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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 contained within the device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate.

StitchKit® is a sterile, single-use plastic canister that is provided pre-loaded with suturing materials with attached needles. The device facilitates endoscopic robotic surgery by introducing multiple strands of suture to the surgical site at one time and allowing for the safe retrieval of the needles. The canister is sized to be passed through a ≥12 mm trocar or passed through an incision sized for an 8 mm trocar under direct endoscopic visualization. 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 either through the ≥ 12 mm trocar or through the 8mm trocar incision in tandem with the 8mm trocar, also under direct endoscopic visualization using the attached retrieval string. It is supplied sterile.

The provided text describes a 510(k) premarket notification for a medical device called StitchKit®. This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically for a minor modification related to the device's insertion and removal method (allowing use through an 8mm trocar incision in addition to a 12mm trocar).

Crucially, this document does NOT describe the acceptance criteria or a study proving the device meets performance criteria for a complex AI/ML medical device. The device in question is a suture delivery canister, a physical surgical tool, not an AI or imaging device. Therefore, many of the requested points related to AI/ML device validation (like expert adjudication, MRMC studies, ground truth for training/test sets, effect size of human reader improvement with AI assistance, and standalone AI performance) are not applicable to this submission.

The "clinical data" mentioned (retrospective case review n=422) is cited in the context of supporting the modification to the instructions for use, not for establishing the core performance of an AI algorithm. The performance data section refers to "functional performance test consisting of simulated surgical testing in an animal model" to demonstrate compatibility with the new insertion/removal technique, which is a physical device test, not an AI/ML study.

Therefore, I cannot fulfill most of your request for an AI/ML device, as the provided document pertains to a physical surgical device and its minor instruction for use modification.

However, I can extract the safety and efficacy information relevant to this device (the StitchKit® suture delivery canister) as presented in the document, acknowledging that it doesn't align with the detailed AI/ML validation questions.

Based on the provided document for the StitchKit® Suture Delivery Canister (a non-AI device):

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

The document does not specify formal, quantitative acceptance criteria for device performance in the typical sense of accuracy, sensitivity, or specificity, as it's a physical tool. Instead, the "performance" demonstrated relates to its functional compatibility with a new surgical technique.

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

• Test Set (for the modification validity):
  • Sample Size: n=422 (Cited as a "retrospective case review clinical study").
  • Data Provenance: Conducted by "an academic medical center." The country of origin is not specified but is implicitly in the US due to FDA submission. The study was retrospective.
• Functional Performance Test: Conducted in an "animal model." Sample size for this specific test is not provided.

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

• Not Applicable. This is a physical device, not an AI/ML diagnostic or image analysis device where "ground truth" would be established by experts interpreting medical data. The "ground truth" for the retrospective case review would likely be the surgical outcomes or successful use reported in the patient records.

4. Adjudication method for the test set

• Not Applicable. As above, no expert adjudication process is described or relevant for this type of device and study.

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. No MRMC study was done, as this is not an AI-assisted diagnostic device.

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

• Not Applicable. No standalone algorithm performance was evaluated, as this is not an algorithm-based device.

7. The type of ground truth used

• For the retrospective case review (n=422), the "ground truth" would be derived from clinical records and surgical outcomes related to the use of the device in actual patient cases, rather than expert interpretation of images or pathology. The document doesn't explicitly state how "success" or "performance" was quantified from these cases, but it supports the safety/effectiveness of the device, particularly with the proposed instruction modification.
• For the animal model functional test, the "ground truth" was direct observation of the device's physical handling and compatibility with the 8mm trocar site.

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an machine learning model.

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

• Not Applicable. No training set was used.

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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 contained within the device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate.

StitchKit® is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of different 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 disposal compartment within the canister for safekeeping until the entire canister is removed through the trocar using the attached retrieval string. It is supplied sterile. Each StitchKit® contains strands of existing legally-marketed Suturing Materials, cleared for use within the device.

The provided document is a 510(k) summary for the StitchKit® Suture Delivery Canister, which is a Class II medical device. This document details the device's indications for use, technological characteristics, and substantiates its substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria in the typical sense of a human-in-the-loop AI effectiveness study.

The device itself is a delivery system for existing sutures and not an AI-powered diagnostic or assistive device. Therefore, many of the requested criteria related to AI performance, AI effect size on human readers, expert ground truth, and training data are not applicable to this submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the StitchKit® are based on demonstrating substantial equivalence to legally marketed predicate devices. The performance data provided focuses on the physical and chemical properties of the device and its included sutures.

