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510(k) Data Aggregation
(36 days)
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.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Compliance |
|---|---|---|
| Technological Characteristics | - Canister is legally marketed and unchanged. - 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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