(497 days)
HS Fiber Cerclage sutures are indicated for use in general soft tissue approximation and/or ligation. These sutures may be used in cardiovascular surgeries, and orthopedic surgeries using allograft tissue. When used as a bone fixation cerclage, the sutures are intended for:
- · Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring.
- · Repair of long bone fracture due to trauma or reconstruction.
The Riverpoint Medical HS Fiber® Cerclage 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 Cerclage sutures are available in common sizes and lengths with or without pre-attached needles. Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.
Here's a breakdown of the acceptance criteria and study information for the Riverpoint Medical HS Fiber® Cerclage, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Material Properties | Suture Material | Multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together. |
| Sterilization | Sterilized by ethylene oxide gas. Meets EN ISO14937:2009. | |
| Biocompatibility | Meets ISO 10993-1:2018. | |
| Device Performance | Needle Attachment | Meets USP performance requirements. |
| Tensile Strength | Meets USP performance requirements. Performed comparably to the predicate device. | |
| Knot Strength | Tested. No specific numerical performance provided, but "met all requirements for its intended use." | |
| Fatigue Strength | Performed comparably to the predicate device. | |
| Creep | Performed comparably to the predicate device. | |
| Wear Debris | Performed comparably to the predicate device. Particle analysis performed. | |
| Packaging & Stability | Product & Packaging Stability | Meets ISO 11607-1:2019. |
| Human Factors/Usability | Usability Validation | Met all acceptance criteria per EN62366-1: 2015. |
| Regulatory Compliance | USP Requirements | Meets USP requirements for non-absorbable suture, except for diameter. |
| FDA Guidance Compliance | Followed "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not explicitly state the sample sizes used for each specific test set. It broadly mentions tests performed, but not the number of units or samples involved in, for example, the tensile strength or fatigue strength testing.
Regarding data provenance, the study appears to be non-clinical, laboratory-based testing conducted by the manufacturer, Riverpoint Medical, LLC. No information is given about the country of origin of the data beyond the manufacturer's location in Portland, Oregon, USA. The studies are retrospective in the sense that they are conducted on manufactured devices as part of the submission process, not on a prospective cohort of patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the studies described are non-clinical, mechanical, and material characteristic tests, not studies requiring expert interpretation of medical images or patient data to establish a ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
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
An MRMC comparative effectiveness study was not done. The device is a physical medical device (suture) and not an AI/software-based medical device that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study was not done. Again, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance studies were:
- Established standards and specifications: United States Pharmacopeia (USP) requirements for sutures (primarily for needle attachment and tensile strength), and various ISO and EN standards for sterilization, biocompatibility, packaging, and usability.
- Predicate device performance: Comparative testing was conducted against a predicate device (Arthrex FiberTape Cerclage - K170206) to demonstrate comparable performance in areas like tensile strength, fatigue strength, creep, and wear debris.
8. The Sample Size for the Training Set
This information is not applicable as there is no "training set" for this type of physical medical device. The device is manufactured based on design specifications and then tested against these specifications and regulatory standards.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.