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The PRO 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 PRO Pen microneedling system is a microneedling device and disposable 14-pin cartridges intended for use in adults. The device can be powered with a rechargeable battery or a provided power adapter. The device uses disposable single-use, sterile 14-pin (14-needle) cartridges made of polymer and stainless steel.

The provided FDA 510(k) Clearance Letter for the PRO Pen Microneedling System (K243800) does not describe specific acceptance criteria and the detailed study that proves the device meets those criteria in the way typically expected for an AI/CAD device. The document is a clearance letter for a physical medical device, a microneedling system, not an AI software.

Therefore, many of the requested items (like ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance of an algorithm, and specifics about training/test sets for an AI) are not applicable to this type of device clearance document.

However, I can extract the information relevant to the performance tests conducted and the conclusions made regarding the device's adherence to regulatory requirements.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes performance tests in accordance with special controls for microneedling devices. While explicit numerical acceptance criteria are not provided in this summary, the conclusion of the testing is that the device "successfully passed all performance tests" and "complies with FDA requirements."

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

The document does not specify general "test set" sample sizes or data provenance (e.g., country of origin, retrospective/prospective) because this clearance is for a physical device, not an AI model. The "tests" mentioned are engineering and biocompatibility evaluations. For human patch testing (HRIPT), the sample size would typically be small (e.g., 50-200 subjects) for such tests, but no specific number is provided in this summary.

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

Not applicable. This is not an AI/CAD system requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the device's performance is established by objective engineering standards, biological assays (cytotoxicity, extractables/leachables), and clinical observation (human patch testing for irritation/sensitization).

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

Not applicable. As this is not an AI/CAD system evaluating diagnostic images, there would be no adjudication method involving multiple 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 is not an AI system.

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

Not applicable. This is not an AI system.

7. The type of ground truth used

The "ground truth" for the PRO Pen Microneedling System's performance is based on:

• Engineering Standards: For needle penetration depth, puncture rate, electrical safety, EMC.
• Biological/Chemical Testing Standards: For sterility, vacuum/fluid ingress, cytotoxicity, extractables/leachables, material characterization.
• Clinical Observation/Standard Dermatological Assessments: For human patch testing (irritation and sensitization reactions).
• Microbiological Standards: For cleaning and disinfection validation.
• Stability/Accelerated Aging Protocols: For shelf-life testing.

8. The sample size for the training set

Not applicable. This is not an AI system.

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

Not applicable. This is not an AI system.

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The E-PEN 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 E-PEN is a 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 E-PEN is comprised of a reusable pen body, a sterile, single use microneedling cartridge, and a power adapter. 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 E-PEN pen body to the power adapter.

This document is a 510(k) clearance letter for the E-pen microneedling device. It contains regulatory information and a summary of performance data. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical effectiveness or performance as an AI/software device. This type of information is typically found in clinical study reports, scientific publications, or more detailed regulatory submissions for AI-powered devices, which are not present in this 510(k) clearance letter for a microneedling device.

The provided information focuses on:

• Regulatory Classification: The device is a Class II microneedling device for aesthetic use (21 CFR 878.4430).
• Intended Use: To improve the appearance of facial acne scars in adults aged 22 years and older.
• Technical Specifications: Comparison with a predicate device (SkinPen Precision System, DEN160029) showing similar design, materials, and operating parameters (e.g., number of needles, needle gauge, penetration depth, speed).
• Non-Clinical Performance Data: Biocompatibility, sterilization validation, sterility/shipping/shelf-life, EMC (Electromagnetic Compatibility), electrical safety, software validation (moderate level of concern), and bench testing (needle length, penetration depth, speed, prevention of re-use).

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving clinical effectiveness or AI performance based on this document. The document primarily demonstrates substantial equivalence to a predicate device based on technical and safety specifications, not a new clinical performance study against specific acceptance criteria for a health outcome based on AI.

If this were a submission for an AI-powered device, the information requested (AI performance, ground truth, experts, etc.) would be crucial and would typically be provided in a different section or supplementary documentation.

