(138 days)
The MINT™ comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.
The MINT™ synthetic absorbable PDO suture is made of polydioxanone has been found to be nonantigenic and to elicit only a slight tissue reaction during absorption. The pigment for the violet dye is D&C Violet No.2. The MINT™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue.
Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament without needle attachment. The MINTM Synthetic Absorbable PDO suture approximate tissues, without the need to tie surgical knots, by using the opposing barbs on the suture surface to embed in the tissues after the surgeon precisely places the suture within the tissues.
While the formation of barbs in the MINT™ reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduce their effective strength. For this reason, the strength of the MINT™ can be compared with USP knot strength of non-barbed sutures and the USP size of MINT™ is 1 while its tensile strength is equivalent to that of USP 2-0.
The provided text for the MINT™ 510(k) submission (K130191) describes the device, its intended use, and its substantial equivalence to predicate devices, but does not include a study proving device performance against acceptance criteria in the way a clinical trial or algorithm performance study would.
Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Quill™ Self-Retaining System) based on similar materials, design features (bi-directional barbs), and intended use. The "Safety and performance" section mentions types of testing performed but does not provide specific performance data or acceptance criteria for those tests.
Therefore, for many of the requested points, the information is not available in the provided text, as this document is a summary for a 510(k) submission, not a detailed study report.
Here's a breakdown of the available and unavailable information based on your request:
Acceptance Criteria and Device Performance Study (K130191 - MINT™ Suture)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Material Composition | Made of polydioxanone (PDO) | "The MINT™ synthetic absorbable PDO suture is made of polydioxanone" |
| Bi-directional Barbs | Has bi-directional barbs | "Each dyed (violet) suture has bi-directional barbs..." |
| Absorption Profile | Degrades or dissolves over time | "degrades or dissolves over time in tissue." |
| Sterility | Sterile after ethylene oxide (EO) gas sterilization | "The MINT™ is available sterile after ethylene oxide (EO) gas sterilization" |
| Biocompatibility | Nonantigenic, slight tissue reaction | "has been found to be nonantigenic and to elicit only a slight tissue reaction during absorption." |
| Tensile Strength | USP size 1, tensile strength equivalent to USP 2-0. | "...the USP size of MINT™ is 1 while its tensile strength is equivalent to that of USP 2-0." |
| Intended Use | Soft tissue approximation where absorbable sutures are appropriate. | "The MINT™ comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate." |
| Safety and Performance Testing | Per FDA's Class II Special Controls Guidance Document: Surgical Sutures, including: |
- USP monograph for absorbable sutures
- In vitro and in vivo resorption testing
- Biocompatibility testing per ISO 10993
- Barb holding strength evaluation | Document states these tests were performed but does not provide specific numerical acceptance criteria or performance results. The conclusion is that it is "substantially equivalent" to predicate devices, implying it met the necessary performance standards to demonstrate this equivalence. |
2. Sample size used for the test set and the data provenance
- Not available: The document does not describe a "test set" in the context of a clinical performance study with a distinct sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission refers to a series of physical and biological tests for the device itself rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not available: Ground truth is not established in the context of a "test set" for diagnostic performance. The document describes product characteristic testing, not a study requiring expert-derived ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not available: No adjudication method is mentioned as there is no "test set" requiring it.
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/Not available: This device is an absorbable surgical suture, not an AI-powered diagnostic or decision support tool. An MRMC study is not relevant to its type of evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not available: This is not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Not available: As this is a medical device (suture) and not an AI/diagnostic tool, the concept of "ground truth" as typically defined for such studies is not directly applicable. The "truth" in this context is adherence to physical, chemical, and biological standards (e.g., USP monographs, ISO 10993).
8. The sample size for the training set
- Not applicable/Not available: There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable/Not available: No training set exists.
Summary of Study (as described in the 510(k) Summary):
The "study" described in the provided text is primarily a demonstration of substantial equivalence to existing predicate devices (Quill™ Self-Retaining System and Quill™ Synthetic Absorbable Barbed Suture). This is a regulatory pathway for medical devices where a new device can be marketed if it is shown to be as safe and effective as a legally marketed device that does not require premarket approval (PMA).
The evidence for this substantial equivalence included:
- Material Comparison: The MINT™ is made of the same material (Polydioxanone, PDO) as the predicate.
- Design Comparison: Both the MINT™ and the predicate have bi-directional barbs. The submission notes a difference in barb size and spacing but implies this does not alter substantial equivalence.
- Intended Use Comparison: Both devices share the same indication for use: "soft tissue approximation where use of an absorbable suture is appropriate."
- Safety and Performance Testing: The submission states that various tests were performed in accordance with FDA guidance and USP monographs, including:
- USP monograph for absorbable sutures (physical properties like tensile strength).
- In vitro and in vivo resorption testing (how it degrades).
- Biocompatibility testing as per ISO 10993 (tissue reaction, toxicity).
- Barb holding strength evaluation.
The conclusion of the submission is that "the MINT™ is substantially equivalent to predicate device as described herein" based on these comparisons and the implied successful completion of the performance tests. The document does not provide the detailed results or specific acceptance criteria for each of these performance tests, as is common in a 510(k) summary which focuses on the overall conclusion of equivalence.
§ 878.4840 Absorbable polydioxanone surgical suture.
(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.