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510(k) Data Aggregation
(337 days)
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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(103 days)
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.
| Acceptance Criterion Type (Implied) | Reported Device Performance Statement |
|---|---|
| Puncture rate, needle penetration depth & accuracy, needle retention, battery life, cartridge reliability, suction prevention | Device was subjected to performance testing and adheres to special controls and standards. (No specific quantitative results provided in the summary). |
| Fluid ingress testing for cross-contamination prevention | Device was subjected to performance testing and adheres to special controls and standards. (No specific quantitative results provided in the summary). |
| Cleaning and disinfection validation for reusable components | Device was subjected to performance testing and adheres to special controls and standards. (No specific quantitative results provided in the summary). |
| Biocompatibility | "The results of these tests demonstrated the device to be biocompatible with no evidence of material mediated pyrogenicity." (Tests included: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity) |
| Sterilization, Shelf Life/Package Integrity | Device was subjected to performance testing and adheres to standards (e.g., Ethylene oxide sterilization per ISO 11135-2014, ASTM-F1980, ASTM-F1886-2016, ASTM-F1929-2015, ASTM-F88, ANSI/AAMI/ISO 11607-1). (No specific quantitative results or acceptance criteria values are provided). |
| Electrical Safety and Electromagnetic Compatibility | Device was subjected to performance testing and adheres to standards (IEC- 60601-1:2005 + A1: 2012, EN/IEC 60601-1-2: 2015 /IEC 60601-1-2:2014). (No specific quantitative results or acceptance criteria values are provided). |
| Clinical Efficacy (Improvement in appearance of wrinkles of the neck / facial acne scars) | The device is substantially equivalent to the predicate device (SkinPen Precision System, K202243) which has established efficacy for these indications. The document does not provide independent clinical trial data for the MicroPen EVO. |
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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