(30 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.
The provided document is a 510(k) summary for the Riverpoint Medical HS Fiber Suture, a non-absorbable surgical suture. It details the device, its intended use, and comparative performance data against a predicate device to establish substantial equivalence for FDA clearance.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the HS Fiber Sutures meet requirements established by the United States Pharmacopeia (USP) for needle attachment and tensile strength. However, specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons, or specific detachment forces for needle attachment) and the reported device performance values against these criteria are not explicitly provided in this summary. Instead, it makes a general statement of compliance.
| Acceptance Criteria (Based on USP) | Reported Device Performance |
|---|---|
| Needle Attachment: Meets USP requirements | Meets USP requirements (Specific values not provided) |
| Tensile Strength: Meets USP requirements | Meets USP requirements (Specific values not provided) |
| Material Biocompatibility: Per ISO 10993-1:2009 | Evaluated and found acceptable (Specific test results not provided) |
| Endotoxin Quantities: Below recommended limits per FDA Guidance | Demonstrated to be below recommended limits (Specific values not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance tests (e.g., for needle attachment or tensile strength).
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, given that it's a 510(k) submission to the FDA, the testing would have been conducted to international and U.S. standards. The tests are prospective in nature, as they are performed to demonstrate product quality and compliance for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission, as the device is a surgical suture, not a diagnostic or AI-driven decision support system that requires expert consensus for ground truth. The "ground truth" here is objective physical and biological properties measured according to established standards (USP/ISO).
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or studies where human interpretation or assessment is involved, often in diagnostic imaging or clinical endpoints. This is not applicable to the performance testing described for a surgical suture, which involves objective, standardized laboratory measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable to this device. This type of study is used to assess the change in human reader performance (e.g., radiologists, pathologists) when aided by an AI algorithm, compared to reading without AI. The HS Fiber Suture is a surgical implant, not an diagnostic or AI-assisted device.
6. Standalone Performance Study (Algorithm Only)
A standalone performance study of an algorithm is not applicable to this device. The HS Fiber Suture is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the HS Fiber Suture is based on objective, standardized measurements of physical and biological properties. This includes:
- USP Performance Requirements: For metrics like tensile strength and needle attachment.
- ISO 10993-1:2009: For biological evaluation (biocompatibility).
- FDA Guidance on Pyrogens and Endotoxins Testing: For endotoxin quantification.
These are established scientific and regulatory standards that define acceptable performance for such devices.
8. Sample Size for the Training Set
This concept is not applicable to this device. "Training set" refers to data used to train machine learning algorithms. The HS Fiber Suture is a physical medical device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" and its associated ground truth is not applicable to this device. The "ground truth" for demonstrating the safety and effectiveness of the suture is established through adherence to recognized manufacturing quality standards and performance specifications, as defined by organizations like USP and ISO.
§ 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.