(90 days)
The PERMALOOP Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue.
The PERMATAPE Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue.
The PERMATAPE™ Suture is a 1.3mm wide, synthetic, sterile, flat braided suture composed of dyed and un-dyed (chromium cobalt aluminum oxide
This document describes the FDA's 510(k) clearance for the PERMALOOP Suture and PERMATAPE Suture, which are non-absorbable polyethylene surgical sutures. The information provided focuses on the substantial equivalence to predicate devices rather than a standalone clinical study with detailed acceptance criteria and performance metrics for a specific algorithm or AI.
Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable as this isn't a submission for an AI-powered diagnostic device but a traditional medical device (surgical suture).
However, I can extract the available information regarding testing and performance for the sutures.
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like sutures, the "acceptance criteria" are typically defined by recognized standards and guidelines, and "device performance" is demonstrated through compliance with these standards.
| Acceptance Criteria / Test Standard | Reported Device Performance |
|---|---|
| USP Tensile Strength for Surgical Sutures | Performance demonstrated as suitable for intended use. |
| USP Needle Attachment Strength for Surgical Sutures | Performance demonstrated as suitable for intended use. |
| USP Diameter and Size Classification | Does not conform due to flat braiding (identified as non-significant difference from predicate). |
| Ethylene Oxide Sterilization (ANSI/AAMI/ISO 11135: 2014) | Validated to a SAL of 1 x 10^-6. |
| EO Residuals (AAMI/ANSI/ISO 10993-7:2008) | Tested and compliant. |
| Non-pyrogenicity (ANSI/AAMI ST-72:2011, USP, EP using BET method) | Determined to be non-pyrogenic. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes for each physical and chemical test mentioned (e.g., how many sutures were tested for tensile strength or how many batches for sterilization validation).
- Data Provenance: The studies were non-clinical (laboratory testing) performed by the manufacturer, Medos International SARL / DePuy Synthes Mitek Sports Medicine.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. For physical device testing, "ground truth" is established by adherence to recognized engineering and material science standards, not by expert consensus in the same way as, for example, image interpretation.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods are typically relevant for human-in-the-loop studies or ground truth establishment based on expert disagreement, which is not the case here.
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 not an AI-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The performance testing described is "standalone" for the device, meaning it evaluates the physical and chemical properties of the suture itself. However, this is not an algorithm, so the term doesn't apply in the common AI/algorithm context.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing of the PERMALOOP and PERMATAPE Suture is established by:
- Performance Standards: Adherence to established standards such as USP (United States Pharmacopeia) for tensile strength and needle attachment strength.
- Sterilization Standards: Compliance with international standards like ANSI/AAMI/ISO 11135 for Ethylene Oxide Sterilization.
- Biocompatibility/Safety Standards: Compliance with standards for EO residuals (AAMI/ANSI/ISO 10993-7) and non-pyrogenicity (ANSI/AAMI ST-72, USP, EP).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. The design, materials, and manufacturing processes are based on established engineering principles and prior validated devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is not an AI/machine learning device.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; 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.