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The 1NEED Pro 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 or older.

The 1NEED Pro is a minimally invasive microneedling device that microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The 1NEED Pro is comprised of a reusable pen body, a sterile, single use microneedling cartridge and a power adapter. 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 of the skin being treated. Charging is accomplished by attaching the 1NEED Pro pen body to the power adapter.

The provided text describes a 510(k) premarket notification for a microneedling device named "1NEED Pro." While it discusses the device's intended use, technological characteristics, and results from non-clinical bench testing, it does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of clinical performance (e.g., efficacy in improving acne scars).

The document focuses on demonstrating substantial equivalence to a predicate device (K230420) based on similar indications for use and technological features, and the results of various engineering and safety bench tests.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to efficacy (e.g., reduction of acne scars) or details about a clinical study. The document explicitly mentions "Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)" but then only lists "Bench testing."

Here's a breakdown of what can be extracted based on the provided text, and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance (Related to Efficacy - Missing)

• There is no information on acceptance criteria for clinical effectiveness (e.g., a specific percentage improvement in acne scar appearance) or reported device performance against such criteria. The document focuses on demonstrating that the device performs similarly to its predicate and passes engineering/safety tests.

2. Sample Size Used for the Test Set and Data Provenance (Missing for Clinical Efficacy)

• The document lists various bench tests (e.g., Motor Speed Puncture Rate Testing, Needle Penetration Depth and Extension Accuracy Testing, etc.). For these engineering tests, the sample sizes and data provenance are not specified.
• For clinical efficacy, this information is entirely missing, as no clinical study is described.

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

• This information is typically relevant for studies involving human assessment (e.g., assessing the severity of acne scars before and after treatment). Since no clinical efficacy study is described, this information is missing.

4. Adjudication Method (Missing)

• Similar to point 3, adjudication methods are used in clinical studies to resolve discrepancies between expert assessments. Since no clinical efficacy study is described, this information is missing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Not Conducted/Not Described)

• The document does not mention any MRMC study. It focuses on the device performing as well as the predicate through technological comparison and non-clinical tests.

6. Standalone (Algorithm Only) Performance (Not Applicable/Missing)

• The "1NEED Pro" is a physical microneedling device, not an algorithm or AI software for diagnosis or image analysis. Therefore, a standalone performance study in that context is not applicable.

7. Type of Ground Truth Used (Missing for Clinical Efficacy)

• For the described bench tests, the "ground truth" would be engineering specifications or expected physical properties, which were then measured against.
• For clinical efficacy, this information is missing as no clinical study defining a ground truth for acne scar improvement is described.

8. Sample Size for the Training Set (Not Applicable/Missing)

• The device is a physical microneedling pen, not a machine learning algorithm that requires a training set in the conventional sense. Therefore, this information is not applicable.

9. How the Ground Truth for the Training Set was Established (Not Applicable/Missing)

• As above, this is not applicable for a physical device.

Summary of available information from the document related to "acceptance criteria" and "proof":

The document argues for substantial equivalence primarily based on:

• Same intended use: "The 1NEED Pro is a microneedling device intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older." This is identical to the predicate device.
• Same technological characteristics and mode of action: Both the 1NEED Pro and the predicate device use microneedling for the stated indication. Specific characteristics like power source, control mechanism, speed, puncture rate, needle details (number, gauge, material, shape, spacing), penetration depth settings, and sterility of cartridges are compared and deemed similar.
• Non-clinical (bench) testing: These tests demonstrate that the device meets engineering specifications and safety requirements. The conclusion states: "Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device."

The listed bench tests are:

• Motor Speed Puncture Rate Testing
• Needle Penetration Depth and Extension Accuracy Testing
• Needle Bonding Strength Test
• Use Life Testing
• Cartridge Life Testing
• Anti-suction Testing
• Microbial Ingress Testing

The document does not provide specific numerical acceptance criteria or results for these bench tests in a detailed table or report. It only lists that these tests were conducted and concluded the device is "as safe, as effective, and performs as well as the legally marketed predicate device." This implies that the device met the internal specifications and performance levels established as acceptable for these bench tests, leading to the conclusion of substantial equivalence. However, the exact criteria and results are not detailed in this 510(k) summary.

