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VASCU-SHEATH II® II INTRODUCERS ARE INTENDED TO OBTAIN CENTRAL VENTRAL VENOUS CHIPEL CATHETER INSERTION INTO THE CENTRAL VENOUS SYSTEM.

The Medcomp Vascu-Sheath® II is a two-part single use device used to obtain vascular access and facilitate intravascular catheter insertion. The Medcomp Vascu-Sheath® II consists of a peel-able introducer sheath and vessel dilator. The dilator is comprised of a cylindrical tube with a hub; the sheath is also a cvlindrical tube with a hub. The dilator extends beyond the sheath to provide a zero tolerance clearance between sheath and dilator. The device is available in three dilator lengths, 5cm, 10cm and 13.5cm and a range of French sizes from 5F thru 7F for the 5 and 10cm lengths and 5F thru 18F for the 10cm length. The sheath and dilator when used in conjunction with an introducer needle and guidewire provide a means to obtain a percutaneous opening to the vascular system to facilitate the insertion of a catheter. After removing the dilator a catheter can then be placed through the sheath. Breaking the sheaths hub and peeling the sheath away from the catheter then allows the sheath to be removed. The dilator is composed of a High Density Polyethylene with Barium Sulfate in the dilator for visibility under fluoroscopy by the attending physician during insertion. The sheath is composed of PTFE to provide a smooth, consistent peel.

The provided 510(k) summary for the Medcomp Vascu-Sheath® II describes an introducer set, not an AI/ML medical device. Therefore, many of the requested elements for describing studies proving a device meets acceptance criteria, particularly those related to algorithms, AI performance, ground truth, and human reader studies, are not applicable.

However, I can extract the relevant information regarding acceptance criteria and the type of study conducted for this specific device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The submission states "In Vitro performance data," which implies testing of units, but the number of units tested is not provided.
• Data Provenance: The data is "In Vitro," meaning it was conducted in a lab setting, not on human subjects. No information on country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Not Applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires expert ground truth for classification or diagnosis. Performance was evaluated against engineering specifications and comparison to predicate device characteristics.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This is not an AI/ML diagnostic device, so MRMC studies are not relevant. Clinical studies were explicitly "not deemed necessary."

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

• Not Applicable. This is not an algorithm. Benchtop "In Vitro performance data" was conducted for the physical device.

7. The Type of Ground Truth Used

• Engineering Specifications and Predicate Equivalence: The "ground truth" (or basis for acceptance) was the ability of the device to meet specified performance criteria (e.g., peel force) and to demonstrate substantial equivalence in design, materials, and intended use as compared to the legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not Applicable. This device uses traditional materials and manufacturing, not AI/ML, so there is no "training set."

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

• Not Applicable. See point 8.

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The Safe-T-Peel® Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick.

single patient, single use, stainless steel needle introducers with splittable sheaths, intended to facilitate the placement of Peripherally Inserted Catheters (PICs). Additionally the Safe-T-Peel® Safetv Needle/Introducer contains a splittable plastic sheath identical to the one used in the TFX Medical Introducer Assembly (K993191).

The provided text describes a 510(k) summary for the HDC Corporation's Safe-T-Peel® Safety Needle/Introducer. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as would be found in a clinical trial or a specific standalone performance assessment.

Therefore, many of the requested elements (acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone study, ground truth type, training set size, training set ground truth establishment) cannot be directly extracted from the provided text for a performance study as typically understood for AI/algorithm-based devices.

However, based on the principle of substantial equivalence, the "acceptance criteria" here is that the device performs similarly to the predicate devices, particularly regarding safety features. The "study" proving this comes in the form of comparing the device's characteristics and functionality to those of already approved predicate devices.

Here's an attempt to address the prompt based on the available information, highlighting what can and cannot be provided:

Acceptance Criteria and Study for HDC Corporation's Safe-T-Peel® Safety Needle/Introducer

The provided 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with explicit acceptance criteria and quantitative results for device performance against a predefined metric. For a 510(k) submission of this nature, the "acceptance criteria" revolve around demonstrating that the new device has the same intended use, similar technological characteristics, and comparable safety/performance to the predicate devices. The "study" involves a comparative analysis of these attributes.

1. Table of Acceptance Criteria and Reported Device Performance

As a 510(k) submission seeking substantial equivalence for a medical device rather than a software algorithm, explicit "acceptance criteria" in terms of sensitivity, specificity, or similar statistical metrics are not provided in this document. Instead, the acceptance criteria relate to structural and functional similarity to predicate devices, particularly for safety features.

2. Sample size used for the test set and the data provenance

Not applicable/provided. This device is a physical medical device, not an AI/algorithm. The "test set" for substantial equivalence is the comparison against the characteristics and performance of the predicate devices. The data provenance would be the design specifications and testing data of the device itself and of the predicate devices, which are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/provided. The concept of "ground truth" established by experts for a test set (as typically used for AI/algorithm evaluation) does not apply directly to this 510(k) summary for a physical medical device. The "truth" here is established by regulatory approval of the predicate devices and the demonstration of equivalence through design and performance testing (not detailed in this summary).

4. Adjudication method for the test set

Not applicable/provided. See explanation for point 3.

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 is a physical safety needle/introducer, not an AI/algorithm-assisted diagnostic tool.

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

Not applicable. This is a physical safety needle/introducer.

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

Not applicable. For this device submission, the "ground truth" is effectively the established safety and efficacy of the predicate devices, against which the new device is compared to demonstrate substantial equivalence, based on design features, materials, and functional testing.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no "training set" in the context of an algorithm.

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

Not applicable. See explanation for point 8.

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