Search Results

"Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe.

The device consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. The infusion set has a luer lock at one end and a 90 degree needle mounted to a butterfly stabilizer at the other end, connected by 42" of 2mm medical grade tubing. The luer lock connects to the infusion pump device. The device is for single use.

The provided text describes a 510(k) premarket notification for a medical device called "Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Tissue Infusion Set. This document evaluates the device's substantial equivalence to a legally marketed predicate device, the Minimed MMT-106 (and related models).

However, the provided text does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance, nor does it describe a study that proves the device meets specific acceptance criteria in the manner requested.

The document from Ko20530 is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics against acceptance criteria. It states that "Testing was performed according to internal company standards to verify device performance. Testing verifies that the actual device performance satisfies the design intent." but it does not provide the specifics of these tests or their results in a quantitative manner.

Therefore, many of the requested fields cannot be directly extracted or inferred from the provided text. I will fill in what can be gathered and explicitly state when information is not available.

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Sample Size: Not specified. The document states "Testing was performed according to internal company standards," but does not detail the sample size for any specific tests.
   • Data Provenance: Not specified. It's likely internal company data given the statement, but no country of origin or retrospective/prospective nature is mentioned.

2. 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 provided in the document. The filing is a 510(k) premarket notification relying on substantial equivalence, and as such, it does not typically detail expert panel reviews or ground truth establishment in this manner for its "internal company standards" testing.

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

   • This information is not provided in the document.

4. 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. An MRMC comparative effectiveness study was not conducted according to the document. This device is a physical medical device (infusion set), not an AI/software device, so such a study would not be applicable.

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

   • No. This is a physical medical device, not an algorithm, so this concept is not applicable.

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

   • The document implies that the ground truth for "design intent" and "device performance" was established through engineering specifications and internal company standards. It does not refer to clinical outcomes, pathology, or expert consensus in the context of a validation study as might be seen for diagnostic devices. The primary "ground truth" for marketing authorization in this document is the predicate device, against which substantial equivalence is claimed.

7. The sample size for the training set:

   • This concept is not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

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

Ask a specific question about this device

The Polylin with Wings infusion set is intended for use as an influsion administration set for delivery of appropriately labeled fluids or solutions from an external infuston purpo or syringe.

This infusion sol is intended for the subculareous administration of medicine, Including from a portable, external purno to a subsble influsion site. The infusion set is designed to be used in conjunction with a Minitod infusion pump, but may be used in other puntus capable of supporting a Lucr connection to a reservoir, however, care must be exercised by the prescriber and user to ensure delivery accuracy if used with other dovices.

Device materials have been successfully tested for biocompairbility. All components liaving contact with solutions being administered most the ISO 10993 standard for medical devices of this (ype.

This document is a 510(k) summary for a medical device (Polyfin® with Wings Infusion Set). It focuses on demonstrating substantial equivalence to a predicate device and does not contain the kind of detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) that would typically be found in a clinical trial report or a performance study summary for an AI/ML-driven device.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the format you've provided, as this document does not contain that specific type of data.

Here's why and what kind of document would typically have this information:

• Acceptance Criteria & Performance Studies: These are common in submissions for devices that incorporate more complex algorithms, AI/ML, or those requiring clinical performance validation beyond substantial equivalence to a predicate device with minor design changes.
• This Document's Purpose: This 510(k) summary is for a mechanical infusion set. The primary goal is to show that the "new device introduces no new technological features" and that adding wings (for easier insertion and stability) and modifying the needle guard are non-significant changes that "raise no new issues of safety or effectiveness" when compared to the predicate device.
• Safety and Effectiveness in this Context: For this type of device, safety and effectiveness are primarily demonstrated through biocompatibility testing (mentioned as successfully completed under ISO 10993) and comparison to a legally marketed predicate device, rather than a clinical performance study with specific outcome metrics against acceptance criteria.

To answer your request directly based on the provided text, I can state:

1. A table of acceptance criteria and the reported device performance: Not available in this document. The document states "Device materials have been successfully tested for biocompairbility" and "All components having contact with solutions being administered meet the ISO 10993 standard for medical devices of this type." This reflects a very high-level "acceptance," but not specific performance metrics against defined criteria.
2. Sample sized used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this type of study is not mentioned as it's not applicable to a mechanical infusion set.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is not an algorithm-driven device.
7. The type of ground truth used: Not applicable in the context of an AI/ML algorithm. The "ground truth" for this device's safety is its successful biocompatibility testing and substantial equivalence to a predicate device.
8. The sample size for the training set: Not applicable; there is no "training set" for this mechanical device.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device