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HS Fiber® Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, and the use of allograft tissue 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. HS SutureTape is a flat braid configuration of the HS Fiber suture.

The provided document is a 510(k) summary for a medical device called HS SutureTape. This type of document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on comparing the new device to the predicate device and establishing substantial equivalence rather than presenting an independent study to prove the device meets specific acceptance criteria in a clinical setting.

Therefore, the document does NOT contain the detailed information typically found in a clinical study report addressing acceptance criteria for device performance as a standalone product. It instead focuses on performance data that demonstrates compliance with recognized standards.

Here's an attempt to answer your questions based on the available information, with clear notes where the information is absent:

1. A table of acceptance criteria and the reported device performance

   Acceptance Criteria	Reported Device Performance
   Compliance with United States Pharmacopeia (USP) requirements for surgical sutures (general standards)	"The Riverpoint Medical HS Fiber Sutures meet requirements established by the United States Pharmacopeia." The HS SutureTape (the new device) is also "tested per USP performance requirements for tensile strength, needle and attachment." This implies the HS SutureTape also meets these requirements.
   USP performance requirements for needle attachment	The HS Fiber sutures and HS SutureTape are "tested per USP performance requirements for needle attachment." This implies compliance, though specific quantitative results are not provided.
   USP performance requirements for tensile strength	The HS Fiber sutures and HS SutureTape are "tested per USP performance requirements for tensile strength." This implies compliance, though specific quantitative results are not provided.
   Biological Evaluation of Medical Devices (ISO 10993-1:2009)	"Materials used were evaluated per ISO 10993-1:2009 - Biological Evaluation of Medical Devices." This indicates that the materials (UHMWPE) used in the suture are biocompatible according to this standard.
   Endotoxin quantities (per FDA Guidance "Pryogens and Endotoxins Testing: Questions and Answers")	"Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments, both process validation and routine testing, demonstrate endotoxin quantities below the recommended limits outlined in FDA Guidance 'Pryogens and Endotoxins Testing: Questions and Answers.'"
   Pyrogenicity (Rabbit pyrogenicity assessments)	"Rabbit pyrogenicity assessments were also performed on a manufacturing process-validation basis with periodic determinations." This implies the device meets pyrogenicity limits, though specific results or quantitative acceptance criteria are not detailed beyond "periodic determinations" and "process-validation basis."
   Substantial Equivalence to Predicate Device (K100006 – Riverpoint Medical HS Fiber)	"The HS SutureTape line extension is substantially equivalent to the previously cleared HS Fiber Sutures. The HS SutureTape has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device... These differences do not raise new questions of safety or effectiveness, therefore the HS SutureTape line extension is substantially equivalent to the currently marketed predicate device." This is the overarching "acceptance criteria" for a 510(k) submission. Specific performance data demonstrating this equivalence (e.g., side-by-side comparison of tensile strength values for both devices) are not provided in this summary, but would have been part of the full 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Sample Size for Test Set: Not specified. The document only states that the sutures are "tested per USP performance requirements" and that "LAL endotoxin quantification assessments" and "Rabbit pyrogenicity assessments" were performed. The specific number of samples for these tests is not provided in this summary.
   • Data Provenance: Not specified. The tests are general performance tests and not clinical data. The location where these tests were conducted is not mentioned.
   • Retrospective or Prospective: Not applicable as these are laboratory and bench testing, not clinical studies in humans.

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)

   • Not applicable. This document describes a medical device's technical and safety performance through laboratory and bench testing against recognized standards (USP, ISO, FDA guidance), not a diagnostic device requiring expert interpretation of results or establishing "ground truth" through expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. This pertains to expert review in diagnostic assessments, which is not relevant for the type of testing described here.

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

   • No. This is a surgical suture, not a diagnostic imaging device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This device does not involve algorithms or AI. It is a physical medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

   • Not applicable. For this type of device, "ground truth" is established by compliance with predefined, objective engineering and material science standards (e.g., a specific tensile strength value, a certain level of biocompatibility, endotoxin limits). The "ground truth" for showing safety and effectiveness is largely based on meeting these established performance criteria from USP, ISO, and FDA guidance documents.

8. The sample size for the training set

   • Not applicable. There is no "training set" as this is not an AI/machine learning device. The document describes the materials and performance characteristics of a physical suture.

9. How the ground truth for the training set was established

   • Not applicable. See explanation for #8.

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