Search Results

The Saph-Loop™ Ligating Loop is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Saph-LOOP is the addition of a means for deployment of a length of Tevdek™ suture with a pre-tied knot for ligation of conduit in minimally invasive and general procedures, particularly conduit harvesting procedures. The deployment device consists of a long tube carier with an offset tip at the distal end, a handle and a pull ring at the proximal end.

The provided text is a 510(k) summary for the Saph-Loop™ Ligating Loop, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information cannot be extracted directly from this document.

Here's an analysis based on the available information:

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

This information is not provided in the document. 510(k) summaries for devices like sutures often rely on comparison to a predicate and adherence to recognized standards, rather than defining specific performance metrics and acceptance thresholds for a new clinical study. The device is a variation of an existing suture with a new deployment mechanism.

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

This information is not provided. As this is a 510(k) for a modified device, the submission primarily focuses on technical comparison to the predicate device and conformance to standards, not a new clinical study with a test set.

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/provided. No "ground truth" or expert consensus for a test set is mentioned, as there isn't a new clinical study described in this summary.

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

This information is not applicable/provided. There is no description of a test set or adjudication process in the summary.

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 information is not applicable. The Saph-Loop™ Ligating Loop is a surgical device, not an AI-powered diagnostic tool, so an MRMC study related to AI assistance is irrelevant.

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

This information is not applicable. See point 5.

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

This information is not applicable/provided. No new ground truth data is established or discussed in this 510(k) summary. The "ground truth" for this submission is substantial equivalence to the predicate device, demonstrated through descriptive comparison and adherence to standards.

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of this device and submission type.

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

This information is not applicable/provided. See point 8.

Summary of what is known from the document regarding meeting acceptance criteria (substantive equivalence):

The device gained 510(k) clearance by demonstrating substantial equivalence to the predicate device, the Tevdek® II suture (K001440).

The basis for this substantial equivalence included:

• A detailed device description of the Saph-Loop™ Ligating Loop.
• The Saph-Loop™ uses the same suture material (Tevdek™) as the predicate.
• The difference lies in the addition of a deployment mechanism (carrier tubing, handle, pull ring) for the pre-tied knot.
• Conformance to consensus standards and voluntary standards (though specific standards are not listed in this summary).

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices..." This indicates that the submitted evidence was sufficient for the FDA to determine that the Saph-Loop™ Ligating Loop met the acceptance criteria for a 510(k) clearance based on substantial equivalence.

Ask a specific question about this device