, non-sensitizing, non-irritating, non-pyrogenic	Passed Cytotoxicity (ISO 10993-5:2009), Sensitization/Irritation/Intracutaneous Reactivity (ISO 10993-10:2010), Acute Systemic Toxicity (ISO 10993-11:2017), Material Mediated Pyrogenicity (ISO 10993-11:2017, USP 41 NF 36:2018, Pyrogen Test). "Demonstrated the device to be biocompatible with no evidence of material mediated pyrogenicity."
   Electrical Safety and EMC: Compliance with medical electrical safety standards	Passed IEC 60601-1:2005 + A1:2012 and EN/IEC 60601-1-2:2015 /IEC 60601-1-2:2014.

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

   • Sample Size: Not applicable in the context of human clinical data for a "test set" as understood for AI performance. The "testing" here refers to bench testing of the device's physical/electrical properties. No patient data or image data test sets are mentioned.
   • Data Provenance: Not applicable. The testing is bench-based, not clinical or image-based.

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

   • Not applicable. This device is not an AI diagnostic tool that requires expert ground truth establishment for a test set.

4. Adjudication method for the test set:

   • Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No. This type of study is typically done for diagnostic imaging AI devices to compare human performance with and without AI assistance. This document is for a physical microneedling device.

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

   • Not applicable. This device does not have a standalone "algorithm only" performance that would be evaluated in this manner.

7. The type of ground truth used:

   • Not applicable. For the bench testing, the "ground truth" would be the established engineering/materials standards and specifications.

8. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device that would have a "training set."

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

   • Not applicable.

Summary Conclusion:

The provided FDA 510(k) clearance letter and summary for the "Dr.pen Microneedling System" is for a physical medical device (a microneedling device). It is not for an AI-powered diagnostic or assistive tool. As such, the information requested regarding AI acceptance criteria, clinical test sets, expert ground truth, MRMC studies, training data, etc., is not relevant or present in this type of regulatory submission. The regulatory pathway followed here relies on demonstrating substantial equivalence to an existing predicate device through bench testing for safety and performance characteristics, not through clinical efficacy studies involving AI performance metrics.

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The Eclipse MicroPen® EVO is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.

The Eclipse MicroPen EVO™ is a minimally invasive microneedling device that mechanically creates microscopic punctures in the epidermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The MicroPen EVO is comprised of a reusable pen body, a sterile, single use microneedlingcartridge, a rechargeable battery pack, and a battery charger with power supply. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetrationcan be adjusted by the user depending on the condition of the skin being treated. Charging is accomplished by placing the MicroPen EVO battery pack on the Charger base.

The information provided focuses on the substantial equivalence of the Eclipse MicroPen EVO to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria. Therefore, several of the requested categories, such as "Effect size of how much human readers improve with AI vs without AI assistance" or "Sample size for the training set," are not applicable.

However, based on the provided text, I can infer information relevant to other categories.

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

The document doesn't explicitly state acceptance criteria in a quantitative format for clinical efficacy. Instead, it relies on demonstrating equivalence to a predicate device which is already cleared for similar indications. The "Performance Data" section lists various engineering and biocompatibility tests whose successful completion serves as an "acceptance criteria" for safety and performance characteristics, but not for clinical appearance improvement.

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

• Sample size: Not applicable for clinical testing of the Eclipse MicroPen EVO as no independent clinical efficacy study is described. The various engineering, biocompatibility, and sterility tests would have used different sample sizes relevant to their respective testing methodologies, but these are not specified in the document.
• Data provenance: Not applicable in terms of clinical trials for the Eclipse MicroPen EVO, as its efficacy is based on substantial equivalence to a predicate device.

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

Not applicable, as no described clinical study involves establishing ground truth through expert review for the Eclipse MicroPen EVO. The "ground truth" for its efficacy is essentially derived from the predicate device's established performance.

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

Not applicable, as no described clinical study involves expert adjudication for the Eclipse MicroPen EVO.

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 microneedling device, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. This device is a microneedling device, not an algorithm.

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

For the safety and performance aspects (biocompatibility, electrical safety, etc.), the ground truth is established by conformity to recognized international and national standards (e.g., ISO, ASTM, IEC).

For the clinical efficacy (improvement in appearance of wrinkles and acne scars), the "ground truth" is indirect, established by substantial equivalence to a legally marketed predicate device (SkinPen Precision System, K202243) that has already demonstrated such efficacy.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device.

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

Not applicable, as this is not an AI/machine learning device.

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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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