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OPTIME® R sutures are intended for use in general soft tissue approximation including ophthalmic procedures, but not in cardiovascular or neurological procedures.

OPTIME®R sutures are intended to be used in suturing in open or laparoscopic surgery. These sutures are available with a disposable needle attachment. OPTIME®R is a sterile, multiple-stranded (multifilament), synthetic bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) used in suturing when short-term support and rapid strength loss are needed. To perform suturing on soft tissue wounds involves a series of precise steps. The surgeon grasps the needle, pushes it through tissue, pulls it through and repeats for continuous suturing. Further, knots are tied, excess thread is cut, and used needles are single use and safely disposed in accordance with hospital procedure.

The provided text is an FDA 510(k) Pre-Market Notification for a medical device called OPTIME® R, which is an absorbable surgical suture. The document primarily focuses on establishing substantial equivalence to a predicate device (Safil Quick Aesculap, K031286) based on technological characteristics and performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

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

The document states that the OPTIME® R suture was subjected to the requirements of the United States Pharmacopeia (U.S.P) monograph for Synthetic Absorbable Sutures. The following tests and their corresponding USP standards are mentioned:

Specific details about the exact numerical acceptance criteria (e.g., minimum tensile strength in Newtons, acceptable diameter range in mm) are not explicitly provided in this document beyond stating compliance with USP standards. The document broadly indicates that the device "meets USP performance requirements."

2. Sample size used for the test set and the data provenance:

• The document does not specify the sample sizes used for the Diameter, Tensile Strength, Needle Attachment, Length, or Resorption testing.
• The data provenance is from Peters Surgical, a French company (Immeuble Aurélium, 1 course de l'Ile Seguin, Boulogne-Billancourt, Hauts-De-Seine 92100 France). The studies appear to be prospective testing conducted by the manufacturer to demonstrate compliance. There is no mention of country of origin of the data beyond the manufacturer's location.

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 information is not applicable in this context. The "ground truth" for a medical device like a surgical suture is established by objective engineering and biological performance standards (USP, ISO) rather than expert consensus on interpretation. There are no images or subjective assessments involved that would require expert adjudication or establishing ground truth in the way it's typically described for AI/diagnostic devices.

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

• This is not applicable. As mentioned above, the tests are objective measurements against predefined standards. There is no subjective assessment 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. OPTIME® R is an absorbable surgical suture, a physical medical device, not an AI or diagnostic software. Therefore, MRMC studies are not relevant.

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

• This is not applicable. OPTIME® R is a physical surgical suture, not an algorithm or AI product.

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

• The "ground truth" for this device's performance is based on established national and international standards for absorbable sutures. Specifically:
  • United States Pharmacopeia (USP) monographs for physical and mechanical properties (Diameter, Tensile Strength, Needle Attachment, Length).
  • ISO 10993 series for biocompatibility (Cytotoxicity, Sensitization, Irritation, Material mediated pyrogenicity, Acute Systemic Toxicity, Sub-acute/sub-chronic Toxicity, Genotoxicity, Chemical characterization and toxicological risk assessment, Implantation, Degradation).
  • Resorption time is a characteristic feature verified against the predicate and established through testing.

8. The sample size for the training set:

• This is not applicable. There is no "training set" as this is a physical device, not a machine learning model.

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

• This is not applicable for the same reason as point 8.

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