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EXELINT SecureTouch Safety Hypodermic Needle is intended for use with syringes for general purpose aspiration and medication administration. It has an antistick mechanism to cover the needle after use.

EXELINT SecureTouch Safety Hypodermic Needle is a sterile, single use, standard luer lock compatible hypodermic needle with a protection shield to enclose the needle after use The device is available in 18 to 30 gauge in length from 10mm to 50mm. The purpose of this submission is to enable Exelint International, Co. to market a line of safety hypodermic needle.

The proposed device is available in EO sterilized sealed in a sterility maintenance package.

The provided text describes the 510(k) premarket notification for the EXELINT SecureTouch Safety Hypodermic Needle. However, it does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria in the context of an AI/algorithm-based medical device.

The document is for a physical medical device (hypodermic needle) and describes its physical characteristics, materials, and non-clinical performance tests against established ISO and ASTM standards. There is no mention of an AI/algorithm, a test set, ground truth, expert readers, or MRMC studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the manner requested, nor can I answer questions about sample sizes, expert involvement, adjudication, or MRMC studies, as these concepts are not applicable to the device described in the provided text.

The closest relevant section is "5. Non-Clinical Test Conclusion," which lists the standards the device complies with and the performance tests performed. These are physical/material tests, not AI model evaluations.

Specifically, the document states:

• "6. Clinical Test Conclusion: No clinical study is included in this submission." This means there are no human subject studies described for this device, which would be essential for an MRMC study or to evaluate human-in-the-loop performance.
• The "Non-Clinical Test Conclusion" section lists various ISO and ASTM standards the device was tested against (e.g., ISO 7864 for sterile hypodermic needles, ISO 10993 for biocompatibility), and specific performance tests like "Test for Tolerance on Length," "Test for Lubricant," "Testing of Force to Activate the Safety Feature," etc. These are the "acceptance criteria" and "reported device performance" for this physical device, but they don't map to the AI-centric questions in the prompt.
• The "510(k) Summary" and "Substantially Equivalent (SE) Comparison" sections compare the proposed device's characteristics and performance to a predicate device (Sol-Care Safety Needle), demonstrating substantial equivalence based on physical and functional attributes.

In summary, the provided text is about a physical medical device and its compliance with established manufacturing and safety standards, not an AI or algorithm-based device.

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The EXELINT Aluminum Hub Blunt Needles are intended to be used in a variety of medical, pharmaceutical and laboratory procedures to extract fluid or medication from vials or ampoule for transfer or for irrigation.

The EXELINT Aluminum Hub Blunt Needles are sterile, non-pyrogenic, single use fluid transfer needles consisting of blunt Type 304 stainless steel cannulas staked into aluminum luer lock hubs. The gauge and length of the cannula determines the final gauge and length of the product. The hubs are identical for all of the needles. Each needle is packaged into a Polypropylene tube and sealed with a polypropylene cap. The needles are final packaged into a multineedle box and ETO sterilized.

The provided text is a 510(k) summary for the EXELINT Aluminum Hub Blunt Needles. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a dedicated study demonstrating performance against those criteria in the way that would typically be expected for an AI/ML medical device.

The "Performance Data" section states: "The devices were tested and found in compliance with the ISO standards for Needles (ISO 7864) and Stainless Steel Tubing (ISO 9626). The packaging was tested for seal strength. These tests demonstrated that the EXELINT Aluminum Hub Blunt Needles are safe and effective and that their performance meets the requirements of their pre-defined acceptance criteria and intended use."

This indicates that the acceptance criteria are based on compliance with specific ISO standards (ISO 7864 for Needles and ISO 9626 for Stainless Steel Tubing) and also included packaging seal strength. However, the document does not provide the specific numerical acceptance criteria (e.g., maximum force for needle bending, specific burst pressure for packaging) nor the reported performance data in a quantitative format.

Given the information, I can only provide a generalized response based on what is stated, acknowledging the lack of detailed quantitative data.

Acceptance Criteria and Study Overview for EXELINT Aluminum Hub Blunt Needles

Based on the provided 510(k) summary, the EXELINT Aluminum Hub Blunt Needles were evaluated for compliance with relevant ISO standards and packaging integrity. The document asserts that the device's performance meets pre-defined acceptance criteria, thereby demonstrating safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table with numerical acceptance criteria and corresponding reported device performance values. Instead, it broadly states compliance with international standards.

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

The document does not specify the sample sizes used for testing, nor does it mention the data provenance (e.g., country of origin, retrospective or prospective). This type of detail is typically found in a full test report, not usually summarized in a 510(k) submission to this extent for a non-AI/ML device.

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

This question is not applicable to this device. The EXELINT Aluminum Hub Blunt Needles are a physical medical device, not an AI/ML algorithm that requires expert-established ground truth for performance evaluation. Performance for such devices is typically determined through physical and material testing against established engineering standards.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1 consensus) are relevant for subjective evaluations, typically in clinical studies or for AI output, involving human interpretation. The testing described for this device is objective, based on physical properties and adherence to standards.

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

This question is not applicable. An MRMC study is designed to assess the diagnostic performance of AI-assisted human readers compared to human readers without AI assistance. This device is a physical fluid transfer needle, not a diagnostic or imaging AI algorithm.

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

This question is not applicable. This device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective engineering standards (ISO 7864 for needles, ISO 9626 for stainless steel tubing) and defined physical properties testing (e.g., seal strength). There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of an AI/ML device.

8. Sample Size for the Training Set

This question is not applicable. This device is a physical product and does not involve AI/ML, therefore, there is no "training set."

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

This question is not applicable. As there is no training set for a physical device, the concept of establishing ground truth for it does not apply.

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EXEL Scalp Vein (butterfly) set is used for administration of IV solution or infusion of medication to the patient via vascular system.

Not Found

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Exel Scalp Butterfly Vein Set." It confirms the device's substantial equivalence to a legally marketed predicate device.

Crucially, this document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details related to AI/algorithm performance.

The letter is an administrative notice confirming market clearance based on substantial equivalence, not a detailed technical report of device validation.

Therefore, I cannot provide the requested information from the given text.

To answer your request, I would need a technical report, a clinical study summary, or a specific performance validation document for the "Exel Scalp Butterfly Vein Set."

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