(36 days)
MonoTex PTFE surgical suture is indicated for use In general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. MonoTex PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues.
MonoTex PTFE suture is provided sterile as a single use device.
MonoTex Polytetrafluoroethylene (PTFE) nonabsorbable surgical sutures are medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury. MonoTex PTFE sutures are monofilament, and are composed of expanded polytetrafluoroethylene material attached to a standard medical grade suture needle as applicable (sutures can be provided without needles as well). Available Suture sizes will be standard according to USP requirements (6/0 through 5).
The provided document describes a 510(k) premarket notification for the Riverpoint Medical MonoTex PTFE Suture. This is a medical device, not an AI/ML algorithm, and as such, the acceptance criteria and study detailed in the document are for a traditional medical device's safety and effectiveness, primarily through demonstrating "substantial equivalence" to a predicate device.
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, training set sample size, how ground truth for training set was established) are not applicable to this type of device submission based on the provided text, as they pertain specifically to the evaluation of AI/ML algorithms.
Here's a breakdown of the information that is available or can be inferred, along with an explanation for the inapplicable sections:
Acceptance Criteria and Device Performance for MonoTex PTFE Suture
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Description & Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Meets USP requirements for "diameter, tensile strength, and needle attachment strength" for nonabsorbable sutures. | "MonoTex PTFE sutures have been designed to meet the requirements for diameter, tensile strength, and needle attachment strength as specified per USP unless stated otherwise on labeling." |
| "All testing performed has demonstrated that MonoTex PTFE sutures are as safe and effective as the predicate, will meet current performance requirements for nonabsorbable surgical sutures unless stated otherwise in labeling..." | ||
| Material Biocompatibility | Biocompatibility testing in accordance to ISO 10993-1. | "biocompatibility testing of the suture material in accordance to ISO 10993-1 has been performed..." |
| "Materials used were selected based on known biocompatibility and established histories of use in the medical device industry for implantable devices, and are identical or substantially equivalent to the materials used in the predicate devices listed." | ||
| Substantial Equivalence | The device must be deemed "substantially equivalent" to a legally marketed predicate device (K072076 - Cytoplast PTFE Suture). | "MonoTex PTFE nonabsorbable sutures have been designed and manufactured to be substantially equivalent to the prodicate device listed for safety and effectiveness." |
| "MonoTex PTFE sutures within this submission have substantially equivalent technological characteristics as the predicate device listed." | ||
| "Riverpoint Medical concludes that the proposed MonoTex PTFE sutures are substantially equivalent to the predicate devices listed according to the requirements of the Federal Food, Drug, and Cosmetic Act." | ||
| Sterility | Provided sterile as a single-use device. | "MonoTex PTFE suture is provided sterile as a single use device." |
| "MonoTex PTFE sutures are provided sterile for one-time use only..." | ||
| Intended Use Compatibility | Indicated for general soft tissue approximation and/or ligation (cardiovascular, dental, general surgery, dura mater repair). Not for microsurgery, ophthalmic, or peripheral neural tissues. | The stated Indications for Use match the intended use the device was tested against and found "substantially equivalent" for. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided for an AI/ML algorithm. The document describes performance testing for a physical medical device (suture) against established standards (USP, ISO). It does not involve a "test set" in the context of an AI/ML algorithm's evaluation with patient data. The testing would involve a sufficient number of suture samples to demonstrate compliance with the mechanical and biocompatibility standards. The specific number of samples for each test (e.g., tensile strength, needle attachment) is not provided in this summary. Data provenance is not relevant in the context of material and mechanical testing of a manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided for an AI/ML algorithm. Ground truth, in the AI/ML sense (e.g., expert annotation of medical images), is not relevant here. The "ground truth" for this device is established by international standards (USP for mechanical properties, ISO for biocompatibility) and the performance of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided for an AI/ML algorithm. Adjudication methods are used in AI/ML studies to resolve discrepancies among expert annotators. This is not pertinent to the mechanical and biocompatibility testing of a physical medical device.
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. An MRMC study is relevant for evaluating the clinical impact of an AI algorithm on human reader performance, typically in diagnostic imaging. This document describes a physical surgical suture, not an AI/ML system.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Not Applicable. This question relates to the independent performance of an AI algorithm. The MonoTex PTFE Suture is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Standards and Predicate Device Performance: The "ground truth" for this device's performance is compliance with established industry standards (e.g., USP monographs for surgical sutures, ISO 10993-1 for biocompatibility) and demonstrated equivalence to a legally marketed predicate device (K072076 Cytoplast PTFE Suture) which has already proven its safety and effectiveness.
8. The sample size for the training set
- Not Applicable / Not Provided for an AI/ML algorithm. The concept of a "training set" applies to AI/ML algorithms. For this physical device, raw materials are sourced, and manufacturing processes are controlled to produce the final suture. The "training" for such a device is the robust design and manufacturing process itself, based on established scientific principles and existing standards.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided for an AI/ML algorithm. As with the "training set" concept, this question is specific to AI/ML. The "ground truth" for the design and manufacturing of the suture is based on known material properties, engineering principles, and the specific requirements outlined in USP standards.
§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(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.