(91 days)
MonoPlus Poly-p-dioxanone absorbable suture are indicated for use in general soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in paediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue.
The subject device is an absorbable, flexible monofilament suture thread which is supplied sterile. It is composed of a synthetic Poly (p-dioxanone), and it is indicated for soft tissue approximation and/or ligation, especially in cases where an extended wound support of more than 4 weeks is desirable. MonoPlus can also be used in paediatric cardiovascular surgery. Not to be used in adult cardiovascular tissue, microsurgery and neural tissue. It will be offered undeyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, §74.3602. It is available uncoated, and will be available with or without standard needles attached.
The provided text is a 510(k) summary for a medical device called MonoPlus Poly-p-dioxanone absorbable suture. It does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically seen for AI/ML or diagnostic devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Here's why the requested information cannot be extracted and what the document does communicate:
- No Performance Data Section: The document explicitly states: "No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices." This means there aren't formal, pre-defined acceptance criteria (like sensitivity/specificity targets) for this type of suture that the manufacturer needed to meet through a specific performance study.
- Substantial Equivalence Pathway: The submission uses the "substantial equivalence" pathway, meaning the manufacturer is demonstrating that their new device is as safe and effective as a legally marketed predicate device (Ethicon's PDS II Polydioxanone Suture). This typically involves comparing design, materials, and intended use, rather than conducting new clinical performance trials against numerical acceptance criteria.
Therefore, most of the requested fields are not applicable or cannot be found in the provided text.
Here's a breakdown of the available information based on your request, with explanations for why other fields are not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The document states, "No performance standards have been promulgated..." and relies on substantial equivalence. Therefore, there are no explicit acceptance criteria or reported performance metrics (e.g., accuracy, sensitivity, specificity) for this device in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No specific performance study with a "test set" is described. The submission focuses on substantial equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No performance study with a test set requiring expert ground truth is described.
4. Adjudication Method for the Test Set
Not applicable. No performance study with a test set is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study is mentioned. The submission is for a medical suture, not a diagnostic or AI-assisted device where such studies are common.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical surgical suture, not an algorithm or software.
7. Type of Ground Truth Used
Not applicable. No performance study requiring ground truth is described. For substantial equivalence, the "ground truth" is effectively that the predicate device is already deemed safe and effective, and the new device is demonstrated to be similar enough.
8. Sample Size for the Training Set
Not applicable. This type of information is relevant for AI/ML models, not for a physical medical device like a suture where the development process would involve materials science, engineering, and biocompatibility testing, not "training sets."
9. How the Ground Truth for the Training Set was Established
Not applicable. As above, this concept doesn't apply to the development of a surgical suture.
Summary of what the document does provide regarding device clearance:
- Device: MonoPlus Poly-p-dioxanone absorbable suture.
- Indicated Use: General soft tissue approximation and/or ligation, especially where extended wound support (>4 weeks) is desired, and in pediatric cardiovascular surgery (not adult cardiovascular, microsurgery, or neural tissue).
- Regulatory Pathway: 510(k) Pre-market Notification, seeking clearance based on substantial equivalence.
- Predicate Device: Ethicon, Inc.; PDS II Polydioxanone Suture (N18331).
- Conclusion: The FDA determined the device is substantially equivalent to the predicate device, allowing it to be marketed.
This document demonstrates compliance through a regulatory pathway of substantial equivalence, which for this type of device, does not involve the detailed performance study and acceptance criteria breakdown you've outlined, which are more typical for novel diagnostic devices, AI/ML products, or devices requiring new clinical efficacy data.
§ 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.