(28 days)
The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.
The Suture-TOOL System is a single-use, sterile, suture applicator with a polydioxanone resorbable suture pre-mounted to the needle. The polydioxanone monofilament synthetic absorbable sutures are prepared from polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is as follows: -(O-CH2-CH2-O-CH2-CO)n- The sutures are dyed with D&C Violet No. 2 (21CFR§ 74.3602). The Suture-TOOL System includes the following: • Polydioxanone resorbable suture pre-mounted on the needle – 1055S, 1020S (Suture&Needle). • Suture-TOOL – 1018S (suture applicator). Before use, the user must follow the instructions to attach the needle, preloaded with the suture, to the applicator.
The provided FDA 510(k) clearance letter pertains to the Suture-TOOL System, which is a surgical suture device, not an AI or software-based medical device. Therefore, the information requested regarding acceptance criteria and study proving performance for an AI/software device (sample size, ground truth, expert adjudication, MRMC studies, standalone performance) is largely not applicable to this submission.
However, I can extract the relevant acceptance criteria and performance study information for this physical medical device based on the provided text.
Acceptance Criteria and Study for Suture-TOOL System (Physical Device)
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Suture-TOOL System are based on established USP (United States Pharmacopeia) standards for surgical sutures. The performance is reported as meeting or exceeding these criteria.
| Acceptance Criterion (USP Standard) | Reported Device Performance |
|---|---|
| USP 41-NF36:2018 Tensile Strength | Met or exceeded USP criteria |
| USP 41-NF36:2018 Sutures - Diameter | Met or exceeded USP criteria |
| USP 41-NF36:2018 Sutures - Needle Attachment | Met or exceeded USP criteria |
| Material/Component Specific: | Reported Performance: |
| Polydioxanone suture (USP 0 size) tensile strength residual at 4 weeks | 71.7% |
| Polydioxanone suture (USP 0 size) tensile strength residual at 8 weeks | 16.5% |
| Absorption time | ~ 180-210 days post-implantation |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the physical and mechanical testing of the sutures (e.g., number of sutures tested for tensile strength, diameter, or needle attachment).
- Sample Size: Not explicitly stated (e.g., "n=" not provided for each test). The text only mentions "Physical testing was performed on the poly(p-dioxanone) synthetic absorbable suture PDO USP 0 to USP 29".
- Data Provenance: Not specified regarding country of origin. The data is derived from physical performance testing of the manufactured device components. It is inherently "prospective" in the sense that the tests are conducted on manufactured products to verify design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this physical device submission. Ground truth, in the context of AI/software, refers to expert interpretations or labels. For a surgical suture, the "ground truth" is defined by the objective, quantitative measurements against established USP physical and mechanical standards. No human expert interpretation is involved in establishing the "ground truth" for suture diameter, tensile strength, or needle attachment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for expert consensus in labeling or interpreting data, common in AI/software performance studies. For physical testing of a medical device like a suture, results are quantitative and objective, eliminating the need for adjudication.
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. MRMC studies are specific to evaluating the clinical impact of AI or imaging devices on human reader performance. This submission is for a physical surgical suture, which does not involve "human readers" in the context of interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical suture, not an algorithm.
7. The type of ground truth used
The "ground truth" for the Suture-TOOL System's performance is based on pre-defined, objective, quantitative physical and mechanical standards set by the United States Pharmacopeia (USP) for surgical sutures. Specifically, USP standards for Suture Diameter, for Suture Attachment, and for Tensile Strength.
8. The sample size for the training set
Not applicable. As a physical medical device, there is no "training set" in the machine learning sense. The device is manufactured and tested based on established engineering and materials science principles.
9. How the ground truth for the training set was established
Not applicable. There is no concept of "ground truth for the training set" for this physical device. The device's design and manufacturing rely on established material properties and engineering standards.
Summary regarding the nature of this 510(k) submission:
This 510(k) submission for the Suture-TOOL System is for a physical medical device (surgical suture). The "study" proving it meets acceptance criteria for FDA clearance predominantly involves physical and mechanical performance testing against recognized industry standards (USP). The questions related to AI/software performance studies (human experts, ground truth adjudication for interpretative tasks, MRMC, standalone algorithm performance, training sets) are therefore not relevant to this specific device and the information provided in the clearance letter. The substantial equivalence claim is primarily based on the device being identical to a previously cleared predicate device, with the addition of a new size (USP 0) that also demonstrated conformance to the same physical and mechanical standards.
§ 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.