• Sutures are legally marketed and have not been modified, only trimmed to length and packaged within the StitchKit® canister. | - Canister is confirmed to be legally marketed and unchanged.
• Sutures are confirmed to be legally marketed, not modified other than trimming and packaging for the StitchKit®. |
  | Performance Testing | - Comparative Physico-Chemical analysis
• LAL Pyrogen testing
• Material Mediated Pyrogen testing
• Stability Evaluations (including USP suture tensile strength, diameter, and needle attachment testing)
• Comparative in-vitro simulated biodegradation testing for absorbable sutures | - Testing performed to verify substantial equivalence to predicate devices.
• Specific results or thresholds are not provided in this summary, but the conclusion states that the device "has been shown to be substantially equivalent to its predicate devices" based on this data. |
  | Indications for Use | - Facilitates minimally invasive robotic surgery by transporting suture and removing used needles.
• Suture intended for soft tissue approximation where use of specific absorbable/non-absorbable sutures is appropriate. | - The device's design directly supports these indications. No performance metrics are given here for success rate of needle removal or ease of transport, rather it's implicit in its design that it fulfills these functions. |

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

The document does not specify a "test set" in the context of an AI study. Instead, it refers to various forms of performance testing on the device and its components. The document doesn't provide specific sample sizes for these tests (e.g., number of sutures tested for tensile strength or number of canisters tested for pyrogenicity). The provenance of the data (e.g., country of origin, retrospective/prospective) is also not specified, as this type of information is typically not included in a 510(k) summary for a physical device.

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

Not applicable. As this is not an AI or diagnostic device, there is no "ground truth" established by experts in the context of image interpretation or clinical diagnosis. The performance criteria are based on objective physical/chemical tests.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. As there are no expert interpretations or subjective assessments requiring adjudication, no such method was used.

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. The StitchKit® is a physical surgical delivery device and does not involve AI or human readers for diagnostic assistance. Therefore, an MRMC study and AI effect size are irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance validation is based on established engineering and material science standards (e.g., USP standards for suture properties, LAL pyrogen testing standards, physicochemical analysis). It's not clinical "ground truth" derived from patient outcomes or expert consensus on a diagnosis.

8. The Sample Size for the Training Set

Not applicable. There is no AI component requiring a training set.

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

Not applicable. There is no AI component requiring a training set and associated ground truth.

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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 contained within the StitchKit® device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate.

StitchKit® COMBO is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of different 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 disposal 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 legallymarketed Suturing Materials, cleared for use within the StitchKit®.

This looks like a 510(k) summary for a medical device called "StitchKit® COMBO Suture Delivery Canister". Based on the provided text, the device is explicitly a suture delivery system and not an AI or imaging device, so the requested information about AI performance, ground truth, expert adjudication, etc., is not applicable.

Here's a breakdown of why the requested information cannot be provided given this document:

• No AI component: The document describes a "suture delivery canister which facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing." There is no mention of artificial intelligence, machine learning, image analysis, or any diagnostic capabilities.
• Physical device, not a diagnostic algorithm: The device handles physical sutures and needles. The performance data listed (knot-pull tensile testing, diameter, needle attachment, biodegradation testing, pyrogen testing, physico-chemical analysis, stability evaluations) are all related to the physical properties and safety of the surgical sutures and the delivery system itself, not to the performance of a software algorithm.

Therefore, since the device is not an AI/ML medical device, the following points from your request are not applicable and cannot be found in the provided text:

1. A table of acceptance criteria and the reported device performance (The "performance data" mentioned refers to physical product testing, not AI performance metrics)
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

In summary, this document describes a traditional medical device (suture delivery system) and does not provide any information relevant to the performance or validation of an AI/ML component.

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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.

Monotex® PTFE surgical suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. Monotex® PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. Monotex® PTFE suture is provided sterile as a single use device.

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.

The provided text does not describe the acceptance criteria, reported device performance, or any study that proves the device meets specific acceptance criteria regarding a medical device that utilizes artificial intelligence.

The document is a 510(k) Premarket Notification from the FDA for a device called "StitchKit® Suture Deliver Canister with PTFE Surgical Suture." The review is for a change to an existing legally marketed device, specifically:

1. Alternate source for suture
2. Choice of finish on stainless steel needle
3. Longer shelf life based on real-time age testing

The document lists performance data that was collected to support these changes. However, these are standard engineering and material tests for sutures and their components, not studies evaluating AI-driven performance or diagnostic accuracy.

Therefore, I cannot provide the requested information from the given text. The text does not contain:

• A table of acceptance criteria and reported device performance (for an AI device).
• Sample size used for a test set or its provenance.
• Number/qualifications of experts for ground truth.
• Adjudication method.
• Details of an MRMC comparative effectiveness study or effect size of AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (for an AI device).
• Sample size for a training set.
• How ground truth for a training set was established.

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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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