(230 days)
STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Devices is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
The STRATAFIX™ Spiral PDS™ Plus Bidirectional Device is an antibacterial monofilament, synthetic absorbable device consisting of dyed (violet) polyester, poly(p-dioxanone), the empirical molecular formula of which is (C4HzO3)y. The device contains IRGACARE®* MP (triclosan), a broad spectrum antibacterial agent, at no more than 2360 µg/m. The pigment for the violet dye is D&C Violet No. 2. Polydioxanone polymer has been found to be nonallergenic, nonpyrogenic and elicits only a slight tissue reaction during absorption.
The STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device consists of barbed suture material, armed with a surgical needle on each end. The STRATAFIX™ Spiral PDSTM Plus Device barbs allow for tissue approximation without the surgical knots.
Acceptance Criteria and Device Performance for STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device
This document outlines the acceptance criteria and the study that demonstrates the STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device meets these criteria. The information is extracted from the provided FDA 510(k) summary (K192144).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device are based on the USP Monograph for absorbable surgical sutures, specifically focusing on tensile strength. The claimed performance relates to meeting the knot tensile strength of equivalent non-barbed USP and EU Pharmacopoeia polydioxanone devices.
| Acceptance Criteria (USP Polydioxanone Knot Tensile Strength) | Reported Device Performance (STRATAFIX™ Spiral PDS™ Plus Bidirectional Straight Tensile Strength) | Device Size (USP/EU Pharmacopoeia) |
|---|---|---|
| USP (kgf) | USP (kgf) | EU Metric / Ph. Eur. Designation |
| 5.08 | 5.08 (meets or exceeds) | 1 / 4 |
| 3.90 | 3.90 (meets or exceeds) | 0 / 3.5 |
| 2.68 | 2.68 (meets or exceeds) | 2-0 / 3 |
| 1.77 | 1.77 (meets or exceeds) | 3-0 / 2 |
| 0.95 | 0.95 (meets or exceeds) | 4-0 / 1.5 |
| Metric / Ph. Eur. (N) | Metric / Ph. Eur. (N) | |
| 50.8 | 50.8 (meets or exceeds) | 1 / 4 |
| 39.0 | 39.0 (meets or exceeds) | 0 / 3.5 |
| 26.8 | 26.8 (meets or exceeds) | 2-0 / 3 |
| 17.5 | 17.5 (meets or exceeds) | 3-0 / 2 |
| 9.32 | 9.32 (meets or exceeds) | 4-0 / 1.5 |
Note: The device's straight tensile strength is compared to the knot tensile strength of conventional non-barbed sutures, as the barbs reduce the overall tensile strength of the barbed suture itself.
2. Sample Size and Data Provenance
The document states that "Non-clinical laboratory performance testings were performed" and "Bench and Animal testings show that the device performed as intended and as claimed." However, specific sample sizes for these tests are not provided in the given text.
- Sample Size for Test Set: Not specified.
- Data Provenance: The tests are described as "Non-clinical laboratory performance testings" and "Bench and Animal testings." This suggests the data is likely generated in a controlled laboratory environment. The country of origin of the data is not explicitly mentioned, but given the submitter (Ethicon, Inc., New Jersey, USA) and the FDA submission, it is likely that parts of these studies were conducted in the USA or by facilities adhering to US regulatory standards. The tests are prospective in nature, as they are conducted to demonstrate compliance with standards for device clearance.
3. Number and Qualifications of Experts for Ground Truth
This information is not applicable and not provided in the given text. The evaluation of this device relies on objective physical property measurements (tensile strength, diameter, etc.) and animal studies. It does not involve human expert interpretation for establishing a "ground truth" in the way an AI diagnostic device would.
4. Adjudication Method
This information is not applicable and not provided in the given text, as the "ground truth" for this device is established through objective physical measurements and animal model observations, not through human expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret images or data, often with and without AI assistance, to assess the AI's impact on human performance. The STRATAFIX™ device is a surgical suture, and its performance is evaluated through physical and biological testing, not through human interpretation of cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This information is not applicable and not provided in the given text. The STRATAFIX™ device is a physical surgical suture, not an algorithm, and therefore does not have a "standalone" algorithmic performance.
7. Type of Ground Truth Used
The ground truth for evaluating the STRATAFIX™ Spiral PDS™ Plus Bidirectional Knotless Tissue Control Device is based on:
- Objective Physical Measurements: Adherence to the USP Monograph for absorbable surgical sutures for properties such as tensile strength (specifically, meeting the knot tensile strength of equivalent non-barbed sutures) and general characteristics (except for diameter, which has minor variations acceptable by the manufacturer).
- Animal Testing: Demonstration that the "device performed as intended and as claimed" in animal models.
8. Sample Size for the Training Set
This information is not applicable and not provided in the given text. As a physical medical device (suture) rather than a machine learning algorithm, there is no "training set" in the context of data-driven model development. The development process would involve materials science and engineering principles, with testing conducted to optimize design and verify performance.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided in the given text. As there is no "training set" for this physical device, there is no ground truth established in that context. Device development and testing rely on established engineering standards and biological effects, not on a machine learning training paradigm.
§ 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.