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The FirmGrip " Peripherally Inserted Catheter device is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling.

The FirmGrip™ peripherally inserted catheter includes a standard catheter encapsulated in a specially designed protective sleeve. The protective sleeve enables manipulation, handling, and insertion of the catheter . The catheter component is a standard, legally marketed catheter. The FirmGrin™ peripherally inserted catheter contains color coded hubs, one cm markings for easier length determination, and is fully radio-opaque. The catheter is incorporated into the FirmGrip™ sterile protective sleeve. A specially designed adapter, called the PeelGuard, and a Peel Away Needle Introducer are supplied with the Firm Grip The device. The FirmGrip™ protective sleeve comprises a long sheath with a special handgrip and a friction unit at the tip. The handgrip portion is located near the tip of the protective sleeve. The special handgrip is shaped like an accordion and moves back automatically in an accordion-like motion to facilitate the catheter insertion. The catheter is advanced slowly by grasping the catheter through the handgrip portion of the FirmGrip™ protective sleeve and pushing it forward. Pressure is released to allow the accordion-like motion of the protective sleeve to return the handgrip portion to its original position. The catheter is continuously advanced as described above until the catheter is completely in place. The long sheath portion of the protective sleeve contains the catheter and is designed to accommodate the length of a midline catheter. The tip of the catheter is located within the tip of the protective sleeve and the remainder of the catheter lies within the long sheath portion. The tip of the protective sleeve contains butterfly wings for ease of use, holding and securing the catheter in place. The tip of the protective sleeve is closed with a luer cap until use. When ready for use, the luer cap is removed and the specially designed adapter, called the PeelGuard is attached to the tip of the protective sleeve. The tip of the protective sleeve connects to the peel-away needle introducer via the PeelGuard adapter. Upon placement of the catheter within the vein, the remainder of the catheter may be removed from the protective sleeve by pulling back on the hand grip of the protective sleeve. The final device is packaged in a blister pack and sterilized by EtO Sterilization

Here's an analysis of the provided text regarding the acceptance criteria and study for the FirmGrip™ Peripherally Inserted Catheter Device:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and does not present an extensive study with detailed acceptance criteria and reported device performance in the way one might expect for a novel AI/software device. Instead, it relies on demonstrating compliance with existing standards and material equivalency.

Therefore, many of the requested fields (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, explicit ground truth for test/training sets, and training set size) are not directly applicable or explicitly mentioned in the context of this traditional medical device submission.

However, I can extract the relevant information and structure it to best answer your prompt, noting where details are not provided or are not applicable.

Acceptance Criteria and Device Performance for FirmGrip™ Peripherally Inserted Catheter Device

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The "Non-Clinical Performance Data" section refers to "In-vitro testing" and a "final device performance test" without specifying sample counts for these tests.
• Data Provenance: The device is manufactured by FlexiCath Ltd. in Israel. Testing would have been conducted by or for FlexiCath Ltd. The type of testing (in-vitro, performance tests) suggests laboratory-based data, not patient data from a specific country or retrospective/prospective study.

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

• Not Applicable/Not Provided: This type of information is generally relevant for AI/software validation involving expert human review. For this traditional physical medical device, "ground truth" is established through engineering specifications, material standards (e.g., ISO), and functional testing, not typically by expert consensus of a test set in the same way.

4. Adjudication Method for the Test Set

• Not Applicable/Not Provided: As above, adjudication methods like N+1 consensus are used in clinical studies or expert review processes for diagnostic accuracy, which is not the focus of this device submission.

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

• No: A MRMC study is not mentioned. This type of study is typically performed to evaluate reader performance (e.g., diagnostic accuracy) with or without an AI-aid, which is not relevant for this physical catheter device.

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

• No: This is a physical medical device. There is no "algorithm" in the context of AI/software for which to conduct standalone performance testing.

7. The Type of Ground Truth Used

• Engineering Specifications, Material Standards, and Functional Performance: The "ground truth" for this device's performance relies on:
  • Compliance with international standards (ISO 10993 for biocompatibility, ISO 10555 for sterile, single-use intravascular catheters).
  • Demonstrating that the device's components and materials are the same as or equivalent to legally marketed predicate devices.
  • Verification of proper mechanical function (e.g., catheter advancement through the sleeve).
  • General principles of good manufacturing practices and device safety.

8. The Sample Size for the Training Set

• Not Applicable/Not Provided: There is no "training set" in the context of machine learning for this physical medical device.

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

• Not Applicable/Not Provided: As above, this concept does not apply to this type of device submission.

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