(86 days)
The intended use of the Multitak Suture Snap System is in general soft tissue approximation and/or ligation. The system is indicated in securing soft tissue in arthroscopic and open surgical procedures where USP Size No. 2-0 through Size 2 nonabsorbable suture is used.
The Multitak Suture Snap System is designed for approximating and securing soft tissue in arthroscopic and open surgical procedures. The resorbable poly-L securing our assue in tasonically welded to secure suture at the wound repair site and takes the place of tying arthroscopic and open surgical repair knots. The system consists of a generator that provides ultrasonic energy to a handpiece. The energy applied to the handpiece is used to ultrasonically weld a resorbable crimp and secure suture during general tissue wound repair. The resorbable poly-L-lactic acid crimp is gradually degraded into lactic acid and excreted as carbon dioxide and water.
The provided text does not contain detailed acceptance criteria for the Multitak Suture Snap System, nor does it describe a comprehensive study with specific performance metrics against those criteria. Instead, it refers to "performance testing comparing the mechanical strengths" and "an in vitro degradation study" that demonstrated "no statistical difference in suture secured with the resorbable crimp and knotted suture" to establish substantial equivalence to a predicate device.
However, based on the information available, here's an attempt to structure an answer, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical strength of secured suture (similar to knotted suture) | "Results of bench testing... demonstrated no statistical difference in suture secured with the resorbable crimp and knotted suture." |
| In vitro degradation profile (similar to existing resorbable devices) | "an in vitro degradation study demonstrated no statistical difference in suture secured with the resorbable crimp and knotted suture." (The phrase "no statistical difference" suggests the degradation profile was deemed acceptable, likely by mirroring a predicate. Specifics are not given). |
| Biocompatibility | Not explicitly stated as an acceptance criterion or reported performance, but is an implicit requirement for medical devices made of "resorbable poly-L-lactic acid." The comparison to "currently marketed poly-L-lactic acid devices including the Mitek BTB Absorbable (PLA) Cross Pin" suggests this. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified for either the "bench testing" or the "in vitro degradation study."
- Data Provenance: The studies were "bench testing" and "in vitro degradation study," implying laboratory-based testing rather than studies involving human or animal subjects. No country of origin is specified for the data itself, but the manufacturer (Bonutti Research, Inc.) is based in Illinois, USA. The studies are by nature prospective as they were conducted to evaluate the device prior to market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The studies described are mechanical and degradation tests, which typically rely on quantitative measurements rather than expert human interpretation for "ground truth."
4. Adjudication Method for the Test Set
This information is not applicable as the described studies are mechanical and degradation tests, not studies requiring human adjudication of qualitative outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The studies described are bench tests and in vitro degradation studies, not clinical studies involving human readers or comparative effectiveness with human operators.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the Multitak Suture Snap System, as it is a mechanical device (a surgical tool and resorbable crimp) and not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the ground truth would be quantitative measurements of mechanical strength (e.g., tensile strength, knot security) derived from standardized testing methods. For the in vitro degradation study, the ground truth would similarly be quantitative measurements of degradation products or material properties over time. These are objective measurements rather than subjective expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not provided and is likely not applicable in the context of this device. The Multitak Suture Snap System is a mechanical device, not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable as there is no mention of a training set for an AI or machine learning model.
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.