(153 days)
FSSB Nylon Surgical Suture (Non-absorbable Polyamide) is indicated for use in general soft tissue approximation and/or ligation including use in ophthalmic and neurological procedures.
FSSB Nylon Surgical Suture is a monofilament non-absorbable sterile surgical suture composed of the long chain aliphatic polymers Nylon 6,6. The suture is provided dyed (black). The pigment for the black dyed suture is Hematein black (Logwood: Color Code 75290). All products meet the requirements of 21 CFR 70.5(c) regarding the use of color additives in sutures.
The product is available in several lengths and USP diameters. The FSSB Surgical Suture is equipped with single or double high-grade stainless steel needles of various types of points, lengths, diameters and curves (Product List provided as Appendix A). The product meets all requirements established by the United States Pharmacopeia (U.S.P.) for nonabsorbable surgical sutures.
The provided 510(k) summary for FSSB Nylon Surgical Sutures does not describe a study involving a device with AI or machine learning components, nor does it detail acceptance criteria and performance against those criteria in the typical sense of a diagnostic or predictive device.
Instead, this document establishes substantial equivalence of the FSSB Nylon Surgical Suture to existing predicate devices based on material composition, intended use, and performance testing that meets established industry standards (USP, ISO) and FDA guidance for surgical sutures.
Therefore, the requested information, which is relevant for AI/ML-driven devices, cannot be extracted from this document in its entirety. However, I can interpret the provided information within the context of demonstrating substantial equivalence, which is a form of "acceptance" for a medical device.
Here's an attempt to structure the information based on the request, noting where the information is not applicable (N/A) for this type of device:
Acceptance Criteria and Study for FSSB Nylon Surgical Sutures
1. Table of Acceptance Criteria and Reported Device Performance
For a surgical suture, "acceptance criteria" are primarily defined by adherence to recognized standards and demonstrated equivalence to legally marketed predicate devices in terms of material properties and performance.
| Criterion Type | Specific Criteria (Derived from USP, ISO, and FDA Guidance) | Reported Device Performance (FSSB Nylon Surgical Sutures) |
|---|---|---|
| Material Composition | Composed of Nylon 6 or Nylon 6,6. Pigment (if dyed) meets 21 CFR 70.5(c). | Composed of Nylon 6,6. Black dye uses Hematein black (Logwood: Color Code 75290), meeting 21 CFR 70.5(c). Meets Criterion. |
| Physical Properties | Meets USP 28 for Diameter. | Meets U.S.P. 28 for diameter 861. Meets Criterion. |
| Meets USP 28 and for Tensile Strength. | Performance testing conducted in accordance with USP 28 and . Implicitly, device meets these requirements as substantial equivalence is claimed. Meets Criterion. | |
| Biocompatibility in accordance with ISO 10993 standards. | Performance testing conducted in accordance with ISO 10993 standards. Implicitly, device meets these requirements. Meets Criterion. | |
| Pliability and handling properties consistent with industry standards and predicate devices. | Performance testing characterized pliability and handling. Minor differences from predicates do not new safety/effectiveness questions. Meets Criterion. | |
| Intended Use | General soft tissue approximation and/or ligation, including ophthalmic and neurological procedures. | Indicated for use in general soft tissue approximation and/or ligation, including ophthalmic and neurological procedures. Equivalent to Predicates. |
| Design Features | Monofilament, nonabsorbable, various lengths/diameters, with/without surgical needle, dyed or undyed. | Monofilament, dyed (black), non-absorbable, available in several lengths and USP diameters, equipped with single/double high-grade stainless steel needles. Equivalent to Predicates. |
2. Sample Size for Test Set and Data Provenance
This information is not explicitly detailed in the provided summary. For a surgical suture, "testing" primarily refers to bench testing of material properties, not a clinical "test set" for diagnostic performance.
- Sample Size for Test Set: Not specified in terms of distinct patient data or a clinical "test set." Testing refers to physical samples of the suture material.
- Data Provenance: N/A for this type of physical product testing. The testing is conducted on manufactured suture product.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is N/A for this type of device. "Ground truth" in the context of AI/ML devices typically refers to expert labels on data. For surgical sutures, "ground truth" is established by adherence to recognized material and performance standards (e.g., USP monographs, ISO) and empirical testing against these standards.
4. Adjudication Method for the Test Set
N/A. Adjudication methods (e.g., 2+1, 3+1) are relevant for human interpretation of data/images to establish ground truth in diagnostic studies, not for the physical properties testing of a surgical suture.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. An MRMC study is relevant for evaluating the impact of an AI tool on the diagnostic performance of human readers. This concept does not apply to a surgical suture.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
N/A. This is a physical medical device (suture), not an algorithm or software. Its performance is inherent in its physical properties and how it functions during surgical use.
7. Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Industry and Regulatory Standards: Specific quantitative and qualitative requirements outlined in the United States Pharmacopeia (USP 28 , , ) and ISO 10993 standards for biocompatibility.
- Comparison to Predicate Devices: Demonstrating that its material composition, intended use, and technological characteristics are "substantially equivalent" to previously cleared surgical sutures. "Equivalence" serves as the functional ground truth for regulatory acceptance.
8. Sample Size for the Training Set
N/A. This device does not use an AI/ML model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set for an AI/ML model, this question is not applicable.
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide 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 monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, 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.