(88 days)
The Frontline Medical Products SafetyNet™ Guidewire Introducer is intended for single use, for percutaneous introduction and placement of guidewires in vascular procedures, with provision of a feature enabling the user to shield the needle point after use to reduce the risk of accidental sharps injury.
The Frontline Medical Products SafetyNet™ Guidewire Introducer is a sterile, single-use disposable device, available in gauge sizes from 18G to 21G and usable lengths up to 2.75." The 18G product is compatible with guidewires up to 0.038" diameter. the 21G is compatible with guidewires up to 0.021" diameter. The product consists of a conventional hypodermic needle-type guidewire introducer with molded plastic luer hub, modified to accept additional components to provide a needle protection feature. The additional components create a spring-loaded molded plastic safety guard assembly that is stored within a semi-rigid housing prior to deployment. After the needle is placed in the blood vessel and the quidewire is introduced, the user deploys the safety guard with a one-handed technique by squeezing two opposing tabs on the housing. This causes the safety quard to move forward to the end of the needle. when a hinged trap within the safety quard drops over the needle point, and is held in place by the spring. The safety guard is restrained from moving off the end of the needle by means of a sliding rigid bushing contained within the safety guard, that stops when reaching a small deformation (bump) that has been created on the distal end of the needle cannula during manufacturing. The used product is then disposed of in a sharps container according to routine policies and procedures. The deployed safety guard provides a reduced risk of accidental needlestick injury. The product will be packaged as single sterile units, or may be provided in bulk non-sterile form to manufacturers of procedure kits for inclusion as an accessory component.
The provided text is a 510(k) summary for the Frontline Medical Products SafetyNet™ Guidewire Introducer. It describes the device, its intended use, and states that performance testing has demonstrated it meets functional requirements. However, this document does not contain the detailed acceptance criteria or the specific results of a study that proves the device meets those criteria, nor does it describe an AI/ML device.
Therefore, I cannot fulfill all your requests as the information is not present in the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot create. The document states "Performance testing has demonstrated that the Frontline Medical Products SafetyNet™ Guidewire Introducer has met the functional requirements and specifications for the device," but it does not list specific acceptance criteria (e.g., tensile strength, flow rate, needle stick protection effectiveness in quantitative terms) or numerical performance results against those criteria.
2. Sample sized used for the test set and the data provenance
- Cannot provide. The document mentions "Performance testing" but does not detail the sample size (number of devices tested) or the provenance of the data (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This relates to studies involving expert review for AI/ML performance. The provided document describes a medical device, not an AI/ML system.
4. Adjudication method for the test set
- Not applicable. This is relevant for AI/ML studies involving multiple expert 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 study type is for AI/ML devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This study type is for AI/ML devices.
7. The type of ground truth used
- Not applicable in the typical sense for AI/ML. For this physical device, "ground truth" would refer to established engineering and biocompatibility standards. The document mentions "Biocompatibility testing on the Frontline Medical Products SafetyNet™ Guidewire Introducer included all tests required to satisfy ISO 10993 and FDA Memorandum G95-1 requirements," which implies adherence to these standards as a form of "ground truth." For performance, general "functional requirements and specifications" were met, but details are not given.
8. The sample size for the training set
- Not applicable. This is for AI/ML devices; there is no "training set" for this physical medical device.
9. How the ground truth for the training set was established
- Not applicable. This is for AI/ML devices.
In summary, the provided text outlines a regulatory submission for a traditional medical device (a guidewire introducer with a safety feature) and does not contain the detailed study results or AI/ML-specific information requested. The document focuses on regulatory compliance through substantial equivalence to predicate devices and general statements about meeting functional and biocompatibility requirements.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).