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Sharpoint® Coated FAST ABSORBING™ PolyGlycolic Acid suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa where only short-term wound support (7-10 days) is required. Coated FAST ABSORBING PolyGlycolic Acid suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Suture is a synthetic absorbable braided, sterile, surgical suture composed of a homopolymer of Glycolic Acid. The suture material is coated with a copolymer of Polycaprolactone and PolyGlycolic Acid. The substances contained in the coating and suture are noncollagenous and nonantigenic.

This document is a 510(k) Summary for a surgical suture, which is a medical device. The information provided heavily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with defined acceptance criteria and performance metrics for a diagnostic or AI-driven device.

Therefore, many of the requested categories for AI/diagnostic device studies (like MRMC studies, ground truth establishment for training sets, number of experts for ground truth, adjudication methods) are not applicable or cannot be extracted from this type of regulatory submission. The "study" here is a set of physical and animal tests to show the suture meets performance standards and is biocompatible.

Here's the information that can be extracted and a clear indication of what is not applicable:

Acceptance Criteria and Device Performance

• U.S.P. 24, Sutures - Diameter
• U.S.P. 24, Sutures - Needle Attachment
• U.S.P. 24, Tensile Strength | Physical testing was conducted on the device to USP 24, including Sutures - Diameter, Sutures- Needle Attachment, and Tensile Strength (implies conformance, as this is a 510(k) approval). |
  | Biocompatibility | Conformance to ISO 10993 for biocompatibility. | Animal testing was performed for conformance to ISO 10993 for biocompatibility. |
  | Implant Performance | Demonstration of rates of tensile strength and mass loss (consistent with absorbable suture expectations). | Animal implant studies were performed to demonstrate rates of tensile strength and mass loss. |
  | Substantial Equivalence | Similar in intended use, materials, design, and performance characteristics to the Ethicon VICRYL Rapide Synthetic Absorbable Surgical Suture (K944110). | The FDA concluded the device is substantially equivalent to the Predicate Device. |

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated as a number of "samples" in a traditional diagnostic sense. Instead, "physical testing was conducted" and "animal testing was performed." The number of sutures tested or animals used is not specified.
   • Data Provenance: The testing was conducted by the manufacturer, Surgical Specialties Corporation. The location of the animal testing is not specified, but it would have been part of preclinical testing required for regulatory submission. This would be considered prospective testing for the purpose of this submission.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not Applicable. For a surgical suture, "ground truth" as typically defined for diagnostic or AI devices (e.g., disease diagnosis) is not relevant. The "truth" is established by adherence to physical standards (USP 24) and biological responses (ISO 10993), which are objectively measured.

3. Adjudication Method for the Test Set:

   • Not Applicable. There was no human adjudication process involved as the "test set" consists of physical and biological measurements against established standards.

4. 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:

   • Not Applicable. This is a surgical suture, not a diagnostic or AI-assisted device for human readers.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not Applicable. This is a physical medical device (suture), not an algorithm or AI system.

6. The Type of Ground Truth Used:

   • For physical properties (diameter, needle attachment, tensile strength): Established industry standards and monographs (USP 24).
   • For biocompatibility and implant studies: Established international medical device standards (ISO 10993) and biological response measurements (rates of tensile strength and mass loss in animal models).

7. The Sample Size for the Training Set:

   • Not Applicable. There is no "training set" in the context of a physical medical device like a suture, as it does not involve machine learning or pattern recognition.

8. How the Ground Truth for the Training Set was Established:

   • Not Applicable. (See point 7).

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