(106 days)
MonoMax absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
The Aesculap® MonoMax Absorbable Sutures are sterile, monofilament, absorbable surgical sutures constructed of poly-4-hydroxybutyrate. The MonoMax sutures will be offered in sizes 2, 1, 0, 2-0, 3-0, 4-0, and 5-0. The sutures will be available in a variety of cut lengths with or without needles attached. The sutures will be available undyed, and dyed with the FDA approved colorant D&C Violet No.2 in accordance with Title 21 CFR, 74.3602.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical testing: must meet USP 28 standards | All specifications were met apart from diameter. |
| Biocompatibility testing: must meet ISO 10993-1 standards | All specifications were met. |
| Resorption profile: demonstrated through animal testing | All specifications were met. |
| Diameter | Not met (implied by "apart from diameter"). The text doesn't specify the accepted diameter range or the actual performance. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample size for the test set used in this specific submission (K100876).
However, it states: "Please reference K082178 for performance data, which were collected by Tepha, Inc. for the predicate device, that were used to support the substantial equivalence of the MonoMax suture device." This indicates that the performance criteria were met by relying on data from a predicate device (TephaFLEX® Absorbable Suture, K082178/K081099/K052225).
- Sample Size for Test Set: Not specified in this document.
- Data Provenance: The performance data was collected by Tepha, Inc. for the predicate device. The country of origin and retrospective/prospective nature of that data are not mentioned in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document describes a medical device (suture) and its performance is evaluated against technical specifications (USP 28, ISO 10993-1, animal testing for resorption profile), not against a 'ground truth' established by medical experts in the way that, for example, an AI diagnostic tool would be. Therefore, this information is not applicable to this type of device and study.
4. Adjudication Method for the Test Set
As mentioned above, this study evaluates technical specifications of a physical device. There is no mention of an adjudication method as it would apply to expert review of a "test set" in the context of diagnostic or interpretive tasks. The "adjudication" is essentially the determination of whether the device meets the predefined technical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is focused on demonstrating the technical performance of a medical device (suture) against established standards, not on evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this refers to a physical medical device (suture), not an algorithm or AI. Therefore, the concept of "standalone performance" in the context of AI is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established industry and regulatory standards:
- USP 28 (United States Pharmacopeia) for mechanical testing.
- ISO 10993-1 (International Organization for Standardization) for biocompatibility.
- Animal testing for the resorption profile.
The "ground truth" is whether the device's physical and biological properties meet these pre-defined, quantitative standards.
8. The Sample Size for the Training Set
This document describes a performance evaluation of a physical medical device (suture) against predefined specifications, not an AI model. Therefore, the concept of a "training set" does not apply.
9. How the Ground Truth for the Training Set Was Established
As stated above, the concept of a "training set" is not applicable here. The ground truth for this device's performance is the adherence to established technical standards.
§ 878.4494 Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
(a)
Identification. An absorbable poly(hydroxybutyrate) surgical suture is an absorbable surgical suture made of material isolated from prokaryotic cells produced by recombinant deoxyribonucleic acid (DNA) technology. The device is intended for use in general soft tissue approximation and ligation.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Absorbable Poly(hydroxybutyrate) Surgical Suture Produced by Recombinant DNA Technology.” For the availability of this guidance document see § 878.1(e).