Search Results

The synthetic absorbable surgical sutures OPTIME® and SINUSORB® PGA are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery; but not for use in cardiovascular and neurological surgery.

OPTIME® and SINUSORB® PGA are synthetic absorbable braids composed of homopolymer of glycolic acid and coated with epsilon-caprolactone and calcium stearate or a mixture composed of polycaprolacton, calcium stearate and fatty acid ester. These surgical sutures are available undyed or violet dyed with an FDA approved color additive: D&C violet nº2, CI 60725. The suture may be provided with or without a standard needle attached.

The provided document is a 510(k) premarket notification for a medical device (surgical sutures) and does not contain information regarding studies with acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

Instead, it focuses on demonstrating substantial equivalence to a predicate device (Coated VICRYL™ (POLYGLACTIN 910) Suture) through non-clinical laboratory testing.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The device's performance was evaluated against the requirements of the United States Pharmacopoeia (USP) Monographs and the European Pharmacopoeia (EP) Monographs for Absorbable surgical sutures.
• Reported Device Performance: The document states, "Non-clinical laboratory testing was performed demonstrating that the device complied with the USP Monographs and with the EP Monographs for Absorbable surgical sutures."

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

• Sample Size: Not specified. The document only mentions "non-clinical laboratory testing" without detailing the number of units tested.
• Data Provenance: Not explicitly stated beyond "non-clinical laboratory testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. Ground truth in this context would likely refer to established pharmacopoeia standards, not human expert consensus.

4. Adjudication method for the test set:

• Not applicable/Not provided. Compliance with pharmacopoeia standards typically involves laboratory testing against defined physical and chemical properties, not human 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:

• Not applicable. This document is for a physical medical device (sutures), not an AI/software 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 document is for a physical medical device (sutures), not an AI/software algorithm.

7. The type of ground truth used:

• Ground Truth: Pharmacopoeia standards (United States Pharmacopoeia (USP) Monographs and European Pharmacopoeia (EP) Monographs for Absorbable surgical sutures).

8. The sample size for the training set:

• Not applicable. This is not an AI/software device that requires a training set. The "new device" is compared to a "predicate device" and its performance against pharmacopoeia standards is established through non-clinical testing.

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

• Not applicable. As above, this is not an AI/software device.

Ask a specific question about this device