(311 days)
The APTOS Threads - Polypropylene Surgical Sutures are indicated for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.
APTOS Threads - Polypropylene Surgical Sutures are a dyed, nonabsorbable, sterile surgical strand of polypropylene in USP size 2-0. The base product is an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is dyed blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility; the colorant meets all requirements of US 21CFR, Parts 70-82. There is no coating or any other additives. The threads incorporate a bidirectional barbed design. The threads are supplied with needles attached to both ends. The thread's upper and lower anchoring sections are barbed in opposite direction with a small unbarbed section between them and two smooth unbarbed sections, each immediately adjacent to needle-thread attachment interfaces. The needles are constructed from 420B stainless steel. The needles are provided sterile via Ethylene Oxide sterilization.
This document describes the premarket notification for APTOS Threads - Polypropylene Surgical Sutures. As a medical device, the acceptance criteria and supporting studies focus on demonstrating its substantial equivalence to a legally marketed predicate device (FilBloc Permanent Sutures, K171039) rather than on specific diagnostic performance metrics of an AI algorithm.
Therefore, the requested information on AI-specific criteria, sample sizes for test/training sets for AI, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable in this context.
The acceptance criteria for this device are based on its physical properties, biocompatibility, and sterility, ensuring it functions similarly and as safely as existing sutures.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (APTOS Threads) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 and FDA Guidance (specifically ISO 10993-5, -10, -11, -6, -4; ASTM F756-17; OECD 471, 487, 476; USP) | Biocompatibility testing was performed in accordance with ANSVAAMI/ISO 10993-1:2009/(R)2013 and FDA's 2016 guidance document. All specific tests (Cytotoxicity, Sensitization, Irritation, Acute systemic Toxicity, Materials Mediated Pyrogenicity, Implantation, Hemocompatibility, Subchronic Toxicity, Genotoxicity, Bacterial Endotoxin Test) were conducted and results demonstrated the device is biocompatible. |
| Physical Testing | USP Suture Diameter | Compliance with USP suture diameter was established through physical testing. |
| USP Suture Attachment | Compliance with USP suture attachment was established through physical testing. | |
| USP Tensile Strength | Compliance with USP tensile strength was established through physical testing. | |
| Tissue Holding Strength | Adequate tissue holding strength comparable to the predicate device. | Ex-vivo tissue holding strength testing was conducted and compared to the predicate device to demonstrate substantially equivalent tissue holding strength. |
| Sterility | Ethylene Oxide Sterilization with a Sterility Assurance Level (SAL) of 10⁻⁶ | Ethylene Oxide sterility validation testing was conducted in accordance with overkill half-cycle methods per ISO 11135:2014, demonstrating an SAL of 10⁻⁶. Residuals were evaluated in accordance with ANSI/AAMI/ISO 10993-7:2008/(R) 2012. |
| Shelf Life | Maintenance of package integrity and seal strength after environmental preconditioning and distribution simulation. | Shelf life testing involved package integrity and seal strength testing subsequent to environmental preconditioning and distribution simulation, in accordance with AAMI/ISO 11607-1: 2006 (R) 2010, ASTM D4169-16, ASTMF88/F88M-15, and ASTM F2096-11. (Results are implied to be satisfactory for clearance). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture, which does not involve "test sets" in the context of AI performance evaluation. The "testing" refers to laboratory and ex-vivo studies on the material and mechanical properties of the suture.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture. Ground truth in this context is established through standardized laboratory testing protocols, not expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture. Adjudication methods are relevant for subjective interpretations, which are not part of the physical and biological 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
This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture. This type of study relates to AI-assisted diagnostic tools and human reader performance, not physical medical devices like sutures.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical surgical suture, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device, in essence, is established through:
- Standardized Material Specifications: Polypropylene material and dye complying with US 21CFR, Parts 70-82.
- USP Standards: Compliance with United States Pharmacopeia (USP) standards ( suture diameter, suture attachment, tensile strength).
- ISO Standards: Compliance with ISO 10993 series for biocompatibility and ISO 11135 for sterilization.
- ASTM Standards: Compliance with relevant ASTM standards for hemocompatibility (F756-17) and shelf life testing (D4169-16, F88/F88M-15, F2096-11).
- Ex-vivo Comparative Performance: Direct comparison of tissue holding strength to a legally marketed predicate device.
These standards and comparative studies serve as the "ground truth" to demonstrate that the device is safe and effective for its intended use and substantially equivalent to predicate devices.
8. The sample size for the training set
This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture, which does not involve "training sets" in the context of AI.
9. How the ground truth for the training set was established
This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture.
§ 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.