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The XCELLARISPRO TWIST microneedling device and accessories is intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I. II, III and IV in adults aged 22 years or older and for treatment of wrinkles in Fitzpatrick skin types I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.

The XCELLARISPRO TWIST is a microneedling device and intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainlesssteel needles. The XCELLARISPRO TWIST has 4 component parts and 2 consumables. Component parts: (1) handpiece, (2) control unit, (3) power supply and (4) foot switch. Consumables: (1) sterile, single-use needling module (Ethylene oxide sterilized) and (2) disposable barrier sleeves that cover the handpiece during each patient use.

This document is a 510(k) premarket notification letter from the FDA regarding the XCELLARISPRO TWIST microneedling device. It clarifies that this device is not an AI/ML powered device, and therefore, the acceptance criteria and study information requested would not be present in this type of document. The document primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices through non-clinical performance testing and adherence to general and special controls, rather than human-in-the-loop or standalone AI performance studies.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning AI/ML performance, cannot be extracted from the provided text.

The closest relevant sections in the document that discuss performance and criteria are under "Non-Clinical Performance Testing" on pages 8-10. These sections outline special controls and non-clinical tests conducted to demonstrate the device's safety and effectiveness without involving AI.

Summary of available information related to device performance in the provided text (not AI-related):

1. Table of Acceptance Criteria and Reported Device Performance (Non-AI related):

The document does not present a formal table of acceptance criteria and reported performance in the way typically seen for AI/ML devices. Instead, it lists "special controls" that the device must meet through non-clinical performance data. These are more akin to design and function requirements than performance metrics in an AI context.

• Safety features (cross-contamination, fluid ingress): Due to a bellows. (Demonstrated).
• Maximum safe needle protrusion depth: Identified in pig skin with high-speed camera measurement. (Demonstrated). |
  | 3. Performance data demonstrate sterility of patient-contacting components (ISO 11737-2, ISO 11135). | Demonstrated for sterile, single-use needling module (Ethylene oxide sterilized). |
  | 4. Performance data supports shelf life (sterility, package integrity, functionality per ISO 11607-1). | Demonstrated. |
  | 5. Performance data demonstrate electrical safety and electromagnetic compatibility (EMC) per IEC 60601-1 and IEC 60601-1-2. | Demonstrated. |
  | 6. Software verification, validation, and hazard analysis. | Conducted. (The device has a control unit and adjustable settings, indicating software or firmware for operation, but this is not an AI/ML software). |
  | 7. Patient-contacting components biocompatible (cytotoxicity, irritation, sensitization, acute systemic toxicity, material pyrogenicity per ISO 10993-1). | Demonstrated. |
  | 8. Cleaning and disinfection validations for reusable components. | Performed for surfaces of the control unit and handpiece. |
  | 9. Labeling includes required information (operation, technical parameters, reprocessing, disposal, shelf life). | Included. |
  | 10. Patient labeling includes required information (operation, risks/benefits, post-operative care). | Included. |

Regarding the AI/ML specific questions:

2. Sample size used for the test set and the data provenance: Not applicable, as this is not an AI/ML device. Performance testing involved pig skin for physical measurements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a microneedling device's physical performance typically relies on instrumental measurements and engineering specifications, not expert human interpretation of data/images.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical performance tests mentioned, the ground truth would be based on validated objective measurements (e.g., high-speed camera measurements for needle protrusion and puncture rate, laboratory tests for sterility, biocompatibility, electrical safety).
8. The sample size for the training set: Not applicable (no AI training set).
9. How the ground truth for the training set was established: Not applicable (no AI training set).

