(31 days)
HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.
The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles.
This submission is for a medical device (HS Fiber surgical suture) and not an AI/ML powered device, therefore most of the requested information cannot be extracted from the text. The document describes the device, its intended use, and its substantial equivalence to a previously cleared predicate device.
However, based on the provided text, here is the information related to the acceptance criteria and performance data for the device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| United States Pharmacopeia (USP) requirements | Meets USP performance requirements |
| USP performance requirements for needle attachment | Tested per USP performance requirements for needle attachment |
| USP performance requirements for tensile strength | Tested per USP performance requirements for tensile strength |
| Endotoxin quantities below recommended limits outlined in FDA Guidance "Pyrogens and Endotoxins Testing: Questions and Answers" | LAL endotoxin quantification assessments demonstrate endotoxin quantities below recommended limits |
| Biological evaluation per ISO 10993-1:2018 - Biological Evaluation of Medical Devices | Materials used were evaluated per ISO 10993-1:2018 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes used for the testing. It generally states that the device "meets requirements" and "is tested," but doesn't provide specific numbers of units tested. The provenance of the data is not mentioned (e.g., country of origin, retrospective/prospective).
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 is not applicable as the submission is for a physical medical device (suture) and not an AI/ML powered device that would require expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the submission is for a physical medical device (suture). Testing involved adherence to established physical and biological standards, not image or data interpretation requiring adjudication.
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 is not applicable as the submission is for a physical medical device (suture) and not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the submission is for a physical medical device (suture).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is based on established, objective, and quantitative performance standards set by:
- United States Pharmacopeia (USP) standards for physical properties like tensile strength and needle attachment.
- ISO 10993-1:2018 (Biological Evaluation of Medical Devices) for biocompatibility.
- FDA Guidance "Pyrogens and Endotoxins Testing: Questions and Answers" for endotoxin levels.
8. The sample size for the training set
This is not applicable as the submission is for a physical medical device (suture) and not an AI/ML powered device that requires a training set. The device is manufactured according to specifications and tested for compliance.
9. How the ground truth for the training set was established
This is not applicable as the submission is for a physical medical device (suture) and not an AI/ML powered 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.