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Gazelle™ Polypropylene Suture and Delivery Device is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures. Gazelle™ Polypropylene Suture and Delivery Device is provided sterile as a single use device.

The Gazelle Polypropylene surgical sutures are sterile, nonabsorbable suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is pigmented blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility. The sutures are attached to a The Gazelle Suture Delivery Device is a Class I Manual Surgical Instrument that assists with suture placement. The Polypropylene suture is loaded into the Gazelle Delivery Device and is delivered to the desired location through the tip of the Gazelle Delivery Device. A standard knot pusher may be included with the Gazelle Polypropylene Suture and Delivery Device.

This document describes the FDA's acceptance of the Gazelle Polypropylene Suture and Delivery Device (K173644) as substantially equivalent to a predicate device. The information details the acceptance criteria and the studies performed to demonstrate this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Gazelle Polypropylene Suture and Delivery Device are primarily based on meeting the requirements specified in the "FDA Guidance, 'Class II Special Controls Guidance Document: Surgical Sutures, Guidance for Industry and FDA'". Additionally, the device had to pass various performance tests.

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

The document does not explicitly state specific sample sizes for the mechanical, biocompatibility, packaging, sterilization, or shelf-life testing of the suture. For the delivery device, the number of devices tested for "Button Push Force, Distal Tip / Shaft Pull Force, Handle / Shaft Pull Force, Stylet / Button Pull Force" is not specified.

The data provenance is from Dura Tap LLC in Wayne, PA, USA. The studies are retrospective in the sense that they were conducted by the manufacturer prior to submission, and the results are presented in the 510(k) summary as already completed performance data. The country of origin of the data is implied to be the USA, where Dura Tap LLC is located.

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

The document mentions "surgeon evaluation" for the Gazelle Delivery Device. However, it does not specify:

• The exact number of surgeons involved in this evaluation.
• The specific qualifications of these surgeons (e.g., years of experience, specialty).
• How their evaluations were quantitatively or qualitatively used to establish 'ground truth' or acceptance.

For the other tests (mechanical, biocompatibility, etc.), the "ground truth" is established by adherence to recognized standards (USP, ISO 10993-1, FDA Guidance), not through expert consensus in a clinical sense.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth, as none was applicable given the nature of the tests (physical, chemical, and biological performance against standards). For the "surgeon evaluation," no specific adjudication method is mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This premarket notification is for a surgical suture and delivery device, not an AI/CAD imaging device that would typically involve MRMC studies to evaluate human reader performance with and without AI assistance. The testing focuses on the physical and biological characteristics of the device and its equivalence to a predicate.

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

This question is not applicable to a physical surgical suture and delivery device. The device itself is an instrument used by a human, and there is no "algorithm only" component to test in isolation in the context of AI performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Compliance with recognized standards and guidance documents: Specifically, the "FDA Guidance, 'Class II Special Controls Guidance Document: Surgical Sutures, Guidance for Industry and FDA'", USP (United States Pharmacopeia) requirements for nonabsorbable sutures (including tensile strength and needle attachment), and ISO 10993-1 for biocompatibility.
• Validation of manufacturing processes: Packaging and sterilization validation.
• Empirical testing results: Mechanical testing of the suture materials and individual components of the delivery device (e.g., Button Push Force).
• Comparison to a legally marketed predicate device: The Riverpoint Medical RIVERPRO Suture (K100006) serves as a benchmark for equivalence in indications for use, technological characteristics, and performance.

There is no mention of pathology, outcomes data, or expert consensus in the typical sense for establishing clinical ground truth for diagnostic accuracy, as this is a surgical tool.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical device, not an AI/machine learning algorithm that requires a training set. The "training set" concept does not apply here.

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

This question is not applicable, as there is no training set for a physical surgical device.

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