Conclusion: The provided FDA 510(k) summary is for a traditional medical device (microneedling device) and focuses on demonstrating substantial equivalence through non-clinical performance and adherence to established regulatory controls, rather than on AI/ML algorithm performance. Therefore, the specific questions related to AI/ML acceptance criteria, study design, and ground truth establishment are not addressed in this document. The document explicitly states: "No clinical studies were performed to test the XCELLARISPRO TWIST microneedling device." This further confirms the absence of human "expert" involvement in establishing performance for this particular device submission beyond standard engineering and lab testing.

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The XCELLARISPRO TWIST microneedling device and accessories is intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I. II, III and IV in adults aged 22 years or older and for treatment of wrinkles in Fitzpatrick skin types I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.

The XCELLARISPRO TWIST is a microneedling device and intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainlesssteel needles. The XCELLARISPRO TWIST has 4 component parts and 2 consumables. Component parts: (1) handpiece, (2) control unit, (3) power supply and (4) foot switch. Consumables: (1) sterile, single-use needling module (Ethylene oxide sterilized) and (2) disposable barrier sleeves that cover the handpiece during each patient use.

The provided text describes the acceptance criteria and supporting studies for the XCELLARISPRO TWIST microneedling device.

It's important to note that this submission does not include clinical performance testing for the XCELLARISPRO TWIST device itself. Instead, it relies on non-clinical performance testing and substantial equivalence to predicate devices, which did undergo clinical studies.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the "Special Controls" for microneedling devices (21 C.F.R. § 878.4430(b)(1)-(10)) and the non-clinical performance data provided. The document primarily focuses on verifying technical specifications and safety aspects.

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

• Test Set Sample Size:
  • For testing "Accuracy of needle protrusion depth and puncture rate" and "Maximum safe needle protrusion depth," pig skin was used. The specific number of pig skin samples or measurements is not provided in the document.
  • For other non-clinical tests (sterility, shelf life, electrical safety, biocompatibility, cleaning/disinfection), the sample sizes are not specified in this summary.
• Data Provenance: The tests are stated as "non-clinical performance testing." The location or specific origin of the data/testing facility is not specified. It is retrospective in the sense that the tests were completed before the 510(k) submission.

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

• This information is not provided in the document. The non-clinical tests described (e.g., high-speed camera measurements on pig skin, electrical safety, sterility) typically rely on standardized measurement techniques and validated protocols rather than expert consensus on a "ground truth" derived from human observation.

4. Adjudication method for the test set

• An adjudication method is typically relevant for studies involving human interpretation or subjective assessment. Since the described tests are non-clinical and objective measurements (e.g., physical parameters, microbiological tests, electrical tests), an adjudication method is not applicable and therefore not 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

• No MRMC comparative effectiveness study was done. This device is a microneedling device, not an AI software or diagnostic tool that would involve human readers interpreting cases.

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

• No standalone algorithm performance study was done. This device is a hardware microneedling device, not an algorithm.

7. The type of ground truth used

• For the non-clinical performance tests:
  • Technical specifications: Measured physical parameters (e.g., needle length, protrusion depth, puncture rate) against engineering specifications.
  • Sterility: Absence of microorganisms (based on microbiological testing).
  • Biocompatibility: Response of biological systems to materials (based on standardized in-vitro/in-vivo tests).
  • Electrical Safety/EMC: Compliance with international safety standards.
  • Cleaning/Disinfection Validation: Reduction of microbial load after reprocessing.
  • The "ground truth" for these tests is defined by established scientific principles, recognized standards, and specific pass/fail criteria outlined in those standards.

8. The sample size for the training set

• Not applicable. This device is a microneedling device and does not involve machine learning or a "training set" in the context of an AI/algorithm.

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

• Not applicable. As above, there is no training set for this device.

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The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.

