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StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture within this StitchKit® device is intended for soft tissue approximation where use of an absorbable suture is appropriate.

StitchKit® is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of suturing materials to the surgical site at one time and allowing for the safe retrieval of the needles. It is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, the used needle is placed into a compartment within the canister for safekeeping until the entire canister is removed through the trocar using the attached retrieval string. It is supplied sterile in a foil pouch.

Each StitchKit® version contains strands of existing legally-marketed Suturing Materials. The subject StitchKit® versions contain:

• StitchKit® V-Loc™90: Contains Covidien V-Loc™90 Wound Closure -Devices
• -StitchKit® V-Loc™180: Contains Covidien V-Loc™180 Wound Closure Devices
• -StitchKit® Quill™ PDO: Contains Quill™ PDO Synthetic Absorbable Barbed Sutures

The provided text is a 510(k) premarket notification for a medical device called StitchKit®. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-based product. As such, it does not contain the information requested regarding acceptance criteria, study methodologies for AI performance, sample sizes for test/training sets, expert involvement in ground truth establishment, or MRMC studies.

The document primarily discusses the physical characteristics and intended use of the StitchKit® (a suture delivery canister) and conducts performance testing to show it functions comparably to predicate suture materials and delivery systems.

Therefore, I cannot provide the requested information based on the provided text.

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StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. It contains polypropylene surgical suture indicated for use in general soft tissue approximation and/or ligation.

The StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture ("StitchKit") is a sterile, single-use plastic canister that is pre-loaded with multiple strands of legally marketed monofilament polypropylene surgical suture (with needles attached). The device facilitates robotic-assisted endoscopic surgery by introducing these multiple strands of suture to the surgical field all at once. The surgeon can then dispense the suture strands one at a time. The device is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, used needles are deposited into a compartment within the StitchKit® canister. Once the surgeon has finished suturing, the device is removed along with the used needles inside. It is supplied sterile in a plastic tray with Tyvek® lid.

The provided document is a 510(k) premarket notification for a medical device (StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture). It describes the device, its intended use, and its substantial equivalence to predicate devices based on performance data. Importantly, this document is for a physical medical device (a suture delivery system), not an AI/ML algorithm or software device. Therefore, many of the requested fields regarding AI/ML study design are not applicable.

Here's the information that can be extracted or stated as not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify exact sample sizes for the various tests. It generally states that "performance testing was performed."
• Data Provenance: Not explicitly stated, but typically such testing is conducted in a controlled lab environment by the manufacturer. The document does not mention human patient data for testing device performance.

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

• Not Applicable. This device is a physical suture delivery system. Its performance is evaluated through engineering and biocompatibility tests, not by expert interpretation of data or images. Ground truth as typically understood in AI/ML validation (e.g., expert consensus on medical images) does not apply.

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

• Not Applicable. See explanation above. The performance tests are objective engineering and biological assessments.

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 medical device, not an AI/ML diagnostic or assistive tool. No human reader studies with or without AI assistance were conducted.

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

• Not Applicable. This is a physical medical device, not an AI/ML algorithm.

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

• Ground Truth for Physical Device Testing: The "ground truth" for this device's performance tests would be established by:
  • Validated Test Methods: Adherence to recognized standards (e.g., USP for suture properties).
  • Objective Measurements: Quantitative measurements of physical properties (knopull strength, diameter, dispensing force, shelf life parameters) and biological responses (pyrogenicity, extraction levels).
  • Predicate Device Performance: Comparison to the known performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no training set.

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

• Not Applicable. No training set exists for this device.

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The StitchKit® device facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The ePTFE suture contained within StitchKit® is indicated for use in all types of soft tissue approximation, including use in cardiovascular surgery and dura mater repair. It is recommended for use where reduced suture line bleeding during cardiovascular anastomotic procedures is desired.

The StitchKit® device is a sterile, single-use plastic canister that is pre-loaded with six strands of non-USP ePTFE suture, (diameter approx. 0.294 mm

Here's an analysis of the acceptance criteria and study information for the StitchKit® device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the types of performance testing conducted but does not explicitly state quantitative acceptance criteria or detailed numerical results for each test. Instead, it offers a high-level summary that "This testing has demonstrated that the StitchKit® device meets its design input requirements."

Therefore, the table below will list the types of performance testing conducted and the general statement regarding their fulfillment, as specific thresholds and results are not available in this document.

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

The document does not specify the exact sample sizes used for each performance test (e.g., number of devices tested for hinge strength, number of suture strands for knot-pull).

It also does not provide information about the country of origin of the data or whether the studies were retrospective or prospective. The nature of these tests (e.g., biocompatibility verification, mechanical testing) typically implies laboratory-based, prospective testing conducted by the manufacturer or contracted labs.

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

This information is not applicable to the StitchKit® device as described. The testing performed involves objective physical and mechanical measurements and validations (e.g., tensile strength, dimensions, sterilization efficacy, biocompatibility). These do not rely on expert interpretation in the way, for example, a diagnostic imaging study would require radiologists to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used for subjective assessments where multiple experts might disagree, which is not the case for the physical and mechanical performance tests described for the StitchKit®.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic or AI-powered devices to assess the impact of the device on human reader performance, which is not relevant for this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was not conducted. The StitchKit® is a medical device (suture delivery canister with pre-loaded suture) that facilitates surgical procedures; it is not an algorithm or an AI-powered system that would have a "standalone performance" in the sense of an algorithm operating independently of human interaction for interpretation or decision-making. Its performance is assessed through its physical and functional attributes.

7. Type of Ground Truth Used

The "ground truth" for the StitchKit® device's performance tests is based on pre-defined design input requirements, industry standards (e.g., USP methods for suture testing), and objective physical and mechanical measurements. For example, for tensile evaluations, the ground truth would be a specific force threshold that the component must withstand, measured objectively. For suture diameter, the ground truth is the specified diameter range. For sterilization, it's the demonstration of sterility per established protocols.

8. Sample Size for the Training Set

This information is not applicable. The StitchKit® is a physical medical device (suture delivery canister and suture), not an AI/ML algorithm or software that requires a "training set."

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

This information is not applicable as there is no "training set" for this device.

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