(145 days)
FilBloc Permanent sutures are intended for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.
The Assut FilBloc Permanent Suture range of devices comprises a variety of gauge sizes and lengths, supplied with or without stainless steel needles, which are also available in a variety of different sizes and shapes. The sutures may have a 'block' at one end, which allows surgeons to close wounds quickly and securely without tying knots or changing suturing techniques. The block is made from the same material as the suture, and is used to anchor the suture.
Assut FilBloc Permanent Sutures contact the patient and remain attached to the patient at the point suturing and may remain in place for significant periods.
The sutures with needles do not need to be used with any other devices, but the needleless sutures need to be used together with legally available separate needles.
This document describes a 510(k) premarket notification for a medical device (Assut FilBloc Permanent Sutures) and focuses on demonstrating substantial equivalence to a predicate device rather than setting and proving new acceptance criteria for a novel AI/software-based medical device.
Therefore, many of the requested sections (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, effect sizes, standalone performance, ground truth establishment) are not applicable to this type of regulatory submission and the information provided. This document is for a physical medical product, not an AI/software device.
However, I can extract information related to performance testing that serves a similar purpose to "acceptance criteria" for a physical device, and indicate which of your requested points are not applicable.
Acceptance Criteria for Assut FilBloc Permanent Sutures and Supporting Study
Note: This document pertains to a physical medical device (surgical sutures) and its 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The concepts of "AI/software acceptance criteria," "training/test sets," "expert ground truth for AI," "MRMC studies," and "effect sizes" for human readers are not applicable to this type of device and submission. The performance data provided are for the physical properties and biocompatibility of the sutures.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on USP 29 and ISO standards) | Reported Device Performance (Implied as Met) |
|---|---|
| Physical Performance: |
- Suture Diameter ()
- Suture Attachment ()
- Tensile Strength ()
- Sterility
- Shelf Life
- Packaging Integrity
- Compliance with applicable USP monographs | Performed and established compliance with USP 29.
Available sterile (ethylene oxide, with SAL 10⁻⁶).
Tests undertaken to establish shelf life and packaging integrity.
Yes (stated in comparison table). |
| Biocompatibility (based on ISO 10993-1, 5, 6, 10, 11, 3): - Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity
- Subchronic Toxicity
- Genotoxicity
- Implantation
- Material Mediated Pyrogenicity
- Bacterial endotoxin testing (LAL test) | All listed tests were carried out to establish biocompatibility, indicating successful completion and acceptance.
Bacterial endotoxin testing (LAL test) is carried out on every batch. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for each physical or biocompatibility test. It broadly states that "Physical testing was performed" and "Tests were also undertaken" and "the following tests were carried out to establish the biocompatibility." For physical medical devices like sutures, these tests are typically conducted on representative batches per established test standards (e.g., USP monographs).
- Data Provenance: The tests were performed by Assut Europe S.p.A. (manufacturer in Italy). The data is generated prospectively as part of the device's development and manufacturing compliance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. For a physical device like a suture, "ground truth" is established by laboratory measurements according to validated standards (e.g., USP monographs, ISO standards) rather than expert human interpretation of data.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for assessing performance in subjective tasks or when reaching consensus on ground truth from human experts, particularly in image interpretation or clinical diagnosis. This is not relevant for the objective physical and biocompatibility testing of a suture.
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. This is a physical medical device, not an AI or imaging diagnostic device. MRMC studies are used to evaluate diagnostic performance of imaging modalities or AI systems.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not Applicable. This is a physical medical device. The concept of "standalone algorithm performance" is not relevant here.
7. The Type of Ground Truth Used
The ground truth for the performance of the sutures is based on objective, standardized laboratory measurements and biological assay results as defined by:
- United States Pharmacopeia (USP) monographs, e.g., USP 29 for suture diameter (), suture attachment (), and tensile strength ().
- International Organization for Standardization (ISO) standards for biocompatibility (e.g., ISO 10993 series).
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/machine learning device. There is no concept of a "training set" for the type of data presented (physical properties and biocompatibility).
9. How the Ground Truth for the Training Set was Established
Not Applicable. As there is no training set mentioned, this question is not relevant. The ground truth for the device's performance relies on adherence to established, internationally recognized medical device standards and regulations.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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.