The SER Pen Carain MicroSystem (MP1209SP) is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a DC motor drive system that rapidly reciprocates an array of 12 needles and 36 needles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, and a disposable, single use cartridge containing an array of needles. The power source consists of a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side. The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm. The SER Pen Carain MicroSystem's disposable cartridge is designed in two configurations, a 12-needle array and a 36-needle array. The needle array is housed in a specially designed cartridge housing with a silicon spring that prevents liquids from entering the motor body via the inside lumen of the cartridge. The SER Pen Carain MicroSystem biolock sleeve is a one end elastic opening PE bag to protect the whole system from cross contamination from the outside during the operation procedure. The SER Pen Carain MicroSystem microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-5, 10993-10, and 10993-11. A metallurgical analysis under GLP testing conditions that conform to ASTM E1019-11(Method A)(C/S Analyzer) was also completed and is attached. Each lot of cartridges are individually packaged and then gamma ray sterilized by TUV Sud accredited facility under procedure code P1501314 with a minimum dose of 25kGy. Certifications on file with the Sponsor and available for review.

This document describes the SER Pen Carain MicroSystem (MP1209SP), a microneedling device cleared via a 510(k) submission (K241355) by demonstrating substantial equivalence to predicate devices, rather than through a direct study proving specified acceptance criteria.

The submission specifically states: "The Sponsor intends to rely on the same performance data submitted in Collagen P.I.N. (K222199) and SkinStylus (K200044 and K231073) devices and not include any clinical data." This means that acceptance criteria and performance data are inferred from the predicate devices through a comparison of technological characteristics, rather than direct testing of the SER Pen Carain MicroSystem against pre-defined acceptance criteria with a dedicated study.

Therefore, the following information is based on the provided document and the nature of a 510(k) submission relying on predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission relying on predicate devices, explicit "acceptance criteria" and "reported device performance" in the context of a de novo clinical study are not directly presented for the SER Pen Carain MicroSystem. Instead, the "acceptance criteria" are implied by meeting the same performance and safety standards demonstrated by the predicate devices, and "device performance" is established by showing identical or highly similar technological characteristics and performance to those predicates.

Based on the document, the "performance" of the SER Pen Carain MicroSystem is derived from its substantial equivalence to the predicate devices across various technological characteristics.

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

• Sample Size for Test Set: This information is not provided as the submission relies on existing data from predicate devices. There was no specific "test set" for the SER Pen Carain MicroSystem in the context of a new clinical study.
• Data Provenance: The document explicitly states the "Sponsor intends to rely on the same performance data submitted in Collagen P.I.N. (K222199) and SkinStylus (K200044 and K231073) devices and not include any clinical data." Therefore, the data provenance would be from the studies conducted for these predicate devices, which are not detailed in this document. Information on country of origin or whether the data was retrospective or prospective is not available in this document.

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

• This information is not applicable as no new clinical study with a "test set" requiring expert ground truth was conducted for the SER Pen Carain MicroSystem. The data used for establishing substantial equivalence comes from pre-existing regulatory submissions for the predicate devices.

4. Adjudication Method for the Test Set

• This information is not applicable as no new clinical study with a "test set" requiring adjudication was conducted for the SER Pen Carain MicroSystem.

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

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states "not include any clinical data," indicating a reliance on non-clinical data and comparison to predicate devices for substantial equivalence.

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

• No, this is a microneedling device, not an AI algorithm. "Standalone performance" in the context of an algorithm is not applicable.

7. The Type of Ground Truth Used

• As no new clinical studies were conducted for the SER Pen Carain MicroSystem, the concept of "ground truth" in this context is not directly applicable. The basis for clearance is established through demonstrating similar technological characteristics and performance to predicate devices that were previously cleared by the FDA based on their own evidence (which may have included clinical data, expert consensus, etc., but that information is not present here). For the non-clinical tests (biocompatibility, sterilization, etc.), the "ground truth" is adherence to established international and national standards (ISO, ASTM, USP).

8. The Sample Size for the Training Set

• This information is not applicable as there was no AI algorithm or "training set" for this device.

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

• This information is not applicable as there was no AI algorithm or "training set" for this device.

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The SkinPen® Precision Elite system 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 vears and older.

The SkinPen® Precision Elite System consists of a microneedling pen handpiece (SkinPen® Precision Elite) and a sterile needle cartridge (SkinPen® Precision Elite Cartridge). The accessories are a charging base with power adaptor and a BioSheath to cover the handpiece.

