(30 days)
The LARIAT® III Suture Delivery Device facilitates suture placement and knot tying for use in surgical applications where soft tissue are being approximated and/or ligated with a pre-tied polyester suture.
The LARIAT® III Suture Delivery Device is a one-piece, single-use suture delivery and deployment device with a pre-tied size "0" polyester suture loop that is pre-loaded on a retractable Delivery Snare on the distal end of the device. The pre-tied suture loop is held onto the Delivery Snare and allows for multiple opening and closings of the suture loop without release. Upon tightening of the suture loop, the suture is released from the Delivery Snare. An accessory lumen within the LARIAT III device is designed for aspiration and flushing. The LARIAT III device is compatible with access site diameters of 4.3mm and larger. The suture is itself a cleared medical device as a part of K021019.
The provided document is a 510(k) premarket notification for the LARIAT® III Suture Delivery Device. It details the device's characteristics, intended use, and claims of substantial equivalence to a predicate device (LARIAT II Suture Delivery Device). This type of submission relies on comparisons to already-cleared devices and bench testing rather than clinical study data for device performance metrics related to diagnostic accuracy or clinical outcomes often seen with AI/ML devices. Therefore, a direct application of typical "acceptance criteria" for AI/ML performance metrics and detailed clinical study information is not present in this document.
However, I can extract the information that is available regarding the device's performance through bench testing in support of its substantial equivalence claims.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical "acceptance criteria" with thresholds for each test, but rather lists the types of bench tests performed to confirm the device performs "according to the stated intended use." The reported device performance is broadly stated as successful completion of these tests.
| Acceptance Criterion (Test Name) | Reported Device Performance |
|---|---|
| Visual and Dimensional Verification | Performed according to stated intended use (implied success) |
| Snare Loop Actuation and Force Testing | Performed according to stated intended use (implied success) |
| Ability to Perfuse and Aspirate Testing | Performed according to stated intended use (implied success) |
| Suture Preparation and Deployment Testing | Performed according to stated intended use (implied success) |
| Snare Loop Lock Testing | Performed according to stated intended use (implied success) |
| Suture Recoil Testing | Performed according to stated intended use (implied success) |
| Suture Tensile Strength Testing | Performed according to stated intended use (implied success) |
| Snare Wire Joint Strength Testing | Performed according to stated intended use (implied success) |
| Shaft to Handle Joint Strength Testing | Performed according to stated intended use (implied success) |
| Catheter Tip to Shaft Joint Strength | Performed according to stated intended use (implied success) |
| Snare Anchor Joint Strength Testing | Performed according to stated intended use (implied success) |
| Hypotube to Shaft Joint Strength Testing | Performed according to stated intended use (implied success) |
| Suture Knot Strength Testing | Performed according to stated intended use (implied success) |
| Suture/Suture Fob Joint Strength Testing | Performed according to stated intended use (implied success) |
2. Sample size used for the test set and the data provenance
The document specifies "bench testing" was conducted. This typically refers to laboratory-based tests on physical devices or components, not clinical data. Therefore, details like "country of origin of the data" or "retrospective or prospective" do not apply. The sample size for each specific bench test is not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Bench testing of a mechanical device does not typically involve human experts establishing ground truth in the way it would for an AI diagnostic device. The "ground truth" for these tests would be derived from engineering specifications and widely accepted physical/material science principles.
4. Adjudication method for the test set
Not applicable, as this refers to a method used to resolve discrepancies among human experts during ground truth establishment for clinical/diagnostic performance, which is not relevant for this type of bench testing.
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 device is a surgical tool, not an AI/ML diagnostic or assistive device that would involve human "readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical surgical tool, not an algorithm.
7. The type of ground truth used
For bench testing, the "ground truth" is typically defined by accepted engineering specifications, material properties, and functionality requirements rather than expert consensus, pathology, or outcomes data. For example, a "suture tensile strength test" would have a specified minimum tensile strength (ground truth) that the suture must meet.
8. The sample size for the training set
Not applicable. This device is not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML model that requires a training set.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.