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The Eclipse Blood Collection Set with holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.

The Eclipse Blood Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needle stick injury if manually activated after the blood draw. For blood collection, the set also includes a blood collection holder for connection to vacuum-based collection vials

The provided text is a U.S. FDA 510(k) summary for the Eclipse Blood Collection Set. It describes the device's characteristics and its comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain the detailed information requested regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment for a diagnostic AI device.

The document states: "The Eclipse Blood Collection Set was tested for validation and verification of functions based on risk analysis and the results passed predetermined acceptance criteria." However, it does not specify what those predetermined acceptance criteria were or present a table comparing them to reported device performance.

It also mentions various types of performance testing, such as biocompatibility, performance data (per ISO 80369-7:2016 and ISO 80369-20:2015), and sterilization/shelf-life testing against relevant ISO and ASTM standards. While these indicate tests were performed to ensure the device meets safety and functionality standards relevant to its type, they are largely about manufacturing and material safety, not diagnostic performance or AI model validation.

Crucially, the document explicitly states: "Clinical Study: Not applicable". This indicates that a clinical study, which would typically involve human subjects and the kind of performance data (e.g., sensitivity, specificity) relevant to AI diagnostic devices, was not performed or deemed necessary for this type of medical device clearance.

Therefore, the requested information, which is more applicable to diagnostic AI devices, cannot be extracted from this document, as the Eclipse Blood Collection Set is a physical blood collection device and not an AI-powered diagnostic tool.

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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 Eclipse MicroPen EVO 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 Eclipse MicroPen EVO™ 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 cartidge head. The MicroPen EVO is comprised of a reusable pen body, a sterile, single use microneedling cartridge, a rechargeable battery pack, a battery charger with power supply, and a disposible MicroSleeve sheath. 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 skin being treated. Charging is accomplished by placing the MicroPen EVO pen body or the battery pack on the Charger base.

The provided text describes the acceptance criteria and performance of the Eclipse MicroPen EVO, a microneedling device. However, it does not contain information related to a study that involves human expert adjudication, multi-reader multi-case (MRMC) studies, or detailed information about training data for an AI model. The document focuses on bench testing and engineering verification for the device's physical and mechanical performance, and its biological compatibility.

Therefore, many of the requested sections (2-9) are not applicable or cannot be answered from the provided text, as they pertain to studies typically done for AI/ML-driven medical devices analyzing images or other complex data. The Eclipse MicroPen EVO is a mechanical device, and its evaluation is based on engineering and materials testing, not AI performance on clinical data or human reader assessments.

Here's a breakdown of what can be extracted about the acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the tests performed and the statements that the device "met the established criteria" or "passed." The reported performance is the outcome of these tests.

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

• Puncture Rate Testing: Not explicitly stated, just "All test articles" and "The MicroPen EVO handpieces with attached needling cartridges and battery pack."
• Needle Penetration Depth and Extension Accuracy: Not explicitly stated, just "All MicroPen EVO test articles."
• Needle Retention: n=35 needles from nine cartridges.
• Battery Life Testing: Thirty trials were completed.
• Use Life Testing: Not explicitly stated, just "test articles."
• Cartridge Reliability Testing: Nine test articles.
• Microbial Ingress Testing: Not explicitly stated, just "Fully assembled MicroPen EVO test units."
• Suction Testing: Not explicitly stated, just "all nine test cartridges."
• Cleaning and Disinfection: Not explicitly stated.
• Data Provenance: All testing appears to be internal company testing ("Eclipse conducted testing/trials"). The testing used synthetic skin (SynDaver SynTissue) to simulate worst-case human skin conditions and, for suction prevention, human forearms. This is retrospective in the sense that the data was collected for this submission, not a prospective clinical trial. The country of origin for the data is implied to be where Eclipse MedCorp LLC conducts its testing.

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

• Not applicable. This device is evaluated through engineering and materials testing, not through expert assessment of clinical data or images.

4. Adjudication method for the test set:

• None. As above, this is laboratory/engineering testing with predefined objective pass/fail criteria.

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. This type of study is for AI-powered diagnostic/interpretive devices, not mechanical microneedling devices.

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

• Not applicable. There is no AI algorithm being evaluated for standalone performance.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established through physical and mechanical measurements against defined engineering specifications and industry standards, and biological testing (biocompatibility, microbial ingress) against established limits. For example, RPMs are measured directly, needle depth is measured directly, and bacterial reduction is measured by CFU counts. For non-quantitative aspects like visual degradation, it's based on observable physical state.

8. The sample size for the training set:

• Not applicable. There is no AI model that requires a training set.

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

• Not applicable.

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The Eclipse DermaFlex Cannula is intended to inject fluids intradermally.

The Eclipse DermaFlex Cannula is provided as a single-use, sterile device. It is comprised of a needle. hub and cap. This device comes in a variety of needle gauges and lengths. The Eclipse DermaFlex Cannula offers AN type and B Type. The AN type is a hypodermic single lumen needle intended to prepare the site for injection. The tip of this pilot needle is sharpened at one end, while the other end is joined to a hub. The B type has a metal tube with the tip, which is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end, the device is joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or secondary medication sets to prepare and administer fluids/ medications/ drugs to a patient.

The Eclipse DermaFlex Cannula is a hypodermic single lumen needle intended to inject fluids intradermally. The submission demonstrates substantial equivalence to predicate device MV INTRADERMIC NEEDLES; MAGIC NEEDLE (K110606) by M.V. S.R.L.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state acceptance criteria in a quantifiable manner for each test. Instead, it refers to performance testing conducted in accordance with various ISO and ASTM standards. The reported device performance is a general statement that the device "meets the established characteristics and performance requirements needed to perform its intended function." It also states, "Substantial equivalence is established as these are the same standards established for the predicate device as well. As the Eclipse meets the required criteria of the standards, its performance may be considered to support substantial equivalence."

Therefore, the table below reflects what can be inferred from the document:

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

The document does not provide details on the specific sample sizes used for each test or the data provenance (country of origin, retrospective/prospective). It only lists the standards followed for the tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device (hypodermic needle). The ground truth for performance testing of a medical device like this is established through adherence to recognized international and national standards, not by expert consensus on clinical findings.

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

This information is not applicable as the evaluation of this device is based on objective performance testing against established standards, not interpretation of data by multiple readers requiring 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

An MRMC comparative effectiveness study is not applicable to this device. This is a physical medical device (cannula/needle), not an AI-powered diagnostic or assistive tool.

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

A standalone algorithm performance study is not applicable as this is a physical medical device, not an algorithm or AI system.

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

The ground truth for this device's performance is based on established national and international standards for medical device manufacturing, sterility, biocompatibility, and functional performance (e.g., needle strength, connection integrity, color coding). These standards define objective, measurable parameters.

8. The sample size for the training set

This information is not applicable as this is a physical medical device and does not involve a training set for machine learning or AI.

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

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

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