(43 days)
Quill™ PDO Knotless Tissue-Closure Device, comprised of Polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
The Quill™ Knotless Tissue-Closure Device comprised of PDO (Polydioxanone) is a synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)] monofilament suture material, dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the length of the device, and a welded loop at the distal end which is used to form the secondary variable loop, used to secure the device at the distal end. The device is available in diameter Size 0 in various lengths affixed to various needle types.
The Quill™ PDO Knotless Tissue-Closure Device (Polydioxanone) was evaluated through non-clinical laboratory performance testing to establish its substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (USP Monograph for Absorbable Sutures) | Reported Device Performance | Outcome |
|---|---|---|
| Tensile Strength (as applicable) | Confirmed to USP monograph | Met |
| Needle Attachment | Confirmed to USP monograph | Met |
2. Sample Size and Data Provenance:
The sample size for the non-clinical laboratory testing is not specified in the provided document. The data provenance is from non-clinical laboratory testing, indicating that it's a prospective study conducted specifically for this device evaluation. The country of origin of the data is not explicitly stated, but the submission is to the US FDA.
3. Number of Experts and Qualifications:
This was a non-clinical laboratory study involving physical performance tests according to a standard. Therefore, there were no human experts used to establish ground truth in the traditional sense of medical image or diagnostic interpretation. The "ground truth" was the adherence to objective performance standards outlined in the USP monograph.
4. Adjudication Method:
As this was a non-clinical laboratory study with objective performance criteria, there was no adjudication method as typically applied in studies involving human interpretation or subjective assessments. Performance was measured against predefined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was performed. This was a non-clinical performance study to demonstrate compliance with material and mechanical standards, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone non-clinical performance study was done. The device's performance (tensile strength and needle attachment) was evaluated against the USP monograph for absorbable sutures, without human intervention in the performance of the device itself.
7. Type of Ground Truth Used:
The ground truth used was objective performance standards defined by the USP Monograph for Absorbable Sutures for tensile strength and needle attachment. This is a scientific and regulatory standard.
8. Sample Size for the Training Set:
Not applicable. This was a non-clinical laboratory performance study, not a study involving machine learning or AI models that require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As no training set was used, no ground truth needed to be established for it.
§ 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.