The provided text is a 510(k) summary for the SkinPen® Precision Elite System. It details the device, its intended use, and comparison to a predicate device. However, it explicitly states "No Clinical testing was conducted as part of this submission" (Section 12, page 6).

Therefore, there is no information within this document to address the requested points regarding acceptance criteria and a study proving the device meets those criteria, as no clinical study was performed for this submission. The device's substantial equivalence was based on non-clinical performance testing (reciprocating rate, puncture depth), electrical safety, risk management, sterility, software verification and validation, and biocompatibility, along with a direct comparison to a predicate device.

To answer your request, if a clinical study had been performed and described in the document, here's what the response would look like if the information were present:

Based on the provided 510(k) summary, no clinical performance study was conducted to demonstrate the device meets specific acceptance criteria based on human subject data. The submission relies on substantial equivalence to a predicate device and non-clinical testing.

Therefore, I cannot provide the detailed information requested in points 1 through 9.

Explanation from the document:

• Section 12 "Clinical Testing Summary" (Page 6): "No Clinical testing was conducted as part of this submission."

The acceptance criteria and study detailed in your request typically refer to clinical performance studies, which were not performed for this device's submission as stated. The changes made to the device (user interface, cartridge connection points, NFC chip for verification) were supported by:

• Non-clinical performance testing (reciprocating rate, puncture depth).
• Software verification and validation.
• Electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6).
• Biocompatibility testing (ISO 10993-1).
• Sterility standards (ISO 11135).
• Risk Management (IEC 62304).

The submission argues that these changes "do not impact the device effectiveness, and safety is increased with the use of the NFC chip," and that "There are no changes to the general technology, mechanism of action, or indications for use." This forms the basis for demonstrating substantial equivalence without a new clinical study.

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The Exceed Unlimited is a microneedling device and accessories intended for the treatment of wrinkles in Fitzpatrick skin types I. Il and/or III in the following facial areas: qlabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.

The Exceed Unlimited is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV in adults aged 22 years or older.

The Exceed Unlimited device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles.

The Exceed Unlimited device consists of 7 component parts; Handpiece, sterile single use Safety needle cartridge, Handpiece holder, Barrier Sleeve, Battery, Charger incl. USB cable, power supply. The handpiece contains a motor that moves the needles. The handpiece receives power via a Li-Ion battery with an output of 3,7 V. The battery charger receives power from a standard 100-240V, 50-60Hz, 0.45A wall socket transformer with an USB output of 5 V, 3.2A.

The frequency of the handpiece can be adjusted from 100-150Hz and is indicated on a display. The needle penetration is adjusted by the needle protrusion setting dial, which can be adjusted between 0.0 (min.) and 1.9 mm (max.).

The standard safety needle cartridge (6-needle plate) contains 6 stainless steel microneedles of 1.5 mm length (0.35 mm gauge) and an internal safety membrane. The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use ONLY.

The provided text is a 510(k) Summary for the Exceed Unlimited microneedling device. It describes the device, its intended use, and compares it to a predicate device (Exceed Microneedling device) to demonstrate substantial equivalence.

However, the document does not contain specific acceptance criteria for a study demonstrating device performance, nor does it present the results of such a study in a quantitative manner (e.g., a table of performance metrics). Instead, it primarily focuses on non-clinical performance testing and risk mitigation measures to establish substantial equivalence.

Based on the provided text, I can infer some aspects and highlight what is explicitly stated versus what is absent:

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

• Absent. The document does not provide a table of acceptance criteria nor reported quantitative device performance metrics from a study. It only lists performance characteristics that were tested during non-clinical performance testing.

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

• Absent directly. The document mentions "non-clinical performance data" and "accuracy of needle penetration depth and puncture rate in pig skin." While this indicates the type of test, it does not specify the sample size used (e.g., number of pigs, number of punctures, number of test runs).
• Data Provenance: The pig skin tests would be considered experimental/laboratory data, not human patient data. The document does not mention the country of origin for these tests. It implicitly would be from the manufacturer's testing facilities or a contracted lab. The tests are not from retrospective or prospective human clinical studies for performance metrics.

