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A percutaneous guide wire introducer for vascular and non-vascular procedures with activating safety shield to reduce needle stick injury during use and disposal.

A needle and hub device for the percutaneous introduction of a guide wire, with a hub modification to allow one-handed activation of a sheath to cover the needle and help prevent accidental needle sticks during use and disposal.

The provided document is a 510(k) Premarket Notification for the "SafetyNET Guidewire Introducer". It contains administrative information, an intended use statement, and a declaration of compliance with ISO 10993-1. However, it does not include specific acceptance criteria, performance data, or details of studies typically found in a clinical or performance study report.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can and cannot be provided:

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

• Cannot be provided. The document states "Product and materials meet all applicable test requirement per ISO 10993-1" under the "Testing" section, which refers to biocompatibility testing. It implies that these requirements were met, but it does not specify what those "applicable test requirements" or their acceptance criteria were, nor does it provide the results of those tests or any other performance metrics for the device itself (e.g., success rate of guidewire introduction, effectiveness of the safety shield in preventing needle sticks, etc.).

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

• Cannot be provided. The document does not describe any specific performance or clinical studies, and therefore no information on sample sizes or data provenance for a test set.

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)

• Cannot be provided. There is no mention of a test set requiring ground truth establishment by experts.

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

• Cannot be provided. There is no mention of a test set or any adjudication process.

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

• Cannot be provided. This device is a manual surgical instrument (a guidewire introducer with a safety mechanism), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study is not applicable and not mentioned.

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

• Cannot be provided. This device is a manual surgical instrument, not an algorithm. Standalone algorithm performance is not applicable.

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

• Cannot be provided. There is no mention of any ground truth being established as no such study is described.

8. The sample size for the training set

• Cannot be provided. There is no mention of a training set, as the device is not an AI/ML algorithm.

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

• Cannot be provided. There is no mention of a training set or ground truth establishment.

Summary of available information related to testing:

The document briefly mentions "Testing" and states:

• "Product and materials meet all applicable test requirement per ISO 10993-1"
  • ISO 10993-1 refers to "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." This standard guides the evaluation of biocompatibility but does not define specific performance criteria for the function of a device. It indicates that the materials used in the SafetyNET Guidewire Introducer have been assessed for their biological safety in accordance with this standard. No specific data or acceptance criteria for this testing are provided in this document.

For this type of device (a manual surgical instrument), the "study" demonstrating its safety and effectiveness for a 510(k) submission typically relies on substantial equivalence to existing predicate devices and in vitro/bench testing (like biocompatibility, sterility, strength, dimensions, and the function of the safety mechanism) rather than large clinical trials or AI performance evaluations. The document does not elaborate on these specific tests or their results, instead summarizing them with the ISO 10993-1 compliance statement.

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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.

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