(126 days)
Absorbable polyglycolic acid suture with needle is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.
Absorbable Polydioxanone Suture with Needle is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.
The applicant devices of absorbable polyglycolic acid suture with needle consist of a polyglycolic acid surgical suture made of polyglycolic acid and a stainless steel needle. It is EO sterilized, and prygon-free.
The applicant devices of absorbable polydioxanone suture with needle consist of a polydioxanone surgical suture made of polyester and a stainless steel needle. It is unbraided. It is EO sterilized, and prygon-free.
The document describes the acceptance criteria and supporting studies for two types of absorbable surgical sutures with needles: Absorbable Polyglycolic Acid Suture with Needle and Absorbable Polydioxanone Suture with Needle.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" with numerical targets and then "reported performance" against those targets in a table format. Instead, it states that performance data was collected in accordance with recognized standards, implying that meeting these standards constitutes the acceptance criteria.
Absorbable Polyglycolic Acid Suture with Needle & Absorbable Polydioxanone Suture with Needle (both devices)
| Acceptance Criteria Category | Standard/Test Performed | Reported Device Performance |
|---|---|---|
| Physical Properties | USP 30, Suture Diameter | Demonstrated compliance with USP 30 for suture diameter. (Implied: met requirements) |
| USP 30, Suture Attachment | Demonstrated compliance with USP 30 for suture attachment. (Implied: met requirements) | |
| USP 30, Tensile Strength | Demonstrated compliance with USP 30 for tensile strength. (Implied: met requirements) | |
| Biocompatibility | ISO 10993 | Biocompatibility studies were performed in accordance with ISO 10993. (Implied: met requirements) |
| In Vivo Strength/Degradation | In vivo strength test | Conducted to demonstrate rates of tensile and mass loss. (Implied: met requirements for intended dissolution profile) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any of the tests (physical, biocompatibility, or in vivo strength).
The data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the studies are focused on material properties and biocompatibility, not diagnostic interpretations requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for material performance 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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for surgical sutures.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a surgical suture, not an algorithm or AI-driven system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance testing of these sutures is established through predefined, standardized test methods and specifications (e.g., USP 30, ISO 10993) which define the acceptable range or characteristics of the material. For in-vivo testing, it would be direct measurement of tensile strength and mass loss over time.
8. The sample size for the training set
This information is not applicable as the device is a manufactured medical product, 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 applicable for the same reason as above.
§ 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.