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

• Absent. This information is relevant for human-in-the-loop studies or studies relying on expert-verified data, typically clinical studies. Since the described performance testing is non-clinical (on pig skin), the concept of "experts establishing ground truth" in the diagnostic sense is not applicable here. The "ground truth" for the pig skin tests would be the measured physical properties (e.g., actual penetration depth, puncture rate) using high-speed cameras or other measurement tools.

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

• Absent. Adjudication methods are typically used in clinical trials where multiple readers or experts assess outcomes. As the described performance testing is non-clinical/technical, this concept does not apply.

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:

• Absent. This device is a microneedling device, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its function and was not performed or described.

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

• Not applicable in the typical sense of AI/software. This is a hardware microneedling device. Its "performance" is evaluated by its physical characteristics (e.g., needle penetration accuracy, frequency, safety features). There isn't an "algorithm only" performance metric in the way it would apply to a diagnostic AI. The performance data mentioned (e.g., accuracy of needle penetration) are inherent to the device's mechanical operation.

7. The type of ground truth used:

• For the non-clinical performance testing mentioned ("Accuracy of needle penetration depth and puncture rate in pig skin with high-speed camera measurement"), the ground truth would be physical measurements (e.g., actual depth measured from camera footage or other instruments). It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set:

• Not applicable. This section is relevant for machine learning models. The Exceed Unlimited is a physical medical device, not a software AI model that requires a training set.

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

• Not applicable. As per point 8, there is no training set for this type of device.

In summary, based solely on the provided text, the document focuses on demonstrating substantial equivalence through non-clinical performance and safety testing, rather than presenting a performance study with acceptance criteria and quantitative results. The provided information is insufficient to complete the requested table and fully answer all questions, as many are relevant to AI/diagnostic software devices, not a microneedling device.

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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 SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.

The SkinStylus SteriLock® MicroSystem is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a 1A DC motor that rapidly reciprocates an array of 32 gauge microneedles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, a removable nosecone interface, and a disposable, single use cartridge containing an array of microneedles. The power source consists of two separate systems. One option is a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. The other option consists of an AC wall adaptor that converts 110v AC into 5v DC. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side. The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm. The removable nosecone interface provides the SkinStylus® the unique ability to have an interface between the motor and the cartridge to ensure there is a secondary control preventing any fluid from entering the motor body. The removable nosecone is autoclave sterilized after every use. The SkinStylus® disposable cartridge is designed in a 36-needle array with all needles at 2.5mm. The needle array is housed in a specially designed and patented cartridge housing that prevents liquids from entering the motor body via the inside lumen of the cartridge. The SkinStylus SteriLock® microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-10, and 10993-11.

The provided text is a 510(k) summary for the SkinStylus SteriLock® MicroSystem. This document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a detailed report of a clinical performance study with specific acceptance criteria and results.

Therefore, I cannot provide the requested information about acceptance criteria and device performance based on the given text.

The document explicitly states: "A new clinical trial was not conducted to support the additional indications for use and overall safety of the device." (Page 5). This means the 510(k) submission relies on non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence, rather than a prospective study with human subjects designed to measure a specific level of clinical performance against pre-defined acceptance criteria.

The information provided covers:

• Non-Clinical Test Reports: This section lists various tests performed (biocompatibility, sterilization validation, reprocessing validation, fluid ingress validation, shelf-life testing, electrical safety, depth penetration validation, needle reciprocal rate validation, clinician usability study). These are engineering and safety tests, not clinical performance studies with acceptance criteria for device efficacy in improving appearance.
• Summary of Substantial Equivalence: This section compares the subject device to a predicate device (Collagen P.I.N. System) and a reference device (SkinStylus SteriLock® MicroSystem). The comparison focuses on technological characteristics like indications for use, mode of action, power source, needle length, geometry, speed, and safety features. The conclusion states that the device "raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate device."

Without a clinical trial designed to establish efficacy against specific performance metrics, the other requested details such as sample size, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable or cannot be extracted from this document.

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